Company: Clonmel Healthcare Ltd.
Legal category: Prescription. Sport permitted.
Active ingredient: Meropenem 500mg, 1g.
Description: Powder for solution for injection or infusion.
Presentation: 500mg-10, €79.30; 1g-10, €158.65.
Indications: Treatment of pneumonia, broncho-pulmonary infections in cystic fibrosis; complicated urinary tract, intra-abdominal, skin and soft tissue infections; intra- and post-partum infections, acute bacterial meningitis. Management of febrile neutropenia.
Pharmacology: Meropenem exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins.
Dosage: Adult: Usually 500mg or 1g by intravenous infusion over 15 to 30 minutes every 8 hours. Doses ≤ 1g may be given as intravenous bolus injection over 5 minutes. Nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.: ≤ 2g. Broncho-pulmonary infections in cystic fibrosis, meningitis: 2g. Febrile neutropenia: 1g. Renal impairment: Administer after completion of haemodialysis cycle. Unit dose = Dose advised above. Creatinine clearance (cc) 26-50ml/min, one unit dose every 12 hours; cc 10-25ml/min, half of one unit dose every 12 hours; cc <10ml/min, half of one unit dose every 24 hours. Elderly: As per adults. Children: Over 12 years or 50kg body weight, as per adults. 3 months to 11 years and ≤ 50kg body weight, usually 10 or 20mg/kg body weight by intravenous infusion over 15 to 30 minutes every 8 hours. Doses ≤20mg/kg may be given as intravenous bolus injection over 5 minutes. Nosocomial infections due to Pseudomonas aeruginosa or Acinetobacter spp.: ≤ 40mg/kg. Broncho-pulmonary infections in cystic fibrosis, meningitis: 40mg/kg. Febrile neutropenia: 20mg/kg. Under 3 months, safety and efficacy not established; 20mg/kg every 8 hours may be used.
Contraindications: Hypersensitivity to the active substance, to any of the excipients or to any other carbapenem antibacterial agent. Severe hypersensitivity to any other type of betalactam antibacterial agent (e.g. penicillins or cephalosporins).
Special precautions: Reported: Antibiotic-associated colitis, pseudomembranous colitis, seizures. Monitor hepatic function closely. Pregnancy (avoid), lactation. Contains sodium.
Drug interactions: Not recommended: Valproic acid/sodium valproate. Caution: Probenecid. Oral anti-coagulants.
Adverse drug reactions: Thrombocythaemia, headache, GI upset, increased transaminases, increased blood alkaline phosphatase, increased blood lactate dehydrogenase, rash, pruritus, inflammation, pain.
Full prescribing information and references available from Clonmel Healthcare Ltd. Telephone: (052) 6177777. Fax: (052) 6177791. E-mail: medicalinformation@clonmel-health.ie