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    3rd Generation Cephalosporin Antibiotics

    DEA CLASS

    Rx

    DESCRIPTION

    Parenteral third-generation cephalosporin
    Extremely active against Pseudomonas aeruginosa; used for lower respiratory tract infections, skin and soft-tissue infections, UTIs, bone and joint infections, and meningitis
    Limited use for empiric monotherapy for neutropenic fever due to emergence of resistant pathogens and poor gram-positive activity

    COMMON BRAND NAMES

    Fortaz, Tazicef, Tazidime

    HOW SUPPLIED

    Ceftazidime/Ceftazidime Pentahydrate/Fortaz/Tazicef/Tazidime Intramuscular Inj Pwd F/Sol: 1g, 2g, 6g, 500mg
    Ceftazidime/Ceftazidime Pentahydrate/Fortaz/Tazicef/Tazidime Intravenous Inj Pwd F/Sol: 1g, 2g, 6g, 500mg
    Fortaz Intravenous Inj Sol: 1mL, 20mg, 40mg

    DOSAGE & INDICATIONS

    For the treatment of intraabdominal infections, including peritonitis.
    For peritonitis in patients undergoing peritoneal dialysis.
    Intraperitoneal dosage†
    Adults

    500 mg/L intraperitoneal (IP) loading dose followed by a maintenance dose of 125 mg/L of peritoneal dialysate. Alternatively, 20 mg/kg IP once daily (Max: 1500 mg/dose) in the long dwell as intermittent therapy. Treat for 2 to 3 weeks depending on infecting organism and the patient's clinical status.

    Infants, Children, and Adolescents

    500 mg/L intraperitoneal (IP) loading dose followed by a maintenance dose of 125 mg/L of peritoneal dialysate. Alternatively, 20 mg/kg IP once daily (Max: 1500 mg/dose) in the long dwell as intermittent therapy. Treat for 2 to 3 weeks depending on infecting organism and the patient's clinical status.

    Intravenous or Intramuscular dosage
    Adults

    2 g IV every 8 hours for 4 to 7 days. Clinical practice guidelines suggest ceftazidime plus metronidazole for empiric treatment of complicated, high risk or severe community-acquired or complicated health-care associated infections.

    Adolescents

    2 g IV every 8 hours. Clinical practice guidelines suggest ceftazidime plus metronidazole for empiric treatment of complicated, high risk or severe community-acquired or complicated health-care associated infections.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Clinical practice guidelines suggest ceftazidime 50 mg/kg/dose IV every 8 hours (Max: 2 g/dose) plus metronidazole for 4 to 7 days for empiric treatment of complicated community-acquired or health-care associated infections. The American Academy of Pediatrics (AAP) recommends 200 mg/kg/day IV divided every 8 hours for severe infections (Max: 2 g/dose).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV or IM every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV or IM every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of bone and joint infections, including osteomyelitis.
    Intravenous or Intramuscular dosage
    Adults

    2 g IV every 12 hours. For severe or life-threatening infections, 2 g IV every 8 hours. Clinical practice guidelines suggest 2 g IV every 8 hours for P. aeruginosa vertebral osteomyelitis or prosthetic joint infection. Treat for 6 weeks (with or without ciprofloxacin or an aminoglycoside) for vertebral osteomyelitis and for 4 to 6 weeks (with or without an aminoglycoside) for prosthetic joint infections.

    Adolescents

    2 g IV every 12 hours. For severe or life-threatening infections, 2 g IV every 8 hours.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Higher doses (e.g., 50 mg/kg/dose IV every 8 hours) are recommended for immunocompromised patients. The American Academy of Pediatrics (AAP) recommends 200 mg/kg/day IV divided every 8 hours for severe infections (Max: 2 g/dose).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV or IM every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV or IM every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of lower respiratory tract infections, including pneumonia such as community-acquired pneumonia (CAP) and nosocomial pneumonia.
    Intravenous or Intramuscular dosage
    Adults

    2 g IV every 8 hours for severe or life-threatening infections, especially in immunocompromised patients. For uncomplicated pneumonia, 500 mg to 1 g IV or IM every 8 hours. For CAP, clinical practice guidelines suggest ceftazidime in combination with ciprofloxacin or levofloxacin or an aminoglycoside as a preferred regimen for Pseudomonas aeruginosa infections. Clinical practice guidelines recommend treatment for a minimum of 5 days; the patient should be afebrile for 48 to 72 hours with no more than 1 sign of clinical instability before discontinuation. For patients with nosocomial pneumonia and risk factors for gram-negative resistance or with a high mortality risk, add a second non-beta-lactam agent with antipseudomonal activity (i.e., quinolone, aminoglycoside, polymyxin). Clinical practice guidelines recommend treatment for 7 days. In patients with risk factors for MRSA, add vancomycin or linezolid.

