2.1 Adult Patients
The recommended dose of Meropenem for Injection I.V. is 500 mg given every 8 hours for skin and skin structure infections and 1 g given every 8 hours for intra-abdominal infections. Meropenem for Injection I.V. should be administered by intravenous infusion over approximately 15 to 30 minutes. Doses of 1 g may also be administered as an intravenous bolus injection (5 to 20 mL) over approximately 3 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)5 may be used to estimate creatinine clearance.
Males: Creatinine Clearance (mL/min) =
Weight (kg) x (140 - age)
72 x serum creatinine (mg/dL)
Females: 0.85 x above value
Recommended Meropenem for Injection I.V. Dosage Schedule for Adult Patients with Renal Impairment
Creatinine Clearance
(mL/min)
Dose (dependent on
type of infection)
Dosing Interval
>50
Recommended dose (500 mg cSSSI and 1 g Intra-abdominal)
Every 8 hours
>25 to 50
Recommended dose
Every 12 hours
10 to 25
One-half recommended dose
Every 12 hours
<10
One-half recommended dose
Every 24 hours
There is inadequate information regarding the use of Meropenem for Injection I.V. in patients on hemodialysis or peritoneal dialysis.
2.3 Use in Pediatric Patients (≥ 3 Months only)
For pediatric patients from 3 months of age and older, the Meropenem for Injection I.V. dose is 10, 20 or 40 mg/kg every 8 hours (maximum dose is 2 g every 8 hours), depending on the type of infection (complicated skin and skin structure, intra-abdominal or meningitis). (See dosing table below.) Pediatric patients weighing over 50 kg should be administered Meropenem for Injection I.V. at a dose of 500 mg every 8 hours for complicated skin and skin structure infections, 1 g every 8 hours for intra-abdominal infections and 2 g every 8 hours for meningitis. Meropenem for Injection I.V. should be given as intravenous infusion over approximately 15 to 30 minutes or as an intravenous bolus injection (5 to 20 mL) over approximately 3 to 5 minutes.
There is limited safety data available to support the administration of a 40 mg/kg (up to a maximum of 2 g) bolus dose.
Recommended Meropenem for Injection I.V. Dosage Schedule for Pediatric Patients with Normal Renal Function
Type of
Infection
Dose
(mg/kg)
Up to a Maximum
Dose
Dosing
Interval
Complicated skin and skin structure
10
500 mg
Every 8 hours
Intra-abdominal
20
1 g
Every 8 hours
Meningitis
40
2 g
Every 8 hours
There is no experience in pediatric patients with renal impairment.
2.4 Preparation of Solution
For Intravenous Bolus Administration
Constitute injection vials (500 mg and 1 g) with sterile Water for Injection. (See table below.) Shake to dissolve and let stand until clear.
Vial size
Amount of Diluent
Added (mL)
Approximate Withdrawable Volume
(mL)
Approximate Average
Concentration
(mg/mL)
500 mg
10
10
50
1 g
20
20
50
For Infusion
Infusion vials (500 mg and 1 g) may be directly constituted with a compatible infusion fluid. Alternatively, an injection vial may be constituted, then the resulting solution added to an I.V. container and further diluted with an appropriate infusion fluid [see Dosage and Administration (2.5) and (2.6)].
WARNING: Do not use flexible container in series connections.
2.5 Compatibility
Compatibility of Meropenem with other drugs has not been established. Meropenem should not be mixed with or physically added to solutions containing other drugs.
2.6 Stability and Storage
Freshly prepared solutions of Meropenem should be used whenever possible. However, constituted solutions of Meropenem maintain satisfactory potency at controlled room temperature 15 to 25ºC (59 to 77ºF) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous Meropenem should not be frozen.
Intravenous Bolus Administration
Meropenem for Injection I.V. vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of Meropenem) may be stored for up to 2 hours at controlled room temperature 15 to 25°C (59 to 77°F) or for up to 12 hours at 4°C (39°F).
Intravenous Infusion Administration
Stability in Infusion Vials:
Meropenem for Injection I.V. infusion vials constituted with Sodium Chloride Injection 0.9% (Meropenem concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 2 hours at controlled room temperature 15 to 25°C (59 to 77°F) or for up to 18 hours at 4°C (39°F). Infusion vials of Meropenem for Injection I.V. constituted with Dextrose Injection 5% (Meropenem concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 1 hour at controlled room temperature 15 to 25°C (59 to 77°F) or for up to 8 hours at 4°C (39°F).
Stability in Plastic I.V. Bags:
Solutions prepared for infusion (Meropenem concentrations ranging from 1 to 20 mg/mL) may be stored in plastic intravenous bags with diluents as shown below:
Number of Hours Stable at Controlled Room
Temperature
15 to 25°C (59 to 77°F)
Number of Hours Stable
at 4°C (39°F)
Sodium Chloride Injection 0.9%
4
24
Dextrose Injection 5%
1
4
Dextrose Injection 10%
1
2
Dextrose and Sodium Chloride Injection 5%/0.9%
1
2
Dextrose and Sodium Chloride Injection 5%/0.2%
1
4
Potassium Chloride in Dextrose Injection 0.15%/5%
1
6
Sodium Bicarbonate in Dextrose Injection 0.02%/5%
1
6
Dextrose Injection 5% in NormosolTM-M
1
8
Dextrose Injection 5% in Ringers Lactate Injection
1
4
Dextrose and Sodium Chloride Injection 2.5%/0.45%
3
12
Mannitol Injection 2.5%
2
16
Ringers Injection
4
24
Ringers Lactate Injection
4
12
Sodium Lactate Injection 1/6 N
2
24
Sodium Bicarbonate Injection 5%
1
4
Stability in Baxter Minibag Plus® (manufactured by Baxter, Inc.):
Solutions of Meropenem (Meropenem concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags® (manufactured by Baxter, Inc.) with Sodium Chloride Injection 0.9% may be stored for up to 4 hours at controlled room temperatures 15 to 25°C (59 to 77°F) or for up to 24 hours at 4°C (39°F). Solutions of Meropenem (Meropenem concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags® (manufactured by Baxter, Inc.) with Dextrose Injection 5% may be stored up to 1 hour at controlled room temperatures 15 to 25°C (59 to 77°F) or for up to 6 hours at 4°C (39°F).
Stability in Plastic Syringes, Tubing and Intravenous Infusion Sets:
Solutions of Meropenem (Meropenem concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 4 hours) or in Dextrose Injection 5% (for up to 2 hours) at controlled room temperatures 15 to 25°C (59 to 77°F) are stable in plastic tubing and volume control devices of common intravenous infusion sets.
Solutions of Meropenem (Meropenem concentrations ranging from 1 to 20 mg/mL) in Water for Injection or Sodium Chloride Injection 0.9% (for up to 48 hours) or in Dextrose Injection 5% (for up to 6 hours) are stable at 4ºC (39ºF) in plastic syringes.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.