MERONEM (MEROPENEM) 500 MG & 1 GM

Powder for Solution for Intravenous Injection / Infusion | Vial

Medical Description

Meronem contains meropenem, a broad-spectrum, injectable carbapenem antibiotic belonging to the beta-lactam class. It is used for the treatment of serious bacterial infections caused by susceptible microorganisms, including certain Gram-positive and Gram-negative bacteria and anaerobic bacteria.

Meropenem works by inhibiting bacterial cell wall synthesis, resulting in bacterial cell death. Its broad antibacterial activity makes it an important treatment option for severe and complicated infections, particularly in hospital settings.

Meronem is available in two strengths:

• Meronem 500 mg: Each vial contains meropenem trihydrate equivalent to 500 mg meropenem.
• Meronem 1 g: Each vial contains meropenem trihydrate equivalent to 1 g meropenem.

Both strengths are supplied as powder for reconstitution before intravenous administration.

Active Ingredients

Active ingredient:

- Meropenem: A bactericidal carbapenem antibiotic that inhibits bacterial cell wall formation.

Other ingredient:

- Sodium carbonate: Used as an excipient in the formulation.

Indications and Uses

Meronem is prescribed for the treatment of various serious bacterial infections, including:

1. Severe Pneumonia: Including hospital-acquired pneumonia and ventilator-associated pneumonia.
2. Complicated Urinary Tract Infections: Including severe infections involving the kidneys and urinary system.
3. Complicated Intra-abdominal Infections: Such as complicated bacterial infections within the abdominal cavity.
4. Complicated Skin and Soft Tissue Infections: Including certain severe bacterial infections affecting the skin and underlying tissues.
5. Bacterial Meningitis: Treatment of acute bacterial meningitis caused by susceptible organisms.
6. Intra-partum and Post-partum Infections: Treatment of certain bacterial infections associated with childbirth.
7. Bronchopulmonary Infections in Cystic Fibrosis: Treatment of susceptible bacterial respiratory infections.
8. Febrile Neutropenia: Management of patients with fever and reduced neutrophil counts when a bacterial infection is suspected.

Meropenem is generally indicated for adults and children aged 3 months and older, depending on the approved product information and specific clinical indication.

Mechanism of Action

Meropenem exerts its antibacterial effect by interfering with the formation of the bacterial cell wall.

• It binds to bacterial penicillin-binding proteins (PBPs), particularly those involved in cell wall synthesis.
• It inhibits the final stages of peptidoglycan synthesis, which is essential for maintaining bacterial cell wall integrity.
• This disruption weakens the bacterial cell wall, leading to cell lysis and bacterial death.

Meropenem is bactericidal and demonstrates activity against a broad range of susceptible aerobic and anaerobic bacteria.

Dosage and Administration

The dosage and duration of treatment depend on the type and severity of infection, the causative microorganism, patient age, body weight, and renal function.

Typical adult dosing regimens:

Administration:

• Meronem is administered intravenously by injection or infusion.
• Intravenous infusion is generally administered over 15–30 minutes.
• Doses up to 1 g may alternatively be administered as an intravenous bolus over approximately 5 minutes, according to the approved product instructions.
• The powder must be reconstituted using an appropriate sterile diluent before administration.
• Dosage adjustments are necessary in patients with impaired renal function.

Important: The above regimens are general adult reference doses, not individualized prescriptions. Pediatric dosing and renal dose adjustments require specific medical assessment.

Contraindications

Meronem is contraindicated in patients with:

• Known hypersensitivity to meropenem or any of its excipients.
• Previous severe allergic reactions to other carbapenem antibiotics.
• History of severe hypersensitivity reactions to other beta-lactam antibiotics, including penicillins or cephalosporins.

Possible Side Effects

Potential adverse effects include:

• Nausea and vomiting.
• Diarrhoea.
• Abdominal pain.
• Headache.
• Skin rash, itching, or urticaria.
• Injection-site pain, inflammation, or phlebitis.
• Elevated liver enzymes.
• Changes in blood cell counts, including thrombocytopenia or eosinophilia.
• Oral or vaginal fungal infections.

Serious but less common adverse reactions:

• Severe allergic reactions, including anaphylaxis.
• Seizures or convulsions.
• Severe skin reactions.
• Antibiotic-associated colitis, including Clostridioides difficile-associated diarrhoea.
• Liver injury.
• Rarely, rhabdomyolysis.

Precautions and Warnings

• Antibiotic Resistance: Meropenem should only be used for infections caused by, or strongly suspected to be caused by, susceptible bacteria. Unnecessary use may contribute to antimicrobial resistance.
• Allergic Reactions: Patients with a history of beta-lactam antibiotic allergies should be carefully evaluated before treatment.
• Renal Impairment: Dose adjustment is necessary in patients with reduced kidney function because meropenem is primarily eliminated through the kidneys.
• Neurological Disorders: Patients with a history of seizures or central nervous system disorders require careful monitoring.
• Valproic Acid Interaction: Concomitant administration with valproic acid or sodium valproate is generally not recommended because meropenem can significantly reduce valproate concentrations and increase the risk of breakthrough seizures.
• Gastrointestinal Effects: Persistent or severe diarrhoea during or after treatment may indicate antibiotic-associated colitis and requires medical evaluation.
• Liver Function: Liver function should be monitored when clinically indicated, particularly in patients with pre-existing hepatic disorders.
• Pregnancy and Breastfeeding: Use only when considered necessary by the treating physician following an appropriate benefit-risk assessment.

Storage Conditions

• Store unopened vials at a temperature not exceeding 30°C.
• Keep in the original packaging to protect the product.
• Do not freeze the reconstituted solution.
• Reconstitute immediately before administration using the recommended diluent and aseptic technique.
• Use the prepared solution immediately from a microbiological safety perspective, unless preparation and storage conditions have been validated according to the product information.
• Discard any unused solution according to local pharmaceutical waste-disposal requirements.

Patient Disclaimer

This information is provided for educational purposes only and is not intended to replace professional medical advice, diagnosis, or treatment. Meronem (Meropenem) is a prescription-only antibiotic intended for use under the supervision of a qualified healthcare professional. The appropriate dose, route of administration, and treatment duration must be determined according to the patient's condition, infection severity, bacterial susceptibility, and kidney function. Patients should never use antibiotics without medical supervision or discontinue prescribed treatment without consulting their healthcare provider.

References

1. Electronic Medicines Compendium (eMC): Meronem 500 mg and 1 g Summary of Product Characteristics (SmPC). Meronem 500 mg – eMC.
2. European Medicines Agency (EMA): Meronem referral documentation, including approved indications, composition, and pharmaceutical information. EMA – Meronem product information.
3. Pfizer: Official Meronem prescribing information, including composition, indications, dosage, and administration. Pfizer – Meronem 500 mg and 1 g.
4. U.S. Food and Drug Administration (FDA): Meropenem prescribing information and safety considerations. FDA – Meropenem prescribing information.
5. Electronic Medicines Compendium (eMC): Meropenem 1 g Summary of Product Characteristics. Meropenem 1 g – eMC.
6. National Library of Medicine (NIH): PubMed – Clinical research and scientific literature on meropenem pharmacology and antibacterial activity.