pharmacopeia
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/api/v1/drug/meropenem

Mechanism of action

Sourced from openFDA

Meropenem is an antibacterial drug [see Microbiology (12.4) ].

Transpeptidase

Indications

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  • Meropenem for Injection, USP is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1 ) Complicated intra-abdominal infections (adult and pediatric patients).

Contraindications

Sourced from openFDA
  • Meropenem for Injection, USP is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. Known hypersensitivity to product components or anaphylactic reactions to β-lactams.contraindicated

Dosage & administration

Sourced from openFDA

500 mg every 8 hours by intravenous infusion over 15 to 30 minutes for complicated skin and skin structure infections (cSSSI) for adult patients. When treating infections caused by Pseudomonas aeruginosa , a dose of 1 gram every 8 hours is recommended. ( 2.1 ) 1 gram every 8 hours by intravenous infusion over 15 minutes to 30 minutes for intra-abdominal infections for adult patients. ( 2.1 ) 1 gram every 8 hours by intravenous bolus injection (5 mL to 20 mL) over 3 minutes to 5 minutes for adult patients. ( 2.1 ) Dosage should be reduced in adult patients with renal impairment. ( 2.2 ) Recommended Meropenem for Injection, USP 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 1 gram Intra-abdominal) Every 8 hours 26 to 50 Recommended dose Every 12 hours 10 to 25 One-half recommended dose Every 12 hours Less than 10 One-half recommended dose Every 24 hours Pediatric patients 3 months of age and older Recommended Meropenem for Injection, USP Dosage Schedule for Pediatric Patients 3 Months of Age and Older with Normal Renal Function ( 2.3 ) Type of Infection Dose (mg/kg) Up to a Maximum Dose Dosing Interval - Intravenous infusion is to be given over approximately 15 minutes to 30 minutes. - Intravenous bolus injection (5 mL to 20 mL) is to be given over approximately 3 minutes to 5 minutes. - There is no experience in pediatric patients with renal impairment.

Warnings & precautions

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Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) Severe cutaneous adverse reactions have been reported in patients receiving Meropenem for Injection, USP. ( 5.2 ) Seizures and other adverse CNS experiences have been reported during treatment. ( 5.3 ) Co-administration of Meropenem for Injection, USP with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.4 , 7.2 ) Clostridium difficile- associated diarrhea (ranging from mild diarrhea to fatal colitis) has been reported. Evaluate if diarrhea occurs. ( 5.5 ) In patients with renal dysfunction, thrombocytopenia has been observed. ( 5.8 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with β-lactams. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe hypersensitivity reactions when treated with another β-lactam. Before initiating therapy with Meropenem for Injection, USP, it is important to inquire about previous hypersensitivity reactions to penicillins, cephalosporins, other β-lactams, and other allergens. If an allergic reaction to Meropenem for Injection, USP occurs, discontinue the drug immediately.

Adverse reactions

Sourced from openFDA

The following are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions (5.2) ] Seizure Potential [see Warnings and Precautions (5.3) ] Risk of Breakthrough Seizures Due to Drug Interaction with Valproic Acid [see Warnings and Precautions (5.4) ] Clostridium difficile – associated Diarrhea [see Warnings and Precautions (5.5) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.6) ] Overgrowth of Nonsusceptible Organisms [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Potential for Neuromotor Impairment [see Warnings and Precautions (5.9) ] Most common adverse reactions (2% or less) are: headache, nausea, constipation, diarrhea, anemia, vomiting, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals USA, LLC at safety@xellia.com or 1-833-295-6953, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Adverse Reactions from Clinical Trials 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, USP (500 mg or 1 gram every 8 hours).

