pharmacopeia
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/api/v1/drug/ertapenem

Mechanism of action

Sourced from openFDA

Ertapenem sodium is a carbapenem antibiotic [see Clinical Pharmacology ( 12.4 )].

Enzyme

Indications

Sourced from openFDA
  • Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.

Contraindications

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  • Ertapenem for injection 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-lactams. Due to the use of lidocaine HCl as a diluent, ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.contraindicated

Dosage & administration

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Do not mix or co-infuse ertapenem for injection with other medications. Do not use diluents containing dextrose ( α –D–glucose) . ( 2.1 ) Ertapenem for injection should be infused over 30 minutes in both the Treatment and Prophylactic regimens. ( 2.1 ) Dosing considerations should be made in adults with advanced or end-stage renal impairment and those on hemodialysis. ( 2.4 , 2.5 ) Treatment regimen: Adults and pediatric patients 13 years of age and older. The dosage should be 1 gram once a day intravenously or intramuscularly. ( 2.2 ) Patients 3 months to 12 years of age should be administered 15 mg/kg twice daily (not to exceed 1 gram/day intravenously or intramuscularly). ( 2.2 ) Intravenous infusion may be administered in adults and pediatrics for up to 14 days or intramuscular injection for up to 7 days. ( 2.1 ) Prophylaxis regimen for adults: 1 gram single dose given 1 hour prior to elective colorectal surgery. ( 2.3 ) 2.1 Instructions for Use in All Patients For Intravenous or Intramuscular Use DO NOT MIX OR CO-INFUSE ERTAPENEM FOR INJECTION WITH OTHER MEDICATIONS. DO NOT USE DILUENTS CONTAINING DEXTROSE (α-D-GLUCOSE). Ertapenem for injection may be administered by intravenous infusion for up to 14 days or intramuscular injection for up to 7 days. When administered intravenously, ertapenem for injection should be infused over a period of 30 minutes. Intramuscular administration of ertapenem for injection may be used as an alternative to intravenous administration in the treatment of those infections for which intramuscular therapy is appropriate.

Warnings & precautions

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Serious hypersensitivity (anaphylactic) reactions have been reported in patients receiving β-lactams. ( 5.1 ) Seizures and other central nervous system adverse experiences have been reported during treatment. ( 5.2 ) Co-administration of ertapenem for injection with valproic acid or divalproex sodium reduces the serum concentration of valproic acid potentially increasing the risk of breakthrough seizures. ( 5.3 ) Clostridioides difficile -associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.4 ) Caution should be taken when administering ertapenem for injection intramuscularly to avoid inadvertent injection into a blood vessel. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-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 beta-lactam. Before initiating therapy with ertapenem for injection, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens. If an allergic reaction to ertapenem for injection occurs, discontinue the drug immediately. Serious anaphylactic reactions require immediate emergency treatment as clinically indicated.

Adverse reactions

Sourced from openFDA

The following are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Seizure Potential [see Warnings and Precautions ( 5.2 )] Interaction with Valproic Acid [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] Caution with Intramuscular Administration [see Warnings and Precautions ( 5.5 )] Development of Drug-Resistant Bacteria [see Warnings and Precautions ( 5.6 )] Laboratory Tests [see Warnings and Precautions ( 5.7 )] Adults: The most common adverse reactions (≥5%) in patients treated with ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, nausea, headache and infused vein complication. ( 6.1 ) In the prophylaxis indication the overall adverse experience profile was generally comparable to that observed for ertapenem in other clinical trials. ( 6.1 ) Pediatrics: Adverse reactions in this population were comparable to adults. The most common adverse reactions (≥5%) in pediatric patients treated with ertapenem for injection, including those who were switched to therapy with an oral antimicrobial, were diarrhea, vomiting and infusion site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Use in specific populations

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Renal Impairment: Dose adjustment is necessary, if creatinine clearance is ≤30 mL/min/1.73 m 2 . ( 2.4 , 8.6 , 12.3 ) 8.1 Pregnancy Risk Summary Available data from a small number of post-marketing cases with ertapenem for injection use in pregnancy are insufficient to inform any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies after intravenous administration of ertapenem during the period of organogenesis, there was no evidence of developmental malformations in rats at systemic exposures (AUC) up to approximately 1.2 times the human exposure at the maximum recommended human dose (MRHD) and in mice at doses up to approximately 3 times the MRHD based on body surface area comparison. In pregnant rats administered ertapenem during organogenesis through lactation, fetal toxicity, developmental delays, and impaired reproduction did not occur in first generation offspring at systemic exposures (AUC) approximately 1.2 times the human exposure at the MRHD (see Data ) . The estimated 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.

Pharmacokinetics

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Metabolism
Average plasma concentrations (mcg/mL) of ertapenem following a single 30-minute infusion of a 1 gram intravenous (IV) dose and administration of a single 1 gram intramuscular (IM) dose in healthy young adults are presented in Table 8 .

Overdosage

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No specific information is available on the treatment of overdosage with ertapenem for injection. Intentional overdosing of ertapenem for injection is unlikely. Intravenous administration of ertapenem for injection at a dose of 2 grams over 30 min or 3 grams over 1 to 2h in healthy adult volunteers resulted in an increased incidence of nausea. In clinical trials in adults, inadvertent administration of three 1 gram doses of ertapenem for injection in a 24 hour period resulted in diarrhea and transient dizziness in one patient. In pediatric clinical trials, a single intravenous dose of 40 mg/kg up to a maximum of 2 grams did not result in toxicity. In the event of an overdose, ertapenem for injection should be discontinued and general supportive treatment given until renal elimination takes place. Ertapenem for injection can be removed by hemodialysis; the plasma clearance of the total fraction of ertapenem was increased 30% in subjects with end-stage renal disease when hemodialysis (4 hour session) was performed immediately following administration. However, no information is available on the use of hemodialysis to treat overdosage.

Approval history

Sourced from openFDA
  • Nov 21, 2001NDANDA021337Msd Sub Merck
  • Apr 16, 2018ANDAANDA208790Acs Dobfar Spa
  • Jun 25, 2018ANDAANDA209133Eugia Pharma
  • Mar 19, 2019ANDAANDA207647Savior Lifetec Corp
  • Mar 26, 2021ANDAANDA212040Gland
  • Oct 31, 2024ANDAANDA218067Qilu Antibiotics

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.
7,195 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 Ineffective1,13316%
  2. 2Macular Degeneration80011%
  3. 3Off Label Use5237.3%
  4. 4Pyrexia4606.4%
  5. 5Confusional State4235.9%
  6. 6Product Use In Unapproved Indication3995.5%
  7. 7Nausea3895.4%
  8. 8Pain3404.7%
  9. 9Weight Decreased2713.8%
  10. 10Malaise2693.7%
  11. 11Anaemia2653.7%
  12. 12Hallucination2633.7%
  13. 13Abdominal Pain2373.3%
  14. 14Headache2333.2%
  15. 15Convulsion2303.2%

Literature

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Recent PubMed references pinned to Ertapenem 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 94 ClinicalTrials.gov registrations naming Ertapenem as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ertapenem work?
Ertapenem sodium is a carbapenem antibiotic [see Clinical Pharmacology ( 12.4 )].
What is Ertapenem used for?
According to FDA labeling, Ertapenem carries indications including: Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ertapenem?
Ertapenem is classified as Carbapenems, Penem Antibacterial, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair, Post Translation Protein Modification Alteration.
What are the brand names for Ertapenem?
Ertapenem is marketed under brand names including Invanz.
What are the contraindications for Ertapenem?
Ertapenem labeling lists contraindications including: Ertapenem for injection 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-lactams. Due to the use of lidocaine HCl as a diluent, ertapenem for injection administered intramuscularly is contraindicated in patients with a known hypersensitivity to local anesthetics of the amide type.. Always consult the full prescribing information and a clinician.
Note. Data for ertapenem 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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