PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Urinary Analgesics and Anesthetics

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Oral urinary tract analgesic; an azo dye than causes urine discoloration with use
    For relief of symptoms of urinary irritation as occurs with urinary tract infection (UTI); should not be used for more than 2 days when given concomitantly with an antibiotic as no benefit to longer use
    May cause rare cases of methemoglobinemia; should not be used by those with G6PD deficiency or renal insufficiency

    COMMON BRAND NAMES

    AZO, Azo-100, Azo-Gesic, Azo-Septic, Azo-Standard, Phenazo, Prodium, Pyridium, Urinary Analgesic, Uristat, Uristat Ultra

    HOW SUPPLIED

    AZO/Azo-100/Azo-Gesic/Azo-Septic/Azo-Standard/Phenazo/Phenazopyridine/Phenazopyridine Hydrochloride/Prodium/Pyridium/Urinary Analgesic/Uristat/Uristat Ultra Oral Tab: 95mg, 97.5mg, 99.5mg, 100mg, 200mg

    DOSAGE & INDICATIONS

    For the symptomatic relief of dysuria, urinary urgency, irritation, and other discomforts of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
    Oral dosage
    Adults

    190 to 200 mg PO 3 times daily with or after meals. When used non-prescription or concomitantly with an antibacterial agent for the treatment of a urinary tract infection, use should not exceed 2 days. For short-term use only; discontinue when symptoms are controlled.

    Children and Adolescents 12 to 17 years

    190 to 200 mg PO 3 times daily with or after meals. When used non-prescription or concomitantly with an antibacterial agent for the treatment of a urinary tract infection, use should not exceed 2 days. For short-term use only; discontinue when symptoms are controlled.

    Children 6 to 11 years†

    Safety and efficacy have not been established; off-label use has been described. Use should be by prescription of a health care professional; do not self-treat. Dose used: 4 mg/kg/dose PO 3 times daily with or after meals for up to 2 days.

    MAXIMUM DOSAGE

    Adults

    600 mg/day PO.

    Geriatric

    600 mg/day PO.

    Adolescents

    600 mg/day PO.

    Children

    12 years: 600 mg/day PO.
    6 to 11 years: Safety and efficacy have not been established; however, 12 mg/kg/day PO has been reported.
    1 to 5 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Dosage adjustment is recommended; however, specific guidelines are not available. Phenazopyridine is metabolized in the liver to potentially active and/or toxic metabolites.

    Renal Impairment

    CrCl > 80 ml/min: No dosage adjustment is needed.
    CrCl 50—80 ml/min: Administer dose every 8—16 hours.
    CrCl < 50 ml/min: Avoid use.

    ADMINISTRATION

    Oral Administration

    Administer phenazopyridine with or after meals to minimize GI discomfort.
    Administer with a full glass of water.
    Do not administer for longer than directed; most patients will take the drug for no more than 2 days.

    Extemporaneous Compounding-Oral

    Extemporaneous compounding instructions for Phenazopyridine oral suspension 10 mg/mL:
    An oral suspension yielding 10 mg/mL may be formulated according to the following procedure:
    Crush three phenazopyridine 200 mg tablets and mix with a small amount of distilled water or glycerin.
    Then, add 20 mL of Cologel and levigate until a uniform mixture is obtained.
    Add sufficient 2:1 simple syrup/cherry syrup mixture to make a final volume of 60 mL.
    Store in an amber container. Preparation is stable for 60 days under refrigeration.
    Shake well before each use.
    For accurrate dose measurement, use a calibrated oral syringe, spoon, or other calibrated oral measuring device. Give dose with or after meals and with a full glass of water.

    STORAGE

    AZO:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Azo-100:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Azo-Gesic:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Azo-Septic:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Azo-Standard:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Phenazo:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Prodium:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Pyridium:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Urinary Analgesic :
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Uristat:
    - Protect from light
    - Store at room temperature (between 59 to 86 degrees F)
    - Store in a dry place
    Uristat Ultra:
    - Protect from light
    - Store between 68 to 77 degrees F
    - Store in a dry place

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Phenazopyridine should not be used in patients who have previously exhibited previous phenazopyridine hypersensitivity.
     
    The use of phenazopyridine for relief of urinary symptoms should not delay the definitive diagnosis and treatment of causative conditions. Because phenazopyridine only provides symptomatic relief, appropriate treatment of the cause of pain must be initiated and phenazopyridine should be discontinued when symptoms are controlled.
     
