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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.

Background

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
Sulfamethoxazole Tablets
国药准字H45020182
化学药品
片剂
8/24/2020
Sulfamethoxazole Tablets
国药准字H51022825
化学药品
片剂
11/18/2020
Sulfamethoxazole Tablets
国药准字H34021941
化学药品
片剂
5/28/2020
Sulfamethoxazole Tablets
国药准字H41023612
化学药品
片剂
6/9/2020
Sulfamethoxazole Tablets
国药准字H65020122
化学药品
片剂
7/20/2022
Sulfamethoxazole Tablets
国药准字H43021194
化学药品
片剂
1/16/2020
Sulfamethoxazole Tablets
国药准字H51021999
化学药品
片剂
12/18/2020
Sulfamethoxazole Tablets
国药准字H41020490
化学药品
片剂
5/14/2020
Sulfamethoxazole Tablets
国药准字H44020384
化学药品
片剂
3/16/2020
Sulfamethoxazole Tablets
国药准字H42020523
化学药品
片剂
9/15/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.
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