Invanz (ertapenem sodium)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ertapenem is a synthetic carbapenem beta-lactam antibiotic.
Ertapenem is a synthetic carbapenem beta-lactam antibiotic that is structurally related to beta-lactam antibiotics. Its bactericidal activity results from the inhibition of bacterial cell wall synthesis, which is mediated by binding to penicillin binding proteins. Ertapenem demonstrates stability in the presence of a variety of beta-lactamases (including penicillinases, cephalosporinases, and extended-spectrum beta-lactamases).
Ertapenem is almost completely absorbed following IM administration, having a mean bioavailability of 90%. No accumulation of ertapenem is observed following repeated IV or IM 1 g daily doses in healthy adults. Following 1 g daily IM administration, peak plasma concentrations of ertapenem are attained in approximately 2.3 hours.
Ertapenem exhibits nonlinear pharmacokinetics and is highly bound to plasma proteins, principally albumin. Ertapenem is 95% bound to plasma proteins at concentrations <100 mcg/mL and 85% bound at concentrations of 300 mcg/mL. Ertapenem does not achieve therapeutic plasma concentrations in the CNS.
The drug distributes into blister fluid. The drug has a mean plasma half-life of approximately 4 hours in healthy adults and pediatric patients 13-17 years of age and may be administered once daily. The mean plasma half-life of ertapenem is 2.5 hours in pediatric patients 3 months to 12 years of age and the drug should be administered twice daily in this age group.
The drug is eliminated principally by renal excretion. Following administration of a 1 g IV radiolabeled ertapenem in healthy adults, approximately 80% of the drug is recovered in urine (approximately 38% as unchanged drug and 37% as the ring-opened metabolite) and 10% in the feces.
Ertapenem has in vitro activity against gram-positive and gram-negative aerobic and anaerobic bacteria. Ertapenem is active in vitro and in clinical infections against most strains of Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus agalactiae, S. pneumoniae (penicillin-susceptible strains only), S. pyogenes, Escherichia coli, Haemophilus influenzae (non-beta-lactamase-producing strains only), Klebsiella pneumoniae, Moraxella catarrhalis, Bacteroides fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. uniformis, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus spp., Porphyromonas asaccharolytica, and Prevotella bivia. Ertapenem also has demonstrated in vitro activity against S. pneumoniae (penicillin-intermediate strains), Citrobacter freundii, C. koseri, Enterobacter aerogenes, E. cloacae, H. influenzae (beta-lactamase-producing strains), H. parainfluenzae, Klebsiella oxytoca (excluding extended-spectrum beta-lactamase-producing strains), Morganella morganii, Proteus mirabilis, P. vulgaris, Serratia marcescens, C. perfringens, and Fusobacterium spp.; however, the safety and efficacy of ertapenem in treating clinical infections caused by these microorganisms have not been established in adequate and well-controlled clinical trials to date.
Each gram of ertapenem provides approximately 6 mEq (137 mg) of sodium.
Ertapenem should only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem and other antibacterial drugs. When available, culture and susceptibility patterns should be considered in selecting or modifying antibacterial therapy. Local epidemiology and susceptibility patterns may contribute to empiric selection of antibiotic therapy in the absence of culture and susceptibility data.
