Meropenem Trihydrate: Uses,Dosage,Side Effects

Generic Name

Meropenem Trihydrate

Therapeutic Class Anti Bacterial (Other beta-lactam Antibiotics)

Indications:
Meropenem 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
• Gynecological Infections, such as endometritis and pelvic inflammatory disease
• Skin and Skin Structure Infections
• Meningitis
• Septicemia
• Pulmonary infections in cystic fibrosis
• Empiric treatment for presumed infections in patients with febrile neutropenia.

Presentation:
250 mg IV Injection: Each vial contains Meropenem 250 mg (as Meropenem for Injection USP).
500 mg IV Injection: Each vial contains Meropenem 500 mg (as Meropenem for Injection USP).
1 gm IV Injection: Each vial contains Meropenem 1 gm (as Meropenem for Injection USP).

Description:
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 & Administration:
The dosage and duration of therapy shall be established depending on the type, the severity of the infection, and the condition of the patient. The recommended daily dosage is as follows-

Adults:

• The usual dose is 500 mg to 1 gm by intravenous administration every 8 hours.
• Pneumonia, urinary tract infections, gynecological infections such as endometritis, pelvic inflammatory disease, skin, and skin structure infections: 500 mg IV every 8 hours.
• Nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients, and septicemia: 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 an intravenous bolus (5 to 20 ml) over approximately 3-5 minutes

Interaction:
Probenecid competes with Meropenem for active tubular secretion and thus inhibits renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Meropenem may reduce serum valproic acid levels. Subtherapeutic 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, diarrhea, headache may occur.

Pregnancy & Lactation:
Pregnancy Category B. There are no adequate and well-controlled studies on 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 Meropenem occurs, the drug should be discontinued and appropriate measures are taken. Use of Meropenem 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 Meropenem after dialysis has been completed.
• Elderly: No dosage adjustments are necessary for 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:
An 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, hemodialysis will remove Meropenem and its metabolite.

Reconstitution:
Preparation of solution:

• Intravenous bolus Administration: Reconstitute Meropenem (500 mg or 1 g) with sterile water for injection. Shake to dissolve and to obtain a solution that is clear and colorless or pale yellow.
• Intravenous infusion administration: Meropenem for intravenous infusion may be directly constituted with a compatible infusion fluid and then further diluted (50 to 200 ml) with the compatible infusion fluid, as needed.
• Meropenem is compatible with the following infusion fluids: 0.9% sodium chloride intravenous infusion, 5% or 10% glucose intravenous infusion, 5% glucose intravenous infusion with 0.02% sodium bicarbonate, 5% glucose and 0.9% sodium chloride intravenous infusion, 5% glucose with 0.225% sodium chloride intravenous infusion, 5% glucose with 0.15% potassium chloride intravenous infusion, 2.5% and 10% mannitol intravenous infusion, normosol-M in 5% glucose intravenous infusion.

The use of a freshly reconstituted solution is recommended. However, it maintains potency for up to 3 hours at up to 25oC or 13 hours at up to 5oC

Storage:
Vial store in a cool, dry place (below 30oC), away from light & moisture. Keep out of the reach of children.