    Adolescents

    2 g IV every 8 hours for severe or life-threatening infections, especially in immunocompromised patients. For uncomplicated pneumonia, 500 mg to 1 g IV or IM every 8 hours.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Higher doses (e.g., 50 mg/kg/dose IV every 8 hours) are recommended for immunocompromised patients. The American Academy of Pediatrics (AAP) recommends 200 mg/kg/day IV divided every 8 hours for severe infections (Max: 2 g/dose).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV or IM every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV or IM every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of urinary tract infection (UTI).
    Intravenous or Intramuscular dosage
    Adults

    250 mg IV or IM every 12 hours for uncomplicated UTI or 500 mg IV or IM every 8 to 12 hours for complicated UTI.

    Adolescents

    250 mg IV or IM every 12 hours for uncomplicated UTI or 500 mg IV or IM every 8 to 12 hours for complicated UTI.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Higher doses (e.g., 50 mg/kg/dose every 8 hours) are recommended for immunocompromised patients. 100 to 150 mg/kg/day IV divided every 8 hours for 7 to 14 days is recommended by the American Academy of Pediatrics (AAP) for the treatment of initial UTI in febrile infants and young children (2 months to 2 years).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV or IM every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV or IM every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of very severe life-threatening infections, such as bacteremia and sepsis.
    Intravenous dosage
    Adults

    2 g IV every 8 hours. Start within 1 hour of recognition as part of empiric multi-drug therapy. Duration of therapy is generally 7 to 10 days, but may be shorter or longer depending upon patient response, site of infection, and pathogen(s) isolated. Treatment may be narrowed with pathogen identification and/or adequate clinical response.

    Adolescents

    2 g IV every 8 hours.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Higher doses (e.g., 50 mg/kg/dose IV every 8 hours) are recommended for immunocompromised patients. The American Academy of Pediatrics (AAP) recommends 200 mg/kg/day IV divided every 8 hours for severe infections (Max: 2 g/dose).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of gynecologic infections, including endometritis and pelvic cellulitis.
    Intravenous or Intramuscular dosage
    Adults

    1 g IV or IM every 8 hours. For serious infections, 2 g IV every 8 hours.

    Adolescents

    1 g IV or IM every 8 hours. For serious infections, 2 g IV every 8 hours.

    For the treatment of central nervous system infections, including meningitis.
    Intravenous dosage
    Adults

    2 g IV every 8 hours for 21 days for aerobic gram-negative infections. Clinical practice guidelines suggest ceftazidime for documented or suspected P. aeruginosa infections or in combination with vancomycin for patients with penetrating head trauma, postneurosurgery, and for those with a cerebrospinal fluid (CSF) shunt.

    Adolescents

    2 g IV every 8 hours for 21 days for aerobic gram-negative infections. Clinical practice guidelines suggest ceftazidime for documented or suspected P. aeruginosa infections or in combination with vancomycin for patients with penetrating head trauma, postneurosurgery, and for those with a cerebrospinal fluid (CSF) shunt.

    Infants and Children

    50 mg/kg/dose IV every 8 hours (Max: 2 g/dose) for 21 days for aerobic gram-negative infections. Clinical practice guidelines suggest ceftazidime for documented or suspected P. aeruginosa infections or in combination with vancomycin for patients with penetrating head trauma, postneurosurgery, and for those with a cerebrospinal fluid (CSF) shunt.

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV every 8 hours is suggested by clinical practice guidelines. The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV every 8 to 12 hours is suggested by clinical practice guidelines, with every 12 hours frequency used for neonates weighing less than 2 kg. The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the treatment of skin and skin structure infections, including diabetic foot ulcer.
    Intravenous or Intramuscular dosage
    Adults

    2 g IV every 8 hours for severe or life-threatening infections, especially in immunocompromised patients. For mild skin-skin structure infections, 500 mg to 1 g IV or IM every 8 hours. Clinical practice guidelines suggest ceftazidime in combination with vancomycin or daptomycin and an anti-anaerobe agent as an option for moderate or severe diabetic foot infections. Treat for 2 to 3 weeks for moderate to severe infections.

    Adolescents

    2 g IV every 8 hours for severe or life-threatening infections, especially in immunocompromised patients. For mild skin-skin structure infections, 500 mg to 1 g IV or IM every 8 hours.

    Infants and Children

    30 to 50 mg/kg/dose IV or IM every 8 hours (Max: 2 g/dose). Higher doses (e.g., 50 mg/kg/dose IV every 8 hours) are recommended for immunocompromised patients. The American Academy of Pediatrics (AAP) recommends 200 mg/kg/day IV divided every 8 hours for severe infections (Max: 2 g/dose).

