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.

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
A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis	2016/08/26	NCT02879981	N/A	Completed	Hoffmann-La Roche
Sulfamethoxazole for the Treatment of Primary PREPL Deficiency	2015/12/29	NCT02640443	Phase 2	UNKNOWN	Universitair Ziekenhuis Brussel
Antibiotic Use Following Distal and Mid-shaft Hypospadias Repair	2015/11/01	NCT02593903	Not Applicable	Completed	Medical College of Wisconsin
Efficacy of Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation	2013/03/29	NCT01820897	Phase 4	Completed	JOSE MANUEL ARREOLA GUERRA
Efficacy and Safety Study of Antibiotic Treatment to Treat Hip Prosthetic Joint Infection	2012/12/28	NCT01757236	Phase 2	UNKNOWN	University Hospital, Tours
New Mexico Honey Wound Treatment Research Study	2012/12/12	NCT01748318	Phase 2	UNKNOWN	R. Stephen Rankin, M.D.
Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine	2011/11/10	NCT01469637	Phase 1	Completed	Shire
Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers	2010/06/07	NCT01137903	Not Applicable	UNKNOWN	Universidad Complutense de Madrid
Prevention of Catheter-Associated Urinary Tract Infection in Incontinence and Reconstructive Pelvic Surgery Patients	2010/04/22	NCT01108757	Not Applicable	Terminated	The Cleveland Clinic
Prospective Randomized Trial of Bactrim on 7 Day Outcome in Patients With Uncomplicated Abscesses	2009/09/09	NCT00973765	Phase 3	Completed	59th Medical Wing

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sulfamethoxazole and Trimethoprim	Amneal Pharmaceuticals LLC	65162-272	ORAL	800 mg in 1 1	12/27/2022
Sulfamethoxazole and Trimethoprim	NuCare Pharmaceuticals,Inc.	68071-4710	ORAL	800 mg in 1 1	3/17/2021
Sulfamethoxazole and Trimethoprim	RedPharm Drug, Inc.	67296-0227	ORAL	800 mg in 1 1	1/19/2022
Sulfamethoxazole and Trimethoprim	Bryant Ranch Prepack	71335-1309	ORAL	800 mg in 1 1	6/29/2021
Sulfamethoxazole and Trimethoprim	Asclemed USA, Inc.	76420-064	ORAL	800 mg in 1 1	9/4/2020
Sulfamethoxazole and Trimethoprim	Bryant Ranch Prepack	63629-1765	ORAL	800 mg in 1 1	9/21/2022
Sulfamethoxazole and Trimethoprim	Major Pharmaceuticals	0904-2725	ORAL	800 mg in 1 1	2/8/2024
Sulfamethoxazole and Trimethoprim	State of Florida DOH Central Pharmacy	53808-0914	ORAL	800 mg in 1 1	8/19/2010
Sulfamethoxazole and Trimethoprim	St. Mary's Medical Park Pharmacy	60760-069	ORAL	800 mg in 1 1	5/12/2022
Sulfamethoxazole and Trimethoprim	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	HOVID BHD, HOVID Bhd.	SIN02308P	TABLET	400.00 mg	8/30/1988
B.S. SUSPENSION	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	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
No NMPA approvals found for this drug.

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	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	9/5/1991

Health Canada Drug Approvals

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Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SEPTRA INJECTION	Aspen Pharmacare Canada Inc.	00550086	Solution - Intravenous	80 MG / ML	12/31/1982
BACTRIM ROCHE SUSPENSION PAEDIATRIC	Hoffmann-La Roche Limited	00272485	Suspension - Oral	200 MG / 5 ML	12/31/1973
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS	d.c. labs limited	00516767	Tablet - Oral	800 MG	12/31/1980
ROUBAC TAB 80/400	rougier pharma division of ratiopharm inc	00529141	Tablet - Oral	400 MG / TAB	12/31/1982
ROUBAC TAB 160/800	rougier pharma division of ratiopharm inc	00529168	Tablet - Oral	800 MG / TAB	12/31/1982
APO SULFAMETHOXAZOLE TAB 500MG	Apotex Inc	00421480	Tablet - Oral	500 MG	12/31/1978
TRISULFA DS TAB	jaapharm canada inc.	00885932	Tablet - Oral	800 MG	12/31/1991
SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP	auro pharma inc	02525917	Solution - Intravenous	80 MG / ML	6/26/2023
BACTRIM DS ROCHE TAB	Hoffmann-La Roche Limited	00371823	Tablet - Oral	800 MG	12/31/1976
SEPTRA DS TABLETS	GlaxoSmithKline Inc	00368040	Tablet - Oral	800 MG	12/31/1976

CIMA AEMPS Drug Approvals

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Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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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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