CLOXACILLIN SODIUM FOR INJECTION BP 1g I.M./I.V. COMPOSITION: Each vial contains cloxacillin sodium dry powder, equivalent to 1 g or 500mg cloxacillin. USES: Cloxacillin is an antibacterial of the penicillin group, acting particularly on penicillinase-producing staphylococci. It is used in the treatment of infections of staphylococci resistant to benzylpenicillin: • chronic osteomyelitis • pulmonary staphylococcal infections of the new-born • infections of soft tissues (abscesses) and skin DOSAGE: Adults: By intramuscular injection: 250 mg every 4 - 6 hours. By slow intravenous injection, over 3 to 4 minutes, or by infusion: 1 - 2 g every 6 hours (depending on severity of the infection). Children up to 2 years: One quarter of the adult dose Children 2 to 10 years: One-half the adult dose Doses may be doubled in severe infections, maximum daily dose is 8 g. A full course of antibiotic therapy of 7 days must be completed. Change to oral treatment as soon as possible. Preparation: Intramuscular dissolve 500 mg powder in 2 ml water for injection. Intravenousdissolve 500 mg powder in 5 - 7 ml water for injection. PREGNANCY AND BREAST FEEDING: Cloxacillin can be used during pregnancy and lactation. CONTRA-INDICATIONS AND WARNINGS: Do not use in case of hypersensitivity to penicillins. Caution with hypersensitivity to cefalosporins. When allergic reactions occur, treatment must be discontinued immediately. In patients with severely impaired renal function dose should be reduced. Concurrent administration of probenecid leads to a decreased renal excretion of cloxacillin, and dose reduction may be necessary. Patients who have syphilis have occasionally suffered from a type of reaction (Jarisch-Herxheimer reaction) after the injection, with fever, chills, headache and heart problems. Cholestatic jaundice may occur up to several weeks after treatment has been stopped. Older patients and those receiving cloxacillin for more than 2 weeks are at increased risk. SIDE EFFECTS: Acute allergic reactions against penicillins may occur. Gastro-intestinal upsets (e.g. nausea, diarrhoea) and skin rashes have been reported infrequently. If a skin rash occurs, treatment should be discontinued. OVERDOSAGE: Overdosage is not likely to occur, but if encountered should be treated symptomatically. STORAGE: Store below 25°C. Use only freshly prepared solutions.