IBIMICYN

What it is

IBIMICYN is ampicillin (as sodium) powder for injection, available in 500 mg and 1 g vial strengths. It is supplied as a white to almost white powder for injection. IBIMICYN may be given by intramuscular injection, by intravenous infusion or by slow intravenous injection.

Approved indications —

Treatment of infections due to susceptible strains of Gram-positive and Gram-negative organisms

Dosing overview

Respiratory tract infections in adults are dosed at 250 to 500 mg six hourly; in children, 25 to 50 mg/kg/day in equally divided doses six hourly. Chronic bronchitis in adults is treated with 500 mg six hourly, or 1 g six hourly for high dosage therapy. Urinary tract infections in adults require 500 mg six hourly; in children, 50 mg/kg/day in equally divided doses six hourly. Gastrointestinal tract infections in adults are dosed at 500 to 750 mg six hourly; in children, 50 to 70 mg/kg/day in equally divided doses six hourly. For bacterial meningitis and septicaemia in adults and children, the dose is 200 mg/kg/day in equally divided doses four to six hourly, intravenously, with an upper limit of 12 g daily. The usual duration of therapy is 5 to 10 days, with treatment continued for a minimum of 48 to 72 hours beyond the time the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

Key safety warnings

Severe cutaneous adverse reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalised exanthematous pustulosis have been reported in patients taking beta-lactam antibiotics. When such reactions are suspected, IBIMICYN should be discontinued immediately and alternative treatment considered. Serious and occasionally fatal hypersensitivity reactions including anaphylaxis have been reported with beta-lactam antibiotics, with anaphylaxis more frequent following parenteral therapy. Before commencing therapy, careful enquiries should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If hypersensitivity occurs, IBIMICYN should be discontinued and appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Antibiotic-associated pseudomembranous colitis has been reported with ampicillin, with severity ranging from mild to life-threatening. This diagnosis should be considered in patients developing diarrhoea or colitis in association with antibiotic use, which may occur up to several weeks after cessation of therapy. Encephalopathy can occur when ampicillin blood level reaches 800 mg/L. As the blood-brain barrier becomes more permeable in meningitis, toxic symptoms may be precipitated by lower levels, resulting in drowsiness, hyper-reflexia, myoclonic twitches, convulsions and coma.

Contraindications

IBIMICYN should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics, including penicillins and cephalosporins.

Regulatory history

IBIMICYN ampicillin 1 g powder for injection vial was first listed on the ARTG on 20 February 2003, and IBIMICYN ampicillin 500 mg powder for injection vial was also first listed on 20 February 2003.