Version May 2024
Dosage guidance:
Clinical considerations: Due to limited clinical data, ertapenem is usually reserved for extended-spectrum beta-lactamase infections with urinary sources or soft tissue infections when adequate source control has been achieved (Ref). Ertapenem lacks activity against Pseudomonas aeruginosa (unlike other carbapenems).
General dosing, susceptible infection (Ref):
Infants and Children: IM, IV: 15 mg/kg/dose twice daily; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily.
Intra-abdominal infection, complicated: Note: Guidelines recommend a treatment duration of 4 to 7 days (provided source controlled) for community-acquired, mild to moderate infections(Ref); manufacturer labeling suggests a duration of 5 to 14 days; however, longer durations (>7 days) have not been associated with improved outcomes (Ref).
Infants ≥3 months and Children: IM, IV: 15 mg/kg/dose twice daily; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily.
Pelvic infections, acute:
Infants ≥3 months and Children: IM, IV: 15 mg/kg/dose twice daily for 3 to 10 days based on severity of infection; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily for 3 to 10 days based on severity of infection.
Pneumonia, community-acquired: Note: Guidelines suggest a usual duration of therapy of 10 days (including both parental and possible switch to appropriate oral step-down therapy); however, longer duration may be necessary for some organisms and/or complicated infections (Ref).
Infants ≥3 months and Children: IM, IV: 15 mg/kg/dose twice daily for 10 to 14 days; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily for 10 to 14 days.
Skin and skin structure infection, complicated or necrotizing: Note: For complicated infection, continue therapy for 7 to 14 days. For necrotizing infection, use in combination with an agent effective against MRSA (eg, vancomycin, linezolid, daptomycin) for empiric therapy of polymicrobial (mixed) infections. Continue until further debridement is not necessary, patient has clinically improved, and patient is afebrile for 48 to 72 hours (Ref).
Infants ≥3 months and Children: IM, IV: 15 mg/kg/dose twice daily; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily.
Surgical prophylaxis: Limited data available: Children and Adolescents: IV: 15 mg/kg within 60 minutes prior to surgical incision; maximum dose: 1,000 mg/dose (Ref).
Urinary tract infection (including pyelonephritis): Note: Duration includes possible switch to appropriate oral therapy after at least 3 days of parenteral treatment, once clinical improvement demonstrated.
Infants ≥3 months and Children: IM, IV: 15 mg/kg/dose twice daily for 10 to 14 days; maximum dose: 500 mg/dose.
Adolescents: IM, IV: 1,000 mg once daily for 10 to 14 days.
There are no pediatric specific recommendations; based on experience in adult patients, dosage adjustment suggested.
There are no dosage adjustments provided in the manufacturer's labeling; has not be adequately studied.
(For additional information see "Ertapenem: Drug information")
Dosage guidance:
Clinical considerations: Generally reserved for pathogens that are resistant to other antibiotics (eg, extended-spectrum beta-lactamase–producing organisms) (Ref). Ertapenem lacks activity against Pseudomonas aeruginosa (unlike other carbapenems).
Bite wound infection, treatment (animal or human bite) (alternative agent) (off-label use): IV: 1 g once daily. Duration of treatment for established infection (which may include oral step-down therapy) is typically 5 to 14 days and varies based on patient-specific factors, including clinical response (Ref).
Bloodstream infection (pathogen-directed therapy for susceptible gram-negative organisms) (off-label use): IV: 1 g once daily (Ref). Duration is 7 to 14 days, depending on source and extent of infection, as well as clinical response; a 7-day duration is recommended for patients with uncomplicated Enterobacteriaceae bacteremia who respond appropriately to antibiotic therapy (Ref).
Diabetic foot infection, moderate to severe: IM, IV: 1 g once daily. Duration (which may include oral step-down therapy) is usually 2 to 4 weeks in the absence of osteomyelitis but varies based on patient-specific factors, including clinical response (Ref).
