Sulfamethoxazole

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

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
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis	2024/11/29	NCT06709196	Phase 4	Recruiting	Rigshospitalet, Denmark
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)	2024/11/26	NCT06706362	Phase 4	Not yet recruiting	Ohio State University
Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy	2023/06/29	NCT05925309	Not Applicable	Recruiting	Children's Hospital of Fudan University
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis	2022/06/01	NCT05398679	Phase 4	Recruiting	Fundacion Clinic per a la Recerca Biomédica
Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome	2022/03/31	NCT05302531	Phase 1	Recruiting	Central Hospital, Nancy, France
Role of Prophylactic Postoperative Antibiotics in HoLEP	2022/03/10	NCT05274672	Phase 4	UNKNOWN	Baylor Research Institute
Collaborative Urological Prosthetics Investigation Directive Research Group	2021/10/29	NCT05100654	Early Phase 1	Active, not recruiting	University of Chicago
Or v IV Antibiotics for Infection	2021/01/26	NCT04723940	Phase 3	UNKNOWN	Rothman Institute Orthopaedics
Effect of Antibiotics on Urinary Microbiome	2020/01/18	NCT04230746	Early Phase 1	Withdrawn	Johns Hopkins University
A Non-Interventional Safety Study of Balsamic Bactrim	2016/09/16	NCT02902640	N/A	Completed	Hoffmann-La Roche

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-5679	ORAL	800 mg in 1 1	6/29/2021
Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	65862-496	ORAL	200 mg in 5 mL	3/12/2024
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-2198	ORAL	800 mg in 1 1	6/3/2021
Sulfamethoxazole and Trimethoprim	NuCare Pharmaceuticals,Inc.	68071-4431	ORAL	800 mg in 1 1	2/16/2021
SULFAMETHOXAZOLE AND TRIMETHOPRIM double strength	New Horizon Rx Group, LLC	58517-140	ORAL	800 mg in 1 1	12/30/2013
Sulfamethoxazole and Trimethoprim	Department of State Health Services, Pharmacy Branch	55695-008	ORAL	800 mg in 1 1	3/11/2016
Sulfamethoxazole and Trimethoprim	AvKARE	42291-758	ORAL	400 mg in 1 1	1/10/2024
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-6901	ORAL	800 mg in 1 1	12/27/2022
Sulfamethoxazole and Trimethoprim	Redpharm Drug	67296-1904	ORAL	800 mg in 1 1	11/27/2023
Sulfamethoxazole and Trimethoprim	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	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN00960P	TABLET	400 mg	5/10/1988
TRIMAXAZOLE TABLETS	BEACONS PHARMACEUTICALS PTE. LTD.	SIN00407P	TABLET	400 mg	4/27/1988
DBL SULFAMETHOXAZOLE 400MG AND TRIMETHOPRIM 80MG CONCENTRATE INJECTION BP	Siegfried Hameln GmbH	SIN02183P	INJECTION	80 mg/mL	6/30/1988
PRIMZOLE TABLETS	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN00901P	TABLET	400 mg	5/9/1988
MORTIN TABLET	MICRO LABS LTD	SIN10251P	TABLET	400 mg	10/10/1998
MORTIN-DS TABLET	MICRO LABS LTD	SIN10250P	TABLET	800 mg	10/10/1998
APO-SULFATRIM PEDIATRIC TABLET	APOTEX INC	SIN00508P	TABLET	100 mg	4/28/1988
APO-SULFATRIM TABLET	APOTEX INC	SIN00435P	TABLET	400 mg	4/27/1988
CO-TRIMEXAZOLE SUSPENSION	BEACONS PHARMACEUTICALS PTE LTD	SIN00583P	SUSPENSION	200 mg/5 ml	4/29/1988
SUPRIM SUSPENSION	HOVID BHD	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	广西金嗓子药业股份有限公司	国药准字H45020182	化学药品	片剂	8/24/2020
Sulfamethoxazole Tablets	成都第一制药有限公司	国药准字H51022825	化学药品	片剂	11/18/2020
Sulfamethoxazole Tablets	九华华源药业股份有限公司	国药准字H34021941	化学药品	片剂	5/28/2020
Sulfamethoxazole Tablets	开封康诺药业有限公司	国药准字H41023612	化学药品	片剂	6/9/2020
Sulfamethoxazole Tablets	新疆生化药业有限公司	国药准字H65020122	化学药品	片剂	7/20/2022
Sulfamethoxazole Tablets	湖南尔康制药股份有限公司	国药准字H43021194	化学药品	片剂	1/16/2020
Sulfamethoxazole Tablets	地奥集团成都药业股份有限公司	国药准字H51021999	化学药品	片剂	12/18/2020
Sulfamethoxazole Tablets	上海凯宝新谊（新乡）药业有限公司	国药准字H41020490	化学药品	片剂	5/14/2020
Sulfamethoxazole Tablets	广州白云山光华制药股份有限公司	国药准字H44020384	化学药品	片剂	3/16/2020
Sulfamethoxazole Tablets	湖北欧立制药有限公司	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.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
RESPRIM trimethoprim/sulfamethoxazole 80 mg/400 mg tablet blister pack	17681	Alphapharm Pty Ltd	Medicine	A	9/20/1991
Septrin Sugar-free Paediatric Suspension	11000	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
BACTRIM DS tablet blister pack	162563	Echo Therapeutics Pty Ltd	Medicine	A	7/8/2009
SEPTRIN FORTE trimethoprim/sulfamethoxazole 160/800 mg tablet blister pack	10998	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
SEPTRIN trimethoprim/sulfamethoxazole 80/400 tablet blister pack	15336	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/5/1991
RESPRIM FORTE trimethoprim/sulfamethoxazole 160 mg/800 mg tablet blister pack	17682	Alphapharm Pty Ltd	Medicine	A	9/20/1991
SEPTRIN trimethorim/sulfazmethoxazole 80/400 mg tablet bottle	11001	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/2/1991
DBL SULFAMETHOXAZOLE 400 mg and TRIMETHOPRIM 80 mg/5 mL concentrated injection ampoule	16293	Pfizer Australia Pty Ltd	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	Echo Therapeutics Pty Ltd	Medicine	A	8/31/2022
Sulfamethoxazole and Trimethoprim 400mg / 80mg tablet bottle	315665	Alphapharm Pty Ltd	Medicine	A	3/22/2019

AI-Powered Research

Premium Access