    Phenazopyridine should not be used for more than 2 days in a patient being treated for a urinary tract infection. There is no evidence that the combined administration of phenazopyridine and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days.

    Geriatric, renal disease, renal failure, renal impairment

    Phenazopyridine is contraindicated in patients with renal impairment, including renal failure. Patients with renal disease should consult with their doctor prior to use. In other patients, a yellowish tinge of the skin or sclera during therapy may indicate accumulation of the drug due to impaired renal excretion. If this occurs, the drug should be discontinued. Because renal function may decline with advancing age, phenazopyridine should be used with caution in geriatric patients.

    G6PD deficiency

    Use of phenazopyridine can cause methemoglobinemia or hemolytic anemia. Because glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency) may predispose to hemolysis, phenazopyridine should not be used in this patient population unless under close supervision of their health care provider.

    Contact lenses

    Phenazopyridine is an azo dye. Phenazopyridine produces an orange to red color in the urine and may stain fabric. The staining of the urine is not harmful, but care should be taken to prevent stains on clothing. Irreversible staining of soft contact lenses has been reported.

    Pregnancy, pregnancy testing

    There are no adequate and well-controlled studies of phenazopyridine use in pregnant women. Reproduction studies in rats at doses up to 50 mg/kg/day have revealed no evidence of impaired fertility or harm to the fetus; however, because animal reproduction studies are not always predictive of human response, phenazopyridine should be used during pregnancy only if clearly needed.[57312] Self-treatment by women of child-bearing potential is not recommended unless pregnancy testing confirms a lack of pregnancy. Awoman who is pregnant should consult her health care provider before use.[60797]

    Breast-feeding

    It is not known whether phenazopyridine is excreted in human milk. Cases of acquired methemoglobinemia in infants after phenazopyridine ingestion have been reported. Phenazopyridine and its metabolites (i.e., aniline) may have the potential to produce methemoglobinemia. Therefore, it is prudent to avoid phenazopyridine use while breast-feeding, especially with an infant less than 1 month of age or has a glucose-6-phosphate dehydrogenase (G6PD) deficiency. [45694] [45704]

    Laboratory test interference

    Due to its properties as an azo dye, phenazopyridine may cause laboratory test interference with urinalysis based on spectrometry or color reactions. Laboratory tests which may be affected include urinary glucose tests and urinary ketone tests.

    ADVERSE REACTIONS

    Severe

    hemolytic anemia / Delayed / Incidence not known
    methemoglobinemia / Early / Incidence not known
    renal tubular necrosis / Delayed / Incidence not known
    aseptic meningitis / Delayed / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    elevated hepatic enzymes / Delayed / Incidence not known
    eosinophilia / Delayed / Incidence not known
    hepatitis / Delayed / Incidence not known
    jaundice / Delayed / Incidence not known

    Mild

    fever / Early / Incidence not known
    urine discoloration / Early / Incidence not known
    contact lens discoloration / Delayed / Incidence not known
    pruritus / Rapid / Incidence not known
    rash / Early / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Phenazopyridine products.

    PREGNANCY AND LACTATION

    Pregnancy

    It is not known whether phenazopyridine is excreted in human milk. Cases of acquired methemoglobinemia in infants after phenazopyridine ingestion have been reported. Phenazopyridine and its metabolites (i.e., aniline) may have the potential to produce methemoglobinemia. Therefore, it is prudent to avoid phenazopyridine use while breast-feeding, especially with an infant less than 1 month of age or has a glucose-6-phosphate dehydrogenase (G6PD) deficiency. [45694] [45704]

    MECHANISM OF ACTION

    The mechanism of action of phenazopyridine has not been fully determined. Phenazopyridine is an azo dye that is excreted in the urine and exerts a topical analgesic or local anesthetic effect on the mucosa of the urinary tract. It possesses no antibacterial actions.

    PHARMACOKINETICS

    Phenazopyridine is administered orally. The pharmacokinetic disposition of phenazopyridine has not been fully established. Trace amounts of the drug are believed to cross the placenta and to enter the CSF. Metabolism of phenazopyridine probably occurs in the liver; one of the metabolites is acetaminophen. The drug is rapidly excreted by the kidneys, with as much as 65% of an oral dose excreted unchanged in the urine.