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Phenazopyridine

Pronunciation

Pronunciation

(fen az oh PEER i deen)

Index Terms

  • Phenazopyridine HCl
  • Phenazopyridine Hydrochloride
  • Phenylazo Diamino Pyridine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as hydrochloride:

Azo-Gesic: 95 mg [DSC]

Baridium: 97.2 mg

Pyridium: 100 mg, 200 mg

Urinary Pain Relief: 95 mg

Generic: 95 mg, 100 mg, 200 mg

Brand Names: U.S.

  • Azo-Gesic [OTC] [DSC]
  • Baridium [OTC]
  • Pyridium
  • Urinary Pain Relief [OTC]

Pharmacologic Category

  • Analgesic, Urinary

Pharmacology

An azo dye which exerts local anesthetic or analgesic action on urinary tract mucosa through an unknown mechanism

Metabolism

In the liver and other tissues

Excretion

Urine (66% as unchanged drug)

Use: Labeled Indications

Dysuria, symptomatic relief: Symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.

Contraindications

Hypersensitivity to phenazopyridine or any component of the formulation; renal insufficiency.

Dosing: Adult

Dysuria, symptomatic relief: Oral:

OTC labeling: Two tablets (190 mg) 3 times daily administered with or after meals for up to 2 days.

Rx labeling: 200 mg 3 times daily after meals for 2 days when used concomitantly with an antibacterial agent.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Dysuria, symptomatic relief: Children ≥12 years and Adolescents: OTC labeling: Oral: Refer to adult dosing.

Dosing: Renal Impairment

Use is contraindicated.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

Administer after meals.

Dietary Considerations

Take after meals.

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.

Drug Interactions

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy

Tetracaine (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy

Test Interactions

Phenazopyridine may interfere with glucose oxidase reagents (Clinistix, Tes-Tape) and urine ketone tests (Acetest, Ketostix).

Adverse Reactions

1% to 10%:

Central nervous system: Headache, dizziness

Gastrointestinal: Stomach cramps

<1% (Limited to important or life-threatening): Acute renal failure, hemolytic anemia, hepatitis, methemoglobinemia

Warnings/Precautions

Concerns related to adverse effects:

• Urine discoloration: A reddish-orange discoloration of the urine occurs.

• Yellow discoloration: Drug should be discontinued if skin or sclera develop a yellow color (may indicate drug accumulation due to impaired renal excretion).

Disease-related concerns:

• Renal impairment: Use is contraindicated in patients with renal impairment.

Special populations:

• Elderly: Use of this agent in the elderly is limited since accumulation can occur in patients with renal insufficiency.

• G6PD deficiency: Use caution in patients with G6PD deficiency; hemolytic anemia may occur in the setting of chronic overdose. OTC labeling recommends use only when directed by physician.

Other warnings/precautions:

• Contact lenses: Staining of contact lenses may occur if handled after touching tablets.

• Limitations of use: Does not treat urinary infection, acts only as an analgesic.

• Self-medication (OTC use): When used for self-medication, patients should be instructed to discontinue use if symptoms last for more than 2 days or if an adverse reaction occurs.

• Staining: May stain fabric or clothing.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. Phenazopyridine crosses the placenta and can be detected in amniotic fluid (Meyer, 1991).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber signs of methemoglobinemia (blue or gray color of the lips, nails, or skin; arrhythmia; seizures; severe dizziness or passing out; severe headache; fatigue; loss of strength and energy; or shortness of breath), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), severe loss of strength and energy, urinary retention, change in amount of urine passed, or vision changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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