PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Fluoroquinolone Antibiotics
    Ophthalmological Anti-infectives
    Otic Anti-infectives

    BOXED WARNING

    Corticosteroid therapy, organ transplant, tendinitis, tendinopathy, tendon pain, tendon rupture

    Systemic quinolones have been associated with disabling and potentially irreversible serious adverse reactions such as tendinopathy, including tendinitis and tendon rupture requiring surgical repair or resulting in prolonged disability. These reactions can occur within hours to weeks after starting these agents in patients of any age, with or without pre-existing risk factors. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used. Discontinue quinolones at the first sign of tendon inflammation or tendon pain as these are symptoms that may precede rupture of the tendon. Avoid quinolone use in patients with a history of tendon disorders or tendon rupture. Tendon rupture typically involves the Achilles tendon; however, ruptures of the hand, shoulder, biceps, thumb, and other tendons have also been reported. Tendinitis and tendon rupture can occur bilaterally. Rupture can occur during therapy or up to a few months after therapy has been stopped. The risk of tendon rupture is increased in older adults more than 60 years of age, those receiving concomitant corticosteroid therapy, and in organ transplant recipients (including kidney, heart, and lung transplants). Other reasons for tendon ruptures include physical activity or exercise, kidney failure, or tendon problems in the past. If patients experience tendon inflammation or pain, they should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.

    Cerebrovascular disease, neurotoxicity, peripheral neuropathy, seizure disorder

    Systemic quinolones have been associated with disabling and potentially irreversible serious neurotoxicity, including central nervous system effects and peripheral neuropathy. These reactions can occur within hours to weeks after starting these agents in patients of any age, with or without pre-existing risk factors. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used. Avoid quinolone use in patients who have previously experienced peripheral neuropathy. Additionally, use quinolones with caution in patients with a known or suspected CNS disorder (e.g., seizure disorder, severe cerebrovascular disease) or in the presence of other risk factors (e.g., certain drug therapy, renal dysfunction) that may predispose to seizures or lower seizure threshold. Therapy should be discontinued at the first signs or symptoms of neuropathy (e.g., pain, burning, tingling, numbness, weakness, or other alterations of sensation such as light touch, temperature, position sense, and vibratory sensation) or central nervous system adverse events (i.e., anxiety, confusion, convulsions, depression, hallucinations, severe headaches, increased intracranial pressure (including pseudotumor cerebri), insomnia, lightheadedness, nightmares, paranoia, restlessness, suicidal thoughts or acts, toxic psychosis, or tremors).

    Myasthenia gravis

    Avoid systemic quinolones, such as ofloxacin, in patients with a history of myasthenia gravis. Systemic quinolones may exacerbate the signs of myasthenia gravis and lead to life threatening weakness of the respiratory muscles. Serious postmarketing events, including deaths and the requirement for ventilatory support, have been associated with quinolone use in patients with myasthenia gravis. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used.

    DEA CLASS

    Rx

    DESCRIPTION

    Oral, ophthalmic, otic fluoroquinolone anti-infective
    Used for acute exacerbations of chronic bronchitis, community-acquired pneumonia, skin and skin structure infections, gonorrhea, NGU, cervicitis, PID, UTIs, and prostatitis
    Associated with disabling and potentially irreversible adverse events, including tendonitis, tendon rupture, and peripheral neuropathy

    COMMON BRAND NAMES

    Floxin, Ocuflox

    HOW SUPPLIED

    Floxin/Ofloxacin Auricular (Otic) Drops: 0.3%
    Floxin/Ofloxacin Auricular (Otic) Sol: 0.3%
    Floxin/Ofloxacin Oral Tab: 200mg, 300mg, 400mg
    Ocuflox/Ofloxacin Ophthalmic Sol: 0.3%

    DOSAGE & INDICATIONS

    For the treatment of urinary tract infection (UTI), including uncomplicated (cystitis) or complicated infections.
    Oral dosage
    Adults

    200 mg PO every 12 hours. Treat for 3 days for uncomplicated cystitis due do E. coli or K. pneumoniae, and treat for 7 days for uncomplicated cystitis due to other pathogens; treat for 10 days for complicated UTIs. Clinical practice guidelines suggest a 3-day regimen may be appropriate for women with uncomplicated cystitis; however, quinolones should be considered alternative therapy. Due to the risk for serious and potentially permanent side effects associated with fluoroquinolone antibiotics, ofloxacin should only be used for uncomplicated urinary tract infections in cases where alternative treatment options cannot be used.

    For the treatment of gonorrhea and chlamydia infection including cervicitis or urethritis as well as non-gonococcal urethritis.
    For acute, uncomplicated gonococcal urethritis or cervicitis caused by N. gonorrhoeae.
    Oral dosage
    Adults

    Because of resistance, the CDC no longer recommends fluoroquinolones for treatment of gonococcal infections. The manufacturer recommends 400 mg PO as a single dose.

    For non-gonococcal urethritis (NGU) or cervicitis caused by C. trachomatis.
    Oral dosage
    Adults and Adolescents†

    The CDC recommends 300 mg PO twice daily for 7 days as an alternative to first line agents doxycycline or azithromycin.

    For the treatment of mixed infection cervicitis or urethritis caused by C. trachomatis and N. gonorrhoeae.
    Oral dosage
    Adults

    Because of resistance, the CDC no longer recommends fluoroquinolones for treatment of gonococcal infections. The manufacturer recommends 300 mg PO twice daily for 7 days.

    For the treatment of pelvic inflammatory disease (PID).
    Oral dosage
    Adults

    Due to resistance, the CDC no longer recommends the use of quinolones. However, if allergy precludes the use of parenteral cephalosporin therapy, ofloxacin 400 mg PO twice daily plus metronidazolefor 14 days may be considered if the community prevalence and individual risk for gonorrhea are low. Diagnostic testing for gonorrhea must be performed before starting therapy. The manufacturer recommends 400 mg PO every 12 hours for 10—14 days.

    For the treatment of bacterial prostatitis due to E. coli.
    Oral dosage
    Adults

    300 mg PO every 12 hours for 6 weeks.

    Intravenous dosage
    Adults

    NOTE: This product is not available in the United States. 300 mg IV administered over 60 minutes every 12 hours. IV administration should only be used for maximum of 10 days, then switch to oral therapy for a total of 6 weeks of therapy.

    For the treatment of otitis media.
    For acute otitis media in children with tympanostomy tubes due to H. influenzae (beta-lactamase negative), H. influenzae (beta-lactamase positive), M. catarrhalis, P. aeruginosa, S. aureus, or S. pneumoniae.
    Otic dosage
    Children

    5 drops (0.25 mL or 0.75 mg ofloxacin) instilled into the affected ear twice daily for 10 days.

    For chronic suppurative otitis media in adults and adolescents with perforated tympanic membranes due to P. mirabilis, P. aeruginosa, or S. aureus.
    Otic dosage
    Adults, Adolescents, and Children >= 12 years

    10 drops (0.5 mL or 1.5 mg ofloxacin) instilled into the affected ear twice daily for 14 days.

    For the treatment of otitis externa due to E. coli, P. aeruginosa, and S. aureus.
    Otic dosage
    Adults and Adolescents

    10 drops (0.5 mL or 1.5 mg ofloxacin) instilled into the affected ear once daily for 7 days.

    Infants and Children age 6 months up to 13 years

    5 drops (0.25 mL or 0.75 mg ofloxacin) instilled into the affected ear once daily for 7 days.

    For the treatment of lower respiratory tract infections (e.g. acute exacerbations of chronic bronchitis, community-acquired pneumonia) due to susceptible organisms.
    Oral dosage
    Adults

    400 mg PO every 12 hours for 10 days. Due to the risk for serious and potentially permanent side effects associated with fluoroquinolone antibiotics, ofloxacin should only be used for uncomplicated infections (i.e., bronchitis) in cases where alternative treatment options cannot be used.

    For the treatment of skin and skin structure infections due to susceptible organisms.
    Oral dosage
    Adults

    400 mg PO every 12 hours for 10 days.

    Intravenous dosage
    Adults

    NOTE: This product is not available in the United States. 400 mg IV every 12 hours for 10 days.

    For the treatment of acute epididymitis†.
    Oral dosage
    Adults and Adolescents

    300 mg PO twice daily for 10 days is recommended by the CDC for acute epididymitis most likely caused by enteric organisms. For acute epididymitis likely caused by gonorrhea, chlamydia, and enteric organisms, give ofloxacin 300 mg PO twice daily for 10 days plus ceftriaxone IM.[59799]

    For the treatment of meningococcal carriers (i.e., for meningococcal infection prophylaxis†).
    Oral dosage
    Adults

    Limited data suggest that a single 400 mg PO dose successfully eradicated nasopharyngeal carriage in 97% of subjects for up to 33 days.

    For the treatment of traveler's diarrhea†.
    For traveler's diarrhea prophylaxis†.
    Oral dosage
    Adults

    300 mg PO once daily for the duration of the period at risk (up to 3 weeks) and continue for 1—2 days after returning home.

    Oral dosage
    Adults

    300 mg PO twice daily for up to 3 days.

    For the treatment of plague† infection due to exposure to Yersinia pestis†.
    For an individual patient† or in a contained casualty setting†.
    NOTE: Streptomycin is the drug of choice to treat plague in most patients; gentamicin is the preferred agent in pregnant women.
    Intravenous dosage
    Adults and Adolescents


    In vitro studies suggest that ofloxacin 400 mg IV every 12 hours for 10 days can be used. NOTE: This product is not available in the United States. If antibiotic susceptibility testing allows, intravenous streptomycin or gentamicin, or, as third line, intravenous doxycycline, ciprofloxacin, or chloramphenicol could be used as alternatives. The risk of serious infection following plague exposure supports the use of fluoroquinolones as initial therapy in pregnant women; change to alternatives when possible. Women who are breastfeeding should be treated with the same antibiotic as the infant.

    For a mass casualty setting†.
    NOTE: Doxycycline is the treatment of choice for plague in the mass casualty setting.
    Oral dosage
    Adults and Adolescents


    In vitro studies suggest that ofloxacin 400 mg PO every 12 hours for 10 days can be used. If antibiotic susceptibility testing allows, doxycycline, ciprofloxacin, or chloramphenicol could be used as alternatives. The risk of serious infection following plague exposure supports the use of fluoroquinolones as initial therapy in pregnant women; change to alternatives when possible. Women who are breastfeeding should be treated with the same antibiotic as the infant.

    For plague prophylaxis† following exposure to Yersinia pestis†.
    NOTE: Doxycycline is the treatment of choice for plague prophylaxis.
    Oral dosage
    Adults and Adolescents


    In vitro studies suggest that ofloxacin 400 mg PO every 12 hours for 7 days can be used. If antibiotic susceptibility testing allows, doxycycline, ciprofloxacin, or chloramphenicol could be used as alternatives. The risk of serious infection following plague exposure supports the use of fluoroquinolones as initial therapy in pregnant women; change to alternatives when possible. Women who are breastfeeding should be treated with the same antibiotic as the infant.

    For the treatment of typhoid fever† caused by Salmonella typhi.
    For uncomplicated typhoid fever†.
    Oral dosage
    Adults

    15 mg/kg/day PO in 2 divided doses for 5—7 days. A 3-day regimen of 15 mg/kg/day PO in 2 divided doses has also been shown to be more effective than oral chloramphenicol for 14 days in patients in Laos.

    Children and Adolescents

    15 mg/kg/day PO in 2 divided doses for 5—7 days. A dose of 10 mg/kg/day PO in 2 divided doses for 2—3 days has also been shown effective in Vietnamese children.

    For severe typhoid fever†.
    Intravenous dosage
    Adults, Adolescents, and Children

    15 mg/kg/day IV in 2 divided doses for 10—14 days. NOTE: This product is not available in the United States.