Use in specific populations

Sourced from openFDA

Renal Impairment: Dose adjustment is necessary, if creatinine clearance is 50 mL/min or less. ( 2.2 , 8.6 ) 8.1 Pregnancy Risk Summary There are insufficient human data to establish whether there is a drug-associated risk of major birth defects or miscarriages with meropenem in pregnant women. No fetal toxicity or malformations were observed in pregnant rats and Cynomolgus monkeys administered intravenous meropenem during organogenesis at doses up to 2.4 and 2.3 times the maximum recommended human dose (MRHD) based on body surface area comparison, respectively. In rats administered intravenous meropenem in late pregnancy and during the lactation period, there were no adverse effects on offspring at doses equivalent to approximately 3.2 times the MRHD based on body surface area comparison ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
Plasma Concentrations At the end of a 30-minute intravenous infusion of a single dose of Meropenem for Injection, USP in healthy volunteers, mean peak plasma concentrations of meropenem are approximately 23 mcg/mL (range 14 to 26) for the 500 mg dose and 49 mcg/mL (range 39 to 58) for the 1 gram dose. A 5-minute intravenous bolus injection of Meropenem for Injection, USP in healthy volunteers results in mean peak plasma concentrations of approximately 45 mcg/mL (range 18 to 65) for the 500 mg dose and 112 mcg/mL (range 83 to 140) for the 1 gram dose.

Overdosage

Sourced from openFDA

In mice and rats, large intravenous doses of meropenem (2200 mg/kg to 4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities. Intentional overdosing of Meropenem for Injection, USP is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours. At this dosage, no adverse pharmacological effects or increased safety risks have been observed. Limited postmarketing experience indicates that if adverse events occur following overdosage, they are consistent with the adverse event profile described in the Adverse Reactions section and are generally mild in severity and resolve on withdrawal or dose reduction. Consider symptomatic treatments. In individuals with normal renal function, rapid renal elimination takes place. Meropenem and its metabolite are readily dialyzable and effectively removed by hemodialysis; however, no information is available on the use of hemodialysis to treat overdosage.

Approval history

Sourced from openFDA
  • Oct 26, 2011ANDAANDA091404Acs Dobfar
  • Apr 30, 2015NDANDA202106B Braun Medical
  • Apr 12, 2016ANDAANDA205883Amneal Pharms
  • Apr 19, 2016ANDAANDA206086Savior Lifetec Corp
  • Jun 8, 2016ANDAANDA206141Gland
  • Mar 27, 2017ANDAANDA205835Eugia Pharma
  • Aug 29, 2017NDANDA209776Rempex
  • Jul 26, 2023NDANDA215212Hq Spclt Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
31,174 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective4,34514%
  2. 2Off Label Use3,24710%
  3. 3Pyrexia2,1376.9%
  4. 4Pneumonia1,4524.7%
  5. 5Septic Shock1,3864.4%
  6. 6Sepsis1,3854.4%
  7. 7Multiple Organ Dysfunction Syndrome1,2594.0%
  8. 8Acute Kidney Injury1,2434.0%
  9. 9Condition Aggravated1,1943.8%
  10. 10Thrombocytopenia1,1073.6%
  11. 11Febrile Neutropenia1,1033.5%
  12. 12Respiratory Failure1,0963.5%
  13. 13Diarrhoea1,0923.5%
  14. 14Drug Interaction9383.0%
  15. 15Neutropenia9132.9%

Literature

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Recent PubMed references pinned to Meropenem as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 263 ClinicalTrials.gov registrations naming Meropenem as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Meropenem work?
Meropenem is an antibacterial drug [see Microbiology (12.4) ].
What is Meropenem used for?
According to FDA labeling, Meropenem carries indications including: Meropenem for Injection, USP is a penem antibacterial indicated for the treatment of: Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1 ) Complicated intra-abdominal infections (adult and pediatric patients).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Meropenem?
Meropenem is classified as Carbapenems, Transpeptidase Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Meropenem?
Meropenem is marketed under brand names including Vabomere.
What are the contraindications for Meropenem?
Meropenem labeling lists contraindications including: Meropenem for Injection, USP is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta (β)-lactams. Known hypersensitivity to product components or anaphylactic reactions to β-lactams.. Always consult the full prescribing information and a clinician.
Note. Data for meropenem is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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