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Merrem I.V.

Indications
Dosage
How Supplied

INDICATIONS

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. 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.

MERREM I.V. is useful as presumptive therapy in the indicated condition (e.g. intra-abdominal infections) prior to the identification of the causative organisms because of its broad spectrum of bactericidal activity.

Skin And Skin Structure Infections (Adult Patients And Pediatric Patients ≥ 3 Months Only)

MERREM I.V. is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections 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.

Intra-Abdominal Infections (Adult Patients And Pediatric Patients ≥ 3 Months Only)

MERREM I.V. is indicated as a single agent therapy 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.

Bacterial Meningitis (Pediatric Patients ≥ 3 Months only)

MERREM I.V. is indicated as a single agent therapy for the treatment of bacterial meningitis caused by Streptococcus pneumoniae‡, Haemophilus influenzae, and Neisseria meningitidis.

MERREM I.V. has been found to be effective in eliminating concurrent bacteremia in association with bacterial meningitis.

For information regarding use in pediatric patients (3 months of age and older) [see DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS].

‡ The efficacy of meropenem as monotherapy in the treatment of meningitis caused by penicillin nonsusceptible isolates of Streptococcus pneumoniae has not been established.

DOSAGE AND ADMINISTRATION

Adult Patients

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. When treating complicated skin and skin structure infections caused by P.aeruginosa, a dose of 1g every 8 hours is recommended.

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 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: (weight in kg) x (140 – age)
(72) x serum creatinine (mg/100 mL)
Females (0.85) x (above value)

Recommended MERREM 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 1g Intra-abdominal) Every 8 hours
> 25-50 Recommended dose Every 12 hours

10 - 25

One-half recommended dose Every 12 hours
< 10 One-half recommended dose Every 24 hours

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

Use In Pediatric Patients ( ≥ 3 Months Only)

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, intraabdominal 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.

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 MERREM 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

When treating complicated skin and skin structure infections caused by P. aeruginosa, a dose of 20 mg/kg (or 1 g for pediatric patients weighing over 50 kg) every 8 hours is recommended.

There is no experience in pediatric patients with renal impairment.

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].

WARNING: Do not use flexible container in series connections.

Compatibility

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.

Stability And Storage

Freshly prepared solutions of MERREM I.V. should be used. However, constituted solutions of MERREM I.V. maintain satisfactory potency under the conditions 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 3 hours at up to 25°C (77°F) or for 13 hours at up to 5°C (41°F).

Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 to 20 mg/mL) constituted with Sodium Chloride Injection 0.9% may be stored for 1 hour at up to 25°C (77°F) or 15 hours at up to 5°C (41°F).

Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 to 20 mg/mL) constituted with Dextrose Injection 5% should be used immediately.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Dosage Forms And Strengths

Single use clear glass vials containing 500 mg or 1 g (as the trihydrate blend with anhydrous sodium carbonate for constitution) of sterile meropenem powder.

Storage And Handling

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 20-25°C (68-77°F) [see USP].

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

REFERENCES

5. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16:31-41.

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Rev 11/2013

Last reviewed on RxList: 12/30/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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