These highlights do not include all the information needed to use MERREM I.V. safely and effectively. See full prescribing information for MERREM I.V.
MERREM ® I.V. (meropenem for injection)
Initial U.S. Approval: 1996
INDICATIONS AND USAGE
MERREM I.V. is a penem antibacterial indicated as single agent therapy for the treatment of:
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Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). (1.1)
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Complicated intra-abdominal infections (adult and pediatric patients). (1.2)
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Bacterial meningitis (pediatric patients 3 months of age and older only). (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM I.V. and other antibacterial drugs, MERREM I.V. should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
DOSAGE AND ADMINISTRATION
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500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for skin and skin structure infections for adult patients. When treating infections caused by Pseudomonas aeruginosa, a dose of 1 gram every 8 hours is recommended. (2.1)
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1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. (2.1)
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1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. (2.1)
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Dosage should be reduced in adult patients with renal impairment. (2.2)
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Recommended MERREM I.V. Dosage Schedule for Adult Patients with Renal Impairment
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Creatinine Clearance (mL/min)
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Dose (dependent on type of infection)
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Dosing Interval
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Greater than 50
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Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal)
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Every 8 hours
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26-50
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Recommended dose
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Every 12 hours
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10-25
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One-half recommended dose
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Every 12 hours
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Less than 10
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One-half recommended dose
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Every 24 hours
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Pediatric patients 3 months of age and older
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Recommended MERREM I.V. Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function (2.3)
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Type of Infection
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Dose (mg/kg)
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Up to a Maximum Dose
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Dosing Interval
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Complicated skin and skin structure*
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10
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500 mg
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Every 8 hours
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Intra-abdominal
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20
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1 gram
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Every 8 hours
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Meningitis
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40
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2 gram
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Every 8 hours
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- Intravenous infusion is to be given over approximately 15 minutes to 30 minutes.
- Intravenous bolus injection (5 mL to 20 mL) is to be given over approximately 3 minutes- 5 minutes.
- There is no experience in pediatric patients with renal impairment.
*20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended when treating complicated skin and skin structure infections caused by P. aeruginosa.(2.3)
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Pediatric patients less than 3 months of age
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Recommended MERREM I.V. Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-Abdominal Infections and Normal Renal Function (2.3)
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Age Group
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Dose (mg/kg)
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Dose Interval
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Infants less than 32 weeks GA and PNA less than 2 weeks
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20
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Every 12 hours
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Infants less than 32 weeks GA and PNA 2 weeks and older
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20
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Every 8 hours
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Infants 32 weeks and older GA and PNA less than 2 weeks
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20
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Every 8 hours
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Infants 32 weeks and older GA and PNA 2 weeks and older
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30
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Every 8 hours
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- Intravenous infusion is to be given over 30 minutes.
- There is no experience in pediatric patients with renal impairment.
GA: gestational age and PNA: postnatal
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DOSAGE FORMS AND STRENGTHS
500 mg Injection Vial (3)
1 gram Injection Vial (3)
CONTRAINDICATIONS
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Known hypersensitivity to product components or anaphylactic reactions to β-lactams. (4)
WARNINGS AND PRECAUTIONS
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Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. (5.1)
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Seizures and other adverse CNS experiences have been reported during treatment. (5.2)
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Co-administration of ME