    Premature and Term Neonates older than 7 days

    50 mg/kg/dose IV or IM every 8 to 12 hours for neonates weighing 2 kg or less and every 8 hours for neonates weighing more than 2 kg is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    Premature and Term Neonates 0 to 7 days

    50 mg/kg/dose IV or IM every 12 hours is recommended by the American Academy of Pediatrics (AAP). The FDA-approved labeling recommends 30 mg/kg/dose IV every 12 hours.

    For the management of pulmonary infections in patients with cystic fibrosis.
    Intravenous dosage
    Adults

    30 to 50 mg/kg IV every 8 hours (Max: 6 g/day). Doses of 200 to 400 mg/kg/day IV divided every 6 to 8 hours (Max: 12 g/day) have been reported.

    Infants, Children, and Adolescents

    150 to 200 mg/kg/day IV divided every 6 to 8 hours (Max: 6 g/day) is recommended by the American Academy of Pediatrics (AAP). Doses of 200 to 400 mg/kg/day IV divided every 6 to 8 hours (Max: 12 g/day) have been reported. The FDA-approved labeling recommends 50 mg/kg/dose IV every 8 hours (Max: 2 g/dose).

    For the empiric treatment of febrile neutropenia†.
    Intravenous dosage
    Adults

    2 g IV every 8 hours with or without an aminoglycoside. Ceftazidime, an antipseudomonal cephalosporin, has been successfully used for the empiric treatment of febrile neutropenia as monotherapy or in combination with an aminoglycoside. Higher rates of resistance among viridans-group streptococci have been noted with ceftazidime compared with cefepime; therefore, ceftazidime monotherapy should not be used if there are concerns about gram-positive or resistant gram-negative infections.

    Infants, Children, and Adolescents

    100 to 150 mg/kg/day IV divided every 8 hours (Max: 2 g/dose) with or without an aminoglycoside. Ceftazidime, an antipseudomonal cephalosporin, has been successfully used for the empiric treatment of febrile neutropenia in pediatric patients as monotherapy or in combination with an aminoglycoside. Higher rates of resistance among viridans-group streptococci have been noted with ceftazidime compared with cefepime in adult studies; therefore, ceftazidime monotherapy should not be used if there are concerns about gram-positive or resistant gram-negative infections.

    For the treatment of melioidosis† due to Burkholderia pseudomallei.
    Intravenous dosage
    Adults

    100 to 120 mg/kg/day IV divided every 8 hours (Max: 2 g/dose) given alone or in combination with sulfamethoxazole; trimethoprim or ciprofloxacin for at least 10 to 14 days. If clinical improvement is achieved, switch to oral maintenance combination therapy with sulfamethoxazole; trimethoprim and doxycycline for 3 to 6 months (with or without an initial 8-week regimen of chloramphenicol). In pregnant patients, the preferred oral therapy is amoxicillin; clavulanic acid.

    Infants, Children, and Adolescents

    100 to 120 mg/kg/day IV divided every 8 hours (Max: 2 g/dose) given alone or in combination with sulfamethoxazole; trimethoprim or ciprofloxacin for at least 10 to 14 days. If clinical improvement is achieved, switch to oral maintenance combination therapy with sulfamethoxazole; trimethoprim and doxycycline for 3 to 6 months (with or without an initial 8-week regimen of chloramphenicol). In children 1 to 7 years, the preferred oral therapy is amoxicillin; clavulanic acid.

    For the treatment of infective endocarditis†.
    Intravenous dosage
    Adults

    2 g IV every 8 hours is recommended in the FDA-approved labeling for very severe, life-threatening infections. Clinical practice guidelines recommend a third- or fourth-generation cephalosporin as an alternate therapy for 4 weeks for native valve endocarditis (NVE) and for 6 weeks for prosthetic valve endocarditis (PVE) caused by HACEK microorganisms. A cephalosporin in combination with an aminoglycoside for 6 weeks is also recommended for endocarditis due to non-HACEK gram-negative microorganisms.

    Children and Adolescents

    100 to 150 mg/kg/day IV divided every 8 hours (Max: 6 g/day). Clinical practice guidelines recommend ceftazidime plus vancomycin, gentamicin, and rifampin (if prosthetic material is present) for culture-negative nosocomial endocarditis associated with vascular cannulae or early (less than 1 year after surgery) prosthetic valve endocarditis; treat for 4 to 6 weeks, with a longer course for PVE. Ceftazidime is also a preferred therapy in combination with an aminoglycoside for at least 6 weeks for non-HACEK gram-negative microorganisms.

