Overview
Sulfamethoxazole is a bacteriostatic sulfonamide antibiotic that interferes with folic acid synthesis in susceptible bacteria. It is generally given in combination with trimethoprim, which inhibits a sequential step in bacterial folic acid synthesis - these agents work synergistically to block two consecutive steps in the biosynthesis of nucleic acids and proteins which are necessary for bacterial growth and division, and using them in conjunction helps to slow the development of bacterial resistance. In this combination, sulfamethoxazole is useful for the treatment of a variety of bacterial infections, including those of the urinary, respiratory, and gastrointestinal tracts.
Indication
Sulfamethoxazole is indicated in combination with trimethoprim, in various formulations, for the following infections caused by bacteria with documented susceptibility: urinary tract infections, acute otitis media in pediatric patients (when clinically indicated), acute exacerbations of chronic bronchitis in adults, enteritis caused by susceptible Shigella, prophylaxis and treatment of Pneumocystis jiroveci pneumonia, and travelers' diarrhea caused by enterotoxigenic E. coli. In Canada, additional indications include the adjunctive treatment of cholera, treatment of bacillary dysentery, nocardiosis, and second-line treatment of brucellosis in combination with gentamicin or rifampicin.
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis (AECB) caused by susceptible bacteria
- Acute Otitis Media caused by susceptible bacteria
- Brucellosis
- Dysentery, Bacillary
- Nocardiosis
- Pneumocystis Jirovecii Pneumonia
- Urinary Tract Infection caused by susceptible bacteria
- Susceptible Cholera
- Susceptible Enteritis infectious caused by Shigella flexneri
- Susceptible Enteritis infectious caused by Shigella sonnei
- Susceptible Travelers' Diarrhea caused by Enterotoxigenic E. Coli (ETEC) Infection
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/08/26 | N/A | Completed | |||
2015/12/29 | Phase 2 | UNKNOWN | |||
2015/11/01 | Not Applicable | Completed | |||
2013/03/29 | Phase 4 | Completed | JOSE MANUEL ARREOLA GUERRA | ||
2012/12/28 | Phase 2 | UNKNOWN | |||
2012/12/12 | Phase 2 | UNKNOWN | R. Stephen Rankin, M.D. | ||
2011/11/10 | Phase 1 | Completed | |||
2010/06/07 | Not Applicable | UNKNOWN | |||
2010/04/22 | Not Applicable | Terminated | |||
2009/09/09 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals LLC | 65162-272 | ORAL | 800 mg in 1 1 | 12/27/2022 | |
| NuCare Pharmaceuticals,Inc. | 68071-4710 | ORAL | 800 mg in 1 1 | 3/17/2021 | |
| RedPharm Drug, Inc. | 67296-0227 | ORAL | 800 mg in 1 1 | 1/19/2022 | |
| Bryant Ranch Prepack | 71335-1309 | ORAL | 800 mg in 1 1 | 6/29/2021 | |
| Asclemed USA, Inc. | 76420-064 | ORAL | 800 mg in 1 1 | 9/4/2020 | |
| Bryant Ranch Prepack | 63629-1765 | ORAL | 800 mg in 1 1 | 9/21/2022 | |
| Major Pharmaceuticals | 0904-2725 | ORAL | 800 mg in 1 1 | 2/8/2024 | |
| State of Florida DOH Central Pharmacy | 53808-0914 | ORAL | 800 mg in 1 1 | 8/19/2010 | |
| St. Mary's Medical Park Pharmacy | 60760-069 | ORAL | 800 mg in 1 1 | 5/12/2022 | |
| Atlantic Biologicals Corps | 17856-0823 | ORAL | 200 mg in 5 mL | 9/18/2019 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SUPRIM B.P. 480 TABLET | SIN02308P | TABLET | 400.00 mg | 8/30/1988 | |
| B.S. SUSPENSION | SIN00526P | SUSPENSION | 200 mg/5 ml | 4/28/1988 |
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sulfamethoxazole Tablets | 国药准字H41020320 | 化学药品 | 片剂 | 5/18/2020 | |
| Sulfamethoxazole Tablets | 国药准字H43021357 | 化学药品 | 片剂 | 12/12/2019 | |
| Sulfamethoxazole Tablets | 国药准字H34020231 | 化学药品 | 片剂 | 6/24/2020 | |
| Sulfamethoxazole Tablets | 国药准字H42020939 | 化学药品 | 片剂 | 7/30/2020 | |
| Sulfamethoxazole Tablets | 国药准字H31020680 | 化学药品 | 片剂 | 8/19/2020 | |
| Sulfamethoxazole Tablets | 国药准字H62020207 | 化学药品 | 片剂 | 4/14/2020 | |
| Sulfamethoxazole Tablets | 国药准字H35020376 | 化学药品 | 片剂 | 9/3/2020 | |
| Sulfamethoxazole Tablets | 国药准字H44022030 | 化学药品 | 片剂 | 10/9/2020 | |
| Sulfamethoxazole Tablets | 国药准字H61021638 | 化学药品 | 片剂 | 11/11/2020 | |
| Sulfamethoxazole Tablets | 国药准字H65020334 | 化学药品 | 片剂 | 11/16/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SEPTRIN FORTE trimethoprim/sulfamethoxazole 160/800 mg tablet bottle | 15334 | Medicine | A | 9/5/1991 |
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