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Intravenous Dilution Guidelines

Meropenem (Merrem ®)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents

NS*, D5W      [*preferred]

Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate]

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 3-5 minutes.

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
Stability: Meropenem injection 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 15-25°C (59-77°F) or for up to 12 hours at 4°C (39°F).

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.

Stability in Infusion Vials: Meropenem 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 15-25°C (59-77°F) or for up to 18 hours at 4°C (39°F). Infusion vials of Meropenem 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 15-25°C (59-77°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:
Sample dilutions[0.5 - 1 gram] [50 ml NS] [15 - 30 minutes]
  Number of Hours Stable at Controlled Room Temperature 15-25°C (59-77°F) Number of Hours Stable at 4°C (39°F)
Sodium Chloride Injection 0.9% 4 24
Dextrose Injection 5.0% 1 4

Stability in Baxter Minibag Plus: Solutions of Meropenem (Meropenem concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags with Sodium Chloride Injection 0.9% may be stored for up to 4 hours at controlled room temperatures 15-25°C (59-77°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 with Dextrose Injection 5% may be stored up to 1 hour at controlled room temperatures 15-25°C (59-77°F) or for up to 6 hours at 4°C (39°F).

Stability / Miscellaneous



DOSAGE AND ADMINISTRATION
Adults

The recommended dose of MERREM 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. MERREM 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 3-5 minutes.

Use in Adults with Renal Impairment
Dosage should be reduced in patients with creatinine clearance less than 51 mL/min. (see dosing table below).

Recommended MERREM I.V.
Dosage Schedule for Adults With Impaired Renal Function .
Creatinine
Clearance
(mL/min)
Dose (dependent on type of infection) Dosing Interval
greater than or equal51 Recommended dose (500 mg cSSSI and 1 g Intra-abdominal) Every 8 hours
26-50 Recommended dose Every 12 hours
10-25 One-half recommended dose Every 12 hours
<10 One-half recommended dose Every 24 hours

When only serum creatinine is available, the following formula (Cockcroft and Gault equation) may be used to estimate creatinine clearance.

Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]


There is inadequate information regarding the use of MERREM I.V. in patients on hemodialysis.

There is no experience with peritoneal dialysis.

Use in Adults With Hepatic Insufficiency
No dosage adjustment is necessary in patients with impaired hepatic function.

Use in Elderly Patients
No dosage adjustment is required for elderly patients with creatinine clearance values above 50 mL/min.

Use in Pediatric Patients
For pediatric patients from 3 months of age and older, the MERREM 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 MERREM 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. MERREM 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 3-5 minutes.

Recommended MERREM I.V. Dosage Schedule for Pediatrics with Normal Renal Function
Type of Infection Dose (mg/kg) Up to 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.

PREPARATION OF SOLUTION
For Intravenous Bolus Administration
Constitute injection vials (500 mg and 1g) 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 1g) may be directly constituted with a compatible infusion fluid (See COMPATIBILITY AND STABILITY.) 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 COMPATIBILITY AND STABILITY.)

WARNING: Do not use flexible container in series connections.

COMPATIBILITY AND STABILITY
Compatibility of MERREM I.V. with other drugs has not been established. MERREM I.V. should not be mixed with or physically added to solutions containing other drugs.

Freshly prepared solutions of MERREM I.V. should be used whenever possible. However, constituted solutions of MERREM I.V. maintain satisfactory potency at controlled room temperature 15-25ºC (59-77°F) or under refrigeration at 4°C (39°F) as described below. Solutions of intravenous MERREM I.V. should not be frozen.

Intravenous Bolus Administration
MERREM I.V. injection vials constituted with sterile Water for Injection for bolus administration (up to 50 mg/mL of MERREM I.V.) may be stored for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 12 hours at 4°C (39°F).

Intravenous Infusion Administration
Stability in Infusion Vials: MERREM I.V. infusion vials constituted with Sodium Chloride Injection 0.9% (MERREM I.V. concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 2 hours at controlled room temperature 15-25°C (59-77°F) or for up to 18 hours at 4°C (39°F). Infusion vials of MERREM I.V. constituted with Dextrose Injection 5% (MERREM I.V. concentrations ranging from 2.5 to 50 mg/mL) are stable for up to 1 hour at controlled room temperature 15-25°C (59-77°F) or for up to 8 hours at 4°C (39°F).

Stability in Plastic I.V. Bags: Solutions prepared for infusion (MERREM I.V. 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 15-25°C (59-77°F) Number of Hours Stable at 4°C (39°F)
Sodium Chloride Injection 0.9% 4 24
Dextrose Injection 5.0% 1 4
Dextrose Injection 10.0% 1 2
Dextrose and Sodium Chloride Injection 5.0%/0.9% 1 2
Dextrose and Sodium Chloride Injection 5.0%/0.2% 1 4
Potassium Chloride in Dextrose Injection 0.15%/5.0% 1 6
Sodium Bicarbonate in Dextrose Injection 0.02%/5.0% 1 6
Dextrose Injection 5.0% in Normosol®-M 1 8
Dextrose Injection 5.0% 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 5.0% 1 4

Stability in Baxter Minibag Plus: Solutions of MERREM I.V. (MERREM I.V. concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags with Sodium Chloride Injection 0.9% may be stored for up to 4 hours at controlled room temperatures 15-25°C (59-77°F) or for up to 24 hours at 4°C (39°F). Solutions of MERREM I.V. (MERREM I.V. concentrations ranging from 2.5 to 20 mg/mL) in Baxter Minibag Plus bags with Dextrose Injection 5.0% may be stored up to 1 hour at controlled room temperatures 15-25°C (59-77°F) or for up to 6 hours at 4°C (39°F).

Stability in Plastic Syringes, Tubing and Intravenous Infusion Sets: Solutions of MERREM I.V. (MERREM I.V. 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 5.0% (for up to 2 hours) at controlled room temperatures 15-25°C (59-77°F) are stable in plastic tubing and volume control devices of common intravenous infusion sets.

Solutions of MERREM I.V. (MERREM I.V. 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.

HOW SUPPLIED
MERREM I.V. is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 g for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20-25ºC (68-77ºF) [see USP].

500 mg Injection Vial (NDC 0310-0325-20)
1 g Injection Vial (NDC 0310-0321-30)

© AstraZeneca 2006, 2007
Manufactured for:
AstraZeneca Pharmaceuticals LP
Wilmington, DE 19850
By:
Dainippon Sumitomo Pharma Co., Ltd
6–8, Doshomachi 2–chrome, Chuo-ku, Osaka 541–8524, Japan
Made in Japan
SIC 30131-05
Rev 11/07

Source: [package insert]
Disclaimer
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material.  PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.
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