Intra-abdominal infection, mild to moderate, community-acquired in patients without risk factors for resistance or treatment failure (alternative agent):
Note: Reserve for patients unable to take first-line agents (eg, piperacillin/tazobactam) (Ref).
Cholecystitis, acute: IV: 1 g once daily; continue for 1 day after gallbladder removal or until clinical resolution in patients managed nonoperatively (Ref).
Other intra-abdominal infections (eg, perforated appendix, appendiceal abscess, cholangitis, diverticulitis): IM, IV: 1 g once daily. Total duration of therapy (which may include transition to oral antibiotics) is 4 to 5 days following adequate source control (Ref). For diverticulitis or uncomplicated appendicitis managed without intervention, duration is 10 to 14 days (Ref); for perforated appendicitis managed with laparoscopic appendectomy, 2 to 4 days may be sufficient (Ref).
Osteomyelitis and/or discitis (pathogen-directed therapy for susceptible gram-negative organisms) (off-label use): IV: 1 g once daily, generally for ≥6 weeks depending on patient-specific factors, such as extent of infection, debridement, and clinical response. Shorter courses are appropriate if the affected bone is completely resected (eg, by amputation) (Ref).
Pelvic infections, acute (eg, postpartum and postsurgical gynecologic infections) (alternative agent): IM, IV: 1 g once daily; duration of therapy varies based on type of infection.
Pneumonia (alternative agent):
Community-acquired pneumonia, empiric therapy (inpatients without risk factors for Pseudomonas aeruginosa ): IM, IV: 1 g once daily as part of an appropriate combination regimen. Duration (which may include oral step-down therapy) is for a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (Ref).
Hospital-acquired pneumonia or ventilator-associated pneumonia (pathogen-directed therapy for extended-spectrum beta-lactamase-producing organisms) (off-label use): IV: 1 g once daily (Ref). Duration of therapy varies based on disease severity and response to therapy; treatment is typically given for 7 days (Ref).
Prosthetic joint infection (pathogen-directed therapy for susceptible gram-negative organisms) (off-label use): IV: 1 g every 24 hours; duration varies, but is generally 4 to 6 weeks for patients who undergo resection arthroplasty (Ref).
Skin and soft tissue infection, moderate to severe:
Note: For patients with select surgical site infections (intestinal, GU tract), necrotizing infections, or patients with or at risk for pathogens resistant to other agents (Ref).
IV: 1 g once daily; often used as part of an appropriate combination regimen. Usual duration (including oral step-down therapy) is 5 to 14 days based on severity and clinical response; for necrotizing infections, continue until further debridement is not necessary and the patient has improved clinically and is afebrile for 48 to 72 hours (Ref).
Surgical prophylaxis (colorectal surgery) (alternative agent): IV: 1 g within 60 minutes prior to surgical incision (Ref). Note: Postoperative prophylaxis is not recommended in clean and clean-contaminated surgeries (Ref). Some experts recommend against using ertapenem for surgical prophylaxis out of concern for inducing resistance (Ref).
Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic signs/symptoms) (alternative agent):
Inpatients: IV, IM: 1 g once daily. Switch to an appropriate oral regimen once symptoms improve, if culture and susceptibility results allow. Total duration of therapy ranges from 5 to 14 days and depends on clinical response and the antimicrobial chosen to complete the regimen (Ref).
Outpatients: IV, IM: 1 g as a single dose, followed by 5 to 14 days of appropriate oral therapy. Note: For patients who are systemically ill, at risk for more severe illness, or at risk for multidrug-resistant infection, some experts continue daily parenteral therapy pending culture and susceptibility testing results (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: IM, IV:
Note: Although the manufacturer’s labeling reports CrCl units as mL/minute/1.73 m2, it is not necessary to adjust CrCl estimates for BSA when dosing ertapenem, as renal clearance of a drug is proportional to an individual’s estimated CrCl in mL/minute, and ertapenem is generally well tolerated (Nix 2017; expert opinion).
CrCl >30 mL/minute: No dosage adjustment necessary.
