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Sulfamethoxazole

Generic Name
Sulfamethoxazole
Brand Names
Bactrim, Septra, Sulfatrim
Drug Type
Small Molecule
Chemical Formula
C10H11N3O3S
CAS Number
723-46-6
Unique Ingredient Identifier
JE42381TNV

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

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.

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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