Pyridium (Phenazopyridine) - Summary

PYRIDIUM SUMMARY

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.

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.)

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NEWS HIGHLIGHTS

Published Studies Related to Pyridium (Phenazopyridine)

Use of phenazopyridine for reducing discomfort during embryo transfer. [2007]
OBJECTIVE: The embryo transfer is a critical part of in vitro fertilization.

Phenazopyridine does not improve catheter discomfort following gynecologic surgery. [2011]
catheterized patients recovering from gynecologic surgery... CONCLUSION: Postoperative VAS scores and pain medicine usage did not change with

A prospective, randomized, double-blinded placebo-controlled comparison of extended release oxybutynin versus phenazopyridine for the management of postoperative ureteral stent discomfort. [2008]
after ureteroscopy... CONCLUSIONS: Although this study failed to show a significant difference in

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Clinical Trials Related to Pyridium (Phenazopyridine)

Phenazopyridine for Confirmation of Ureteral Patency [Recruiting]
In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.

Study to Assess the Efficacy and Safety of "P�lulas de Lussen�" Compared to the Pyridium� in the Symptomatic Control of Dysuria [Not yet recruiting]
Clinical Study, prospective, comparative, randomized, double-dummy entry with random from a total of 80 patients, 40 patients will receive the test medication (Pílulas de Lussen®) plus placebo and 40 patients will receive the comparative (Pyridium®) plus placebo.

Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo [Completed]
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)

Bioequivalence of Phenazopyridine HCl in Healthy Volunteers [Active, not recruiting]

Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI) [Completed]
The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain upon urination associated with Uncomplicated Urinary Tract Infections (uUTI). The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated with uUTI.

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