Brand names: Azo-Dine, Azo-Gesic, Azo-Natural, Azo-Standard, Baridium, ... show all 9 brands Prodium, Pyridium, Re-Azo, UTI Relief
Drug class: Antipruritics and Local Anesthetics
VA class: GU100
CAS number: 136-40-3

Medically reviewed by Drugs.com on Aug 22, 2024. Written by ASHP.

Introduction

Analgesic or local anesthetic; an azo dye.

Uses for Phenazopyridine

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.

Phenazopyridine 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 for Phenazopyridine

Contraindications

• Impaired renal function, glomerulonephritis, uremia, or pyelonephritis during pregnancy.

• Severe hepatitis.

• Known hypersensitivity to phenazopyridine or any ingredient in the formulation.

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.

Drug Interactions

Specific Laboratory Tests

Phenazopyridine Pharmacokinetics

Pharmacokinetic properties have not been determined.

Distribution

Extent

Trace amounts may enter the CSF.

Trace amounts may cross the placenta; not known if distributed into milk.

Elimination

Metabolism

May be metabolized in the liver and other body tissues; metabolites not identified.

Elimination Route

Excreted principally in urine as unchanged drug (up to 65%); small amounts excreted in feces.

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.

Actions

• Exerts analgesic or local anesthetic action on the urinary tract mucosa; precise mechanism of action is not known.

• Little or no antibacterial activity in the urine.

• Importance of discontinuing the drug if yellowish color of the skin or sclerae occurs.

• Importance of discontinuing self-medication and consulting clinician if pain and discomfort persist for longer than 2 days.

• Advise that urine will 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.

• Potential of contact lens staining.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.

• Importance of possible interference with urinary glucose or ketone tests.

• Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• Why do you not take phenazopyridine for more than two days?

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