SEPTRIN

What it is

SEPTRIN is sulfamethoxazole/trimethoprim, available as tablets containing 800 mg sulfamethoxazole and 160 mg trimethoprim.

Approved indications

— Upper and lower respiratory tract infections. — Renal and urinary tract infections. — Genital tract infections. — Gastrointestinal tract infections. — Skin and wound infections. — Septicaemias and other infections caused by sensitive organisms.

Dosing overview

For adults and children over 12 years of age, the standard dosage is one tablet morning and evening after meals. In acute infections, SEPTRIN should be given for at least five days or until the patient has been symptom-free for two days. The minimum dosage is half a tablet twice daily. The maximum dosage for particularly severe infections is one and a half tablets twice daily. For 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. Dosage adjustment is required for patients with renal impairment, based on creatinine clearance. SEPTRIN should not be used in patients with creatinine clearance below 15 mL/min.

Key safety warnings

Fatalities, although rare, have occurred due to severe reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), fulminant hepatic necrosis, agranulocytosis, aplastic anaemia and other blood dyscrasias. Circulatory shock with fever, severe hypotension, elevated heart rate and confusion requiring intravenous fluid resuscitation and vasopressors has occurred within minutes to hours of re-challenge with SEPTRIN in patients with history of recent exposure to the drug. The incidence of side effects, particularly rash, fever, and leucopenia, with SEPTRIN therapy in AIDS patients who are being treated for Pneumocystis jirovecii pneumonia has been reported to be greatly increased compared with the incidence normally associated with the use of the drug in non-AIDS patients. SEPTRIN can lead in very rare instances to the development of severe colitis as a result of colonisation with C. difficile. The colitis can be fatal. If significant diarrhoea occurs, SEPTRIN should be discontinued. In glucose-6-phosphate dehydrogenase deficient individuals, haemolysis may occur. SEPTRIN should not be given to patients with this deficiency unless absolutely essential, and then only in minimal doses. Close monitoring of serum potassium and renal function is warranted in patients receiving high-dose SEPTRIN, as used in patients with Pneumocystis jirovecii pneumonia, or in patients receiving standard-dose SEPTRIN with underlying disorders of potassium metabolism or renal insufficiency, or who are receiving drugs which induce hyperkalaemia. The use of SEPTRIN in elderly patients carries an increased risk of severe adverse reactions. In rare instances fatalities have occurred. The risk is particularly greater when complicating conditions exist, such as impaired kidney and/or liver function, or concomitant use of other drugs.

Contraindications

SEPTRIN is contraindicated in patients showing marked liver parenchymal damage, blood dyscrasias, megaloblastic bone marrow or severe renal insufficiency, characterised by creatinine clearance less than 15 mL/min. SEPTRIN should not be given to patients with a history of hypersensitivity to the active ingredients or the excipients, or other sulfonamides. SEPTRIN should not be used in the treatment of streptococcal pharyngitis, as clinical studies have documented a greater incidence of bacteriologic failure when treated with this drug than with penicillin. SEPTRIN must not be given in combination with dofetilide. SEPTRIN must not be given to premature babies, nor during the first six weeks of life because of the risk of producing kernicterus.

Regulatory history

SEPTRIN was first approved on 18 August 2005. ARTG registrations for SEPTRIN FORTE (160/800 mg) and SEPTRIN (80/400 mg) tablets and oral liquid formulations were first listed on 1991-08-02 and 1991-09-05 by sponsor Arrotex Pharmaceuticals.