Overview
Phenazopyridine, also known as Pyridium, is a urinary tract analgesic used for the short-term management of urinary tract irritation and its associated unpleasant symptoms such as burning and pain during urination. In the USA, this drug was previously marked by Roche but has been discontinued by the FDA. It is still used in various parts of the world. Ingestion of phenazopyridine is found to change the appearance of the urine by imparting an orange or red color, as it is considered an azo dye.
Indication
Phenazopyridine hydrochloride is indicated to relieve uncomfortable symptoms that occur as a consequence of mucosal irritation of the lower urinary tract in adults. The irritation may be a result of trauma, surgery, endoscopic procedures, infection, or the insertion of instruments or urinary catheters. Phenazopyridine may be used in combination with antimicrobial therapy but is not used as an antimicrobial agent. It contributes to the relief of discomfort and pain before antimicrobial therapy begins to take effect. It is important to note that the duration of treatment with this drug should last a maximum of 2 days. Phenazopyridine is available in many countries as an over the counter drug.
Associated Conditions
- Lower Urinary Tract Infection
- Signs or symptoms of urinary tract irritation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/29 | Phase 4 | Recruiting | |||
2024/07/23 | Phase 4 | Not yet recruiting | |||
2018/11/27 | Phase 4 | UNKNOWN | Women and Infants Hospital of Rhode Island | ||
2018/02/14 | Early Phase 1 | Completed | |||
2017/10/05 | Phase 4 | Completed | |||
2017/02/27 | Phase 3 | Completed | University of Massachusetts, Worcester | ||
2016/06/21 | Phase 3 | Completed | University of Massachusetts, Worcester | ||
2016/05/02 | Not Applicable | Withdrawn | |||
2016/03/22 | Not Applicable | UNKNOWN | Boston Urogynecology Associates | ||
2016/03/09 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-0218 | ORAL | 100 mg in 1 1 | 1/19/2024 | |
| Rebel Distributors Corp | 21695-301 | ORAL | 200 mg in 1 1 | 1/31/2011 | |
| RPK Pharmaceuticals, Inc. | 53002-3153 | ORAL | 200 mg in 1 1 | 10/31/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-362 | ORAL | 100 mg in 1 1 | 2/20/2024 | |
| RPK Pharmaceuticals, Inc. | 53002-3152 | ORAL | 200 mg in 1 1 | 12/16/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-5274 | ORAL | 100 mg in 1 1 | 2/7/2022 | |
| Direct_Rx | 61919-098 | ORAL | 200 mg in 1 1 | 1/21/2020 | |
| Preferred Pharmaceuticals Inc. | 68788-7981 | ORAL | 100 mg in 1 1 | 8/25/2023 | |
| Redpharm Drug, Inc. | 67296-1447 | ORAL | 200 mg in 1 1 | 2/6/2023 | |
| RedPharm Drug, Inc. | 67296-1350 | ORAL | 100 mg in 1 1 | 1/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Phenazopyridine Hydrochloride Capsules | 国药准字H20052581 | 化学药品 | 胶囊剂 | 8/17/2020 | |
| Phenazopyridine hydrochloride Tablets | 国药准字H20094071 | 化学药品 | 片剂 | 3/21/2024 | |
| Phenazopyridine hydrochloride Tablets | 国药准字H20052612 | 化学药品 | 片剂 | 8/18/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| UROSINA CAP | N/A | N/A | N/A | 12/28/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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