Pyridium: Package Insert and Label Information
By Gemini Laboratories, LLC | Last revised: 23 July 2015
PYRIDIUM- phenazopyridine hydrochloride tablet, film coated
Gemini Laboratories, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
?CAUTION: ? Federal law prohibits dispensing without prescription.
DESCRIPTION
Pyridium � (Phenazopyridine Hydrochloride) is light or dark red to dark violet, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain. It has the following structural formula:
Structural Formula
(click image for full-size original)
CLINICAL PHARMACOLOGY
Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is not known.
The pharmacokinetic properties of Phenazopyridine HCl have not been determined. Phenazopyridine HCl is rapidly excreted by the kidneys, with as much as 66% of an oral dose being excreted unchanged in the urine.
INDICATIONS AND USAGE
Pyridium is indicated for the 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. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Phenazopyridine HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine HCl should not exceed two days because there is a lack of evidence that the combined administration of Phenazopyridine HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)
CONTRAINDICATIONS
Phenazopyridine HCl should not be used in patients who have previously exhibited sensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.
ADVERSE REACTIONS
Headache, rash, pruritus and occasional gastrointestinal disturbance. At anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section).