CrCl ≤30 mL/minute: 500 mg once daily.
Hemodialysis, intermittent (thrice weekly):
Daily dosing: IM, IV: 500 mg once daily. When scheduled dose falls on a hemodialysis day, administer at least 6 hours prior to hemodialysis or wait until after hemodialysis; however, if the dose is given within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is required following hemodialysis.
Three times weekly (post hemodialysis) dosing: IM, IV: 500 mg or 1 g 3 times weekly after hemodialysis on hemodialysis days (Ref).
Note: Consider patient-specific factors such as body weight, infection severity, and residual kidney function when deciding between doses (Ref).
Peritoneal dialysis: IM, IV: 500 mg once daily (Ref).
CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations were developed through Monte Carlo simulation only and based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), organism minimum inhibitory concentration (MIC), and residual kidney function. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.
IM, IV: 1 g once daily (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on daily treatments with 4 to 5 L/hour (Ref) or 10 L/hour (Burkhardt 2009) of dialysate/ultrafiltrate flow rate for each 8- to 10-hour session. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection), organism MIC, and residual kidney function. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug accumulation is important.
IM, IV: 500 mg initially, then 500 mg post each PIRRT session or 1 g once daily (Ref).
Adjustments cannot be recommended (lack of experience and research in this patient population).
Clostridioides difficile infection (CDI) has occurred with ertapenem, including Clostridioides difficile-associated diarrhea (CDAD) and Clostridioides difficile colitis. Ertapenem for surgical prophylaxis is associated with an increased incidence of hospital-onset CDI (Ref). Ertapenem does not appear to have a higher risk of CDI compared to other carbapenems (Ref).
Mechanism: Dose- and time-related; potentially related to recent or cumulative antibiotic exposure. Ertapenem may cause disruption of the intestinal microbiota resulting in the overgrowth of pathogens, such as C. difficile (Ref).
Onset: Varied; often occurs between 5 and 30 days after initial dose (Ref).
Risk factors:
• Antibiotic exposure (highest risk factor) (Ref)
• Type of antibiotic (carbapenems among highest risk) (Ref)
• Long durations in a hospital or other healthcare setting (recent or current) (Ref)
• Older adults (Ref)
• Immunocompromised conditions (Ref)
• A serious underlying condition (Ref)
• GI surgery/manipulation (Ref)
• Antiulcer medications (eg, proton pump inhibitors, H2 blockers) (Ref)
• Chemotherapy (Ref)
Carbapenems, including ertapenem, may cause CNS toxicity. Noteworthy CNS effects caused by ertapenem include encephalopathy, altered mental status, hallucinations, and seizures (Ref). Ertapenem is associated with a lower seizure risk than other carbapenems, potentially due to structural differences at the C-2 position and/or unique pharmacokinetic properties, such as small volume of distribution and high protein binding (Ref). Resolution to baseline mental status after discontinuation often occurs within 2 to 14 days (Ref).
Mechanism: Not clearly established; postulated to be due to the antagonism of the GABAA receptor binding site. A carbapenem with a basic C-2 side chain increases the binding to GABAA (eg, imipenem) (Ref). Ertapenem has an acidic carboxyl group at the C-2 position and is expected to have the lowest binding to GABAA, subsequently reducing its potential for neurotoxic activity (Ref).
Onset: Varied; signs of neurotoxicity are often observed within 5 to 7 days after the initial ertapenem dose (Ref).
Risk factors:
• Preexisting neurologic conditions (eg, brain injury, seizures, stroke) (Ref)
• Drug accumulation in kidney impairment or hemodialysis (Ref)
Immediate (including anaphylaxis and urticaria) and delayed hypersensitivity reactions have been reported. Delayed hypersensitivity reactions range from skin rash to rare severe cutaneous adverse reactions (SCARs), including acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (Ref).
Mechanism: Non–dose-related; immunologic. Immediate hypersensitivity reactions (eg, anaphylaxis, urticaria) are IgE-mediated. Delayed hypersensitivity reactions, including morbilliform drug eruptions (MDE) and SCARs, are generally mediated by T-cells (Ref).
