Phenazopyridine Hydrochloride

Pronunciation

Class: Antipruritics and Local Anesthetics
VA Class: GU100
CAS Number: 136-40-3
Brands: Azo-Dine, Azo-Gesic, Azo-Natural, Azo-Standard, Baridium, Prodium, Pyridium, Pyridium Plus, Re-Azo, UTI Relief

Introduction

Analgesic or local anesthetic; an azo dye.a

Uses for Phenazopyridine Hydrochloride

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.c

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Use should not delay definitive diagnosis and treatment of cause; not a substitute for specific surgery or anti-infective therapy.a

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.a c However, there is lack of evidence that such combinations provide greater benefit than an anti-infective agent alone after 2 days;a continue treatment after 2 days with anti-infective agent alone.a

Also may be used for self-medication for the symptomatic relief of minor pain, urgency, frequency, and burning on urination.a

Phenazopyridine Hydrochloride Dosage and Administration

Administration

Administer orally after meals.a

Dosage

Available as phenazopyridine hydrochloride; dosage expressed in terms of the salt.c

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.a

Discontinue when pain and discomfort are relieved, usually after 3–15 days.a

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.a c

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.a c

Discontinue when pain and discomfort are relieved, usually after 3–15 days.a

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.a c

Self-Medication
Oral

190 mg 3 times daily for up to 2 days.a

Consult clinician if symptoms persist for >2 days.a

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.a c

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.a c

Self-Medication
Oral

Maximum 190 mg 3 times daily for no more than 2 days.a

Cautions for Phenazopyridine Hydrochloride

Contraindications

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

  • Severe hepatitis.a

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

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).a

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.a

Self-medication

Discontinue and consult a clinician if pain and discomfort persist for longer than 2 days.a

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.b c

Lactation

Not known whether phenzopyridine or metabolites are distributed into milk.a b c

Hepatic Impairment

Contraindicated in severe hepatic impairment.a

Renal Impairment

Possible accumulation of phenazopyridine; use is contraindicated.a

Interactions for Phenazopyridine Hydrochloride

Specific Laboratory Tests

Test

Interaction

Comments

Spectrometry or color reaction urinalysis; phenolsulfonphthalein (PSP) excretion test of kidney function.

Butanol may be used to extract phenazopyridine from the final alkaline urine dilution to give accurate resultsa

Urinary glucose tests: glucose oxidase reagent (Clinistix, Tes-Tape)

Delayed reactions with glucose oxidase reagent may be interpreted as false-negative reactions; occasional false-positive tests occur with Tes-Tapea

Cupric sulfate (Clinitest) is not affecteda

Urinary bilirubin tests (e.g., Ictotest)

May give false-positive results for the foam test and atypical color reactions with p-nitrobenzene diazonium p-toluene sulfonate reagent (Ictotest)a

Urinary ketone tests using sodium nitroprusside (Acetest, Ketostix) or Gerhardt ferric chloride

May produce interfering colorsa

Prevent by adding a small amount of sodium dithionate to urine before performing the testsa

Urinary protein tests

May discolor bromophenol blue test areas of commercial reagent strips and interfere with the nitric acid ring testa

Sulfosalicylic acid and heat-acetic acid tests are unaffecteda

Determination of urinary steroids

May interfere by affecting absorbancy in the modified Glenn-Nelson method of 17-hydroxycorticosteroid determination and the Holtorff-Koch modification of the Zimmerman reaction for determining 17-ketosteroidsa

Urinary urobilinogen determinations (Ehrlich’s reagent)

Color interferencea

Spectrophotofluorimetric screening tests and assays for porphyrins

May produce falsely elevated readingsa

Phenazopyridine Hydrochloride Pharmacokinetics

Pharmacokinetic properties have not been determined.a

Distribution

Extent

Trace amounts may enter the CSF.a

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

Elimination

Metabolism

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

Elimination Route

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

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.a

Actions

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

  • Little or no antibacterial activity in the urine.a

Advice to Patients

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

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

  • 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.a

  • Potential of contact lens staining.c

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

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

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

  • 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.

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

Phenazopyridine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

95 mg

Azo-Gesic

Major, United Research

Azo-Standard

PolyMedica

Prodium

Requa

97 mg

Re-Azo

Reese

97.2 mg

Azo-Dine

Republic

Azo-Natural

Cemco

Baridium

Pfeiffer

UTI Relief

Consumers Choice

100 mg*

Pyridium

Warner Chilcott

200 mg*

Pyridium

Warner Chilcott

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

Phenazopyridine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

150 mg with Butabarbital 15 mg, and Hyoscyamine Hydrobromide 0.3 mg*

Pyridium Plus (with parabens)

Warner-Chilcott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Phenazopyridine HCl 100MG Tablets (QUALITEST): 30/$13.99 or 90/$41.13

Phenazopyridine HCl 200MG Tablets (AMNEAL PHARMACEUTICALS): 30/$20.44 or 60/$29.88

Pyridium 100MG Tablets (AMNEAL PHARMACEUTICALS): 30/$39.99 or 90/$99.97

Pyridium 200MG Tablets (AMNEAL PHARMACEUTICALS): 30/$64.99 or 90/$175.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Phenazopyridine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:3413-4.

b. Briggs GC, Freeman RK, Yaffee SJ. Drugs in pregnancy and lactation. 6th ed. Phenazopyridine. Philadelphia, PA: Lippincott, Williams & Wilkins; 2002: 1093-4/p.

c. Amide Pharmaceuticals. Phenazopyridine hydrochloride tablets prescribing information. Little Falls, NJ; 1998:Jun.

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