Trimethoprim

Overview

Trimethoprim is an antifolate antibacterial agent that inhibits bacterial dihydrofolate reductase (DHFR), a critical enzyme that catalyzes the formation of tetrahydrofolic acid (THF) - in doing so, it prevents the synthesis of bacterial DNA and ultimately continued bacterial survival. Trimethoprim is often used in combination with sulfamethoxazole due to their complementary and synergistic mechanisms but may be used as a monotherapy in the treatment and/or prophylaxis of urinary tract infections. It is structurally and chemically related to pyrimethamine, another antifolate antimicrobial used in the treatment of plasmodial infections.

Indication

As a monotherapy, trimethoprim is indicated for the treatment of acute episodes of uncomplicated urinary tract infections caused by susceptible bacteria, including E. coli., K. pneumoniae, Enterobacter spp., P. mirabilis, and coagulase-negative Staphylococcus species. In various formulations in combination with sulfamethoxazole, trimethoprim is indicated 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. Trimethoprim is available as an ophthalmic solution in combination with polymyxin B for the treatment of acute bacterial conjunctivitis, blepharitis, and blepharoconjunctivitis caused by susceptible bacteria.

Associated Conditions

Acute Exacerbation of Chronic Bronchitis (AECB) caused by susceptible bacteria
Acute Otitis Media caused by susceptible bacteria
Bacterial Conjunctivitis caused by susceptible bacteria
Blepharoconjunctivitis caused by susceptible bacteria
Brucellosis
Dysentery, Bacillary
Nocardiosis
Pneumocystis Jirovecii Pneumonia
Urinary Tract Infection caused by susceptible bacteria
Bacterial blepharitis 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
Uncomplicated Urinary Tract Infection caused by susceptible bacteria

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections	2025/05/21	NCT06982105	Phase 4	Recruiting	Indiana University
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
Folate Study in Men With Advanced Prostate Cancer	2024/08/02	NCT06536374	Phase 2	Not yet recruiting	The University of Texas Health Science Center at San Antonio
Treatment of Pneumocystis in COPD (the TOPIC Study)	2022/06/14	NCT05418777	Phase 1	Terminated	William Beaumont Hospitals
MRSA Decolonization in Complicated Carriage	2022/03/07	NCT05268120	Not Applicable	Recruiting	Leiden University Medical Center
Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.	2020/03/13	NCT04306731	Not Applicable	Completed	University of Sulaimani
TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis	2019/04/18	NCT03919435	Phase 1	Active, not recruiting	University of Pennsylvania
The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine	2018/11/19	NCT03746106	Phase 4	Completed	University of California, San Francisco
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)	2018/04/05	NCT03489629	Phase 2	Active, not recruiting	University of North Carolina, Chapel Hill
Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients	2017/08/01	NCT03235947	Phase 4	Completed	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-5679	ORAL	160 mg in 1 1	6/29/2021
Sulfamethoxazole and Trimethoprim	Aurobindo Pharma Limited	65862-496	ORAL	40 mg in 5 mL	3/12/2024
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-2198	ORAL	160 mg in 1 1	6/3/2021
Sulfamethoxazole and Trimethoprim	NuCare Pharmaceuticals,Inc.	68071-4431	ORAL	160 mg in 1 1	2/16/2021
SULFAMETHOXAZOLE AND TRIMETHOPRIM double strength	New Horizon Rx Group, LLC	58517-140	ORAL	160 mg in 1 1	12/30/2013
Sulfamethoxazole and Trimethoprim	Department of State Health Services, Pharmacy Branch	55695-008	ORAL	160 mg in 1 1	3/11/2016
Trimethoprim	Mayne Pharma	51862-486	ORAL	100 mg in 1 1	2/16/2021
Sulfamethoxazole and Trimethoprim	AvKARE	42291-758	ORAL	80 mg in 1 1	1/10/2024
Sulfamethoxazole and Trimethoprim	A-S Medication Solutions	50090-6901	ORAL	160 mg in 1 1	12/27/2022
Sulfamethoxazole and Trimethoprim	Redpharm Drug	67296-1904	ORAL	160 mg in 1 1	11/27/2023

