Product Dossier
BACTRIM
Product Dossier for BACTRIM (sulfamethoxazole, trimethoprim, Echo Therapeutics). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Echo Therapeutics
- Active ingredient: sulfamethoxazole, trimethoprim
- Therapeutic area: Infectious Disease
- Related brand: ALPRIM
- Related brand: RESPRIM
- Related brand: SEPTRIN
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
BACTRIM contains sulfamethoxazole and trimethoprim as active ingredients. The standard tablet formulation contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim, while the BACTRIM FORTE variant contains 800 mg of sulfamethoxazole and 160 mg of trimethoprim.
Approved indications
— Upper and lower respiratory tract infections. — Renal and urinary tract infections. — Skin and wound infections. — Septicaemias and other infections caused by sensitive organisms.
Dosing overview
For adults and children over 12 years with standard dosage, the recommended dose is 2 BACTRIM tablets or 1 BACTRIM FORTE tablet every 12 hours after meals. For severe infections, the dose is 3 BACTRIM tablets or 1½ BACTRIM FORTE tablets every 12 hours, which is the maximum daily dosage. For patients with documented Pneumocystis jirovecii pneumonitis, the recommended dose is 20 mg/kg trimethoprim and 100 mg/kg sulfamethoxazole per 24 hours given in equally divided doses every six hours for 14 days. In acute infections, trimethoprim/sulfamethoxazole should be given for at least 5 days or until the patient has been symptom-free for 2 days. Dosage adjustment is required for patients with reduced renal function according to serum creatinine levels.
Regulatory history
BACTRIM DS tablet was first registered on the ARTG on 8 July 2009. A concentrate for solution for infusion formulation was registered on 31 August 2022.