I-Penam 250 mg/vial (IV Injection or Infusion)
Medicine Details
Category | Details |
---|---|
Generic | Meropenem trihydrate |
Company | Incepta pharmaceuticals ltd |
Also available as |
Indications
- Pneumonia and Nosocomial Pneumonia
- Urinary Tract Infections
- Intra-abdominal Infections
- Gynaecological Infections
- Skin and Skin Structure Infections
- Meningitis
- Septicaemia
- Pulmonary infections in cystic fibrosis
- Empiric treatment for presumed infections in patients with febrile neutropenia
Pharmacology
Meropenem is a carbapenem antibiotic for parenteral use. It exerts its bactericidal action by interfering with bacterial cell wall synthesis. It penetrates bacterial cell walls, its high level of stability to all serine beta-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria.
Dosage
- Adults:
- 500 mg to 1 gm by intravenous administration every 8 hours
- Pneumonia, urinary tract infections, gynaecological infections such as endometritis, pelvic inflammatory disease, skin and skin structure infections: 500 mg IV every 8 hours
- Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: 1 g IV every 8 hours
- Intra-abdominal infections: 500 mg to 1 gm every 8 hours
- Cystic fibrosis: Upto 2 gm every 8 hours
- Meningitis: 2 gm IV every 8 hours
- Children:
- 3 months to 12 years: 10 to 40 mg/kg intravenously every 8 hours depending on type and severity of infection, susceptibility of the pathogens and the condition of the patient
- Intra-abdominal infections: 20 mg/kg every 8 hours
- Cystic fibrosis (4-18 years): 25-40 mg/kg every 8 hours
- Meningitis: 40 mg/kg IV every 8 hours
- Febrile neutropenia: 20 mg/kg every 8 hours
- Children over 50 kg weight: use adult dosage
- There is no experience in children with hepatic or renal impairment
Administration
Meropenem should be administered by intravenous Infusion over approximately 15-30 minutes or as intravenous bolus (5 to 20 ml) over approximately 3-5 minutes
Interaction
- Probenecid competes with I-Penam for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem
- I-Penam 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
- Inflammation
- Thrombophlebitis
- Pain at the site of injection
- Skin reactions like rash, pruritus, urticaria
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Headache
Pregnancy & Lactation
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Because many drugs are excreted in human milk, caution should be exercised when Meropenem is administered to a nursing woman.
Precautions & Warnings
If an allergic reaction to I-Penam occurs, the drug should be discontinued and appropriate measures taken. Use of I-Penam in patients with hepatic disease should be made with careful monitoring of transaminase and bilirubin levels
Use in Special Populations
- Renal impairment: Dosage should be reduced in patients with creatinine clearance less than 51 ml/min
- Hepatic impairment: No dosage adjustments are necessary with impairment of liver function. Hemodialysis patients should receive I-Penam after dialysis has been completed
- Elderly: No dosage adjustments are necessary in elderly patients unless creatinine clearance is <51 ml/min
- Use in Children: Efficacy and tolerability in infants under 3 months have not been established
Overdose Effects
Accidental overdose could occur during therapy, particularly in patients with renal impairment. Treatment of overdose should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove I-Penam and its metabolite
Therapeutic Class
Other beta-lactam Antibiotics
Reconstitution
Preparation of solution for Intravenous bolus administration and Intravenous infusion administration
Storage Conditions
Vial store in a cool, dry place (below 30°C), away from light & moisture. Keep out of the reach of children
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