Onset: Immediate hypersensitivity reactions: Rapid; IgE-mediated reactions (anaphylaxis, urticaria) generally occur within 1 hour of administration but may occur up to 6 hours after exposure (Ref). Delayed hypersensitivity reactions: Varied; MDE typically occur ~7 to 10 days after initiation. Other delayed hypersensitivity reactions, including SCARs, typically occur days to 8 weeks after drug exposure, but may occur more rapidly (usually within 1 to 4 days) upon reexposure (Ref). AGEP has been reported within 2 days after initiation of ertapenem (Ref).
Risk factors:
• Previous hypersensitivity to carbapenems
• Cross-reactivity between penicillins/cephalosporins and carbapenems is considered ≤1% (Ref)
- Despite similar core structures, cross-reactions between carbapenems have not been well described and several case reports of selective immediate or delayed reactions to a specific carbapenem with tolerance to another have been reported (Ref). Ertapenem has been tolerated in a patient following a hypersensitivity reaction to meropenem (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported in adults, unless otherwise noted.
>10%: Gastrointestinal: Diarrhea (infants, children, adolescents, adults: 9% to 12%)
1% to 10%:
Cardiovascular: Asystole (<2%), atrial fibrillation (<2%), bradycardia (<2%), cardiac arrhythmia (<2%), chest pain (infants, children, adolescents, adults: <2%), edema (≤3%), flushing (<2%), heart failure (<2%), heart murmur(<2%), hypertension (<2%), hypotension (1% to 2%), phlebitis (infants, children, adolescents, adults: <2%), syncope (<2%), tachycardia (<2%), thrombophlebitis (<2%), ventricular tachycardia (<2%)
Dermatologic: Dermatitis (infants, children, adolescents, adults: <2%), desquamation (<2%), diaphoresis (<2%), erythema of skin (<2%), erythematous rash (infants, children, and adolescents: <2%), pruritus (infants, children, adolescents, adults: ≤2%), skin lesion (infants, children, and adolescents: <2%), skin rash (infants, children, adolescents, adults: 2% to 3%) (table 1), urticaria (<2%)
|
Drug (Ertapenem) |
Comparator |
Population |
Dose |
Number of Patients (Ertapenem) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
3% |
2% |
Infants, children, and adolescents |
15 mg/kg twice daily up to a maximum of 1 g daily |
384 |
100 |
Comparator: Ceftriaxone |
|
3% |
8% |
Infants, children, and adolescents |
15 mg/kg twice daily up to maximum of 1 g daily |
384 |
24 |
Comparator: Ticarcillin and Clavulanate |
|
3% |
3% |
Adults |
1 g daily |
802 |
774 |
Comparator: Piperacillin and Tazobactam |
|
2% |
2% |
Adults |
1 g daily |
1,152 |
942 |
Comparator: Ceftriaxone |
Endocrine & metabolic: Decreased serum albumin (<2%), decreased serum potassium (<2%), dehydration (<2%), increased serum glucose (<2%), increased serum potassium (<2%), increased serum sodium (<2%), weight loss (<2%)
Gastrointestinal: Abdominal distention (<2%), abdominal pain (infants, children, adolescents, adults: 4% to 5%), acid regurgitation (<2%), anorexia (<2%), cholelithiasis (<2%), Clostridioides difficile-associated diarrhea (<2%), constipation (infants, children, adolescents, adults: 2% to 4%), decreased appetite (infants, children, and adolescents: <2%), duodenitis (<2%), dysgeusia (<2%), dyspepsia (<2%), dysphagia (<2%), esophagitis (<2%), flatulence (<2%), gastritis (<2%), gastrointestinal hemorrhage (<2%), hemorrhoids (<2%), hiccups (<2%), intestinal obstruction (<2%), nausea (infants, children, adolescents: <2%; adults: 6% to 9%), oral candidiasis (infants, children, adolescents, adults: <2%), oral mucosa ulcer (<2%), pancreatitis (<2%), pyloric stenosis (<2%), sore throat (<2%), stomatitis (<2%), upper abdominal pain (infants, children, and adolescents: <2%), vomiting (infants, children, adolescents, adults: 4% to 10%)
