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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/29 | Phase 4 | Recruiting | |||
2024/11/26 | Phase 4 | Not yet recruiting | |||
2023/06/29 | Not Applicable | Recruiting | |||
2022/06/01 | Phase 4 | Recruiting | Fundacion Clinic per a la Recerca Biomédica | ||
2022/03/31 | Phase 1 | Recruiting | Central Hospital, Nancy, France | ||
2022/03/10 | Phase 4 | UNKNOWN | |||
2021/10/29 | Early Phase 1 | Active, not recruiting | |||
2021/01/26 | Phase 3 | UNKNOWN | |||
2020/01/18 | Early Phase 1 | Withdrawn | |||
2016/09/16 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-5679 | ORAL | 800 mg in 1 1 | 6/29/2021 | |
| Aurobindo Pharma Limited | 65862-496 | ORAL | 200 mg in 5 mL | 3/12/2024 | |
| A-S Medication Solutions | 50090-2198 | ORAL | 800 mg in 1 1 | 6/3/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-4431 | ORAL | 800 mg in 1 1 | 2/16/2021 | |
| New Horizon Rx Group, LLC | 58517-140 | ORAL | 800 mg in 1 1 | 12/30/2013 | |
| Department of State Health Services, Pharmacy Branch | 55695-008 | ORAL | 800 mg in 1 1 | 3/11/2016 | |
| AvKARE | 42291-758 | ORAL | 400 mg in 1 1 | 1/10/2024 | |
| A-S Medication Solutions | 50090-6901 | ORAL | 800 mg in 1 1 | 12/27/2022 | |
| Redpharm Drug | 67296-1904 | ORAL | 800 mg in 1 1 | 11/27/2023 | |
| Contract Pharmacy Services-PA | 67046-715 | ORAL | 800 mg in 1 1 | 3/25/2009 |
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 |
|---|---|---|---|---|---|
| B.S. TABLET | SIN00960P | TABLET | 400 mg | 5/10/1988 | |
| TRIMAXAZOLE TABLETS | SIN00407P | TABLET | 400 mg | 4/27/1988 | |
| DBL SULFAMETHOXAZOLE 400MG AND TRIMETHOPRIM 80MG CONCENTRATE INJECTION BP | SIN02183P | INJECTION | 80 mg/mL | 6/30/1988 | |
| PRIMZOLE TABLETS | SIN00901P | TABLET | 400 mg | 5/9/1988 | |
| MORTIN TABLET | SIN10251P | TABLET | 400 mg | 10/10/1998 | |
| MORTIN-DS TABLET | SIN10250P | TABLET | 800 mg | 10/10/1998 | |
| APO-SULFATRIM PEDIATRIC TABLET | SIN00508P | TABLET | 100 mg | 4/28/1988 | |
| APO-SULFATRIM TABLET | SIN00435P | TABLET | 400 mg | 4/27/1988 | |
| CO-TRIMEXAZOLE SUSPENSION | SIN00583P | SUSPENSION | 200 mg/5 ml | 4/29/1988 | |
| SUPRIM SUSPENSION | SIN01417P | SUSPENSION | 200 mg/5 ml | 5/20/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RESPRIM trimethoprim/sulfamethoxazole 80 mg/400 mg tablet blister pack | 17681 | Medicine | A | 9/20/1991 | |
| Septrin Sugar-free Paediatric Suspension | 11000 | Medicine | A | 8/2/1991 | |
| BACTRIM DS tablet blister pack | 162563 | Medicine | A | 7/8/2009 | |
| SEPTRIN FORTE trimethoprim/sulfamethoxazole 160/800 mg tablet blister pack | 10998 | Medicine | A | 8/2/1991 | |
| SEPTRIN trimethoprim/sulfamethoxazole 80/400 tablet blister pack | 15336 | Medicine | A | 9/5/1991 | |
| RESPRIM FORTE trimethoprim/sulfamethoxazole 160 mg/800 mg tablet blister pack | 17682 | Medicine | A | 9/20/1991 | |
| SEPTRIN trimethorim/sulfazmethoxazole 80/400 mg tablet bottle | 11001 | Medicine | A | 8/2/1991 | |
| DBL SULFAMETHOXAZOLE 400 mg and TRIMETHOPRIM 80 mg/5 mL concentrated injection ampoule | 16293 | Medicine | A | 10/8/1991 | |
| BACTRIM 400/80 sulfamethoxazole 400 mg/5 mL and trimethoprim 80 mg/5mL concentrate for solution for infusion ampoulee | 367590 | Medicine | A | 8/31/2022 | |
| Sulfamethoxazole and Trimethoprim 400mg / 80mg tablet bottle | 315665 | Medicine | A | 3/22/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS | d.c. labs limited | 00516759 | Tablet - Oral | 400 MG | 12/31/1980 |
| SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP | eugia pharma inc. | 02534746 | Solution - Intravenous | 80 MG / ML | N/A |
| APO-SULFATRIM ORAL SUSPENSION | 00846465 | Suspension - Oral | 40 MG / ML | 12/31/1989 | |
| SEPTRA | 00270636 | Tablet - Oral | 400 MG | 12/31/1973 | |
| BACTRIM ROCHE INJ | Hoffmann-La Roche Limited | 00550078 | Liquid - Intravenous | 80 MG / ML | 12/31/1981 |
| TRISULFA TAB | jaapharm canada inc. | 00885924 | Tablet - Oral | 400 MG | 12/31/1991 |
| TEVA-TRIMEL | teva canada limited | 00510637 | Tablet - Oral | 400 MG | 12/31/1981 |
| BACTRIM ROCHE TAB | Hoffmann-La Roche Limited | 00272469 | Tablet - Oral | 400 MG | 12/31/1977 |
| SULFATRIM PEDIATRIC | aa pharma inc | 00445266 | Tablet - Oral | 100 MG | 12/31/1979 |
| NU-COTRIMOX TAB 400/80MG | nu-pharm inc | 00865710 | Tablet - Oral | 400 MG | 12/31/1990 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| BACTOPUMON | Laboratorios Cinfa S.A. | 47949 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| BRONCOVIR SUSPENSION ORAL | Industria Quimica Y Farmaceutica Vir S.A. | 45611 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| BALSOPRIM 26,6MG/ML+5,4MG/ML+0,5MG/ML SUSPENSIÓN ORAL | Desma Laboratorio Farmaceutico S.L. | 49391 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| SEPTRIN 80 mg/400 mg COMPRIMIDOS | Teofarma S.R.L. | 48670 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| SEPTRIN PEDIATRICO 8 mg/40 mg/ml SUSPENSION ORAL | Teofarma S.R.L. | 48671 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| BRONQUIDIAZINA CR SUSPENSIÓN ORAL | 33618 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SOLTRIM 160MG/ 800MG POLVO Y SOLUCION PARA SOLUCION INYECTABLE | 54920 | POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| SEPTRIN FORTE 160 mg/800 mg COMPRIMIDOS | Teofarma S.R.L. | 58501 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
| SEPTRIN PEDIATRICO 20 mg/100 mg COMPRIMIDOS | Teofarma S.R.L. | 48669 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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