Meropenem

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Meropenem
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

Disclaimer

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Overview

Meropenem is a Carbapenem that is FDA approved for the treatment of complicated skin and skin structure infections, intra-abdominal infections, bacterial meningitis (pediatric patients).. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Skin and Skin Structure Infections

  • Dosage: 500 mg IV every 8 hours.

Is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to:

Intra-abdominal Infections

  • 1 g IV every 8 hours

Is indicated as a single agent therapy for the treatment of complicated appendicitis and peritonitis caused by:

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.

Use in Adult Patients with Renal Impairment

There is inadequate information regarding the use of Meropenem for injection (I.V.) in patients on hemodialysis or peritoneal dialysis.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meropenem in adult patients.

Non–Guideline-Supported Use

Cystic Fibrosis

  • 120 mg/kg IV t.i.d. (maximum 2 g/dose)[1]
  • In combination with tobramycin

Nosocomial Pneumonia

  • 1 g IV t.i.d.[2]
  • As monotherapy

Febrile Neutropenia

  • 1 g t.i.d.[3]
  • As monotherapy.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Skin and Skin Structure Infections (Pediatric Patients ≥ 3 Months only)

  • 10m/kg IV every 8 hours.
  • Up to a maximum Dose of 500 mg
  • 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.

Is indicated as a single agent therapy for the treatment of complicated skin and skin structure infections due to:

Intra-abdominal Infections (Pediatric Patients ≥ 3 Months only)

  • 20 mg/kg IV every 8 hours
  • Up to a maximum dose of 1g
  • Pediatric patients weighing over 50 kg should be administered Meropenem for injection (I.V.) at a dose of 1 g every 8 hours for intra-abdominal infections.

Is indicated as a single agent therapy for the treatment of complicated appendicitis and peritonitis caused by:


Bacterial Meningitis (Pediatric Patients ≥ 3 Months only)

  • 40 mg IV every 8 hours.
  • Up to a maximum of 2 g.

Pediatric patients weighing over 50 kg should be administered Meropenem for injection (I.V.) at a dose of 2 g every 8 hours for meningitis. Meropenem for injection (I.V.) is indicated as a single agent therapy for the treatment of bacterial meningitis caused by:


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 3-5 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. There is no experience in pediatric patients with renal impairment.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Meropenem in pediatric patients.

Non–Guideline-Supported Use

Cystic Fibrosis

  • 120 mg/kg IV t.i.d. (maximum 2 g/dose)[1]
  • In combination with tobramycin

Febrile Neutropenia

  • 60 mg/kg/day t.i.d.[4]
  • As monotherapy

Contraindications

Warnings

Hypersensitivity Reactions

Seizure Potential

  • Seizures and other adverse CNS experiences have been reported during treatment with Meropenem for injection (I.V.).
  • These experiences have occurred most commonly in patients with CNS disorders (e.g., brain lesions or history of seizures) or with bacterial meningitis and/or compromised renal function.
  • During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with the overall seizure rate being 0.7% (based on 20 patients with this adverse event).
  • All meropenem-treated patients with seizures had pre-existing contributing factors.
  • Among these are included prior history of seizures or CNS abnormality and concomitant medications with seizure potential.
  • Dosage adjustment is recommended in patients with advanced age and/or reduced renal function.
  • Close adherence to the recommended dosage regimens is urged, especially in patients with known factors that predispose to convulsive activity.
  • Anti-convulsant therapy should be continued in patients with known seizure disorders.
  • If focal tremors, myoclonus, or seizures occur, patients should be evaluated neurologically, placed on anti-convulsant therapy if not already instituted, and the dosage of Meropenem for injection (I.V.) re-examined to determine whether it should be decreased or the antibiotic discontinued.

Interaction with Valproic Acid

Clostridium difficile–Associated Diarrhea

Development of Drug-Resistant Bacteria

  • Prescribing Meropenem for injection (I.V.) in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Overgrowth of Nonsusceptible Organisms

  • As with other broad-spectrum antibiotics, prolonged use of meropenem may result in overgrowth of nonsusceptible organisms.
  • Repeated evaluation of the patient is essential.
  • If superinfection does occur during therapy, appropriate measures should be taken.

