MEROPENEM-AFT

What it is

MEROPENEM-AFT is a powder for intravenous injection or infusion containing meropenem as trihydrate, available in strengths of 500 mg or 1 g. It is presented as a white to light yellow crystalline powder for injection.

Approved indications

MEROPENEM-AFT is indicated for treatment of the following infections in adults and children aged 3 months and over, when the causative organisms are known or suspected to be resistant to commonly used antibiotics: — Community acquired lower respiratory tract infection — Hospital acquired lower respiratory tract infection — Complicated urinary tract infection — Febrile neutropenia — Intra-abdominal and gynaecological (polymicrobial) infections — Complicated skin and skin structure infections — Meningitis — Septicaemia

Dosing overview

The usual adult dose is 500 mg to 1 g by intravenous administration every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. For febrile episodes in neutropenic patients, the dose should be 1 g every 8 hours. For meningitis, the dose should be 2 g every 8 hours. MEROPENEM-AFT should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes. Dosage should be reduced in patients with creatinine clearance less than 51 mL/min: for creatinine clearance 26–50 mL/min, one unit dose every 12 hours; for 10–25 mL/min, one-half unit dose every 12 hours; for less than 10 mL/min, one-half unit dose every 24 hours. For infants and children over 3 months and up to 12 years of age the recommended intravenous dose is 10 to 40 mg/kg every 8 hours depending on type and severity of infection, the known or suspected susceptibility of the pathogen(s) and the condition of the patient. For febrile episodes in neutropenic patients, the dose should be 20 mg/kg every 8 hours. For meningitis, the dose should be 40 mg/kg every 8 hours.

Key safety warnings

Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving therapy with β-lactams, particularly in persons with a history of sensitivity to multiple allergens. There have been reports of patients with a history of penicillin hypersensitivity who have experienced severe hypersensitivity when treated with another β-lactam. Before initiating treatment with meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, or other β-lactam antibiotics. Serious hypersensitivity reactions may require adrenaline and other emergency measures. Rhabdomyolysis has been reported with the use of meropenem. If signs or symptoms of rhabdomyolysis are observed, meropenem should be discontinued and appropriate therapy initiated. Pseudomembranous colitis has been reported with meropenem as with practically all antibiotics and may vary in severity from slight to life-threatening. Antibiotics should be prescribed with care for individuals with a history of gastrointestinal complaints, particularly colitis. It is important to consider the diagnosis of pseudomembranous colitis in the case of patients who develop diarrhoea when using an antibiotic. Severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, erythema multiforme and acute generalised exanthematous pustulosis have been reported in patients receiving meropenem. If signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately and an alternative treatment should be considered. The concomitant use of valproic acid/sodium valproate and MEROPENEM-AFT is not recommended because meropenem may reduce serum valproic acid levels, with subtherapeutic levels being reached in some patients.

Contraindications

MEROPENEM-AFT is contraindicated in patients who have demonstrated hypersensitivity to this product.

Regulatory history

MEROPENEM-AFT 500 mg powder for injection vial (ARTG 384155) and 1000 mg powder for injection vial (ARTG 384153) were first listed on the ARTG on 19 June 2024.