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Merrem IV

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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.

For information regarding use in pediatric patients see Skin and Skin Structure Infections (Adult Patients and Pediatric Patients 3 Months of age and older only); DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS, and CLINICAL PHARMACOLOGY.

Skin And Skin Structure Infections (Adult Patients And Pediatric Patients 3 Months Of Age And Older 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 and Pediatric Patients)

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 of age and older 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.

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

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

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 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 I.V. 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-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
Greater than 50 Recommended dose (500 mg cSSSI and 1gram Intraabdominal) Every 8 hours
Greater than 25-50 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 I.V. in patients on hemodialysis or peritoneal dialysis.

Use In Pediatric Patients Pediatric

Patients 3 Months Of Age And Older

For pediatric patients 3 months of age and older, the MERREM I.V. 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 (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 gram every 8 hours for intra-abdominal infections and 2 grams every 8 hours for meningitis. MERREM I.V. should be given as intravenous infusion over approximately 15 minutes to 30 minutes or as an intravenous bolus injection (5 mL to 20 mL) over approximately 3 minutes-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.

Recommended MERREM I.V. 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
Complicated skin and skin structure 10 500 mg Every 8 hours
Intra-abdominal 20 1 gram Every 8 hours
Meningitis 40 2 grams Every 8 hours
There is no experience in pediatric patients with renal impairment.
When treating complicated skin and skin structure infections 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 intra-abdominal infections, the MERREM I.V. dose is based on gestational age (GA) and postnatal age (PNA). (See dosing table below). MERREM I.V. should be given as intravenous infusion over 30 minutes.

Recommended MERREM I.V. 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
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
There is no experience in pediatric patients with renal impairment.

Preparation Of Solution

For Intravenous Bolus Administration

Constitute injection vials (500 mg and 1 gram) 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 gram 20 20 50

For Infusion

Infusion vials (500 mg and 1 gram) may be directly constituted with a compatible infusion fluid. Alternatively, an injection vial may be constituted, then the resulting solution added to an intravenous container and further diluted with an appropriate infusion fluid [see Compatibility and Stability and Storage sections below].

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).

Intravenous Infusion Administration

Solutions prepared for infusion (MERREM I.V. concentrations ranging from 1 mg/mL 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 mg/mL 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 gram (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 gram 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 gram Injection Vial (NDC 0310-0321-30)

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Revised: Dec 2014

Last reviewed on RxList: 3/3/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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