Laboratory Tests

  • While Meropenem for injection (I.V.) possesses the characteristic low toxicity of the beta-lactam group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, is advisable during prolonged therapy.

Patients with Renal Impairment

Dialysis

Potential for Neuromotor Impairment

  • Patients receiving Meropenem for injection (I.V.) on an outpatient basis may develop adverse events such as seizures, headaches and/or paresthesias that could interfere with mental alertness and/or cause motor impairment.
  • Until it is reasonably well established that Meropenem for injection (I.V.) is well tolerated, patients should not operate machinery or motorized vehicles.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adult Patients

  • During clinical investigations, 2904 immunocompetent adult patients were treated for non-CNS infections with Meropenem for injection (I.V.) (500 mg or 1000 mg every 8 hours).
  • Deaths in 5 patients were assessed as possibly related to meropenem; 36 (1.2%) patients had meropenem discontinued because of adverse events.
  • Many patients in these trials were severely ill and had multiple background diseases, physiological impairments and were receiving multiple other drug therapies.
  • In the seriously ill patient population, it was not possible to determine the relationship between observed adverse events and therapy with Meropenem for injection (I.V.).

The following adverse reaction frequencies were derived from the clinical trials in the 2904 patients treated with Meropenem for injection (I.V.)

Local Adverse Reactions

Local adverse reactions that were reported irrespective of the relationship to therapy with Meropenem for injection (I.V.) were as follows:

Systemic Adverse Reactions

Systemic adverse reactions that were reported irrespective of the relationship to Meropenem for injection (I.V.) occurring in greater than 1% of the patients were diarrhea (4.8%), nausea/vomiting (3.6%), headache (2.3%), rash (1.9%), sepsis (1.6%), constipation (1.4%), apnea (1.3%), shock (1.2%), and pruritus (1.2%).

Additional systemic adverse reactions that were reported irrespective of relationship to therapy with Meropenem for injection (I.V.) and occurring in less than or equal to 1% but greater than 0.1% of the patients are listed below within each body system in order of decreasing frequency:

Body as a Whole
Cardiovascular
Digestive System
Hemic/Lymphatic
Metabolic/Nutritional
Nervous System
Respiratory
Skin and Appendages
Urogenital System
Adverse Laboratory Changes

Adverse laboratory changes that were reported irrespective of relationship to Meropenem for injection (I.V.) and occurring in greater than 0.2% of the patients were as follows:

Hepatic
Hematologic
Renal


For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported irrespective of relationship to Meropenem for injection (I.V.), increased in patients with moderately severe renal impairment (creatinine clearance > 10 to 26 mL/min).

Urinalysis
Complicated Skin and Skin Structure Infections

In a study of complicated skin and skin structure infections, the adverse reactions were similar to those listed above. The most common adverse events occurring in > 5% of the patients were:

Adverse events with an incidence of > 1%, and not listed above, include:


Pediatric Patients

Clinical Adverse Reactions

Meropenem for injection (I.V.) was studied in 515 pediatric patients (≥ 3 months to < 13 years of age) with serious bacterial infections (excluding meningitis. At dosages of 10 to 20 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to Meropenem for injection (I.V.) and their rates of occurrence as follows:

Meropenem for injection (I.V.) was studied in 321 pediatric patients (≥ 3 months to < 17 years of age) with meningitis at a dosage of 40 mg/kg every 8 hours. The types of clinical adverse events seen in these patients are similar to the adults, with the most common adverse events reported as possibly, probably, or definitely related to Meropenem for injection (I.V.) and their rates of occurrence as follows:

In the meningitis studies, the rates of seizure activity during therapy were comparable between patients with no CNS abnormalities who received meropenem and those who received comparator agents (either cefotaxime or ceftriaxone). In the Meropenem for injection (I.V.) treated group, 12/15 patients with seizures had late onset seizures (defined as occurring on day 3 or later) versus 7/20 in the comparator arm.

Adverse Laboratory Changes

Laboratory changes seen in the pediatric studies, including the meningitis studies, were similar to those reported in the adult studies.

