Skin and Mucous Membrane Agents; Antipruritics and Local Anesthetics. Urinary Analgesic. (ATC-Code: G04BX06).
Mechanism of action
An azo dye which exerts local anesthetic or analgesic action on urinary tract mucosa through unknown mechanism. Little or no antibacterial activity in urine.
Therapeutic use
Symptomatic relief of urinary burning, itching, frequency and urgency in association with urinary tract infection or following urologic procedures.
Pregnancy and lactiation implications
Use caution during pregnancy or lactation (excretion in breast milk unknown).
Unlabeled use
Contraindications
Hypersensitivity to phenazopyridine or any component of the formulation. Impaired renal function, glomerulonephritis, uremia, or pyelonephritis during pregnancy. Severe hepatitis.
Warnings and precautions
Skin or sclera may develop a yellow color (may indicate accumulation resulting from renal impairment). Urine may become orange to red in color. Use with caution in renal impairment. Use contraindicated in severe hepatic impairment (CrCl <50 mL/minute). Use in the elderly limited since accumulation can occur in renal insufficiency.