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
APO-SULFATRIM PEDIATRIC TABLET	APOTEX INC	SIN00508P	TABLET	20 mg	4/28/1988
MORTIN TABLET	MICRO LABS LTD	SIN10251P	TABLET	80 mg	10/10/1998
MORTIN-DS TABLET	MICRO LABS LTD	SIN10250P	TABLET	160 mg	10/10/1998
APO-SULFATRIM TABLET	APOTEX INC	SIN00435P	TABLET	80 mg	4/27/1988
SUPRIM B.P. 480 TABLET	HOVID BHD, HOVID Bhd.	SIN02308P	TABLET	80.00 mg	8/30/1988
B.S. SUSPENSION	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN00526P	SUSPENSION	40 mg/5 ml	4/28/1988
CO-TRIMEXAZOLE SUSPENSION	BEACONS PHARMACEUTICALS PTE LTD	SIN00583P	SUSPENSION	40 mg/5 ml	4/29/1988
SUPRIM SUSPENSION	HOVID BHD	SIN01417P	SUSPENSION	40 mg/5 ml	5/20/1988
B.S. TABLET	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	SIN00960P	TABLET	80 mg	5/10/1988
DBL SULFAMETHOXAZOLE 400MG AND TRIMETHOPRIM 80MG CONCENTRATE INJECTION BP	Siegfried Hameln GmbH	SIN02183P	INJECTION	16mg/mL	6/30/1988

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	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
TRIMETHOPRIM-WGR trimethoprim 300 mg tablet bottle	431671	GM Pharma International Pty Ltd	Medicine	A	5/31/2024
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

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLETS	d.c. labs limited	00516759	Tablet - Oral	80 MG	12/31/1980
COPTIN TAB	Pfizer Canada Ulc	00478717	Tablet - Oral	90 MG / TAB	12/31/1979
TRIMETHOPRIM TABLETS	aa pharma inc	02243117	Tablet - Oral	200 MG	7/30/2001
SULFAMETHOXAZOLE AND TRIMETHOPRIM FOR INJECTION, USP	eugia pharma inc.	02534746	Solution - Intravenous	16 MG / ML	N/A
APO-SULFATRIM ORAL SUSPENSION	Apotex Inc	00846465	Suspension - Oral	8 MG / ML	12/31/1989
SEPTRA	GlaxoSmithKline Inc	00270636	Tablet - Oral	80 MG	12/31/1973
BACTRIM ROCHE INJ	Hoffmann-La Roche Limited	00550078	Liquid - Intravenous	16 MG / ML	12/31/1981
TRISULFA TAB	jaapharm canada inc.	00885924	Tablet - Oral	80 MG	12/31/1991
TRIMETHOPRIM TABLETS	aa pharma inc	02243116	Tablet - Oral	100 MG	1/1/2001
TEVA-TRIMEL	teva canada limited	00510637	Tablet - Oral	80 MG	12/31/1981

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	Faes Farma S.A.	33618	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized
OTIX GOTAS OTICAS EN SOLUCIÓN	M4 Pharma S.L.	59381	GOTAS ÓTICAS EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
SOLTRIM 160MG/ 800MG POLVO Y SOLUCION PARA SOLUCION INYECTABLE	Almirall S.A.	54920	POLVO Y SOLUCIÓN PARA SOLUCIÓN INYECTABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
TEDIPRIMA 160 MG CÁPSULAS DURAS	Laboratorio Estedi S.L.	52548	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
TEDIPRIMA 16 MG/ML SUSPENSIÓN ORAL	Laboratorio Estedi S.L.	52547	SUSPENSIÓN ORAL	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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