MEROPENEM

MEROPENEM- meropenem injection
Xellia Pharmaceuticals USA LLC

1 INDICATIONS AND USAGE

1.1 Complicated Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of Age and Older Only)

Meropenem for Injection, USP 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.

1.2 Complicated Intra-abdominal Infections (Adult and Pediatric Patients)

Meropenem for Injection, USP 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.

1.3 Bacterial Meningitis (Pediatric Patients 3 Months of Age and Older Only)

Meropenem for Injection, USP is indicated for the treatment of bacterial meningitis caused by Haemophilus influenzae, Neisseria meningitidis and penicillin-susceptible isolates of Streptococcus pneumoniae.

Meropenem for Injection, USP has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

1.4 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Meropenem for Injection, USP and other antibacterial drugs, Meropenem for Injection, USP 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.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

The recommended dose of Meropenem for Injection, USP 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.

Meropenem for Injection, USP 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.

2.2 Use in Adult Patients with Renal Impairment

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

Table 1: Recommended Meropenem for Injection, USP Dosage Schedule for Adult Patients with Renal Impairment
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 to 50 Recommended dose Every 12 hours
10 to 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 Meropenem for Injection, USP in patients on hemodialysis or peritoneal dialysis.

2.3 Use in Pediatric Patients

Pediatric Patients 3 Months of Age and Older

  • For pediatric patients 3 months of age and older, the Meropenem for Injection, USP 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 Meropenem for Injection, USP 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 Meropenem for Injection, USP 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.
Table 2: Recommended Meropenem for Injection, USP Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function
Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval
There is no experience in pediatric patients with renal impairment.
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

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.

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 Meropenem for Injection, USP dose is based on gestational age (GA) and postnatal age (PNA). See dosing table 3 below. Meropenem for Injection, USP should be given as intravenous infusion over 30 minutes.

Table 3: Recommended Meropenem for Injection, USP Dosage Schedule for Pediatric Patients Less than 3 Months of Age with Complicated Intra-abdominal Infections and Normal Renal Function
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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