There is no experience in pediatric patients with renal impairment.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Meropenem for injection (I.V.). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Worldwide post-marketing adverse reactions not otherwise listed in the Adverse Reactions section of this product label and reported as possibly, probably, or definitely drug related are listed within each body system in order of decreasing severity.

Hematologic
Skin

Drug Interactions

There is limited information regarding Meropenem Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Meropenem in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Meropenem in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Meropenem during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Meropenem in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Meropenem in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Meropenem in geriatric settings.

Gender

There is no FDA guidance on the use of Meropenem with respect to specific gender populations.

Race

There is no FDA guidance on the use of Meropenem with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Meropenem in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Meropenem in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Meropenem in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Meropenem in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Meropenem Administration in the drug label.

Monitoring

There is limited information regarding Meropenem Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Meropenem and IV administrations.

Overdosage

There is limited information regarding Meropenem overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Meropenem Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Meropenem Mechanism of Action in the drug label.

Structure

There is limited information regarding Meropenem Structure in the drug label.

Pharmacodynamics

There is limited information regarding Meropenem Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Meropenem Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Meropenem Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Meropenem Clinical Studies in the drug label.

How Supplied

There is limited information regarding Meropenem How Supplied in the drug label.

Storage

There is limited information regarding Meropenem Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Meropenem Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Meropenem interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • Merrem IV

Look-Alike Drug Names

There is limited information regarding Meropenem Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ 1.0 1.1 Latzin P, Fehling M, Bauernfeind A, Reinhardt D, Kappler M, Griese M (2008). "Efficacy and safety of intravenous meropenem and tobramycin versus ceftazidime and tobramycin in cystic fibrosis". J Cyst Fibros. 7 (2): 142–6. doi:10.1016/j.jcf.2007.07.001. PMID 17766190.
  2. ↑ Alvarez Lerma F, Serious Infection Study Group (2001). "Efficacy of meropenem as monotherapy in the treatment of ventilator-associated pneumonia". J Chemother. 13 (1): 70–81. doi:10.1179/joc.2001.13.1.70. PMID 11233804.
  3. ↑ "Equivalent efficacies of meropenem and ceftazidime as empirical monotherapy of febrile neutropenic patients. The Meropenem Study Group of Leuven, London and Nijmegen". J Antimicrob Chemother. 36 (1): 185–200. 1995. PMID 8537265.
  4. ↑ Oguz A, Karadeniz C, Citak EC, Cil V, Eldes N (2006). "Experience with cefepime versus meropenem as empiric monotherapy for neutropenia and fever in pediatric patients with solid tumors". Pediatr Hematol Oncol. 23 (3): 245–53. doi:10.1080/08880010500506867. PMID 16517540.


Meropenem
MERREM® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
Compatibility, Reconstitution, and Stability
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [4]

Overview

Meropenem is an ultra-broad spectrum injectable antibiotic used to treat a wide variety of infections, including meningitis and pneumonia. It is a beta-lactam and belongs to the subgroup of carbapenem, similar to imipenem and ertapenem. Meropenem gained FDA approval in July 1996. It penetrates well into many tissues and body fluids including the cerebrospinal fluid,bile, heart valves, lung, and peritoneal fluid.[1]

Category

Carbapenem

US Brand Names

MERREM®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings | Precautions | Adverse Reactions | Overdosage | Clinical Studies | Dosage and Administration | Compatibility, Reconstitution, and Stability | How Supplied | Labels and Packages

Mechanism of action

Meropenem is bactericidal except against Listeria monocytogenes where it is bacteriostatic. It inhibits bacterial wall synthesis like other beta-lactam antibiotics. In contrast to other beta-lactams, it is highly resistant to degradation by beta-lactamase or cephalosporinase. Resistance generally arises due to mutations in penicillin binding proteins, production of metallo-beta-lactamases, or resistance to diffusion across the bacterial outer membrane.[2] Unlike imipenem, it is stable to dehydropeptidase-1 and can therefore be given without cilastatin.

References

  1. ↑ AHFS DRUG INFORMATION® 2006 (2006 ed ed.). American Society of Health-System Pharmacists. 2006.
  2. ↑ Mosby's Drug Consult 2006 (16 ed ed.). Mosby, Inc. 2006.
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