A) Adults: The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patient. The recommended daily dosage is as follows: In the treatment of pneumonia, UTI, gynaecological infections such as endometritis, skin and skin structure infections- 500 mg IV every 8 hours. In the treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicaemia- 1 g IV every 8 hours. In cystic fibrosis- doses up to 2 g every 8 hours. In meningitis- 2 g every 8 hours. Exceptions: 1. Febrile episodes in neutropenic patients – the dose should be 1 g every 8 hours. 2. Meningitis – the dose should be 2 g every 8 hours. As with other antibiotics caution may be required in using Meropenem as monotherapy in critically ill patients with known or suspected Pseudomonas aeruginosa lower respiratory tract infections. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infections. Meropenem should be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes. Dosage Schedule for Adults with Impaired Renal Function: Dosage should be reduced in patients with creatinine clearance less than 51 mL/min, as scheduled below: Table-1 Use in Adults with Hepatic Insufficiency: No dosage adjustment is necessary in patients with impaired hepatic metabolism. B) Elderly: No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 mL/min. C) Children: For infants and children under 3 months: The efficacy and safety for infants and children under 3 months have not been established, therefore not recommended for such group of patients. 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. In children over 50 kg weight, adult dosage should be used. 4 years to 18 years with cystic fibrosis: 25 to 40 mg/kg every 8 hours. Exceptions: 1. Febrile episodes in neutropenic patients – the dose should be 20 mg/kg every 8 hours. 2. Meningitis the dose should be 40 mg/kg every 8 hours. Meropenem should be given as an IV bolus over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes. There is no experience in children with renal impairment.

Side Effects

Meropenem is generally well tolerated. Adverse events rarely lead to cessation of treatment. Serious adverse events are rare. The following adverse events may occur: inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria etc, abdominal pain, nausea, vomiting, diarrhoea,headache, paraesthesiae.

Contraindications

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

Drug Interactions

Probenecid competes with Meropenem for active tubular secretion and thus inhibits the renal excretion of Meropenem with the effect of increasing the elimination half-life and plasma concentration of Meropenem. So, co-administration of Probenecid with Meropenem is not recommended. The potential effect of Meropenem on the protein binding of other medicines or metabolism has not been studied. However, the protein binding is so low (approximately 2%) that no interactions with other compounds would be expected on the basis of this mechanism. Meropenem has been administered concomitantly with many other medications without apparent adverse interaction. Meropenem may reduce serum Valproic acid levels. Subtherapeutic levels may be reached in some patients. However, no specific drug interaction studies other than with Probenecid were conducted.

Precautions

As with all beta-lactam antibiotics, rare hypersensitivity reactions have been reported. Before initiating therapy with Meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures should be taken. Use in infections caused by Methicillin resistant staphylococci is not recommended. The co-administration of Meropenem with potentially nephrotoxic drugs should be considered with caution. Rarely, pseudomembranous colitis has been reported with Meropenem as with virtually all antibiotics; therefore, its diagnosis should be considered in patients who develop diarrhoea in association with the use of Meropenem. Use in children: Efficacy and tolerability in infants under 3 months old have not been established; therefore, Meropenem is not recommended for use below this age. Use in patients with liver disease: Patients with pre-existing liver disorders should have liver function monitored during treatment with Meropenem. Use in pregnancy: The safety of Meropenem in human pregnancy has not been established, although animal studies have not shown an adverse effect on the developing foetus. Meropenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. Use in lactation: Meropenem is detectable at very low concentrations in animal breast milk. Meropenem should not be used in breast-feeding women unless the potential benefit justifies the potential risk to the baby.