Genitourinary: Anuria (<2%), bladder dysfunction (<2%), finding of blood in urine (increased red blood cells: 1% to 3%), genital rash (infants, children, and adolescents: <2%), hematuria (<2%), oliguria (<2%), proteinuria (infants, children, and adolescents: <2%), urinary retention (<2%), vaginitis (1% to 3%), vulvovaginal candidiasis (<2%), vulvovaginal pruritus (<2%), vulvovaginitis (<2%)
Hematologic & oncologic: Decreased hematocrit (3%), decreased hemoglobin (5%), decreased neutrophils (infants, children, adolescents: 6%; adults: <2%), decreased platelet count (<2%), decreased white blood cell count (infants, children, adolescents, adults: <2%), eosinophilia (infants, children, adolescents, adults: ≤2%), hematoma (<2%), leukocyturia (2% to 3%), prolonged partial thromboplastin time (<2%), prolonged prothrombin time (<2%), thrombocythemia (infants, children, adolescents: <2%; adults: 4% to 7%)
Hepatic: Increased serum alanine aminotransferase (infants, children, adolescents, adults: 4% to 9%), increased serum alkaline phosphatase (infants, children, adolescents: <2%; adults: 4% to 7%), increased serum aspartate transaminase (infants, children, adolescents, adults: 4% to 8%), increased serum bilirubin (<2%; including increased direct serum bilirubin or increased indirect serum bilirubin), jaundice (<2%)
Hypersensitivity: Facial edema (<2%)
Infection: Abscess (abdominal: infants, children, and adolescents: <2%), candidiasis (infants, children, adolescents, adults: <2%), herpes simplex infection (infants, children, and adolescents: <2%), septic shock (<2%), septicemia (<2%)
Local: Erythema at injection site (infants, children, and adolescents: 4%), induration at injection site (infants, children, adolescents, adults: <2%), infused vein complication (5% to 7%), infusion-site pain (infants, children, adolescents: 7%), injection-site phlebitis (infants, children, adolescents: <2%), injection-site pruritus (infants, children, and adolescents: <2%), pain at injection site (<2%), swelling at injection site (infants, children, and adolescents: <2%), warm sensation at injection site (infants, children, and adolescents: <2%)
Nervous system: Aggressive behavior (<2%), altered mental status (3% to 5%; including agitation, confusion, decreased mental acuity, delirium, disorientation, drowsiness, stupor) (table 2), anxiety (<2%), asthenia (<2%), chills (<2%), depression (<2%), dizziness (infants, children, adolescents, adults: ≤2%), fatigue (<2%), headache (infants, children, adolescents, adults: 4% to 7%), hypoesthesia (<2%), hypothermia (infants, children, and adolescents: <2%), insomnia (infants, children, adolescents, adults: ≤3%), malaise (<2%), nervousness (<2%), pain (<2%), paresthesia (<2%), subdural hematoma (<2%), tremor (<2%), vertigo (<2%), voice disorder (<2%)
|
Drug (Ertapenem) |
Comparator |
Population |
Dose |
Number of Patients (Ertapenem) |
Number of Patients (Comparator) |
Comments |
|---|---|---|---|---|---|---|
|
5% |
3% |
Adults |
1 g daily |
802 |
774 |
Comparator: Piperacillin and Tazobactam |
|
3% |
3% |
Adults |
1 g daily |
1,152 |
942 |
Comparator: Ceftriaxone |
Neuromuscular & skeletal: Arthralgia (infants, children, and adolescents: <2%), gout (<2%), lower extremity pain (<2%), muscle spasm (<2%)
Renal: Flank pain (<2%), increased blood urea nitrogen (<2%), increased serum creatinine (<2%), renal insufficiency (<2%)
