PREGNANCY AND BREASTFEEDING SAFETY: Phenazopyridine is classified as FDA pregnancy risk category B (animal studies show no harm to fetuses but there are no well-controlled studies in pregnant women). Reproduction studies in rats at doses up to 50 mg/kg//day have shown no evidence of fetal harm. However, as with all drugs, phenazopyridine should be used in pregnancy only if clearly needed.
It is not known if phenazopyridine is excreted in breast milk.
STORAGE: Tablets should be stored at room temperature between 15 C and 30 C (59 F to 86 F). Keep phenazopyridine and all medications away from pets and children.
DOSAGE: The usual recommended adult dose of phenazopyridine is 100 to 200 mg three times daily after meals. Treatment should not exceed 2 days when used in-combination with an antibacterial agent. The maximum daily dose for adults is 600 mg.
Dose adjustment may be required for patients who have kidney disease. Phenazopyridine should not be used in patients whose creatinine clearance is less than 50 ml/min. Phenazopyridine should be administered every 8-16 hours in patients whose creatinine clearance is between 50-80 ml/min.
The usual recommended dose for children and adolescents is 4 mg/kg orally three times daily after meals. The child's pediatric doctor should calculate the dose. Treatment should not exceed 2 days when used in-combination with an antibacterial agent.
DRUG CLASS AND MECHANISM: Phenazopyridine is an oral urinary analgesic (pain relieving medication). It is available over-the-counter (without a prescription or OTC) in lower strengths, and with a prescription for higher strengths. It is used commonly to treat symptoms of pain, burning, urgency, frequency, and other symptoms associated with lower urinary tract infections (UTIs).
Although the exact mechanism of action is unknown, phenazopyridine is thought to provide relief of symptoms of UTIs by acting as a local anesthetic on the lining of the urinary tract. Phenazopyridine is excreted in the urine and may cause urine to change to an orange or red color. Phenazopyridine does not have any antibacterial action and should not be used to treat UTIs. It is only used to provide relief of symptoms associated with UTIs.
Medically reviewed by Eni Williams, PharmD, PhD
REFERENCE: FDA Prescribing Information.
Quick GuideBladder Infections: UTI Causes, Symptoms, Treatments
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