    For the treatment of tuberculosis infection† in patients with multi-drug resistant Myocbacterium tuberculosis.
    NOTE: The American Thoracic Society (ATS), Infectious Diseases Society of America (IDSA), and the Centers for Disease Control and Prevention (CDC) recommend short-course regimens (e.g., at least 6 months) for uncomplicated pulmonary tuberculosis and most cases of extrapulmonary tuberculosis in adults. According to the ATS, IDSA, CDC, and American Academy of Pediatrics (AAP), short-course regimens are also suitable in children. Directly observed therapy (DOT) should be used for all regimens administered 1, 2, 3, or 5 times per week. The initial treatment regimen should include 4 drugs unless the likelihood of INH or rifampin resistance is low (i.e., less than 4%), in which case an initial regimen of INH, rifampin, and pyrazinamide may be considered. HIV-infected patients should always receive induction therapy with 4 drugs by DOT. When drug susceptibility results are available, the regimen should be altered as appropriate. For multidrug resistant tuberculosis (MDR-TB), drug therapy choice should be based on specific resistance patterns. For pediatrics, the CDC recommends treatment for 18—24 months after culture conversion in patients with bacteriologic confirmation and for at least 12 months in patients who are culture-negative. The World Health Organization (WHO) recommends at least 8 months of an intensive phase of treatment with a total treatment duration of 20 months in MDR-TB.
    Oral dosage
    Adults

    The WHO recommends 400 mg PO twice daily as an option in patients with multiresistant infections. In patients less than 33 kg, they recommend 15—20 mg/kg PO daily.

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults

    800 mg/day PO/IV. For ophthalmic and otic dosages, see indications.

    Elderly

    800 mg/day PO/IV. For ophthalmic and otic dosages, see indications.

    Adolescents

    Systemic safety and efficacy have not been established. For ophthalmic and otic dosages, see indications.

    Children

    Systemic safety and efficacy have not been established. For ophthalmic and otic dosages, see indications.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    In patients with severe liver function disorders (e.g., cirrhosis with or without ascites), a maximum dose of 400 mg/day of ofloxacin should not be exceeded.

    Renal Impairment

    CrCl more than 50 mL/minute: no dosage adjustment needed.
    CrCl 20 to 50 mL/minute: extend dosing interval to every 24 hours.
    CrCl less than 20 mL/minute: reduce recommended dose by 50% and extend dosing interval to 24 hours.
     
    For tuberculosis, guidelines suggest 600 mg to 800 mg PO dosed 3 times weekly in patients with a CrCl less than 30 mL/minute.
     
    Intermittent Hemodialysis
    Reduce recommended dose by 50% and extend dosing interval to 24 hours. For tuberculosis, guidelines suggest 600 mg to 800 mg PO dosed 3 times weekly in patients on dialysis.

    ADMINISTRATION

    Oral Administration

    Ofloxacin may be taken without regard to meals. However, to avoid interactions with divalent or trivalent cations, the following should not be taken within the 2-hour period before or within the 2-hour period after taking ofloxacin: mineral supplements; vitamins with iron or minerals; calcium-, aluminum- or magnesium-based antacids; sucralfate; or Videx (didanosine, ddI) chewable/buffered tablets or powder for oral solution.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Intravenous Administration

    20 or 40 mg/ml vials: Dilute in a compatible IV solution to a concentration of 4 mg/ml. Solutions contain no preservatives; any unused portions must be discarded.
    Premixed ofloxacin injection (4 mg/ml): No dilution necessary.
    Infuse over 60 minutes. Shorter infusions or bolus injections should be avoided because of the risk of hypotension.

    Ophthalmic Administration

    Apply topically to the eye taking care to avoid contamination. For ophthalmic use only.
    Instruct patient on proper instillation of eye solution (see Patient Information).
    Do not to touch the tip of the dropper to the eye, fingertips, or other surface.

    Otic Administration

    The solution should be warmed by holding the bottle in the hand for 1—2 minutes to avoid dizziness which may result from instillation of a cold solution.
    The patient should lie with the affected ear upward during installation of the drops. If used to treat otitis media, the tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. After the drops are instilled, the patient should remain lying with the affected ear upward for 5 minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

    STORAGE

    Floxin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ocuflox:
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    False-positive urine screening results for opiates have been reported in patients using some quinolones. These false-positives are more likely to occur with levofloxacin, ofloxacin, and pefloxacin when used clinically because they produce urinary concentrations sufficient to interfere with commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.

    Viral infection

    This drug does not treat viral infection (e.g., common cold). Prescribing ofloxacin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Patients should be told to complete the full course of treatment, even if they feel better earlier.

    Quinolone hypersensitivity

    Ofloxacin should not be used in patients with quinolone hypersensitivity. Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving quinolone therapy, even after the initial dose of the drug. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and pruritus. Only a few patients had a history of hypersensitivity reactions. Severe hypersensitivity reactions characterized by rash, fever, eosinophilia, angioedema and other severe symptoms have also been reported in patients receiving quinolones. Ofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious anaphylactic reactions require immediate emergency treatment.

    Corticosteroid therapy, organ transplant, tendinitis, tendinopathy, tendon pain, tendon rupture

    Systemic quinolones have been associated with disabling and potentially irreversible serious adverse reactions such as tendinopathy, including tendinitis and tendon rupture requiring surgical repair or resulting in prolonged disability. These reactions can occur within hours to weeks after starting these agents in patients of any age, with or without pre-existing risk factors. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used. Discontinue quinolones at the first sign of tendon inflammation or tendon pain as these are symptoms that may precede rupture of the tendon. Avoid quinolone use in patients with a history of tendon disorders or tendon rupture. Tendon rupture typically involves the Achilles tendon; however, ruptures of the hand, shoulder, biceps, thumb, and other tendons have also been reported. Tendinitis and tendon rupture can occur bilaterally. Rupture can occur during therapy or up to a few months after therapy has been stopped. The risk of tendon rupture is increased in older adults more than 60 years of age, those receiving concomitant corticosteroid therapy, and in organ transplant recipients (including kidney, heart, and lung transplants). Other reasons for tendon ruptures include physical activity or exercise, kidney failure, or tendon problems in the past. If patients experience tendon inflammation or pain, they should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.

    Acute myocardial infarction, alcoholism, atrial fibrillation, bradycardia, cardiac arrhythmias, cardiac disease, coronary artery disease, females, heart failure, hypertension, hypocalcemia, hypokalemia, hypomagnesemia, long QT syndrome, malnutrition, QT prolongation, thyroid disease, torsade de pointes

    Ofloxacin should be used cautiously in patients with cardiac arrhythmias or other cardiac disease that predisposes to cardiac arrhythmias. Fluoroquinolones have the potential to cause QT prolongation and possibly torsade de pointes (TdP) by blocking human cardiac potassium (K+) channel currents. The potency of this blockade varies among the quinolones. Ofloxacin appears to block human cardiac K+ channels with a lower potency than other quinolones such as levofloxacin. Rare cases of TdP during postmarketing experience have been reported with ofloxacin; however, no cardiovascular morbidity or deaths have been reported due to ofloxacin-associated QT prolongation. The unmonitored use of fluoroquinolones in patients with a stable ischemic heart and preserved left ventricular function is likely safe and the risk of QT prolongation and TdP is low. However, fluoroquinolones should not be used unmonitored in patients with known QT prolongation, patients with ongoing proarrhythmic conditions that may increase the risk of developing TdP (e.g., uncorrected hypokalemia or hypomagnesemia, significant bradycardia, congestive heart failure, acute myocardial infarction/ischemia, and atrial fibrillation), or patients receiving drugs that prolong the QT interval. Use ofloxacin with caution in patients with other conditions that may increase the risk of QT prolongation including congenital long QT syndrome, hypertension, coronary artery disease, or hypocalcemia. Females, elderly patients, patients with diabetes, thyroid disease, malnutrition, alcoholism, or hepatic dysfunction may also be at increased risk for QT prolongation. Silent mutations and genetic polymorphisms in potassium channels may further increase the risk of QT prolongation in patients taking fluoroquinolones. If a fluoroquinolone is desired in patients with risk factors for QT prolongation, the use of ciprofloxacin with ECG monitoring at initiation of therapy may be recommended. If other quinolones are used, ECG and/or Holter monitoring during therapy may be recommended.

    Cerebrovascular disease, neurotoxicity, peripheral neuropathy, seizure disorder

    Systemic quinolones have been associated with disabling and potentially irreversible serious neurotoxicity, including central nervous system effects and peripheral neuropathy. These reactions can occur within hours to weeks after starting these agents in patients of any age, with or without pre-existing risk factors. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used. Avoid quinolone use in patients who have previously experienced peripheral neuropathy. Additionally, use quinolones with caution in patients with a known or suspected CNS disorder (e.g., seizure disorder, severe cerebrovascular disease) or in the presence of other risk factors (e.g., certain drug therapy, renal dysfunction) that may predispose to seizures or lower seizure threshold. Therapy should be discontinued at the first signs or symptoms of neuropathy (e.g., pain, burning, tingling, numbness, weakness, or other alterations of sensation such as light touch, temperature, position sense, and vibratory sensation) or central nervous system adverse events (i.e., anxiety, confusion, convulsions, depression, hallucinations, severe headaches, increased intracranial pressure (including pseudotumor cerebri), insomnia, lightheadedness, nightmares, paranoia, restlessness, suicidal thoughts or acts, toxic psychosis, or tremors).

    Myasthenia gravis

    Avoid systemic quinolones, such as ofloxacin, in patients with a history of myasthenia gravis. Systemic quinolones may exacerbate the signs of myasthenia gravis and lead to life threatening weakness of the respiratory muscles. Serious postmarketing events, including deaths and the requirement for ventilatory support, have been associated with quinolone use in patients with myasthenia gravis. Because of this risk for serious and potentially permanent side effects, quinolones should only be used for the treatment of uncomplicated urinary tract infection or acute bacterial exacerbation of chronic bronchitis in cases where alternative treatment options cannot be used.

    Renal failure, renal impairment

    Ofloxacin is extensively eliminated via the kidneys. Patients with renal impairment or renal failure, especially those with a creatinine clearance of 50 mL/minute or less, should have their systemic ofloxacin dosage adjusted.

    Dehydration

    Systemic ofloxacin should be used with caution in patients who have dehydration. Hydration may help prevent the formation of highly concentrated urine and prevent crystalluria.

    Hepatic disease, hepatitis, hepatotoxicity, jaundice

    A dosage adjustment of systemic ofloxacin therapy is recommended for patients with severe hepatic disease (e.g., cirrhosis with ascites). Patients with severe hepatic disease have decreased systemic ofloxacin clearance, increasing the risk of toxicity. Severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ofloxacin or other quinolones. Patients should promptly report any signs or symptoms of liver injury including loss of appetite, nausea, vomiting, fever, weakness, fatigue, right upper abdominal pain, jaundice, light colored bowel movements or dark colored urine. Discontinue ofloxacin immediately in any patient who has signs and symptoms suggesting hepatotoxicity.

    Diabetes mellitus

    Disturbances of blood glucose have been reported in patients with diabetes mellitus who were receiving an oral hypoglycemic agent or insulin concomitantly with systemic quinolone antibiotics. Careful monitoring of blood glucose is recommended while receiving ofloxacin therapy. Patients with diabetes may also be at an increased risk of developing detachment of the retina.

    Sunlight (UV) exposure

    Patients receiving systemic ofloxacin or other fluoroquinolones have experienced phototoxic reactions. Patients should avoid excessive sunlight (UV) exposure or artificial ultraviolet light. Ofloxacin therapy should be discontinued if phototoxicity occurs.

    Colitis, diarrhea, GI disease, inflammatory bowel disease, pseudomembranous colitis, ulcerative colitis

    Almost all antibacterial agents, including systemic ofloxacin, have been associated with pseudomembranous colitis (antibiotic-associated colitis) which may range in severity from mild to life-threatening. In the colon, overgrowth of Clostridia may exist when normal flora is altered subsequent to antibacterial administration. The toxin produced by Clostridium difficile is a primary cause of pseudomembranous colitis. It is known that systemic use of antibiotics predisposes patients to development of pseudomembranous colitis. Consideration should be given to the diagnosis of pseudomembranous colitis in patients presenting with diarrhea following ofloxacin administration. Systemic antibiotics should be prescribed with caution to patients with inflammatory bowel disease such as ulcerative colitis or other GI disease. If diarrhea develops during therapy, the drug should be discontinued. Following diagnosis of pseudomembranous colitis, therapeutic measures should be instituted. In milder cases, the colitis may respond to discontinuation of the offending agent. In moderate to severe cases, fluids and electrolytes, protein supplementation, and treatment with an antibacterial effective against Clostridium difficile may be warranted. Products inhibiting peristalsis are contraindicated in this clinical situation. Practitioners should be aware that antibiotic-associated colitis has been observed to occur over two months or more following discontinuation of systemic antibiotic therapy; a careful medical history should be taken.

