MEROPENEM RANBAXY

What it is

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

Approved indications

Meropenem 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

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, with adjustments based on renal function. No dosage adjustment is necessary in patients with impaired hepatic metabolism. No dosage adjustment is required for elderly patients with normal renal function or creatinine clearance values above 50 mL/min.

Key safety warnings

Serious and occasionally fatal hypersensitivity reactions have been reported in patients receiving therapy with β-lactams, and these reactions are more likely to occur 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, and careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, or other β-lactam antibiotics before initiating treatment. Rhabdomyolysis has been reported with the use of meropenem, and if signs or symptoms of rhabdomyolysis are observed, meropenem should be discontinued and appropriate therapy initiated. Pseudomembranous colitis has been rarely reported with meropenem and may vary in severity from slight to life-threatening, therefore antibiotics should be prescribed with care for individuals with a history of gastrointestinal complaints, particularly colitis. 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, and if signs and symptoms suggestive of these reactions appear, meropenem should be withdrawn immediately. The concomitant use of valproic acid/sodium valproate and Meropenem-AFT is not recommended as meropenem may reduce serum valproic acid levels, with subtherapeutic levels reached in some patients.

Contraindications

Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

Regulatory history

Meropenem-AFT was first registered on the Australian Register of Therapeutic Goods on 19 June 2014, with both 500 mg and 1 g powder for injection formulations registered.