Respiratory: Asthma (<2%), bronchoconstriction (<2%), cough (infants, children, adolescents, adults: ≤4%), dyspnea (1% to 3%), epistaxis (<2%), hemoptysis (<2%), hypoxemia (<2%), nasopharyngitis (infants, children, and adolescents: <2%), pharyngitis (infants, children, adolescents, adults: <2%; including viral), pleural effusion (infants, children, adolescents, adults: <2%), pleuritic chest pain (<2%), rales (<2%), respiratory distress (<2%), rhinitis (infants, children, and adolescents: <2%), rhinorrhea (infants, children, and adolescents: <2%), rhonchi (<2%), upper respiratory tract infection (infants, children, and adolescents: 2%), wheezing (infants, children, and adolescents: <2%)
Miscellaneous: Fever (infants, children, adolescents, adults: 2% to 5%), swelling (infants, children, adolescents, adults: ≤3%), tissue necrosis (<2%)
<1%: Nervous system: Seizure (table 3)
|
Drug (Ertapenem) |
Comparator (Piperacillin and Tazobactam) |
Comparator (Ceftriaxone) |
Population |
Dose |
Number of Patients (Ertapenem) |
Number of Patients (Piperacillin and Tazobactam) |
Number of Patients (Ceftriaxone) |
|---|---|---|---|---|---|---|---|
|
0.5% |
0.3% |
0% |
Adults |
1 g daily |
1,954 |
774 |
942 |
Postmarking (any population):
Dermatologic: Acute generalized exanthematous pustulosis (Fernando 2013)
Endocrine & metabolic: Hypoglycemia (Kennedy 2019)
Gastrointestinal: Clostridioides difficile colitis (Itani 2006), staining of tooth
Hypersensitivity: Anaphylaxis, drug reaction with eosinophilia and systemic symptoms, hypersensitivity angiitis, nonimmune anaphylaxis
Nervous system: Abnormal gait, ataxia, encephalopathy (Sutton 2017), hallucination (Sutton 2017), impaired consciousness, myasthenia, myoclonus
Neuromuscular & skeletal: Dyskinesia
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; known hypersensitivity to local anesthetics of the amide type due to the use of lidocaine as a diluent (IM use only).
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in patients with moderate to severe renal dysfunction. Increased seizure risk has been reported in patients with renal dysfunction.
Concurrent drug therapy issues:
• Valproic acid and derivatives: Carbapenems, including ertapenem, may decrease the serum concentration of divalproex sodium/valproic acid increasing the risk of breakthrough seizures. Concurrent use of carbapenem antibiotics with divalproex sodium/valproic acid is generally not recommended. Alternative antimicrobial agents should be considered, but if a concurrent carbapenem is necessary, consider additional antiseizure medication.
Special populations:
• Older adult: Lower doses (based upon renal function) are often required in the elderly.
Other warnings/precautions:
• IM administration: Doses for IM administration are mixed with lidocaine; consult Lidocaine (Systemic) information for associated Warnings/Precautions.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
Generic: 1 g (1 ea)
Solution Reconstituted, Injection [preservative free]:
INVanz: 1 g (1 ea)
Generic: 1 g (1 ea)
Yes
Solution (reconstituted) (Ertapenem Sodium Injection)
1 g (per each): $48.00 - $166.56
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Injection:
INVanz: 1 g (3.2 mL)
Generic: 1 g (1 ea)
Sodium content: 1,000 mg ertapenem contains 6 mEq
Parenteral:
IM: Administer by deep IM injection into a large muscle mass such as the gluteus maximus or lateral part of the thigh. Avoid injection into a blood vessel. Must be administered within 1 hour of reconstitution.
Intermittent IV infusion: Infuse over 30 minutes; administration should be completed within 6 hours of reconstitution. Do not coinfuse with other medications. Do not infuse with dextrose-containing solutions.
