Pyridium

INDICATIONS

Pyridium® (phenazopyridine) 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride should not exceed 2 days because there is a lack of evidence that the combined administration of Phenazopyridine Hydrochloride and an antibacterial provides greater benefit than administration of the antibacterial alone after 2 days. (See DOSAGE AND ADMINISTRATION Section)

DOSAGE AND ADMINISTRATION

100 mg tablets: Adult dosage is two tablets 3 times a day after meals. 200 mg tablets: Adult dosage is one tablet 3 times a day after meals.

When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.

HOW SUPPLIED

Pyridium® (Phenazopyridine Hydrochloride Tablets, USP) is supplied as follows:

100 mg - maroon, round tablets imprinted "WC 180"

Bottles of 100: N 0430-0180-24

200 mg - maroon, round tablets imprinted "WC 181"

Bottles of 100: N 0430-0181-24

Store at controlled room temperature 15° to 30° C (59° to 86° F)[See USP].

Manufactured by: Actavis Totowa LLC Totowa, NJ 07512 USA.
Marketed by: Warner Chilcott (US), Inc. Rockaway, NJ 07866. FDA rev date:

Last reviewed on RxList: 8/22/2007
This monograph has been modified to include the generic and brand name in many instances.

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