    Geriatric

    Based on clinical trial data for systemic ofloxacin, there is no difference in safety or efficacy in older adult patients 65 years of age or older compared to younger adult patients. Geriatric patients may be more susceptible to drug-associated adverse effects, such as prolongation of the QT interval. Older adults are also more susceptible to tendon effects which may be increased if corticosteroids are also used. Prescribing quinolones to geriatric patients should be done with caution especially if corticosteroids are used concurrently. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities (LTCFs). According to OBRA, use of antibiotics should be limited to confirmed or suspected bacterial infections. Antibiotics are non-selective and may result in the eradication of beneficial microorganisms while promoting the emergence of undesired ones, causing secondary infections such as oral thrush, colitis, or vaginitis. Any antibiotic may cause diarrhea, nausea, vomiting, anorexia, and hypersensitivity reactions. Fluoroquinolones may cause a prolonged QT interval, may increase the risk of acute tendonitis, and may increase the risk of hypoglycemia or hyperglycemia in adults 65 years or older, and in individuals with diabetes, renal sufficiency (CrCl less than 60 mL/minute), or those receiving other glucose-altering medications. Per OBRA, use should be avoided in individuals with prolonged QTc intervals or who are receiving selected anti-arrhythmic agents.

    Pregnancy

    There are no adequate and well-controlled studies of systemic ofloxacin during human pregnancy. Systemic ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ofloxacin has not been shown to have any teratogenic effects at oral doses as high as 810 mg/kg/day (11 times the oral maximum recommended human dose (MRHD) based on body surface area) or 160 mg/kg/day (4 times the oral MRHD based body surface area) when administered to pregnant rats or rabbits, respectively. Additional studies in rats with oral doses up to 5 times the MRHD based on surface area demonstrated no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. Doses equivalent to 50 and 10 times the oral MRHD dose of ofloxacin (based on mg/kg) were fetotoxic (i.e., decreased fetal body weight and increased fetal mortality) in rats and rabbits, respectively. Minor skeletal variations were reported in rats receiving doses of 810 mg/kg/day, which is more than 10 times higher than the oral MRHD based on body surface area. These effects occurred at doses that are thousands of times the maximum recommended daily ophthalmic and otic doses; although systemic exposure is likely to be minimal, caution is recommended with use of ophthalmic and otic dosage forms of ofloxacin in pregnant women.

    Breast-feeding

    The manufacturer states that because of the potential for serious adverse reactions in a nursing infant, a decision should be made to discontinue breast-feeding or discontinue systemic ofloxacin therapy. Ofloxacin is known to be excreted into breast milk after systemic administration; concentrations of ofloxacin in breast milk are about equal to those in maternal serum. Ten lactating women (time postpartum not stated) were given ofloxacin 400 mg orally every 12 hours for 3 doses. Milk concentrations were measured after the third dose. The highest concentrations averaging 2.41 mg/L occurred 2 hours after the dose. Average milk concentrations then decreased to 1.91 mg/L at 4 hours, 1.25 mg/L at 6 hours, 0.64 mg/L at 9 hours, 0.29 mg/L at 12 hours, and 0.05 mg/L at 24 hours after the dose. Using the peak milk concentrations data from this study, an exclusively breastfed infant would receive an estimated maximum of 0.36 mg/kg daily with this maternal dosage regimen. Other antibiotics considered to be usually compatible with breast-feeding include trimethoprim (in combination with sulfamethoxazole) and ceftriaxone. Levofloxacin is the S-enantiomer of ofloxacin and although it is excreted in breast milk, the estimated amount that a nursing infant would receive, 1.23 mg/day, is less than doses that have been used to treat an infant. Site of infection, patient factors, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Systemic absorption after otic or ophthalmic administration of ofloxacin has been reported to be very low. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Sexually transmitted disease

    While ofloxacin may be used to treat certain sexually transmitted diseases (STD), the drug may mask or delay the symptoms of incubating syphilis when given as part of an STD treatment regimen. All patients with a diagnosed or suspected STD should be tested for other STDs, which may include HIV, syphilis, chlamydia, and gonorrhea, at the time of diagnosis. Initiate appropriate therapy and perform follow-up testing as recommended based upon sexually transmitted disease diagnosis.

    Children, infants, neonates

    The safe and effective use of systemic ofloxacin has not been established in neonates, infants, children, or adolescents. Systemic quinolones cause arthropathy in juvenile animals of several species. Evidence supporting sustained injury to developing joints in humans is lacking at this time; however, the possibility of rare occurrences has not been excluded. One retrospective study compared the rate of tendon or joint disorders in more than 7,000 children less than 19 years old who received ciprofloxacin, ofloxacin, or levofloxacin with more than 20,000 children who received azithromycin. The incidence of potential tendon or joint disorders was found to be approximately 2% in both the quinolone and azithromycin groups, and verified disorders were reported in less than 1% in both groups. The authors state that this incidence is likely to reflect the background incidence of these disorders in children. Due to concerns of increasing bacterial resistance, the possibility of rare joint injury, and other possible serious adverse reactions (i.e., CNS effects, peripheral neuropathy), the American Academy of Pediatrics Committee on Infectious Diseases recommends reserving the use of systemic quinolones for infections caused by multidrug-resistant pathogens for which there is no safe and effective alternative, for the treatment of infections when parenteral therapy is not feasible and no other effective oral agent is available, and for the treatment of infections as an alternative to standard therapy because of concerns for antimicrobial resistance, toxicity, or characteristics of tissue penetration. Otic and topical ocular administration of ofloxacin has not been associated with arthropathy. The safe and effective use of otic or ophthalmic ofloxacin has not been established in infants less than 1 year old.

    Contact lenses

    Whenever clinical judgment dictates, examine patients receiving ophthalmic ofloxacin with the aid of magnification, such as slitlamp biomicroscopy, and where appropriate, fluorescein staining. Advise patients not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.

    Driving or operating machinery

    Systemic ofloxacin can cause dizziness and light-headedness; therefore, patients should know how they react to the drug before driving or operating machinery or engaging in an activity requiring mental alertness or coordination.

    ADVERSE REACTIONS

    Severe

    visual impairment / Early / 1.0-3.0
    hepatic necrosis / Delayed / 0-1.0
    hepatic failure / Delayed / 0-1.0
    renal failure (unspecified) / Delayed / 0-1.0
    interstitial nephritis / Delayed / 0-1.0
    seizures / Delayed / 0-1.0
    torsade de pointes / Rapid / 0-1.0
    cardiac arrest / Early / 0-1.0
    respiratory arrest / Rapid / 0-1.0
    tendon rupture / Delayed / 0-1.0
    angioedema / Rapid / 0-1.0
    anaphylactoid reactions / Rapid / 0-1.0
    erythema multiforme / Delayed / 0-1.0
    laryngeal edema / Rapid / 0-1.0
    bronchospasm / Rapid / 0-1.0
    toxic epidermal necrolysis / Delayed / 0-1.0
    exfoliative dermatitis / Delayed / 0-1.0
    vasculitis / Delayed / 0-1.0
    anaphylactic shock / Rapid / 0-1.0
    erythema nodosum / Delayed / 0-1.0
    Stevens-Johnson syndrome / Delayed / 0-1.0
    serum sickness / Delayed / 0-1.0
    aplastic anemia / Delayed / 0-1.0
    hemolytic anemia / Delayed / 0-1.0
    pancytopenia / Delayed / 0-1.0
    agranulocytosis / Delayed / 0-1.0
    thrombotic thrombocytopenic purpura (TTP) / Delayed / 0-1.0
    hearing loss / Delayed / 0-1.0
    rhabdomyolysis / Delayed / 0-1.0
    hyposthenuria / Delayed / 1.0
    increased intracranial pressure / Early / Incidence not known
    suicidal ideation / Delayed / Incidence not known
    keratitis / Delayed / Incidence not known

    Moderate

    candidiasis / Delayed / 1.0-10.0
    pseudomembranous colitis / Delayed / 1.0-10.0
    superinfection / Delayed / 1.0-10.0
    vaginitis / Delayed / 1.0-5.0
    constipation / Delayed / 1.0-3.0
    chest pain (unspecified) / Early / 1.0-3.0
    jaundice / Delayed / 0-1.0
    hepatitis / Delayed / 0-1.0
    dysuria / Early / 0-1.0
    vaginal pain / Early / 0-1.0
    urinary retention / Early / 0-1.0
    depression / Delayed / 0-1.0
    psychosis / Early / 0-1.0
    euphoria / Early / 0-1.0
    hallucinations / Early / 0-1.0
    confusion / Early / 0-1.0
    impaired cognition / Early / 0-1.0
    QT prolongation / Rapid / 0-1.0
    edema / Delayed / 0-1.0
    peripheral vasodilation / Rapid / 0-1.0
    hypotension / Rapid / 0-1.0
    sinus tachycardia / Rapid / 0-1.0
    hypertension / Early / 0-1.0
    palpitations / Early / 0-1.0
    pneumonitis / Delayed / 0-1.0
    dyspnea / Early / 0-1.0
    bullous rash / Early / 0-1.0
    bleeding / Early / 0-1.0
    hypoglycemia / Early / 0-1.0
    hyperglycemia / Delayed / 0-1.0
    photophobia / Early / 0-1.0
    conjunctivitis / Delayed / 0-1.0
    myasthenia / Delayed / 0-1.0
    elevated hepatic enzymes / Delayed / 1.0
    hematuria / Delayed / 1.0
    glycosuria / Early / 1.0
    pyuria / Delayed / 1.0
    leukopenia / Delayed / 1.0
    eosinophilia / Delayed / 1.0
    lymphopenia / Delayed / 1.0
    thrombocytopenia / Delayed / 1.0
    thrombocytosis / Delayed / 1.0
    neutropenia / Delayed / 1.0
    lymphocytosis / Delayed / 1.0
    anemia / Delayed / 1.0
    mania / Early / Incidence not known
    pseudotumor cerebri / Delayed / Incidence not known
    blurred vision / Early / Incidence not known
    nystagmus / Delayed / Incidence not known
    peripheral neuropathy / Delayed / Incidence not known

    Mild

    nausea / Early / 0.3-10.0
    polyuria / Early / 1.0-10.0
    pruritus / Rapid / 1.0-10.0
    headache / Early / 1.0-9.0
    dysgeusia / Early / 1.0-7.0
    insomnia / Early / 3.0-7.0
    dizziness / Early / 1.0-5.0
    diarrhea / Early / 0.6-4.0
    vomiting / Early / 0.3-4.0
    pharyngitis / Delayed / 1.0-3.0
    flatulence / Early / 1.0-3.0
    abdominal pain / Early / 1.0-3.0
    xerostomia / Early / 0.5-3.0
    fatigue / Early / 1.0-3.0
    drowsiness / Early / 1.0-3.0
    rash (unspecified) / Early / 1.0-3.0
    fever / Early / 0-3.0
    chills / Rapid / 0-1.0
    malaise / Early / 0-1.0
    epistaxis / Delayed / 0-1.0
    asthenia / Delayed / 0-1.0
    dyspepsia / Early / 0-1.0
    weight loss / Delayed / 0-1.0
    dysmenorrhea / Delayed / 0-1.0
    vaginal irritation / Early / 0-1.0
    menorrhagia / Delayed / 0-1.0
    increased urinary frequency / Early / 0-1.0
    paresthesias / Delayed / 0-1.0
    anxiety / Delayed / 0-1.0
    dysesthesia / Delayed / 0-1.0
    syncope / Early / 0-1.0
    vertigo / Early / 0-1.0
    tremor / Early / 0-1.0
    hypoesthesia / Delayed / 0-1.0
    sinusitis / Delayed / 0-1.0
    rhinorrhea / Early / 0-1.0
    cough / Delayed / 0-1.0
    rhinitis / Early / 0-1.0
    arthralgia / Delayed / 0-1.0
    purpura / Delayed / 0-1.0
    skin hyperpigmentation / Delayed / 0-1.0
    photosensitivity / Delayed / 0-1.0
    seborrhea / Delayed / 0-1.0
    diaphoresis / Early / 0-1.0
    urticaria / Rapid / 0-1.0
    vesicular rash / Delayed / 0-1.0
    otalgia / Early / 0-1.0
    tinnitus / Delayed / 0-1.0
    flushing / Rapid / 0-1.0
    halitosis / Early / 0-1.0
    weakness / Early / 0-1.0
    myalgia / Early / 0-1.0
    leukocytosis / Delayed / 1.0
    nightmares / Early / Incidence not known
    abnormal dreams / Early / Incidence not known
    paranoia / Early / Incidence not known
    xerophthalmia / Early / Incidence not known
    diplopia / Early / Incidence not known
    lacrimation / Early / Incidence not known
    ocular irritation / Rapid / Incidence not known
    foreign body sensation / Rapid / Incidence not known
    ocular pain / Early / Incidence not known
    ocular pruritus / Rapid / Incidence not known

