MEROZA 1GM

MEROZA 1GM is a sterile, pyrogen-free, white to light yellow lyophilized powder containing meropenem trihydrate equivalent to 1g meropenem. It is a broad-spectrum carbapenem antibiotic for intravenous administration, effective against both Gram-positive and Gram-negative aerobic and anaerobic bacteria.

Composition:

• Active ingredient: Meropenem trihydrate equivalent to 1g meropenem per vial

• Inactive ingredients: Sodium carbonate (as buffer)

Mechanism of Action:

1. Bactericidal activity through inhibition of bacterial cell wall synthesis

2. Binds to penicillin-binding proteins (PBPs) 1A, 1B, 2, 3, 4 and 5

3. Stable against hydrolysis by most β-lactamases including:

   • Extended-spectrum β-lactamases (ESBLs)

   • AmpC β-lactamases

   • Some carbapenemases (except metallo-β-lactamases)

Dosage and Administration:

Standard Adult Dosage:

• 1g every 8 hours by IV infusion over 15-30 minutes

• For meningitis: 2g every 8 hours

• For febrile neutropenia: 1g every 8 hours

Pediatric Dosage:

• Children >3 months: 20-40mg/kg every 8 hours (max 2g per dose)

• Meningitis: 40mg/kg every 8 hours

Renal Impairment Adjustment:

• CrCl 25-50 mL/min: 1g every 12 hours

• CrCl 10-25 mL/min: 500mg every 12 hours

• CrCl <10 mL/min: 500mg every 24 hours

Uses (Indications):

1. Complicated intra-abdominal infections

2. Complicated skin and skin structure infections

3. Bacterial meningitis (pediatric patients ≥3 months)

4. Complicated urinary tract infections

5. Hospital-acquired pneumonia including ventilator-associated pneumonia

6. Empirical therapy for presumed infections in febrile neutropenic patients

Storage:

• Store unopened vials at controlled room temperature (20-25°C)

• Protect from light and moisture

• Reconstituted solution:

  • Stable for 2 hours at room temperature (25°C)

  • Stable for 12 hours when refrigerated (4°C)

  • Do not freeze reconstituted solutions

Recommendations:

1. Administer as IV infusion over 15-30 minutes

2. Monitor renal function during therapy

3. Assess for CNS adverse effects in patients with CNS disorders

4. Monitor for signs of superinfection or pseudomembranous colitis

5. Consider therapeutic drug monitoring in critically ill patients

Important Notes:

Contraindications:

• Hypersensitivity to meropenem or other carbapenems

• History of anaphylactic reactions to β-lactams

Warnings and Precautions:

• Risk of severe hypersensitivity reactions

• Potential for seizures and other CNS adverse effects

• May reduce serum valproic acid levels

• Clostridium difficile-associated diarrhea reported

• Thrombocytopenia may occur (monitor platelet counts)

Pregnancy Category: B

• Use only if clearly needed

• Excreted in breast milk – caution if breastfeeding

Drug Interactions:

• Probenecid may increase meropenem concentrations

• May reduce valproic acid levels significantly

• Potential interaction with other nephrotoxic drugs

Side Effects: Most common (≥1%):

• Diarrhea, nausea/vomiting

• Headache

• Rash

• Pruritus

• Injection site reactions

Serious adverse effects:

• Anaphylaxis

• Seizures

• Blood dyscrasias

• Hepatic dysfunction

• Acute kidney injury

Presentation:

• Single-dose 30mL glass vial containing 1g meropenem (as trihydrate)

• Pack of 1 vial per box