Uses
Urinary Tract Mucosal Anesthesia or Analgesia
Symptomatic relief of pain, burning, urgency, frequency, and other discomforts resulting from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
Use should not delay definitive diagnosis and treatment of cause; not a substitute for specific surgery or anti-infective therapy.
Used in combination with appropriate anti-infective agents for initial treatment (first 2 days) of uncomplicated urinary tract infections when pain, burning, or urgency relief is needed. However, there is lack of evidence that such combinations provide greater benefit than an anti-infective agent alone after 2 days; continue treatment after 2 days with anti-infective agent alone.
Also may be used for self-medication for the symptomatic relief of minor pain, urgency, frequency, and burning on urination.
Dosage and Administration
Administration
Administer orally after meals.
Dosage
Available as phenazopyridine hydrochloride; dosage expressed in terms of the salt.
Pediatric Patients
Urinary Tract Mucosal Anesthesia or Analgesia
Relief of Irritation Due to Trauma, Surgery, Endoscopic Procedures, or the Passage of Sounds or Catheters
Oral
12 mg/kg daily, in 3 divided doses.
Discontinue when pain and discomfort are relieved, usually after 3–15 days.
Relief of Irritation Due to Infection
Oral
12 mg/kg daily, in 3 divided doses, for no more than 2 days; use in combination with an anti-infective agent and then continue therapy with anti-infective agent alone.
Adults
Urinary Tract Mucosal Anesthesia or Analgesia
Relief of Irritation Due to Trauma, Surgery, Endoscopic Procedures, or the Passage of Sounds or Catheters
Oral
Usually, 200 mg 3 times daily.
Discontinue when pain and discomfort are relieved, usually after 3–15 days.
Relief of Irritation Due to Infection
Oral
Usually, 200 mg 3 times daily for no more than 2 days; use in combination with an anti-infective agent and then continue therapy with anti-infective agent alone.
Self-Medication
Oral
190 mg 3 times daily for up to 2 days.
Consult clinician if symptoms persist for >2 days.
Prescribing Limits
Pediatric Patients
Urinary Tract Anesthesia or Analgesia
Relief of Irritation Due to Infection
Oral
Maximum 12 mg/kg daily, in 3 divided doses, for no more than 2 days.
Adults
Urinary Tract Anesthesia or Analgesia
Relief of Irritation Due to Infection
Oral
Maximum 200 mg 3 times daily for no more than 2 days.
Self-Medication
Oral
Maximum 190 mg 3 times daily for no more than 2 days.
Cautions
Contraindications
Warnings/Precautions
General Precautions
Skin and/or Sclerae Discoloration
Discontinue if yellowish color of the skin or sclerae occurs (may indicate accumulation resulting from renal impairment).
Urine Discoloration
Urine may become orange to red in color, and may stain fabric; remove stains by soaking fabric in a 0.25% sodium dithionate or sodium hydrosulfite solution.
Self-medication
Discontinue and consult a clinician if pain and discomfort persist for longer than 2 days.
Use of Fixed Combination
When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Specific Populations
Pregnancy
Category B.
Lactation
Not known whether phenzopyridine or metabolites are distributed into milk.
Hepatic Impairment
Contraindicated in severe hepatic impairment.
Renal Impairment
Possible accumulation of phenazopyridine; use is contraindicated.
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