    Infants

    200 mg/kg/day IV divided every 8 hours is the general dosage recommended by the American Academy of Pediatrics (AAP) for severe infections.

    Neonates older than 7 days

    50 mg/kg/dose IV every 8 to 12 hours for neonates weighing 2 kg or less and 50 mg/kg/dose IV every 8 hours for neonates weighing more than 2 kg is the general dosage recommended by the American Academy of Pediatrics (AAP).

    Neonates 0 to 7 days

    50 mg/kg/dose IV every 12 hours is the general dosage recommended by the American Academy of Pediatrics (AAP).

    †Indicates off-label use

    MAXIMUM DOSAGE

    Adults
    Geriatric
    Adolescents
    Children
    Infants
    Neonates

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    Adult patients
    FDA-approved labeling renal adjustment:
    NOTE: In patients with severe infections who would normally receive a 6 g/day dose were it not for renal impairment, the adjusted renal dose listed below may be increased by 50% or the dosing frequency listed below may be increased appropriately. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organism.
    CrCl more than 50 mL/minute: no dosage adjustment needed.
    CrCl 31 to 50 mL/minute: 1 g IV/IM every 12 hours.
    CrCl 16 to 30 mL/minute: 1 g IV/IM every 24 hours.
    CrCl 6 to 15 mL/minute: 1 g IV/IM loading dose, then 500 mg IV/IM every 24 hours.
    CrCl less than 5 mL/minute: 1 g IV/IM loading dose, then 500 mg IV/IM every 48 hours.
     
    Alternative renal adjustment:
    CrCl more than 50 mL/minute: 1 to 2 g IV/IM every 8 to 12 hours.
    CrCl 10 to 50 mL/minute: 1 to 2 g IV/IM every 12 to 24 hours.
    CrCl less than 10 mL/minute: 1 to 2 g IV/IM every 24 to 48 hours.
     
    Pediatric patients
    The following dose adjustments are based on the usual recommended dose in children of 75 to 150 mg/kg/day IV divided every 8 hours.
    CrCl more than 50 mL/minute/1.73 m2: no dosage adjustment needed.
    CrCl 30 to 50 mL/minute/1.73 m2: 50 mg/kg/dose IV every 12 hours (Max: 2 g/dose).
    CrCl 10 to 29 mL/minute/1.73 m2: 50 mg/kg/dose IV every 24 hours (Max: 2 g/dose).
    CrCl less than 10 mL/minute/1.73 m2: 50 mg/kg/dose IV every 48 hours (Max: 2 g/dose).
     
    Intermittent hemodialysis
    In adults, 1 g IV loading dose, then 1 g IV dose after each standard dialysis session. For children receiving hemodialysis, 50 mg/kg/dose IV every 48 hours (Max: 2 g/dose), given after hemodialysis on dialysis days. During a standard intermittent hemodialysis session, 50% to 100% of a dose of ceftazidime is removed.
     
    Continuous renal replacement therapy (CRRT)
    1 to 2 g IV every 12 hours, or a 2 g IV loading dose then 3 g/day continuous IV infusion. Ceftazidime is significantly removed by CRRT. A daily dose 2.4 times that used for anuric non dialyzed patients has been recommended, assuming a combined dialysis and ultrafiltrate flow rate of 1.5 L/hour. For children receiving CRRT, 50 mg/kg/dose IV every 12 hours (Max: 2 g/dose).
     
    Peritoneal dialysis:
    In adults and adolescents old enough to receive adult dosage, 1 g IV/IM loading dose, then 500 mg IV/IM every 24 hours. For children receiving peritoneal dialysis, 50 mg/kg/dose IV every 48 hours (Max: 2 g/dose).

    ADMINISTRATION

    For storage information, see specific product information within the How Supplied section.