IM: Avoid injection into a blood vessel. Make sure patient does not have an allergy to lidocaine or another anesthetic of the amide type. Administer by deep IM injection into a large muscle mass (eg, gluteal muscle or lateral part of the thigh). Do not administer IM preparation or drug reconstituted for IM administration intravenously.
IV: Administer as an IV infusion over 30 minutes. May also administer IV push over 5 minutes (Ref).
Prior to reconstitution, store vials at ≤25°C (77°F). The reconstituted IM solution should be used within 1 hour after preparation. The reconstituted IV solution may be stored at room temperature (25°C [77°F]) and used within 6 hours, or stored for 24 hours under refrigeration (5°C [41°F]) and used within 4 hours after removal from refrigeration. Do not freeze.
Treatment of moderate to severe infections caused by susceptible organisms including: Complicated intra-abdominal infections caused by Clostridioides clostridioforme, Escherichia coli, Eubacterium lentum, Peptostreptococcus spp, Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis; acute pelvic infections (including postpartum endomyometritis, septic abortion, and postsurgical gynecologic infections) caused by Streptococcus agalactiae, E. coli, B. fragilis, Porphyromonas asaccharolytica, Peptostreptococcus spp, or Prevotella bivia; complicated skin and skin structure infections (including diabetic foot infections without osteomyelitis) caused by Staphylococcus aureus (methicillin-susceptible isolates only), S. agalactiae, Streptococcus pyogenes, E. coli, Klebsiella pneumoniae, Proteus mirabilis, B. fragilis, Peptostreptococcus spp, P. asaccharolytica, or P. bivia; community-acquired pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates only), including cases with concurrent bacteremia; Haemophilus influenzae (beta-lactamase-negative isolates only); or Moraxella catarrhalis; and complicated urinary tract infections (including pyelonephritis) caused by E. coli, including cases with concurrent bacteremia or K. pneumoniae (All indications: FDA approved in ages ≥3 months and adults); prophylaxis of surgical site infection following colorectal surgery (FDA approved in adults)
Ertapenem may be confused with doripenem, imipenem, meropenem
Invanz may be confused with IV vancomycin
Invanz [US, Canada, Qatar] may be confused with Avinza [Puerto Rico] and Evista brand name for raloxifene [US, Canada, and multiple international markets]
Substrate of OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider therapy modification
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Leflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Nitisinone: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Pretomanid: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Ertapenem. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Tacrolimus (Systemic): Ertapenem may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Taurursodiol: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk X: Avoid combination
Teriflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vaborbactam: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy
Valproate Products: Carbapenems may decrease the serum concentration of Valproate Products. Management: Concurrent use of carbapenem antibiotics with valproic acid is generally not recommended. Alternative antimicrobial agents should be considered, but if a concurrent carbapenem is necessary, consider additional anti-seizure medication. Risk D: Consider therapy modification
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Ertapenem is approved for the treatment of postpartum endomyometritis, septic abortion, and postsurgical infections. Ertapenem may be considered for use as an alternative antibiotic in the treatment of intraamniotic infection (ACOG 712 2017).
Periodic renal, hepatic, and hematologic function tests; neurological assessment
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins; which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.
Absorption: IM: Almost complete
Distribution: Vdss:
Infants ≥3 months and Children: ~0.2 L/kg
Adolescents 13 to 17 years: ~0.16 L/kg
Adults: ~0.12 L/kg
Protein binding (concentration dependent, primarily to albumin): 85% at 300 mcg/mL, 95% at <100 mcg/mL
Metabolism: Non-CYP-mediated hydrolysis to inactive metabolite
Bioavailability: IM: ~90%
Half-life elimination:
Infants ≥3 months and Children: ~2.5 hours
Adolescents and Adults: ~4 hours
Time to peak: IM: ~2.3 hours
Excretion: Urine (~80% as unchanged drug and metabolite); feces (~10%)
Altered kidney function: Unbound AUC increased 1.5- and 2.3-fold in those with mild and moderate renal function impairment, respectively. