Meropenem
Visa No.: 893110550024
Product: Pimenem
API: Meropenem
Product Category: Antibiotics
Version approved leaflet: 41/QÐ-QLD_06/02/ 2017_157
INDICATIONS
Meropenem for intravenous (IV) use is indicated for the treatment of infections caused by susceptible bacteria in the following conditions:
• Pneumonia, including hospital-acquired pneumonia
• Urinary tract infections
• Intra-abdominal infections
• Gynecological infections, including endometritis and pelvic inflammatory disease
• Skin and skin structure infections
• Meningitis
• Septicemia
• Meropenem is also indicated for empirical treatment of suspected bacterial infections in febrile neutropenic adults, either as monotherapy or in combination with antiviral or antifungal agents.
Meropenem, used alone or in combination with other antibacterial agents, has been shown to be effective in the treatment of mixed infections.
Intravenous meropenem has also demonstrated efficacy in patients with cystic fibrosis and chronic lower respiratory tract infections, when used either as monotherapy or in combination with other antibacterial agents.
DOSAGE AND ADMINISTRATION
Dosage:
Adults: The dosage and duration of treatment depend on the type and severity of the infection and the patient’s clinical condition.
Recommended doses: The recommended dose is 500 mg meropenem administered intravenously every 8 hours for the treatment of pneumonia, urinary tract infections, gynecological infections such as endometritis, and skin and skin structure infections.
A dose of 1 g meropenem administered intravenously every 8 hours is recommended for the treatment of hospital-acquired pneumonia, peritonitis, suspected infections in neutropenic patients, and septicemia.
Cystic fibrosis: doses of up to 2 g every 8 hours
Treatment of meningitis: the recommended dose is 2 g every 8 hours.
Patients with hepatic impairment:
| Creatinine clearance (mL/min) | Dose (based on 500 mg, 1 g, or 2 g unit dose) | Dosing frequency |
| 26-50 | 1 unit dose | Every 12 hours |
| 10-25 | ½ unit dose | Every 12 hours |
| <10 | ½ unit dose | Every 24 hours |
Patients with hepatic impairment: No dose adjustment is required.
Elderly: No dose adjustment is required in patients with normal renal function or with creatinine clearance > 50 mL/min.
Children:
Children older than 3 months and weighing less than 50 kg: the recommended dose is 10–20 mg/kg every 8 hours, depending on the type and severity of the infection, the susceptibility of the causative organism, and the patient’s clinical condition.
Children weighing more than 50 kg> 50 kg: adult dosage is recommended.
Treatment of meningitis: the recommended dose is 40 mg/kg every 8 hours.
Method of administration:
Meropenem should be administered by intravenous injection over approximately 5 minutes or by intravenous infusion over approximately 15–30 minutes.
- For intravenous injection, meropenem should be reconstituted with sterile water for injection to obtain a solution with a concentration of approximately 50 mg/mL.
- For intravenous infusion, meropenem may be reconstituted with compatible infusion solutions
CONTRAINDICATIONS
Patients with hypersensitivity to any component of the product or to beta-lactam antibiotics.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
