Indications
Meropenem IV is indicated for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to meropenem.
Pneumonia and Nosocomial Pneumonia
Urinary Tract Infections
Intra-abdominal Infections
Gynaecological Infections, such as endometritis and pelvic inflammatory disease
Skin and Skin Structure Infections
Meningitis
Septicaemia
Empiric treatment, for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with anti-viral or anti-fungal agents.
Therapeutic Class
Other beta-lactam Antibiotics
Pharmacology
Meropenem is a carbapenem antibiotic for parenteral use. It is structurally similar to imipenem but is stable to human dehydropeptidase-1 (DHP-1). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria as it can penetrates bacterial cell wall excellently, it has high level of stability to all serine ß-lactamases and it has marked affinity for the Penicillin Binding Proteins (PBPs).
Dosage & Administration
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 infection. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection. Meropenem should be given as an intravenous bolus injection over approximately 3-5 minutes or by intravenous infusion over approximately 15 to 30 minutes using the specific available presentations.
Adults-
The dosage and duration of therapy should be established depending on type and severity of infection and the condition of the patient. The recommended daily dosage of adult is as follows:
Pneumonias, Urinary tract infections, gynaecological infections such as endometritis and pelvic inflammatory disease; skin and skin structure infections: Meropenem 500 mg IV every 8 hours
Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: Meropenem 1 g IV every 8 hours
Meningitis: Meropenem 2 g IV every 8 hours
Cystic fibrosis: Meropenem IV up to 2 g every 8 hours
Use in children:
Children 0 to 3 months: Efficacy and tolerability in children under 3 months old have not been established; therefore Meropenem is not recommended.
For children over 3 months to 12 years of age: The recommended dose of Meropenem IV is 10 to 20 mg/kg every 8 hours depending on type and severity of infection, susceptibility of the pathogen and the condition of the patient.
For children aged 4 to 18 years with cystic fibrosis: The doses ranging of Meropenem IV is 25 to 40 mg/kg every 8 hours.
In children 50 kg weight: Adult dosage should be used.
In meningitis: The recommended dose of Meropenem IV is 40 mg/kg every 8 hours.
There is no experience in children with hepatic or renal impairment.
Elderly patients: No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.
Interaction
Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.
Contraindications
Meropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.
Side Effects
Meropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhoea, headache, parasthesiae may occur.
Pregnancy & Lactation
The safety of Meropenem in human pregnancy has not been evaluated. Animal studies have not shown any adverse effect on the developing foetus. Meropenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. Meropenem is detectable at very low concentrations in animal breast milk. It should be used in lactating women unless the potential benefit justifies the potential risk to the baby.
Precautions
Caution in patients with history of hypersensitivity to carbapenems or other β-lactam antibiotics. Before initiating therapy with Meropenem, careful inquiry should be made concerning previous hypersensitivity reactions to β-lactam antibiotics. If an allergic reaction to Meropenem occurs, the drug should be discontinued and appropriate measures should be taken. Monitor transaminase and bilirubin levels when used in hepatic disease. Not recommended for methicillin-resistant staphylococci infections. Monitor for overgrowth of non susceptible organisms. In patients who develop diarrhoea, consider diagnosis of pseudomembranous colitis. Caution in individuals with a history of gastro-intestinal complaints, particularly colitis. Caution if to be co-administered with potentially nephrotoxic drugs. Co-administration with probenicid not recommended. Meronem may reduce serum valproic acid levels, sub-therapeutic levels may occur. No specific drug interaction data are available. Caution when used as monotherapy for known or suspected Pseudomonas aeruginosa lower respiratory tract infections, regular sensitivity testing is recommended.
Overdose Effects
Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove meropenem and its metabolite.
Use in Special Population
Renal Impairment:
CrCl 10-25: Half the usual dose 12 hrly.
CrCl 26-50: Usual dose 12 hrly.
Meropenem is cleared by haemodialysis; if continued treatment with Meropenem is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations. There is no experience with the use of Meropenem in patients under peritoneal dialysis.
Hepatic Impairment: No dosage adjustment needed.
Reconstitutions
The content of one vial is to be dissolved in 10 ml water for injection for Meropenem 500 mg IV injection and 20 ml water for injection for Meropenem 1 gm IV injection.
Preparation for injection:
Bolus: Meropenem 500 mg IV injection vials should be constituted with 10 ml sterile water for injections /Meropenem 1g IV injection vials should be constituted with 20 ml sterile water for injections (5 ml per 250 mg meropenem). This provides an approximate concentration of 50 mg/ml. Injection for bolus administration, may be stored for up to 2 hours at controlled room temperature 25°C or for up to 12 hours at 4°C.
Infusion: Meropenem (500 mg and 1 gm) IV injection vials may be directly constituted with a compatible infusion fluid (50 to 200 ml). Alternatively, an injection vial may be constituted, then the resulting solution added to an IV container and further diluted with an appropriate infusion fluid, as needed.
Storage Conditions
Store in a cool and dry place (below 30° C). It is recommended to use freshly prepared solutions of Meropenem for IV injection and infusion. Reconstituted product should be used immediately and must be stored for no longer than 24 hours under refrigeration, only if necessary.
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