    Injectable Administration

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

    Intravenous Administration

    Powder vials for injection
    Reconstitution
    Vials are supplied under reduce pressure. Carbon dioxide gas is released upon reconstitution.
    Reconstitute 500 mg, 1 g, or 2 g vial with 5.3, 10, or 10 mL, respectively, of Sterile Water for Injection to give approximate concentrations of 100, 100, and 170 mg/mL, respectively.
    Shake well to dissolve the drug; the solution should become clear within 1 to 2 minutes.
    May be used for direct intermittent IV administration or further diluted for intermittent IV infusion.
    Storage: Storage recommendations for constituted and thawed solutions vary by manufacturer. Constituted solutions that are frozen immediately after constitution in the original container are stable for 3 months at negative 20 degrees C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Some manufacturers recommend against freezing.
    Dilution
    Withdraw the appropriate dose and dilute in compatible IV solution to a concentration of 1 to 40 mg/mL.
    Compatible solutions include 0.9% Sodium Chloride Injection, 1/6 M Sodium Lactate Injections, 5% Dextrose Injection, 5% Dextrose and 0.225% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injections, 5% Dextrose and 0.9% Sodium Chloride Injection, 10% Dextrose Injection, Lactated Ringer's Injection, 10% Invert Sugar in Water for Injection, and NORMOSOL-M in 5% Dextrose Injection.
    Storage: Storage recommendations for diluted and thawed solutions vary by manufacturer. Solutions in 0.9% Sodium Chloride Injection in VIAFLEX small-volume containers that are frozen immediately after constitution are stable for 3 months when stored at negative 20 degrees C. Do not force thaw by immersion in water baths or by microwave irradiation. Once thawed, solutions should not be refrozen. Some manufacturers recommend against freezing.
     
    Bulk vials for injection
    Reconstitution
    Vials are supplied under reduce pressure. Carbon dioxide gas is released upon reconstitution.
    Reconstitute 6 g vial with 26 mL of a compatible solution to give a concentration of 200 mg/mL.
    Shake well to dissolve the drug; the solution should become clear within 1 to 2 minutes.
    Pressure inside the container will increase due to carbon dioxide gas production. To release pressure, insert a vent needle only after the drug has completely dissolved. Remove the vent needle before using solution.
    FURTHER DILUTION IS REQUIRED. Vial contents should be withdrawn within 4 hours.
    Storage: Storage recommendations for the constituted solution vary by manufacturer.
    Dilution
    Withdraw the appropriate dose and dilute in compatible IV solution to a concentration of 1 to 40 mg/mL.
    Compatible solutions include 0.9% Sodium Chloride Injection, 1/6 M Sodium Lactate Injections, 5% Dextrose Injection, 5% Dextrose and 0.225% Sodium Chloride Injection, 5% Dextrose and 0.45% Sodium Chloride Injections, 5% Dextrose and 0.9% Sodium Chloride Injection, 10% Dextrose Injection, Lactated Ringer's Injection, 10% Invert Sugar in Water for Injection, and NORMOSOL-M in 5% Dextrose Injection.
    Ceftazidime is not recommended for use in Sodium Bicarbonate Injection.
    Storage: Storage recommendations for diluted solutions vary by manufacturer. Solutions in 5% Dextrose Injection and 0.9% Sodium Chloride Injection are stable for at least 6 hours at room temperature when in plastic tubing, drip chambers, and volume control devices of common IV infusion sets.
     
    ADD-Vantage vials
    Reconstitution
    Reconstitute with 50 mL or 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection or 50 mL of 0.45% Sodium Chloride Injection.
    Remove the protective covers from the top of the vial and vial port on the diluent container.
    Screw the vial into the vial port until it will go no further to assure a seal. Once vial is sealed to the port, do not remove.
    To activate the contents of the vial, squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. With the other hand, push the drug vial down into the container telescoping the walls of the container, and grasp the inner cap of the vial through the walls of the container. Pull the inner cap from the drug vial. Verify the rubber stopper has been pulled out, allowing the drug and diluent to mix.
    Mix the container contents thoroughly.
    Do not use in series connections with flexible containers.
    Storage: The admixture solution may be stored for up to 24 hours at room temperature. Solutions in 0.9% Sodium Chloride Injection or 5% Dextrose Injection are stable for at least 6 hours at room temperature in plastic tubing, drip chambers, and volume control devices of common IV infusion sets.
     
    TwistVial vials
    Reconstitution
    Reconstitute 1 or 2 g with 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose Injection in the appropriate 50 or 100 mL flexible diluent container.
    Follow the manufacturer's instructions for vial activation.
    Storage: TwistVials that have been joined to compatible diluent containers, but not activated, may be used within a 14-day period. Once reconstituted (activated), vials are stable for 12 hours at room temperature or 3 days in the refrigerator.
     
    Frozen Pre-mixed Bags
    Thaw at room temperature (25 degrees C) or under refrigeration (5 degrees C). Do not force thaw by immersion in water baths or by microwave irradiation.
    Mix after the solution has reached room temperature.
    No reconstitution necessary.
    Storage: Thawed solution is stable for 8 hours at room temperature or 3 days in the refrigerator. Do not refreeze thawed antibiotics.
     