Generic name: ertapenem sodium
Pronunciation: (ER-ta-PEN-em)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Invanz:
- Abortion With Sepsis
- Bacterial Pneumonia
- Bacteroides Septic Abortion
- Colorectal Surgery Infection Prevention
- Complicated Bacterial Peritonitis
- Complicated Bacteroides Peritonitis
- Complicated E. Coli Peritonitis
- Complicated E. Coli Uti
- Complicated Peptostreptococcus Peritonitis
- Complicated Peritonitis Due To Clostridium
- Complicated Peritonitis Due To Eubacterium
- Complicated Skin And Skin Structure E. Coli Infection
- Complicated Skin And Skin Structure Infection
- Complicated Skin And Skin Structure Peptostreptococcus Infection
- Complicated Skin And Skin Structure Staphylococcus Aureus Infection
- Complicated Skin And Skin Structure Streptococcus Pyogenes Infection
- Diabetic Foot Infection
- E. Coli Pyelonephritis
- E. Coli Septic Abortion
- Female Genital Tract Infection
- Haemophilus Influenzae Pneumonia
- Infectious Disease Of Abdomen
- Intra-Abdominal Abscess
- Klebsiella Complicated Uti
- Klebsiella Pyelonephritis
- Moraxella Catarrhalis Pneumonia
- Peptostreptococcus Septic Abortion
- Pneumococcal Pneumonia
- Post-Op Gynecologic Infection Due To Bacteroides
- Post-Op Gynecologic Infection Due To Porphyromonas
- Post-Op Gynecologic Infection Due To Prevotella
- Post-Op Gynecologic Infection Due To Streptococcus
- Post-Op Gynecological Infection Due To E. Coli
- Post-Op Gynecological Peptostreptococcus Infection
- Postpartum Endomyometritis Due To Bacteroides
- Postpartum Endomyometritis Due To E. Coli
- Postpartum Endomyometritis Due To Peptostreptococcus
- Postpartum Endomyometritis Due To Porphyromonas
- Postpartum Endomyometritis Due To Prevotella
- Postpartum Endomyometritis Due To Streptococcus
- Prevotella Septic Abortion
- Septic Abortion Due To Porphyromonas
- Streptococcal Septic Abortion
Also known as: Abdominal Abscess, Abortion Complicated By A Septic Porphyromonas Infection, Complicated Bacterial Skin And Skin Structure Infection, Complicated E. Coli Skin And Skin Structure Infection, Complicated Peritonitis Due To Bacteroides Species, Complicated Peritonitis Due To Clostridium Spp., Complicated Peritonitis Due To E. Coli, Complicated Peritonitis Due To Escherichia Coli, Complicated Peritonitis Due To Eubacterium Spp., Complicated Peritonitis Due To Peptostreptococcus, Complicated Skin And Skin Soft Tissue Infection, Complicated Skin And Skin Soft Tissue Infection Due To Streptococcus Pyogenes, Complicated Skin And Skin Structure Bacterial Infection, Complicated Skin And Skin Structure Escherichia Coli Infection, Complicated Staphylococcus Aureus Skin And Skin Soft Tissue Infection, Complicated Streptococcus Pyogenes Skin And Skin Structure Infection, Complicated Urinary Tract Infection Due To Escherichia Coli, Complicated Urinary Tract Infection Due To Klebsiella, Complicated Uti Due To E. Coli, Complicated Uti Due To Klebsiella Species, Gynecologic Infection, H. Flu Pneumonia, H. Influenzae Pneumonia, Hemophilus Influenzae Pneumonia, Infected Abortion, Infected Abortion Due To Bacteroides Species, Infected Abortion Due To Escherichia Coli, Infected Abortion Due To Peptostreptococcus, Infected Abortion Due To Porphyromonas Species, Infected Abortion Due To Prevotella Species, Infected Abortion Due To Streptococcus Species, Infection Prophylaxis For Colorectal Surgery, Influenza Bacillus Pneumonia, Intra-Abdominal Infection, Nephropyelitis Due To Escherichia Coli, Nephropyelitis Due To Klebsiella Species, Pfeiffer's Bacillus Pneumonia, Pneumonia Due To B. Catarrhalis, Pneumonia Due To Branhamella Catarrhalis, Pneumonia Due To Haemophilus Influenzae, Pneumonia Due To M. Catarrhalis, Pneumonia Due To Moraxella Catarrhalis, Pneumonia Due To Neisseria Catarrhalis, Pneumonia Due To Streptococcus Pneumoniae, Post-Op Gynecological Infection Due To Prevotella, Postoperative Bacteroides Species Gynecologic Infection, Postoperative E. Coli Gynecologic Infection, Postoperative Gynecological Infection Due To Bacteroides, Postoperative Gynecological Infection Due To E. Coli, Postoperative Gynecological Infection Due To Porphyromonas, Postoperative Gynecological Infection Due To Prevotella, Postoperative Gynecological Infection Due To Streptococcus, Postoperative Gynecological Peptostreptococcus Infection, Postpartum Bacteroides Species Sepsis Of Uterine Tissue, Postpartum Endomyometritis Due To Bacteroides Spp., Postpartum Endomyometritis Due To Escherichia Coli, Postpartum Endomyometritis Due To Porphyromonas Spp., Postpartum Endomyometritis Due To Prevotella Spp., Postpartum Endomyometritis Due To Streptococcus Spp., Postpartum Peptostreptococcus Sepsis Of Uterine Tissue, Postpartum Peptostreptococcus Spp. Endomyometritis, Postpartum Porphyromonas Sepsis Of Tissues Of The Uterus, Postpartum Uterine Tissue Prevotella Species Sepsis, Postpartum Uterine