    DRUG INTERACTIONS

    Abarelix: (Major) Since abarelix can cause QT prolongation, abarelix should be used cautiously with other drugs that are associated with QT prolongation, such as ofloxacin.
    Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: (Major) Administer magnesium salicylate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Albuterol: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Albuterol; Ipratropium: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Alfuzosin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering alfuzosin with ofloxacin. Alfuzosin has a slight QT prolonging effect, based on electrophysiology studies performed by the manufacturer. The QT prolongation appeared less with alfuzosin 10 mg than with 40 mg. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Alogliptin; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Alpha-glucosidase Inhibitors: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Monitor blood glucose when quinolones and antidiabetic agents are coadministered.
    Aluminum Hydroxide: (Major) Administer products that contain aluminum hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain aluminum hydroxide.
    Aluminum Hydroxide; Magnesium Carbonate: (Major) Administer products that contain aluminum hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain aluminum hydroxide. (Major) Quinolone absorption may be reduced by concurrent medications. Quinolone antibiotics can chelate with divalent or trivalent cations. The oral absorption of these antibiotics will be significantly reduced by other orally administered compounds that contain aluminum salts (like aluminum hydroxide), calcium salts (including calcium carbonate), iron salts, magnesium salts, and/or zinc salts, particularly if the time of administration is within 60 minutes of each other. Examples of compounds that may interfere with fluoroquinolone bioavailability include antacids (e.g., aluminum hydroxide, magnesium hydroxide, calcium carbonate or combination antacids containing aluminum, magnesium or calcium); sucralfate; magnesium citrate; magnesium salicylate; polysaccharide-iron complex; and multivitamins that contain iron, calcium, manganese, or zinc. It is not yet clear if bismuth subsalicylate (Pepto-Bismol) can interfere with fluoroquinolone bioavailability. These agents should not be taken within the two-hour period before or after ofloxacin administration. Because many foods contain divalent or trivalent cations, food interactions with quinolones are also significant. Clinicians should warn patients about all dairy products and other high calcium- and iron-containing foods. Ofloxacin administration is recommended either 2 hours before or 2 hours after iron or other mineral administration. Enteral feedings may also affect the serum concentrations of selected quinolone antimicrobials. The enteral formulation Ensure (Ross Products Division, Abbott Laboratories, Columbus, OH) significantly decreased the serum concentrations of ciprofloxacin, levofloxacin, and ofloxacin tablets by 83%, 61%, and 46%, respectively, when they were crushed and mixed with 240 ml of Ensure. Finally, some quinolones can inhibit the hepatic clearance of caffeine; however, ofloxacin appears to be devoid of this interaction.
    Aluminum Hydroxide; Magnesium Hydroxide: (Major) Administer magnesium hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain magnesium hydroxide. (Major) Administer products that contain aluminum hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain aluminum hydroxide.
    Aluminum Hydroxide; Magnesium Hydroxide; Simethicone: (Major) Administer magnesium hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain magnesium hydroxide. (Major) Administer products that contain aluminum hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain aluminum hydroxide.
    Aluminum Hydroxide; Magnesium Trisilicate: (Major) Administer products that contain aluminum hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain aluminum hydroxide. (Major) Administer products that contain magnesium trisilicate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Amiodarone: (Major) The concomitant use of amiodarone and other drugs known to prolong the QT interval, such as ofloxacin, should only be done after careful assessment of risks versus benefits. Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). If possible, avoid coadministration of amiodarone and ofloxacin. Amiodarone, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and TdP. Although the frequency of TdP is less with amiodarone than with other Class III agents, amiodarone is still associated with a risk of TdP. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after discontinuation of amiodarone.
    Amitriptyline: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Amitriptyline; Chlordiazepoxide: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Amoxicillin; Clarithromycin; Lansoprazole: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering clarithromycin with ofloxacin. Clarithromycin is associated with an established risk for QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Amoxicillin; Clarithromycin; Omeprazole: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering clarithromycin with ofloxacin. Clarithromycin is associated with an established risk for QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Anagrelide: (Major) Torsades de pointes (TdP) and ventricular tachycardia have been reported during post-marketing use of anagrelide. A cardiovascular examination, including an ECG, should be obtained in all patients prior to initiating anagrelide therapy. Monitor patients during anagrelide therapy for cardiovascular effects and evaluate as necessary. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with anagrelide include ofloxacin.
    Apomorphine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering apomorphine with ofloxacin. Limited data indicate that QT prolongation is possible with apomorphine administration; the change in QTc interval is not significant in most patients receiving dosages within the manufacturer's guidelines. In one study, a single mean dose of 5.2 mg (range 2 to 10 mg) prolonged the QT interval by about 3 msec. However, large increases (> 60 msecs from pre-dose) have occurred in two patients receiving 6 mg doses. Doses <= 6 mg SC are associated with minimal increases in QTc; doses > 6 mg SC do not provide additional clinical benefit and are not recommended. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Arformoterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Aripiprazole: (Major) QT prolongation has occurred during therapeutic use of aripiprazole and following overdose. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Aripiprazole should be used cautiously and with close monitoring with ofloxacin.
    Arsenic Trioxide: (Major) Concurrent use of arsenic trioxide and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). If possible, ofloxacin should be discontinued prior to initiating arsenic trioxide therapy. QT prolongation should be expected with the administration of arsenic trioxide. TdP and complete atrioventricular block have been reported. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Artemether; Lumefantrine: (Major) Concurrent use of artemether; lumefantrine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Consider ECG monitoring if ofloxacin must be used with or after artemether; lumefantrine treatment. The administration of artemether; lumefantrine is associated with prolongation of the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Asenapine: (Major) Concurrent use of asenapine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Asenapine has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Atomoxetine: (Major) QT prolongation has occurred during therapeutic use of atomoxetine and following overdose. Atomoxetine is considered a drug with a possible risk of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with atomoxetine include ofloxacin.
    Azelaic Acid; Copper; Folic Acid; Nicotinamide; Pyridoxine; Zinc: (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Azelastine; Fluticasone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Azithromycin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering ofloxacin with azithromycin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Cases of QT prolongation and TdP have also been reported with the post-marketing use of azithromycin.
    Bacillus Calmette-Guerin Vaccine, BCG: (Major) Urinary concentrations of ofloxacin could interfere with the therapeutic effectiveness of BCG. Postpone instillation of BCG if the patient is receiving antibiotics.
    Bedaquiline: (Major) Coadministration of bedaquiline with other QT prolonging drugs, such as ofloxacin, may result in additive or synergistic prolongation of the QT interval. Prior to initiating bedaquiline, obtain serum electrolyte concentrations and a baseline ECG. An ECG should also be performed at least 2, 12, and 24 weeks after starting bedaquiline therapy.
    Bepridil: (Major) Bepridil administration is associated with a well-established risk of QT prolongation and torsades de pointes. Patients receiving other drugs which have the potential for QT prolongation, such as ofloxacin, have an increased risk of developing proarrhythmias during bepridil therapy.
    Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Major) Potential QT prolongation has been reported in limited case reports with metronidazole. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with metronidazole include ofloxacin.
    Bismuth Subsalicylate; Metronidazole; Tetracycline: (Major) Potential QT prolongation has been reported in limited case reports with metronidazole. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with metronidazole include ofloxacin.
    Budesonide: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Budesonide; Formoterol: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon. (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Buprenorphine: (Major) Buprenorphine should be used cautiously and with close monitoring with ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Buprenorphine has been associated with QT prolongation and has a possible risk of torsade de pointes (TdP). FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
    Buprenorphine; Naloxone: (Major) Buprenorphine should be used cautiously and with close monitoring with ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Buprenorphine has been associated with QT prolongation and has a possible risk of torsade de pointes (TdP). FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
    Calcium Carbonate: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Calcium Carbonate; Magnesium Hydroxide: (Major) Administer magnesium hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain magnesium hydroxide. (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Calcium Carbonate; Risedronate: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Calcium Salts: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Calcium: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Calcium; Vitamin D: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Canagliflozin; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Carbetapentane; Guaifenesin; Phenylephrine: (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Carbetapentane; Phenylephrine: (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Celecoxib: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ceritinib: (Major) Periodically monitor electrolytes and ECGs in patients receiving concomitant treatment with ceritinib and ofloxacin; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if QT prolongation occurs. Ceritinib causes concentration-dependent prolongation of the QT interval. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin; these reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Chloroprocaine: (Major) Due to the cardiotoxic potential of all local anesthetics, they should be used with caution with other agents that can prolong the QT interval, such as ofloxacin.
    Chloroquine: (Major) Concurrent use of chloroquine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). The need to coadminister these drugs should be done with a careful assessment of risks versus benefits. Chloroquine administration is associated with an increased risk of QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Chlorpheniramine; Pseudoephedrine: (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Chlorpromazine: (Major) Concurrent use of chlorpromazine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Phenothiazines have been associated with QT prolongation and/or TdP. The risk is generally higher at elevated drugs concentrations of phenothiazines. Chlorpromazine is specifically associated with an established risk of QT prolongation and TdP; case reports have included patients receiving therapeutic doses of chlorpromazine. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Choline Salicylate; Magnesium Salicylate: (Major) Administer magnesium salicylate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Chromium: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Ciprofloxacin: (Major) Both ciprofloxacin and ofloxacin are quinolone antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may also increase the risk for QT prolongation and torsade de pointes (TdP). Ciprofloxacin is associated with a possible risk for QT prolongation and TdP. Ofloxacin has also been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Cisapride: (Severe) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Postmarketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Because of the potential for TdP, use of cisapride with ofloxacin is contraindicated.
    Citalopram: (Major) Concurrent use of citalopram and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). If concurrent therapy is considered essential, ECG monitoring is recommended. Citalopram causes dose-dependent QT interval prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Clarithromycin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering clarithromycin with ofloxacin. Clarithromycin is associated with an established risk for QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Class IA Antiarrhythmics: (Major) Class IA antiarrhythmics (such as disopyramide, quinidine, and procainamide) should be used cautiously and with close monitoring with ofloxacin. Class IA antiarrhythmics (such as disopyramide, quinidine, and procainamide) are associated with QT prolongation and torsades de pointes (TdP). Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Clindamycin; Tretinoin: (Moderate) Use tretinoin with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Clomipramine: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Clozapine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering clozapine with ofloxacin. Treatment with clozapine has been associated with QT prolongation, TdP, cardiac arrest, and sudden death. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Codeine; Phenylephrine; Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Codeine; Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Collagenase: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Crizotinib: (Major) Monitor ECGs for QT prolongation and monitor electrolytes in patients receiving crizotinib concomitantly with ofloxacin. An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib patients if QT prolongation occurs. Crizotinib has been associated with concentration-dependent QT prolongation. Quinolones have also been associated with a risk of QT prolongation as well as torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Cyanocobalamin, Vitamin B12: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Cyclobenzaprine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering cyclobenzaprine with ofloxacin. Cyclobenzaprine is structurally similar to tricyclic antidepressants. Tricyclic antidepressants have been reported to prolong the QT interval, especially when given in excessive doses (or in overdosage settings). Cyclobenzaprine is associated with a possible risk of QT prolongation and TdP, particularly in the event of acute overdose. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, postmarketing surveillance for ofloxacin has identified very rare cases of TdP.
    Dapagliflozin; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Dapagliflozin; Saxagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: (Major) Concomitant use of ritonavir with ofloxacin may theoretically increase the risk for QT prolongation. Fluoroquinolones, including ofloxacin, have been associated with QT prolongation and cases of torsade de pointes (TdP). Ritonavir has been associated with dose-related QT prolongation. Caution and close monitoring is advised if these drugs are administered together.
    Dasatinib: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering dasatinib with ofloxacin. In vitro studies have shown that dasatinib has the potential to prolong cardiac ventricular repolarization (prolong QT interval). Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Daunorubicin: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Acute cardiotoxicity can occur during administration of daunorubicin or doxorubicin; cumulative, dose-dependent cardiomyopathy may also occur. Acute ECG changes during anthracycline therapy are usually transient and include ST-T wave changes, QT prolongation, and changes in QRS voltage. Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia (SVT), ventricular tachycardia, heart block, and premature ventricular contractions (PVCs) have been reported during anthracycline therapy.
    Deflazacort: (Moderate) Quinolones (e.g., ofloxacin) have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids, such as deflazacort. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain as these are symptoms that may precede rupture of the tendon.
    Degarelix: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with ofloxacin include degarelix.
    Desflurane: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Desipramine: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Deutetrabenazine: (Major) For patients taking a deutetrabenazine dosage more than 24 mg/day with ofloxacin, assess the QTc interval before and after increasing the dosage of either medication. Ofloxacin should be used cautiously with other agents that may prolong the QT interval or increase the risk of torsade de pointes (TdP). Clinically relevant QTc prolongation may occur with deutetrabenazine. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Dexamethasone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Dextromethorphan; Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Diclofenac: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Diclofenac; Misoprostol: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Didanosine, ddI: (Major) Administer didanosine tablets or powder for oral solution at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as it can chelate with the buffering agents contained in didanosine tablets and powder. The delayed-release didanosine capsules do not contain a buffering agent and would not be expected to interact with ofloxacin.
    Dienogest; Estradiol valerate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Diflunisal: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Diphenhydramine; Ibuprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Diphenhydramine; Naproxen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Dofetilide: (Severe) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Because of the potential for TdP, use of dofetilide with ofloxacin is contraindicated. Dofetilide, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and TdP.
    Dolasetron: (Major) Due to a possible risk for QT prolongation and torsade de pointes (TdP), dolasetron and ofloxacin should be used together cautiously. Dolasetron has been associated with a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. Ofloxacin should be used cautiously with other agents that may prolong the QT interval or increase the risk of TdP.
    Donepezil: (Major) Case reports indicate that QT prolongation and torsade de pointes (TdP) can occur during donepezil therapy. Donepezil is considered a drug with a known risk of TdP. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with donepezil include ofloxacin.
    Donepezil; Memantine: (Major) Case reports indicate that QT prolongation and torsade de pointes (TdP) can occur during donepezil therapy. Donepezil is considered a drug with a known risk of TdP. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with donepezil include ofloxacin.
    Doxepin: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Doxorubicin: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Acute cardiotoxicity can occur during administration of daunorubicin, doxorubicin, epirubicin, and idarubicin; cumulative, dose-dependent cardiomyopathy may also occur. Acute ECG changes during anthracycline therapy are usually transient and include ST-T wave changes, QT prolongation, and changes in QRS voltage. Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia (SVT), ventricular tachycardia, heart block, and premature ventricular contractions (PVCs) have been reported during anthracycline therapy.
    Dronedarone: (Severe) Coadministration of dronedarone and ofloxacin is contraindicated. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Dronedarone administration is associated with a dose-related increase in the QTc interval. The increase in QTc is approximately 10 milliseconds at doses of 400 mg twice daily (the FDA-approved dose) and up to 25 milliseconds at doses of 1600 mg twice daily. Although there are no studies examining the effects of dronedarone in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation. The concomitant use of dronedarone with other drugs that prolong the QTc may induce TdP and is contraindicated.
    Droperidol: (Major) Droperidol should not be used in combination with any drug known to have potential to prolong the QT interval, such as ofloxacin. Droperidol administration is associated with an established risk for QT prolongation and torsade de pointes (TdP). Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. If coadministration cannot be avoided, use extreme caution; initiate droperidol at a low dose and increase the dose as needed to achieve the desired effect.
    Drospirenone; Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Drospirenone; Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Drospirenone; Ethinyl Estradiol; Levomefolate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Efavirenz: (Major) Ccoadministration of efavirenz and ofloxacin may increase the risk for QT prolongation and torsade de pointes (TdP). QT prolongation has been observed with use of efavirenz. Although data are limited, the manufacturer of efavirenz recommends an alternative antiretroviral be considered for patients receiving medications with a known risk for TdP. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, torsade de pointes has been reported during post-marketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Efavirenz; Emtricitabine; Tenofovir: (Major) Ccoadministration of efavirenz and ofloxacin may increase the risk for QT prolongation and torsade de pointes (TdP). QT prolongation has been observed with use of efavirenz. Although data are limited, the manufacturer of efavirenz recommends an alternative antiretroviral be considered for patients receiving medications with a known risk for TdP. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, torsade de pointes has been reported during post-marketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Eliglustat: (Major) Eliglustat is predicted to cause PR, QRS, and/or QT prolongation at significantly elevated plasma concentrations. Drugs with a possible risk for QT prolongation and torsade de pointes (TdP) that should be used cautiously and with close monitoring with eliglustat include ofloxacin.
    Empagliflozin; Linagliptin: (Moderate) Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents, including linagliptin, are coadministered.
    Empagliflozin; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering rilpivirine with ofloxacin. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering rilpivirine with ofloxacin. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Enflurane: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Enteral Feedings: (Major) Enteral feedings may decrease the serum concentrations of ofloxacin if administered concurrently. Ofloxacin administration is recommended either 2 hours before or 2 hours after iron or other mineral administration. Enteral feedings may also affect the serum concentrations of selected quinolone antimicrobials. The enteral formulation Ensure significantly decreased the serum concentrations of ofloxacin tablets by 46% when they were crushed and mixed with 240 ml of Ensure.
    Epirubicin: (Major) Due to the potential for QT prolongation and torsade de pointes (TdP), caution is advised when administering ofloxacin with epirubicin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Acute cardiotoxicity can also occur during administration of epirubicin; although, the incidence is rare. Acute ECG changes during anthracycline therapy are usually transient and include ST-T wave changes, QT prolongation, and changes in QRS voltage. Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia (SVT), ventricular tachycardia, heart block, and premature ventricular contractions (PVCs) have been reported.
    Eribulin: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with ofloxacin include eribulin. ECG monitoring is recommended; closely monitor the patient for QT interval prolongation.
    Erythromycin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering erythromycin with ofloxacin. Erythromycin is associated with QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Erythromycin; Sulfisoxazole: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering erythromycin with ofloxacin. Erythromycin is associated with QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Escitalopram: (Major) Escitalopram has been associated with QT prolongation. Coadministration with other drugs that have a possible risk for QT prolongation and torsade de pointes (TdP), such as ofloxacin, should be done with caution and close monitoring.