    DUPLEX Drug Delivery System
    Use only if container and seals are intact. To inspect the drug powder for foreign matter or discoloration, peel the foil strip from the drug chamber.
    Protect from light after removal of foil strip. If the foil strip is removed and the container will not be used immediately, refold container and latch the side tab until ready to activate and use within 7 days.
    Once ready for activation, allow the product to reach room temperature before patient use.
    Unfold Duplex container and point the set port downward. Starting at the hanger tab end, fold the Duplex container just below the diluent meniscus trapping all air above the fold.
    To activate, squeeze the folded diluent chamber until the seal between the diluent and powder opens, releasing diluent into the drug powder chamber.
    Agitate the liquid-powder mixture until the drug powder completely dissolves.
    Storage: After reconstitution (activation), use within 12 hours if stored at room temperature or within 3 days if stored under refrigeration.
     
    Intermittent IV Infusion
    Infuse IV over 30 minutes.
    Do not use plastic containers in series connections.
     
    Direct Intermittent IV Administration
    Only with powder vials for injection.
    Withdraw the appropriate dose and inject directly into a vein over 3 to 5 minutes or slowly into the tubing of a freely-flowing compatible IV solution.
     
    Plasmapheresis
    Administer IV doses at least 2 hours before plasmapheresis.

    Intramuscular Administration

    Reconstitution
    Reconstitute 500 mg or 1 g vial with 1.5 or 3 mL, respectively, of Sterile or Bacteriostatic Water for Injection or 0.5% to 1% lidocaine to give solutions containing approximately 280 mg/mL.
    Storage: Once reconstituted, the solution is stable for 12 hours at room temperature or 3 days under refrigeration.[29916]
     
    IM Injection
    Inject deeply into a large muscle (e.g., anterolateral thigh or deltoid).[29916]
    In general, IM administration of antibiotics in very low birth weight premature neonates is not practical due to small muscle mass, and absorption is unreliable due to hemodynamic instability that is relatively common in this population.[53249]
    Plasmapheresis: Administer IM doses at least 3 hours before plasmapheresis.[33359]

    STORAGE

    Generic:
    - Protect from freezing
    - Protect from light
    - Store unreconstituted product at 68 to 77 degrees F; excursions permitted to 59 to 86 degrees F
    Fortaz:
    - Do not refreeze
    - Store frozen product at or below -4 degrees F
    Tazicef:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion 4 hours after initial entry of container
    - Discard unused portion 4 hours after initial puncture of container
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    - Store in carton until time of use
    Tazidime:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion 4 hours after initial entry of container
    - Discard unused portion 4 hours after initial puncture of container
    - Protect from light
    - Store at controlled room temperature (between 68 and 77 degrees F)
    - Store in carton until time of use

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    A false-positive reaction for glucose in the urine has been observed in patients receiving cephalosporins, such as ceftazidime, and using Benedict's solution, Fehling's solution, or Clinitest tablets for urine glucose testing. However, this reaction has not been observed with glucose oxidase tests (e.g., Tes-tape, Clinistix, Diastix). Patients with diabetes mellitus who test their urine for glucose should use glucose tests based on enzymatic glucose oxidase reactions while on ceftazidime treatment.
     
    A positive direct Coombs test may develop in some patients. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs test of newborns whose mothers received ceftazidime before delivery, clinicians should keep in mind that a positive Coombs test may be due to the drug.

    Cephalosporin hypersensitivity, penicillin hypersensitivity

    Ceftazidime is contraindicated in patients with cephalosporin hypersensitivity or cephamycin hypersensitivity. Ceftazidime should be used cautiously in patients with hypersensitivity to penicillin. The structural similarity between ceftazidime and penicillin means that cross-reactivity can occur. Penicillins can cause a variety of hypersensitivity reactions ranging from mild rash to fatal anaphylaxis. Patients who have experienced severe penicillin hypersensitivity should not receive ceftazidime. Cross-reactivity to cephalosporins is approximately 3% to 7% with a documented history to penicillin.

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

    Almost all antibacterial agents, including ceftazidime, 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 antibacterial 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.

    Coagulopathy, vitamin K deficiency

    All cephalosporins, including ceftazidime, may rarely cause hypothrombinemia and have the potential to cause bleeding. Cephalosporins which contain the NMTT side chain (e.g., cefoperazone, cefamandole, cefotetan) have been associated with an increased risk for bleeding. Cephalosporins should be used cautiously in patients with a preexisting coagulopathy (e.g., vitamin K deficiency) since these patients are at a higher risk for developing bleeding complications.

    Renal failure, renal impairment

    Ceftazidime should be used with caution in patients with renal impairment or renal failure since the drug is eliminated via renal mechanisms. High and prolonged serum ceftazidime concentrations can occur from usual dosages in patients with transient or persistent reduction of urinary output because of renal insufficiency. Elevated levels of ceftazidime in patients with renal insufficiency can lead to neurotoxicity, including seizures, nonconvulsive status epilepticus (NCSE), encephalopathy, asterixis, neuromuscular excitability, and myoclonia. Dosage should be adjusted in patients with impaired renal function.

