ARTG Entry
RESPRIM
ARTG entry for RESPRIM (sulfamethoxazole), ARTG 17682 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: sulfamethoxazole
- Therapeutic area: Infectious Disease
What it is
RESPRIM contains sulfamethoxazole and trimethoprim as active ingredients. The standard formulation contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim per tablet. RESPRIM FORTE contains 800 mg of sulfamethoxazole and 160 mg of trimethoprim per tablet.
Approved indications RESPRIM is indicated for:
— 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
In acute infections, trimethoprim/sulfamethoxazole should be given for at least 5 days or until the patient has been symptom-free for 2 days. For adults and children over 12 years, the standard dosage is 2 RESPRIM tablets or 1 RESPRIM FORTE tablet every 12 hours after meals. For severe infections, the dose is 3 RESPRIM tablets or 1½ RESPRIM FORTE tablets every 12 hours. 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.
Key safety warnings
Attention should be paid to the folate status of the patient should treatment be prolonged.
Regulatory history
RESPRIM trimethoprim/sulfamethoxazole 80 mg/400 mg tablets and RESPRIM FORTE trimethoprim/sulfamethoxazole 160 mg/800 mg tablets were first listed on the ARTG on 20 September 1991.