    Esomeprazole; Naproxen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ester local anesthetics: (Major) Due to the cardiotoxic potential of all local anesthetics, they should be used with caution with other agents that can prolong the QT interval, such as ofloxacin.
    Estradiol; Levonorgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Estradiol; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Estradiol; Norgestimate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Desogestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Ethynodiol Diacetate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Etonogestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Levonorgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norelgestromin: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norethindrone Acetate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron. (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norethindrone; Ferrous fumarate: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron. (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norgestimate: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Ethinyl Estradiol; Norgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Etodolac: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ezogabine: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with ofloxacin include ezogabine.
    Famotidine; Ibuprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Fenoprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ferric Citrate: (Major) Administer ferric citrate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Fingolimod: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Fingolimod initiation results in decreased heart rate and may prolong the QT interval. After the first fingolimod dose, overnight monitoring with continuous ECG in a medical facility is advised for patients taking QT prolonging drugs with a known risk of torsades de pointes (TdP). Fingolimod has not been studied in patients treated with drugs that prolong the QT interval, but drugs that prolong the QT interval have been associated with cases of TdP in patients with bradycardia.
    Flecainide: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering flecainide with ofloxacin. Flecainide is a Class IC antiarrhythmic associated with a possible risk for QT prolongation and/or TdP; flecainide increases the QT interval, but largely due to prolongation of the QRS interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Fluconazole: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering fluconazole with ofloxacin. Fluconazole has been associated with QT prolongation and rare cases of TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Fluocinolone; Hydroquinone; Tretinoin: (Moderate) Use tretinoin with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Fluoxetine: (Major) Because QT prolongation and torsade de pointes (TdP) have been reported in patients treated with fluoxetine, the manufacturer recommends caution when using fluoxetine with other drugs that prolong the QT interval. Drugs with a possible risk for QT prolongation and TdP include ofloxacin.
    Fluoxetine; Olanzapine: (Major) Because QT prolongation and torsade de pointes (TdP) have been reported in patients treated with fluoxetine, the manufacturer recommends caution when using fluoxetine with other drugs that prolong the QT interval. Drugs with a possible risk for QT prolongation and TdP include ofloxacin. (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering olanzapine with ofloxacin. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Fluphenazine: (Minor) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering fluphenazine with ofloxacin. Fluphenazine, a phenothiazine, is associated with a possible risk for QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Flurbiprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Fluticasone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Fluticasone; Salmeterol: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon. (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Fluticasone; Umeclidinium; Vilanterol: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon. (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Fluticasone; Vilanterol: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon. (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Fluvoxamine: (Major) There may be an increased risk for QT prolongation and torsade de pointes (TdP) during concurrent use of fluvoxamine and ofloxacin. Cases of QT prolongation and TdP have been reported during postmarketing use of fluvoxamine. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Formoterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Formoterol; Mometasone: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Foscarnet: (Major) When possible, avoid concurrent use of foscarnet with other drugs known to prolong the QT interval, such as ofloxacin. Foscarnet has been associated with postmarketing reports of both QT prolongation and torsade de pointes (TdP). Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. If these drugs are administered together, obtain an electrocardiogram and electrolyte concentrations before and periodically during treatment.
    Gemifloxacin: (Major) Both ofloxacin and gemifloxacin are quinolone antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may increase the risk for QT prolongation and torsade de pointes (TdP). Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Gemifloxacin may also prolong the QT interaval, with the maximal change in the QTc interval occurring approximately 5 to 10 hours following oral administration. The likelihood of QTc prolongation may increase with increasing dose of the drug; therefore, the recommended dose should not be exceeded especially in patients with renal or hepatic impairment where the Cmax and AUC are slightly higher.
    Gemtuzumab Ozogamicin: (Major) Use gemtuzumab ozogamicin and ofloxacin together with caution due to the potential for additive QT interval prolongation and risk of torsade de pointes (TdP). If these agents are used together, obtain an ECG and serum electrolytes prior to the start of gemtuzumab and as needed during treatment. Although QT interval prolongation has not been reported with gemtuzumab, it has been reported with other drugs that contain calicheamicin. Quinolones have been associated with a risk of QT prolongation and TdP. TdP has been reported during postmarketing surveillance of ofloxacin.
    Glipizide; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Glyburide; Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Glycopyrrolate; Formoterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Goserelin: (Major) Ofloxacin should be used cautiously and with close monitoring with goserelin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Androgen deprivation therapy (e.g., goserelin) prolongs the QT interval; the risk may be increased with the concurrent use of drugs that may prolong the QT interval.
    Granisetron: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering granisetron with ofloxacin. Granisetron has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Halofantrine: (Major) Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Other medications which may prolong the QT interval, such as halofantrine, should be used cautiously when given concurrently with ofloxacin.
    Halogenated Anesthetics: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Haloperidol: (Major) QT prolongation and torsade de pointes (TdP) have been observed during haloperidol treatment. Excessive doses (particularly in the overdose setting) or IV administration of haloperidol may be associated with a higher risk of QT prolongation. According to the manufacturer of haloperidol, caution is advisable when prescribing the drug concurrently with medications known to prolong the QT interval, including ofloxacin.
    Halothane: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Hetastarch; Dextrose; Electrolytes: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Hydrochlorothiazide, HCTZ; Quinapril: (Major) Administer quinapril tablets, which contain magnesium, at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Hydrocodone; Ibuprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Hydroxychloroquine: (Major) Avoid coadministration of hydroxychloroquine and ofloxacin. Hydroxychloroquine increases the QT interval and should not be administered with other drugs known to prolong the QT interval. Ventricular arrhythmias and torsade de pointes (TdP) have been reported with the use of hydroxychloroquine. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Hydroxyzine: (Major) Post-marketing data indicate that hydroxyzine causes QT prolongation and Torsade de Pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with hydroxyzine include ofloxacin.
    Ibuprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ibuprofen; Oxycodone: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ibuprofen; Pseudoephedrine: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ibutilide: (Major) Ibutilide administration can cause QT prolongation and torsades de pointes (TdP); proarrhythmic events should be anticipated. The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval, such as ofloxacin. Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Use caution during concurrent administration.
    Idarubicin: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Acute cardiotoxicity can occur during administration of daunorubicin, doxorubicin, epirubicin, and idarubicin; cumulative, dose-dependent cardiomyopathy may also occur. Acute ECG changes during anthracycline therapy are usually transient and include ST-T wave changes, QT prolongation, and changes in QRS voltage. Sinus tachycardia is the most common arrhythmia, but other arrhythmias such as supraventricular tachycardia (SVT), ventricular tachycardia, heart block, and premature ventricular contractions (PVCs) have been reported during anthracycline therapy.
    Iloperidone: (Major) Concurrent use of iloperidone and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Some quinolones, including ofloxacin, have been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Iloperidone has also been associated with QT prolongation; however, TdP has not been reported.
    Imipramine: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Incretin Mimetics: (Moderate) Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones, such as ofloxacin, and an antidiabetic agent, including incretin mimetics. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents, are coadministered.
    Indacaterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Indacaterol; Glycopyrrolate: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Indomethacin: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Inotuzumab Ozogamicin: (Major) Avoid coadministration of inotuzumab ozogamicin with ofloxacin due to the potential for additive QT prolongation and risk of torsade de pointes (TdP). If coadministration is unavoidable, obtain an ECG and serum electrolytes prior to the start of treatment, after treatment initiation, and periodically during treatment. Both inotuzumab and ofloxacin have been associated with QT interval prolongation. Although extremely rare, TdP has also been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Insulins: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Iron Salts: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
    Iron: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
    Isoflurane: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Itraconazole: (Major) Itraconazole has been associated with prolongation of the QT interval. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with itraconazole include ofloxacin.
    Ketoconazole: (Major) Ketoconazole has been associated with prolongation of the QT interval. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with ketoconazole include ofloxacin.
    Ketoprofen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Ketorolac: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Lansoprazole; Naproxen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Lanthanum Carbonate: (Major) Administer lanthanum carbonate at least 2 hours before or 2 hours after ofloxacin. When oral quinolones are given for short courses, consider eliminating the lanthanum carbonate doses that would be normally scheduled near the time of quinolone intake. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Lapatinib: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering lapatinib with ofloxacin. Lapatinib can prolong the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Lenvatinib: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with ofloxacin include lenvatinib. QT prolongation was reported in patients with radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) in a double-blind, randomized, placebo-controlled clinical trial after receiving lenvatinib daily at the recommended dose; the QT/QTc interval was not prolonged, however, after a single 32 mg dose (1.3 times the recommended daily dose) in healthy subjects.
    Leuprolide; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Levalbuterol: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Levofloxacin: (Major) Both levofloxacin and ofloxacin are quinolone antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may increase the risk for QT prolongation and torsade de pointes (TdP). Levofloxacin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Rare cases of TdP have been spontaneously reported during postmarketing surveillance in patients receiving levofloxacin. Post-marketing surveillance has also identified very rare cases of TdP for ofloxacin.
    Levomethadyl: (Major) Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Other medications which may prolong the QT interval, such as levomethadyl, should be used cautiously when given concurrently with ofloxacin.
    Levonorgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Linagliptin: (Moderate) Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents, including linagliptin, are coadministered.
    Linagliptin; Metformin: (Moderate) Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents, including linagliptin, are coadministered. (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Lithium: (Major) Lithium should be used cautiously and with close monitoring with ofloxacin. Lithium has been associated with QT prolongation. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Long-acting beta-agonists: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Loperamide: (Major) At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes (TdP), and cardiac arrest. Drugs with a possible risk for QT prolongation and TdP, like ofloxacin, should be used cautiously and with close monitoring with loperamide
    Loperamide; Simethicone: (Major) At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes (TdP), and cardiac arrest. Drugs with a possible risk for QT prolongation and TdP, like ofloxacin, should be used cautiously and with close monitoring with loperamide
    Lopinavir; Ritonavir: (Major) Concomitant use of ritonavir with ofloxacin may theoretically increase the risk for QT prolongation. Fluoroquinolones, including ofloxacin, have been associated with QT prolongation and cases of torsade de pointes (TdP). Ritonavir has been associated with dose-related QT prolongation. Caution and close monitoring is advised if these drugs are administered together. (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering lopinavir; ritonavir with ofloxacin. Lopinavir; ritonavir is associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Magnesium Citrate: (Major) Administer magnesium citrate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Magnesium Hydroxide: (Major) Administer magnesium hydroxide at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids that contain magnesium hydroxide.
    Magnesium Salicylate: (Major) Administer magnesium salicylate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Magnesium: (Major) Administer oral products that contain magnesium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain magnesium.
    Maprotiline: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering maprotiline with ofloxacin. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Cases of long QT syndrome and TdP tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Meclofenamate Sodium: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Mefenamic Acid: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Mefloquine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering mefloquine with ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP. There is also evidence that the use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation. However, due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval.
    Meglitinides: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Meloxicam: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Meperidine; Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Mequinol; Tretinoin: (Moderate) Use tretinoin with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Mestranol; Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Metaproterenol: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Metformin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Metformin; Pioglitazone: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Metformin; Repaglinide: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Metformin; Rosiglitazone: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Metformin; Saxagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered. (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Metformin; Sitagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered. (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Methadone: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering methadone with ofloxacin. Methadone is associated with QT prolongation and TdP, especially at higher doses (> 200 mg/day but averaging approximately 400 mg/day in adult patients). Laboratory studies, both in vivo and in vitro, have demonstrated that methadone inhibits cardiac potassium channels and prolongs the QT interval. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Methylprednisolone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Metronidazole: (Major) Potential QT prolongation has been reported in limited case reports with metronidazole. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with metronidazole include ofloxacin.
    Midostaurin: (Major) The concomitant use of midostaurin and ofloxacin may lead to additive QT interval prolongation. If these drugs are used together, consider electrocardiogram monitoring. In clinical trials, QT prolongation has been reported in patients who received midostaurin as single-agent therapy or in combination with cytarabine and daunorubicin. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin.
    Mifepristone, RU-486: (Major) Due to a possible risk for QT prolongation and torsade de pointes (TdP), concurrent use of mifepristone and ofloxacin should be avoided if possible. Mifepristone has been associated with dose-dependent prolongation of the QT interval. There is no experience with high exposure or concomitant use with other QT prolonging drugs. To minimize the risk of QT prolongation, the lowest effective dose should always be used. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Postmarketing surveillance for ofloxacin has identified very rare cases of TdP.
    Mirtazapine: (Major) There may be an increased risk for QT prolongation and torsade de pointes (TdP) during concurrent use of mirtazapine and ofloxacin. Coadminister with caution. Cases of QT prolongation, TdP, ventricular tachycardia, and sudden death have been reported during postmarketing use of mirtazapine, primarily following overdose or in patients with other risk factors for QT prolongation, including concomitant use of other medications associated with QT prolongation. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Moxifloxacin: (Major) Both ofloxacin and moxifloxacin are quinolone antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may increase the risk for QT prolongation and torsade de pointes (TdP). Moxifloxacin has been associated with prolongation of the QT interval. Post-marketing surveillance has identified very rare cases of ventricular arrhythmias including TdP, usually in patients with severe underlying proarrhythmic conditions. The likelihood of QT prolongation may increase with increasing concentrations of moxifloxacin, therefore the recommended dose or infusion rate should not be exceeded. Ofloxacin has also been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Nabumetone: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Naproxen: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Naproxen; Pseudoephedrine: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Naproxen; Sumatriptan: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Nilotinib: (Major) Concurrent use of nilotinib and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). If concurrent administration is unavoidable, the manufacturer of nilotinib recommends interruption of nilotinib treatment. If nilotinib must be continued, closely monitor the patient for QT interval prolongation. Nilotinib prolongs the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Nonsteroidal antiinflammatory drugs: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Norethindrone: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Norfloxacin: (Major) Both ofloxacin and norfloxacin are quinolone antibiotics and coadministration would represent duplicate therapy. Additionally, coadministration may increase the risk for QT prolongation and torsade de pointes (TdP). Ofloxacin has been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Extremely rare cases of TdP have also been reported during post-marketing surveillance of norfloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Norgestrel: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Nortriptyline: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Octreotide: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering octreotide with ofloxacin. Arrhythmias, sinus bradycardia, and conduction disturbances have occurred during octreotide therapy warranting more cautious monitoring during octreotide administration in higher risk patients with cardiac disease. Since bradycardia is a risk factor for development of TdP, the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Olanzapine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering olanzapine with ofloxacin. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Olodaterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Ombitasvir; Paritaprevir; Ritonavir: (Major) Concomitant use of ritonavir with ofloxacin may theoretically increase the risk for QT prolongation. Fluoroquinolones, including ofloxacin, have been associated with QT prolongation and cases of torsade de pointes (TdP). Ritonavir has been associated with dose-related QT prolongation. Caution and close monitoring is advised if these drugs are administered together.
    Ondansetron: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering ondansetron with ofloxacin. If these drugs must be coadministered, ECG monitoring is recommended. Ondansetron has been associated with QT prolongation and post-marketing reports of TdP. Among 42 patients receiving a 4 mg bolus dose of intravenous ondansetron for the treatment of postoperative nausea and vomiting, the mean maximal QTc interval prolongation was 20 +/- 13 msec at the third minute after antiemetic administration (p < 0.0001). Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Oral Contraceptives: (Moderate) It would be prudent to recommend alternative or additional contraception when oral contraceptives (OCs) are used in conjunction with antibiotics. It was previously thought that antibiotics may decrease the effectiveness of OCs containing estrogens due to stimulation of metabolism or a reduction in enterohepatic circulation via changes in GI flora. One retrospective study reviewed the literature to determine the effects of oral antibiotics on the pharmacokinetics of contraceptive estrogens and progestins, and also examined clinical studies in which the incidence of pregnancy with OCs and antibiotics was reported. It was concluded that the antibiotics ampicillin, ciprofloxacin, clarithromycin, doxycycline, metronidazole, ofloxacin, roxithromycin, temafloxacin, and tetracycline did not alter plasma concentrations of OCs. Antituberculous drugs (e.g., rifampin) were the only agents associated with OC failure and pregnancy. Based on the study results, these authors recommended that back-up contraception may not be necessary if OCs are used reliably during oral antibiotic use. Another review concurred with these data, but noted that individual patients have been identified who experienced significant decreases in plasma concentrations of combined OC components and who appeared to ovulate; the agents most often associated with these changes were rifampin, tetracyclines, and penicillin derivatives. These authors concluded that because females most at risk for OC failure or noncompliance may not be easily identified and the true incidence of such events may be under-reported, and given the serious consequence of unwanted pregnancy, that recommending an additional method of contraception during short-term antibiotic use may be justified. During long-term antibiotic administration, the risk for drug interaction with OCs is less clear, but alternative or additional contraception may be advisable in selected circumstances. Data regarding progestin-only contraceptives or for newer combined contraceptive deliveries (e.g., patches, rings) are not available.
    Osimertinib: (Major) Monitor electrolytes and ECGs for QT prolongation if coadministration of ofloxacin with osimertinib is necessary; an interruption of osimertinib therapy and dose reduction may be necessary if QT prolongation occurs. Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Oxaliplatin: (Major) Monitor electrolytes and ECGs for QT prolongation if coadministration of oxaliplatin with oxaliplatin is necessary; correct electrolyte abnormalities prior to administration of oxaliplatin. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. QT prolongation and ventricular arrhythmias including fatal TdP have also been reported with oxaliplatin use in postmarketing experience.
    Oxaprozin: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Paliperidone: (Major) Paliperidone has been associated with QT prolongation; however, torsade de pointes (TdP) has not been reported. According to the manufacturer, since paliperidone may prolong the QT interval, it should be avoided in combination with other agents also known to have this effect, such as ofloxacin. However, if coadministration is considered necessary by the practitioner, and the patient has known risk factors for cardiac disease or arrhythmia, then close monitoring is essential.
    Panobinostat: (Major) QT prolongation has been reported with panobinostat therapy in patients with multiple myeloma in a clinical trial; use of panobinostat with other agents that prolong the QT interval is not recommended. Obtain an electrocardiogram at baseline and periodically during treatment. Hold panobinostat if the QTcF increases to >= 480 milliseconds during therapy; permanently discontinue if QT prolongation does not resolve. Drugs with a possible risk for QT prolongation and torsade de pointes that should be used cautiously and with close monitoring with panobinostat include ofloxacin.
    Pantothenic Acid, Vitamin B5: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Pasireotide: (Major) Cautious use of pasireotide and drugs that prolong the QT interval is needed, as coadministration may have additive effects on the prolongation of the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Pazopanib: (Major) Concurrent use of pazopanib and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). If these drugs must be coadministered, closely monitor the patient for QT interval prolongation. Pazopanib has been reported to prolong the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Pentamidine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering pentamidine with ofloxacin. Pentamidine has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Perphenazine: (Minor) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering perphenazine with ofloxacin. Perphenazine, a phenothiazine, is associated with a possible risk for QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Perphenazine; Amitriptyline: (Minor) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering perphenazine with ofloxacin. Perphenazine, a phenothiazine, is associated with a possible risk for QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP. (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Phenylephrine; Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Pimavanserin: (Major) Pimavanserin should be avoided in combination with ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Pimavanserin may also cause QT prolongation. Coadministration may increase the risk for QT prolongation.
    Pimozide: (Major) Pimozide is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Because of the potential for TdP, use of ofloxacin with pimozide is contraindicated.
    Pirbuterol: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Piroxicam: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Polycarbophil: (Major) Administer calcium polycarbophil at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Polysaccharide-Iron Complex: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
    Posaconazole: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering posaconazole with ofloxacin. Posaconazole has been associated with a possible risk for QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Pramlintide: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Prednisolone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Prednisone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Primaquine: (Major) Due to the potential for QT interval prolongation with primaquine, caution is advised with other drugs that prolong the QT interval. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with primaquine include ofloxacin.
    Procaine: (Major) Due to the cardiotoxic potential of all local anesthetics, they should be used with caution with other agents that can prolong the QT interval, such as ofloxacin.
    Prochlorperazine: (Minor) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering prochlorperazine with ofloxacin. If coadministration is considered necessary, and the patient has known risk factors for cardiac disease or arrhythmia, then close monitoring is essential. Prochlorperazine, a phenothiazine, has been reported to prolong the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Promethazine: (Moderate) Promethazine carries a possible risk of QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with promethazine include ofloxacin.
    Propafenone: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering propafenone with ofloxacin. Propafenone is a Class IC antiarrhythmic which increases the QT interval, but largely due to prolongation of the QRS interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Protriptyline: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Pyridoxine, Vitamin B6: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium.
    Quetiapine: (Major) Concurrent use of quetiapine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Limited data, including some case reports, suggest that quetiapine may be associated with a significant prolongation of the QTc interval in rare instances. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Quinapril: (Major) Administer quinapril tablets, which contain magnesium, at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Quinine: (Major) Concurrent use of quinine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Quinine has been associated with prolongation of the QT interval and rare cases of TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Ranolazine: (Major) Ranolazine is associated with dose- and plasma concentration-related increases in the QTc interval. The mean increase in QTc is about 6 milliseconds, measured at the tmax of the maximum dosage (1000 mg PO twice daily). However, in 5% of the population studied, increases in the QTc of at least 15 milliseconds have been reported. Although there are no studies examining the effects of ranolazine in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with ranolazine include ofloxacin.
    Regadenoson: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP that should be used cautiously with ofloxacin include regadenoson.
    Ribociclib: (Major) Avoid coadministration of ribociclib with ofloxacin due to an increased risk for QT prolongation and torsade de pointes (TdP). Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, torsade de pointes has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. Concomitant use may increase the risk for QT prolongation.
    Ribociclib; Letrozole: (Major) Avoid coadministration of ribociclib with ofloxacin due to an increased risk for QT prolongation and torsade de pointes (TdP). Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, torsade de pointes has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. Concomitant use may increase the risk for QT prolongation.
    Rilpivirine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering rilpivirine with ofloxacin. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Risperidone: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering risperidone with ofloxacin. If coadministration is chosen, and the patient has known risk factors for cardiac disease or arrhythmia, then the patient should be closely monitored clinically. Risperidone has been associated with a possible risk for QT prolongation and/or torsade de pointes; however, data are currently lacking to establish causality in association with TdP. Reports of QT prolongation and TdP during risperidone therapy are noted by the manufacturer, primarily in the overdosage setting. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Ritonavir: (Major) Concomitant use of ritonavir with ofloxacin may theoretically increase the risk for QT prolongation. Fluoroquinolones, including ofloxacin, have been associated with QT prolongation and cases of torsade de pointes (TdP). Ritonavir has been associated with dose-related QT prolongation. Caution and close monitoring is advised if these drugs are administered together.
    Rofecoxib: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Romidepsin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering romidepsin with ofloxacin. If these drugs must be coadministered, appropriate cardiovascular monitoring precautions should be considered, such as the monitoring of electrolytes and ECGs at baseline and periodically during treatment. Romidepsin has been reported to prolong the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Salmeterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Saquinavir: (Major) Concurrent use of saquinavir boosted with ritonavir and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). If no acceptable alternative therapy is available, perform a baseline ECG prior to initiation of concomitant therapy and carefully follow monitoring recommendations. Saquinavir boosted with ritonavir increases the QT interval in a dose-dependent fashion, which may increase the risk for serious arrhythmias such as TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Saxagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Sertraline: (Major) There have been post-marketing reports of QT prolongation and Torsade de Pointes (TdP) during treatment with sertraline; therefore, caution is advisable when using sertraline in patients with risk factors for QT prolongation, including concurrent use of other drugs that prolong the QTc interval. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with sertraline include ofloxacin.
    Sevelamer: (Major) Administer sevelamer at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations.
    Sevoflurane: (Major) Halogenated anesthetics should be used cautiously and with close monitoring with ofloxacin. Halogenated anesthetics can prolong the QT interval. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    SGLT2 Inhibitors: (Moderate) Careful monitoring of blood glucose is recommended when other quinolones andantidiabetic agents, including the sodium-glucose co-transporter 2 (SGLT2) inhibitors, are coadministered. Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent.
    Short-acting beta-agonists: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Simvastatin; Sitagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Sitagliptin: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate: (Major) Administer oral products that contain iron at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain iron.
    Sodium picosulfate; Magnesium oxide; Anhydrous citric acid: (Major) Prior or concomitant use of antibiotics with sodium picosulfate; magnesium oxide; anhydrous citric acid may reduce efficacy of the bowel preparation as conversion of sodium picosulfate to its active metabolite bis-(p-hydroxy-phenyl)-pyridyl-2-methane (BHPM) is mediated by colonic bacteria. If possible, avoid coadministration. Certain antibiotics (i.e., tetracyclines and quinolones) may chelate with the magnesium in sodium picosulfate; magnesium oxide; anhydrous citric acid solution. Therefore, these antibiotics should be taken at least 2 hours before and not less than 6 hours after the administration of sodium picosulfate; magnesium oxide; anhydrous citric acid solution.
    Solifenacin: (Major) Due to the potential for QT prolongation and torsade de pointes (TdP), caution is advised when administering solifenacin with ofloxacin. Solifenacin has been associated with dose-dependent prolongation of the QT interval; TdP has been reported during post-marketing use, although causality was not determined. Some quinolones, including ofloxacin, have also been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Sorafenib: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering sorafenib with ofloxacin. If these drugs must be coadministered, ECG monitoring is recommended; closely monitor the patient for QT interval prolongation. Sorafenib has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Sotalol: (Major) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Drugs with a possible risk for QT prolongation and TdP should be used cautiously with ofloxacin. Sotalol administration is associated with QT prolongation and TdP. Proarrhythmic events should be anticipated after initiation of therapy and after each upward dosage adjustment.
    St. John's Wort, Hypericum perforatum: (Moderate) Use St. John's Wort with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Sucralfate: (Major) Administer sucralfate at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with sucralfate. This interaction appears to be the result of chelation by the aluminum content of sucralfate.
    Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole: (Major) QT prolongation resulting in ventricular tachycardia and torsade de pointes (TdP) have been reported during post-marketing use of sulfamethoxazole; trimethoprim. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with sulfamethoxazole; trimethoprim include ofloxacin.
    Sulfonylureas: (Moderate) Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with quinolones and an antidiabetic agent. Rare cases of severe hypoglycemia have been reported with concomitant use of quinolones and glyburide. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered. Monitor blood glucose when quinolones and antidiabetic agents are coadministered.
    Sulindac: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Sunitinib: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering sunitinib with ofloxacin. Sunitinib can prolong the QT interval. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Tacrolimus: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering tacrolimus with ofloxacin. Tacrolimus causes QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Tamoxifen: (Major) Caution is advised with the concomitant use of tamoxifen with ofloxacin due to an increased risk of QT prolongation and torsade de pointes (TdP). Tamoxifen has been reported to prolong the QT interval, usually in overdose or when used in high doses. Rare case reports of QT prolongation have also been described when tamoxifen is used at lower doses. Quinolones have been associated with a risk of QT prolongation; although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Tazarotene: (Moderate) Use tazarotene with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Telavancin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering telavancin with ofloxacin. Telavancin has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Telithromycin: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering telithromycin with ofloxacin. Telithromycin is associated with QT prolongation and TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Terbutaline: (Minor) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Tetrabenazine: (Major) Concurrent use of tetrabenazine and ofloxacin should be avoided due to an increased risk for QT prolongation and torsade de pointes (TdP). Tetrabenazine causes a small increase in the corrected QT interval (QTc). Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Tetracaine: (Major) Due to the cardiotoxic potential of all local anesthetics, they should be used with caution with other agents that can prolong the QT interval, such as ofloxacin.
    Thiazolidinediones: (Moderate) Hyperglycemia and hypoglycemia have been reported in patients treated concomitantly with quinolones and antidiabetic agents. Therefore, careful monitoring of blood glucose is recommended when quinolones and antidiabetic agents are coadministered.
    Thioridazine: (Severe) Thioridazine is associated with a well-established risk of QT prolongation and torsades de pointes (TdP). Thioridazine is considered contraindicated for use with ofloxacin which, when combined with thioridazine, may prolong the QT interval and increase the risk of TdP, and/or cause orthostatic hypotension.
    Tiotropium; Olodaterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Tizanidine: (Major) Tizanidine should be used cautiously and with close monitoring with ofloxacin. Tizanidine administration may result in QT prolongation. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP).
    Tolmetin: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Tolterodine: (Major) Due to the potential for QT prolongation and torsade de pointes (TdP), caution is advised when administering tolterodine with ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Tolterodine has also been associated with dose-dependent prolongation of the QT interval, especially in poor CYP2D6 metabolizers.
    Toremifene: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering toremifene with ofloxacin. Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Trazodone: (Major) Avoid coadministration of trazodone and ofloxacin. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Trazodone can prolong the QT/QTc interval at therapeutic doses. In addition, there are post-marketing reports of TdP. Therefore, the manufacturer recommends avoiding trazodone in patients receiving other drugs that increase the QT interval.
    Tretinoin, ATRA: (Moderate) Use tretinoin with caution in patients who are also taking drugs known to be photosensitizers, such as ofloxacin, as concomitant use may augment phototoxicity. Patients should take care and use proper techniques to limit sunlight and UV exposure of treated areas.
    Triamcinolone: (Moderate) Quinolones have been associated with an increased risk of tendon rupture requiring surgical repair or resulting in prolonged disability; this risk is further increased in those receiving concomitant corticosteroids. Discontinue quinolone therapy at the first sign of tendon inflammation or tendon pain, as these are symptoms that may precede rupture of the tendon.
    Tricyclic antidepressants: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Trifluoperazine: (Minor) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering trifluoperazine with ofloxacin. Trifluoperazine, a phenothiazine, is associated with a possible risk for QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Trimipramine: (Minor) Ofloxacin should be used cautiously and with close monitoring with tricyclic antidepressants. Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsades de pointes (TdP). Tricyclic antidepressants (TCAs) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations).
    Triptorelin: (Major) Androgen deprivation therapy (e.g., triptorelin) prolongs the QT interval; the risk may be increased with the concurrent use of drugs that may prolong the QT interval. Drugs with a possible risk for QT prolongation and TdP that should be used cautiously and with close monitoring with triptorelin include ofloxacin.
    Umeclidinium; Vilanterol: (Moderate) Some quinolones, including ofloxacin, have been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of torsade de pointes (TdP). Drugs with a possible risk for QT prolongation that should be used cautiously and with close monitoring with ofloxacin include the beta-agonists. Beta-agonists may be associated with adverse cardiovascular effects including QT interval prolongation, usually at higher doses and/or when associated with hypokalemia.
    Valdecoxib: (Moderate) The concomitant administration of quinolones and nonsteroidal antiinflammatory drugs has been reported to increase the risk of CNS stimulation and convulsive seizures. Patients with CNS disorders or other risk factors that may predispose them to seizure development or patients taking drugs that lower the seizure threshold may not be appropriate candidates for NSAID usage if they are also taking a quinolone. Use a quinolone with caution in individuals who take a NSAID concomitantly.
    Vandetanib: (Major) The manufacturer of vandetanib recommends avoiding coadministration with other drugs that prolong the QT interval due to an increased risk of QT prolongation and torsade de pointes (TdP). Some quinolones, including ofloxacin, have been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP. Vandetanib can also prolong the QT interval in a concentration-dependent manner. TdP and sudden death have been reported in patients receiving vandetanib. Coadministration may further increase the risk of QT prolongation and TdP. If coadministration of these drugs is necessary, monitor the ECG and QT interval more frequently, including at baseline before coadministration occurs. If the QTcF is greater than 500 msec, interrupt vandetanib dosing until the QTcF is less than 450 msec; then, resume vandetanib at a reduced dose.
    Vardenafil: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering vardenafil with ofloxacin. Therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil produces an increase in QTc interval (e.g., 4 to 6 msec calculated by individual QT correction). Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Vemurafenib: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering vemurafenib with ofloxacin. If these drugs must be coadministered, ECG monitoring is recommended; closely monitor the patient for QT interval prolongation. Vemurafenib has been associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Venlafaxine: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering venlafaxine with ofloxacin. Venlafaxine administration is associated with a possible risk of QT prolongation; TdP has reported with post-marketing use. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Voriconazole: (Major) Due to the potential for QT prolongation and torsade de pointes (TdP), caution is advised when administering voriconazole with ofloxacin. Voriconazole has been associated with prolongation of the QT interval and rare cases of arrhythmias, including TdP. Some quinolones, including ofloxacin, have also been associated with QT prolongation and infrequent cases of arrhythmia. Post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Vorinostat: (Major) Due to an increased risk for QT prolongation and torsade de pointes (TdP), caution is advised when administering vorinostat with ofloxacin. Vorinostat therapy is associated with QT prolongation. Some quinolones, including ofloxacin, have also been associated with QT prolongation. Additionally, post-marketing surveillance for ofloxacin has identified very rare cases of TdP.
    Warfarin: (Major) Concurrent use of warfarin and systemic quinolones may result in an increased PT/INR. Patients receiving this combination should be closely monitored for bleeding adverse effects. Case reports have noted that quinolones have enhanced the effects of warfarin. Other patient specific factors, such as fever, other disease states (i.e., cancer), or other concurrent medication, may play an important role in precipitating this interaction.
    Zinc Salts: (Major) Administer oral products that contain calcium at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include antacids and multivitamins that contain calcium. (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Zinc: (Major) Administer oral products that contain zinc at least 2 hours before or 2 hours after ofloxacin. Ofloxacin absorption may be reduced as quinolone antibiotics can chelate with divalent or trivalent cations. Examples of compounds that may interfere with quinolone bioavailability include multivitamins that contain zinc.
    Ziprasidone: (Severe) According to the manufacturer, ziprasidone is contraindicated with any drugs that list QT prolongation as a pharmacodynamic effect when this effect has been described within the contraindications or bolded or boxed warnings of the official labeling for such drugs. Ziprasidone has been associated with a possible risk for QT prolongation and/or torsades de pointes (TdP). Clinical trial data indicate that ziprasidone causes QT prolongation. In one study, ziprasidone increased the QT interval 10 msec more than placebo at the maximum recommended dosage. Comparative data with other antipsychotics have shown that the mean QTc interval prolongation occurring with ziprasidone exceeds that of haloperidol, quetiapine, olanzapine, and risperidone, but is less than that which occurs with thioridazine. Given the potential for QT prolongation, ziprasidone is contraindicated for use with drugs that are known to cause QT prolongation with potential for torsades de pointes including ofloxacin.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate and well-controlled studies of systemic ofloxacin during human pregnancy. Systemic ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ofloxacin has not been shown to have any teratogenic effects at oral doses as high as 810 mg/kg/day (11 times the oral maximum recommended human dose (MRHD) based on body surface area) or 160 mg/kg/day (4 times the oral MRHD based body surface area) when administered to pregnant rats or rabbits, respectively. Additional studies in rats with oral doses up to 5 times the MRHD based on surface area demonstrated no adverse effect on late fetal development, labor, delivery, lactation, neonatal viability, or growth of the newborn. Doses equivalent to 50 and 10 times the oral MRHD dose of ofloxacin (based on mg/kg) were fetotoxic (i.e., decreased fetal body weight and increased fetal mortality) in rats and rabbits, respectively. Minor skeletal variations were reported in rats receiving doses of 810 mg/kg/day, which is more than 10 times higher than the oral MRHD based on body surface area. These effects occurred at doses that are thousands of times the maximum recommended daily ophthalmic and otic doses; although systemic exposure is likely to be minimal, caution is recommended with use of ophthalmic and otic dosage forms of ofloxacin in pregnant women.

    The manufacturer states that because of the potential for serious adverse reactions in a nursing infant, a decision should be made to discontinue breast-feeding or discontinue systemic ofloxacin therapy. Ofloxacin is known to be excreted into breast milk after systemic administration; concentrations of ofloxacin in breast milk are about equal to those in maternal serum. Ten lactating women (time postpartum not stated) were given ofloxacin 400 mg orally every 12 hours for 3 doses. Milk concentrations were measured after the third dose. The highest concentrations averaging 2.41 mg/L occurred 2 hours after the dose. Average milk concentrations then decreased to 1.91 mg/L at 4 hours, 1.25 mg/L at 6 hours, 0.64 mg/L at 9 hours, 0.29 mg/L at 12 hours, and 0.05 mg/L at 24 hours after the dose. Using the peak milk concentrations data from this study, an exclusively breastfed infant would receive an estimated maximum of 0.36 mg/kg daily with this maternal dosage regimen. Other antibiotics considered to be usually compatible with breast-feeding include trimethoprim (in combination with sulfamethoxazole) and ceftriaxone. Levofloxacin is the S-enantiomer of ofloxacin and although it is excreted in breast milk, the estimated amount that a nursing infant would receive, 1.23 mg/day, is less than doses that have been used to treat an infant. Site of infection, patient factors, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Systemic absorption after otic or ophthalmic administration of ofloxacin has been reported to be very low. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Ofloxacin is bactericidal via inhibition of DNA gyrase (topoisomerase II), an enzyme responsible for counteracting the excessive supercoiling of DNA during replication or transcription and topoisomerase IV, an enzyme that helps separate the daughter DNA molecules. In gram-negative bacteria, the primary target is the DNA gyrase A subunit, while the primary target in gram-positive bacteria is generally topoisomerase IV. Ofloxacin exhibits concentration-dependent pharmacodynamics. Additionally, ofloxacin and other fluoroquinolones exhibit a prolonged post-antibiotic effect (PAE) for gram-negative organisms.

    PHARMACOKINETICS

    Ofloxacin formulations are available for oral, intravenous, ophthalmic, or otic administration.
     
    Once in the systemic circulation, ofloxacin is widely distributed throughout the body, with highest concentrations appearing in the lungs, gallbladder, prostate, bile, tonsils, liver, muscle, and genitourinary tissue. Ofloxacin appears to cross the placenta and is excreted in breast milk. The drug enters the cerebrospinal fluid in the presence or absence of meningeal inflammation. Ofloxacin is minimally metabolized in the liver, with 70—90% of an oral dose excreted unchanged in the urine within 36 hours of dosing. Less than 5% is excreted as metabolites, and 4—8% is excreted in the feces. The elimination half-life of ofloxacin in young, healthy adults is 4—8 hours, slightly longer than norfloxacin or ciprofloxacin and less than lomefloxacin.

    Oral Route

    Following oral administration, the absolute bioavailability of ofloxacin is roughly 98%. The presence of food in the GI tract can slightly delay the absorption of ofloxacin, but not to an appreciable extent. Divalent and trivalent cations, however, can significantly reduce ofloxacin absorption. After oral administration, peak serum concentrations are achieved within 0.5—2 hours. Predicted peak serum concentrations from administration of multiple 200 mg or 300 mg oral doses are 2.2 mcg/ml and 3.6 mcg/ml, respectively. When the injectable and tablet formulations of ofloxacin were administered in equal doses (mg/mg) to the same group of subjects, the reported AUCs were 43.5 mcg x hr/ml vs. 41.2 mcg x hr/ml, respectively.

    Intravenous Route

    Following administration of 200 mg IV every 12 hours, mean peak and trough concentrations at steady state are about 2.9 and 0.5 mcg/ml, respectively. With a dosage of 400 mg IV every 12 hours, concentrations of 5.5—7.2 mcg/ml (peak) and 1.2—1.9 mcg/ml (trough) are achieved. When the injectable and tablet formulations of ofloxacin were administered in equal doses (mg/mg) to the same group of subjects, the reported AUCs were 43.5 mcg x hr/ml vs. 41.2 mcg x hr/ml, respectively.

    Other Route(s)

    Ophthalmic Route
    Following ocular administration of ofloxacin, the mean tear concentration measured 4 hours after dosing was 9.2 mcg/g. There is minimal systemic absorption after ophthalmic dosing. Corneal tissue concentration observed 4 hours after ocular application of 2 drops every 30 minutes was 4.4 mcg/g.
     
    Otic Route
    Following otic administration of a 0.3% solution to adults with perforated tympanic membranes, the maximum serum concentration detected was 10 ng/ml. In these same patients, ofloxacin concentration in the middle ear mucosa was highly variable and ranged 1.2—602 mcg/g.