Each vial contains: Meropenem trihydrate IP equivalent to anhydrous meropenem 1g, Sulbactam Sodium USP equivalent to Sulbactam 0.5 gm.
Indicated for the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only.
Meropenem is a broad-spectrum carbapenem antibiotic. The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets. Its strongest affinities are toward PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa and PBPs 1, 2, and 4 of Staphylococcus aureus. Sulbactam is a synthetic beta-lactamase inhibitor. A feature that distinguishes sulbactam from other available beta-lactamase inhibitors is its direct antimicrobial activity against the Acinetobacter species and Bacteriodes fragilis.
IV bolus injection over approximately five minutes, or by IV infusion over approximately 15-30 minutes, using the specific available diluents, every eight hours.
If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Seizures and other CNS experiences have been reported during treatment. Co-administration of Meropenem with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. Clostridium difficle-asssociated diarrhoea has been reported. Patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem.
Pregnancy Category B. has been reported to be excreted in human milk. Caution should be exercised when meropenem is administered to a nursing woman. The safety and effectiveness of meropenem have been established for paediatric patients 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for paediatric patients of all ages with complicated intra-abdominal infections.
The co-administration of probenecid with meropenem I.V. is not recommended. If administration of meropenem I.V. is necessary, then supplemental anti-convulsant therapy should be considered.
Inflammation at the injection site, thrombophlebitis, injection site reaction, pain at the injection site, and oedema at the injection site. diarrhoea, nausea/vomiting, headache, rash, sepsis, constipation, apnoea, shock and pruritus.