Phenazopyridine Hydrochloride

Contraindications

CONTRAINDICATIONS Phenazopyridine Hydrochloride should not be used in patients who are hypersensitive to the drug or its ingredients. Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis or pyelonephritis of pregnancy. It should be used cautiously in the presence of GI disturbances.

Pregnancy & Breastfeeding

Pregnancy Category B Reproductive studies with Phenazopyridine Hydrochloride (in combination with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis revealed no evidence of harm to offspring. One prospective study in humans demonstrated that Phenazopyridine Hydrochloride traverses the placenta into the fetal compartment. There are no adequate and well-controlled studies in pregnant women. Therefore, Phenazopyridine Hydrochloride should be used in pregnant women only if the benefit clearly outweighs the risk.