MERREM IV- meropenem injection
Pfizer Laboratories Div Pfizer Inc
1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)
MERREM IV is indicated for the treatment of complicated skin and skin structure infections (cSSSI) due to Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae , viridans group streptococci, Enterococcus faecalis (vancomycin-susceptible isolates only), Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species.
MERREM IV is indicated for the treatment of complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species.
MERREM IV is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.
MERREM IV has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MERREM IV and other antibacterial drugs, MERREM IV should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
The recommended dose of MERREM IV is 500 mg given every 8 hours for skin and skin structure infections and 1 gram given every 8 hours for intra-abdominal infections. When treating complicated skin and skin structure infections caused by P. aeruginosa , a dose of 1 gram every 8 hours is recommended.
MERREM IV should be administered by intravenous infusion over approximately 15 minutes to 30 minutes. Doses of 1 gram may also be administered as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.
Dosage should be reduced in patients with creatinine clearance of 50 mL/min or less. (See dosing table below.)
When only serum creatinine is available, the following formula (Cockcroft and Gault equation)1 may be used to estimate creatinine clearance.
Males: Creatinine Clearance (mL/min) =
Weight (kg) × (140 — age)72 × serum creatinine (mg/dL)
Females: 0.85 × above value
|Creatinine Clearance (mL/min)||Dose (dependent on type of infection)||Dosing Interval|
|Greater than 50||Recommended dose (500 mg cSSSI and 1 gram Intra-abdominal)||Every 8 hours|
|26–50||Recommended dose||Every 12 hours|
|10–25||One-half recommended dose||Every 12 hours|
|Less than 10||One-half recommended dose||Every 24 hours|
There is inadequate information regarding the use of MERREM IV in patients on hemodialysis or peritoneal dialysis.
Pediatric Patients 3 Months of Age and Older
- For pediatric patients 3 months of age and older, the MERREM IV dose is 10 mg/kg, 20 mg/kg or 40 mg/kg every 8 hours (maximum dose is 2 grams every 8 hours), depending on the type of infection (cSSSI, cIAI, intra-abdominal infection or meningitis). See dosing table 2 below.
- For pediatric patients weighing over 50 kg administer MERREM IV at a dose of 500 mg every 8 hours for cSSSI, 1 gram every 8 hours for cIAI and 2 grams every 8 hours for meningitis.
- Administer MERREM IV as an intravenous infusion over approximately 15 minutes to 30 minutes or as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes to 5 minutes.
- There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 grams) bolus dose.
|Type of Infection||Dose (mg/kg)||Up to a Maximum Dose||Dosing Interval|
|There is no experience in pediatric patients with renal impairment.When treating cSSSI caused by P. aeruginosa , a dose of 20 mg/kg (or 1 gram for pediatric patients weighing over 50 kg) every 8 hours is recommended.|
|Complicated skin and skin structure infections||10||500 mg||Every 8 hours|
|Complicated intra-abdominal infections||20||1 gram||Every 8 hours|
|Meningitis||40||2 grams||Every 8 hours|
Pediatric Patients Less Than 3 Months of Age
For pediatric patients (with normal renal function) less than 3 months of age, with complicated intra-abdominal infections, the MERREM IV dose is based on gestational age (GA) and postnatal age (PNA). See dosing table 3 below. MERREM IV should be given as intravenous infusion over 30 minutes.
|Age Group||Dose (mg/kg)||Dose Interval|
|There is no experience in pediatric patients with renal impairment.|
|Infants less than 32 weeks GA and PNA less than 2 weeks||20||Every 12 hours|
|Infants less than 32 weeks GA and PNA 2 weeks and older||20||Every 8 hours|
|Infants 32 weeks and older GA and PNA less than 2 weeks||20||Every 8 hours|
|Infants 32 weeks and older GA and PNA 2 weeks and older||30||Every 8 hours|
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