meropenem
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Meropenem is a broad-spectrum carbapenem antibiotic administered intravenously for the treatment of various bacterial infections. It has activity against both Gram-positive and Gram-negative aerobic and anaerobic bacteria. Meropenem is primarily excreted unchanged by the kidneys and dosage must be adjusted based on renal function. Common adverse effects include headache, nausea, vomiting, diarrhea and hypersensitivity reactions.
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meropenem
- 2. TABLE OF CONTENTS 01 02 03 04 Description Indications About it Spectrum of activity
- 4. Description Meropenem for injection is a sterile, pyrogen-free, synthetic, carbapenem antibacterial drug for intravenous administration. It belongs to Beta lactam antibiotics and exerts its bactericidal activity by inhibiting bacterial cell wall synthesis in Gram-positive and Gram-negative bacteria through binding to penicillin-binding proteins (PBPs). Peak tissue time : 1 hr after infusion Distribution : Meropenem has been shown to penetrate well into several body fluids and tissues: including lung, bronchial secretions, bile, cerebrospinal fluid, gynecological tissues, skin, fascia, muscle, and peritoneal exudates. Elimination : Meropenem is primarily ( 70%) excreted unchanged by the kidneys. Half-Life : 1 – 1.5 hr in normal renal function 1.9 – 3.3 hr in Cr.cl. 30-80 ml/min 3.8 – 5.7 hr in Cr.Cl 2 – 30 ml/min
- 5. Spectrum of activity $ Species that show natural intermediate susceptibility £ All methicillin-resistant staphylococci are resistant to meropenem † Resistance rate≥ 50% in one or more EU countries. 02
- 6. Gram-positive aerobes Enterococcus faecalis$ Staphylococcus aureus (methicillin-susceptible)£ Staphylococcus species (methicillin-susceptible) including Staphylococcus epidermidis Streptococcus agalactiae (Group B) Streptococcus milleri group (S. anginosus, S. constellatus, and S. intermedius) Streptococcus pneumoniae Streptococcus pyogenes (Group A) Gram-negative aerobes Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Neisseria meningitides Proteus mirabilis Proteus vulgaris Serratia marcescens
- 7. Gram-positive anaerobes Clostridium perfringens Peptoniphilus asaccharolyticus Peptostreptococcus species Gram-negative anaerobes Bacteroides caccae Bacteroides fragilis group Prevotella bivia Prevotella disiens
- 8. Species for which acquired resistance may be a problem Gram-positive aerobes Enterococcus faecium $† Gram-negative aerobes Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa Inherently resistant organisms Gram-negative aerobes Stenotrophomonas maltophilia Legionella species Other micro-organisms Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetii Mycoplasma pneumonia
- 10. 500mg – 1g q8hr 1g q8hr 2g q8hr - Severe pneumonia including hospital and ventilator- associated pneumonia. - Complicated UTIs - Complicated intra-abdominal infections - Intra- and post-partum infections - Complicated skin and soft tissue infections Management of febrile neutropenic patients -Broncho-pulmonary infections in cystic fibrosis -Acute bacterial meningitis
- 11. Dose modification according to Cr.Cl 10-25 half of one unit dose q 12 hr half of one unit dose every 24 hours one unit dose q 12 hr <10 26-50
- 12. About it Contraindications of meropenem : 1. Hypersensitivity to the active substance or to any of the excipients 2. Hypersensitivity to any other carbapenem or beta lactam antibacterial agent. 3. Contraindicated where the administration of sodium or chloride could be clinically detrimental. (Each ml of reconstituted solution contains 50 mg Meropenem. ) Hepatic function monitoring 1. Hepatic function should be closely monitored during treatment with meropenem due to the risk of hepatic toxicity (hepatic dysfunction with cholestasis and cytolysis) 2. Use in patients with liver disease: patients with pre-existing liver disorders should have liver function monitored during treatment with meropenem. There is no dose adjustment necessary
- 13. Direct antiglobulin test (Coombs test) seroconversion A positive direct or indirect Coombs test may develop during treatment with meropenem. Drug-Drug interactions : 1. valproic acid/sodium valproate/valpromide 2. Probenecid 3. BCG , Typhoid , choera vaccines Pregnancy 1. There are no or limited amount of data from the use of meropenem in pregnant women. 2. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
- 14. Stability : Meropenem injection, powder, for solution : Freshly prepared solutions of Meropenem should be used. However, re-constituted solutions of Meropenem maintain satisfactory potency under the conditions described below. Solutions of intravenous Meropenem should not be frozen. 1. Intravenous Bolus Administration: Meropenem injection vials re-constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F). 2. Intravenous Infusion Administration: Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F). 3. Solutions prepared for infusion (Meropenem concentrations ranging from 1 mg/mL to 20 mg/mL) re-constituted with Dextrose Injection 5% should be used immediately.
- 15. Adverse events Headache Nausea & vomiting Constipation OR Diarrhea Hypersensitivity Seizures Thrombocytopenia