    Pregnancy

    Ceftazidime is classified as FDA pregnancy risk category B. Animal data reveal no teratogenic effects. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ceftazidime has not been studied for use during labor and delivery. Treatment should be given only if clearly needed.

    Breast-feeding

    Ceftazidime is excreted in human breast milk in small quantities. The manufacturer recommends to exercise caution with use during breast-feeding. Rare potential complications in the nursing infant include alterations of gut flora that might result in diarrhea or related complications (e.g., dehydration). Because the risk of serious reactions is relatively rare, the use of many cephalosporins is considered compatible with breast feeding. Ceftazidime is generally considered compatible for use for breast-feeding women by the American Academy of Pediatrics (AAP). 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.

    Geriatric

    No overall differences in safety or effectiveness were observed between older adult and younger adult subjects in clinical trials or other reported clinical experience. Ceftazidime is renally eliminated; because geriatric patients are more likely to have decreased renal function, care should be taken in ceftazidime dose selection, and it may be useful to monitor renal function. The federal Omnibus Budget Reconciliation Act (OBRA) regulates medication use in residents of long-term care facilities. 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.

    ADVERSE REACTIONS

    Severe

    agranulocytosis / Delayed / 0-1.0
    hemolytic anemia / Delayed / 0-1.0
    bronchospasm / Rapid / 0-1.0
    interstitial nephritis / Delayed / 0-1.0
    angioedema / Rapid / 0-1.0
    pancytopenia / Delayed / Incidence not known
    aplastic anemia / Delayed / Incidence not known
    coma / Early / Incidence not known
    seizures / Delayed / Incidence not known
    toxic epidermal necrolysis / Delayed / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    Stevens-Johnson syndrome / Delayed / Incidence not known
    acute generalized exanthematous pustulosis (AGEP) / Delayed / Incidence not known

    Moderate

    eosinophilia / Delayed / 7.7-7.7
    thrombocytosis / Delayed / 2.2-2.2
    phlebitis / Rapid / 0-2.0
    vaginitis / Delayed / 0-1.0
    candidiasis / Delayed / 0-1.0
    pseudomembranous colitis / Delayed / 0-1.0
    thrombocytopenia / Delayed / 0-1.0
    neutropenia / Delayed / 0-1.0
    lymphocytosis / Delayed / 0-1.0
    leukopenia / Delayed / 0-1.0
    hypotension / Rapid / 0-1.0
    jaundice / Delayed / 0-1.0
    hyperbilirubinemia / Delayed / 0-1.0
    cholestasis / Delayed / 0-1.0
    superinfection / Delayed / Incidence not known
    hypoprothrombinemia / Delayed / Incidence not known
    myoclonia / Delayed / Incidence not known
    encephalopathy / Delayed / Incidence not known
    elevated hepatic enzymes / Delayed / Incidence not known

    Mild

    injection site reaction / Rapid / 0-2.0
    maculopapular rash / Early / 2.0-2.0
    fever / Early / 2.0-2.0
    pruritus / Rapid / 2.0-2.0
    diarrhea / Early / 1.3-1.3
    nausea / Early / 0.6-0.6
    abdominal pain / Early / 0.2-0.2
    vomiting / Early / 0.2-0.2
    paresthesias / Delayed / Incidence not known
    asterixis / Delayed / Incidence not known
    headache / Early / Incidence not known
    dizziness / Early / Incidence not known
    urticaria / Rapid / Incidence not known

    DRUG INTERACTIONS

    Amikacin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Aminoglycosides: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Bumetanide: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Ethacrynic Acid: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Furosemide: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Gentamicin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Kanamycin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Loop diuretics: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    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.
    Paromomycin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Plazomicin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    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.
    Streptomycin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Tobramycin: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Torsemide: (Minor) Ceftazidime's product label states that cephalosporins may potentiate the adverse renal effects of nephrotoxic agents, such as aminoglycosides and loop diuretics. Carefully monitor renal function, especially during prolonged therapy or use of high aminoglycoside doses. The majority of reported cases involve the combination of aminoglycosides and cephalothin or cephaloridine, which are associated with dose-related nephrotoxicity as singular agents. Limited but conflicting data with other cephalosporins have been noted.
    Warfarin: (Moderate) The concomitant use of warfarin with many classes of antibiotics, including cephalosporins, may increase the INR thereby potentiating the risk for bleeding. Inhibition of vitamin K synthesis due to alterations in the intestinal flora may be a mechanism; however, concurrent infection is also a potential risk factor for elevated INR. Additionally, certain cephalosporins (cefotetan, cefoperazone, cefamandole) are associated with prolongation of the prothrombin time due to the methylthiotetrazole (MTT) side chain at the R2 position, which disturbs the synthesis of vitamin K-dependent clotting factors in the liver. Monitor patients for signs and symptoms of bleeding. Additionally, increased monitoring of the INR, especially during initiation and upon discontinuation of the antibiotic, may be necessary.

    PREGNANCY AND LACTATION

    Pregnancy

    Ceftazidime is classified as FDA pregnancy risk category B. Animal data reveal no teratogenic effects. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ceftazidime has not been studied for use during labor and delivery. Treatment should be given only if clearly needed.

    Ceftazidime is excreted in human breast milk in small quantities. The manufacturer recommends to exercise caution with use during breast-feeding. Rare potential complications in the nursing infant include alterations of gut flora that might result in diarrhea or related complications (e.g., dehydration). Because the risk of serious reactions is relatively rare, the use of many cephalosporins is considered compatible with breast feeding. Ceftazidime is generally considered compatible for use for breast-feeding women by the American Academy of Pediatrics (AAP). 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

    Ceftazidime, a beta-lactam antibiotic like the penicillins, is mainly bactericidal. It inhibits the third and final stage of bacterial cell wall synthesis by preferentially binding to specific penicillin-binding proteins (PBPs) that are located inside the bacterial cell wall. Penicillin-binding proteins are responsible for several steps in the synthesis of the cell wall and are found in quantities of several hundred to several thousand molecules per bacterial cell. Penicillin-binding proteins vary among different bacterial species. Thus, the intrinsic activity of ceftazidime as well as the other cephalosporins and penicillins against a particular organism depends on their ability to gain access to and bind with the necessary PBP. Resistance occurs as a result of decreased permeability, alterations of PBPs, and hydrolysis by beta-lactamases.
     
    In particular, ceftazidime preferentially binds to PBP-3 of gram-negative rods. Since PBP-3 is responsible for formation of the septum during cell division, ceftazidime's inhibition of these proteins causes elongation of the bacteria, inhibition of bacterial cell division, and breakage of the cell wall resulting in cell lysis and death. Lysis is mediated by bacterial cell wall autolytic enzymes (i.e., autolysins). The relationship between PBPs and autolysins is unclear, but it is possible that the beta-lactam antibiotic interferes with an autolysin inhibitor.
     
    Due to the presence of an aminothiazolyl side chain, ceftazidime displays enhanced antibacterial activity against particularly the Enterobacteriaceae. In addition, because ceftazidime also contains a 2-carboxy-2-oxypropane imino group, it shows increased activity against Pseudomonas aeruginosa, which gives it an important advantage over other cephalosporins. Its gram-negative spectrum includes E. coli, Klebsiella, H. influenzae (including ampicillin-resistant strains), H. parainfluenzae, Enterobacter, Proteus, Citrobacter, Morganella, Providencia, Salmonella, Shigella, Serratia, N. meningitidis, N. gonorrhoeae, Yersinia enterocolitica, Acinetobacter, and Pseudomonas aeruginosa. Ceftazidime is more active against P. aeruginosa than are the antipseudomonal penicillins and is synergistic with the aminoglycosides. It is inactive against the anaerobe B. fragilis and C. difficile. Ceftazidime has limited activity against most gram-positive bacteria including nonpencillinase- and pencillinase-producing staphylococci (e.g., S. aureus) and streptococci and offers no clinical advantage over the first-generation cephalosporins in treating gram-positive infections.

    PHARMACOKINETICS

    Ceftazidime is administered intravenously or intramuscularly. Approximately 10% of the circulating drug is protein-bound. Ceftazidime is distributed into most body tissues and fluids, including urine, bile, peritoneal fluid, sputum, bone, skin, muscle, and cerebrospinal fluid (CSF). Average ceftazidime concentrations in the CSF and CSF with inflamed meninges after a 2 g IV dose were 9.8 mcg/mL and 9.4 mcg/mL, respectively. The drug is excreted into the urine primarily via glomerular filtration and achieves high therapeutic concentrations in the urine (2100 mcg/mL after a 500 mg IM dose and 12,000 mcg/mL after a 2 g IV dose). Approximately 80% to 90% is excreted unchanged by the kidneys over 24 hours. In patients with normal renal function, the elimination half-life of ceftazidime is approximately 1.4 to 2 hours, but half-life increases as renal function declines.
     
    Affected cytochrome P450 isoenzymes and drug transporters: none

    Intravenous Route

    Peak concentrations are reached approximately 30 minutes after IV administration.

    Intramuscular Route

    Peak concentrations are reached approximately 1 hour after IM administration.