Tissue Sepsis Due To Escherichia Coli, Postpartum Uterine Tissue Streptococcus Species Sepsis, Postsurgical Gynecologic Infection Due To E. Coli, Postsurgical Gynecological Infection Due To Bacteroides, Postsurgical Gynecological Infection Due To Porphyromonas, Postsurgical Gynecological Infection Due To Prevotella, Postsurgical Gynecological Infection Due To Streptococcus, Postsurgical Gynecological Peptostreptococcus Infection, Pyelonephritis Due To E. Coli, Pyelonephritis Due To Escherichia Coli, Pyelonephritis Due To Klebsiella Species, Renal & Pelvis Renalis Infection Due To Klebsiella, Renal & Ureteric Pelvis Infection Due To Escherichia Coli, Renal & Ureteric Pelvis Infection Due To Klebsiella, Renal And Pelvis Renalis Escherichia Coli Infection, Septic Abortion, Septic Abortion Due To Bacteroides Species, Septic Abortion Due To E. Coli, Septic Abortion Due To Escherichia Coli, Septic Abortion Due To Peptostreptococcus, Septic Abortion Due To Porphyromonas Spp., Septic Abortion Due To Prevotella Species, Septic Abortion Due To Streptococcus Species.
Dosing
Dosage of ertapenem sodium is expressed in terms of ertapenem.
Ertapenem sodium is administered by IV infusion or by IM injection. The manufacturer states that the drug may be administered once daily by IV infusion for up to 14 days or by IM injection for up to 7 days.
Store lyophilized powder vials at <=25degreesC.
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Drug interactions
Ertapenem does not inhibit cytochrome P-450 (CYP) isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 in vitro and does not inhibit the P-glycoprotein transport system or act as a substrate for P-glycoprotein-mediated transport.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to ertapenem, other carbapenems, or any ingredient in the formulation.
*History of anaphylactic reaction to beta-lactams.
*IM injections are prepared using lidocaine hydrochloride and are contraindicated in patients with known hypersensitivity to local anesthetics of the amide type.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects occurring in >=5% of adult patients receiving ertapenem sodium, including those who were switched to an oral antimicrobial, include diarrhea, nausea, headache, and infused vein complication.
Adverse effects reported in pediatric patients were similar to those in adults.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
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Safety and efficacy of ertapenem for labeled indications have been established in pediatric patients >=3 months to 17 years of age based on evidence from adequate and well-controlled clinical trials in adults, pharmacokinetic data in pediatric patients, and additional data from pediatric studies in patients >=3 months to 17 years of age.
The manufacturer states that safety and efficacy have not been established in infants <3 months of age.
Ertapenem is not recommended for the treatment of meningitis in pediatric patients due to insufficient cerebrospinal fluid (CSF) penetration.
Data on ertapenem use during pregnancy are insufficient to establish a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, systemic exposure to ertapenem up to 1.2 times the human exposure at the maximum recommended human dose (MRHD) in rats and up to 3 times the MRHD in mice during the period of organogenesis did not result in developmental malformations. At systemic exposures of ertapenem 1.2 times the MRHD in pregnant rats during the period of organogenesis through lactation, there was no evidence of fetal toxicity, developmental delays, or impaired reproduction in offspring.
Ertapenem is distributed into breast milk. The effects on the breast-fed child or on milk production are not known. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed child from ertapenem or from the underlying maternal condition.
Following the last 1 g dose of IV therapy for pelvic infections (3-10 days of therapy), the ertapenem concentration in breast milk within 24 hours of the last dose ranged from <0.13 (lower limit of quantitation) to 38 mcg/mL in 5 women. By the fifth day after discontinuation of therapy, levels of ertapenem were undetectable in the breast milk of 4 women, and below the lower limit of quantitation (<0.13 mcg/mL) in 1 woman.
Because geriatric patients are more likely to have reduced renal function compared to younger adults, caution should be undertaken during dosage selection. Monitoring of renal function may be useful in geriatric patients receiving ertapenem.
No substantial differences in safety and efficacy relative to younger adults. Total and unbound area under the curve (AUC) concentrations of ertapenem are increased 37% and 67%, respectively, in geriatric patients compared with younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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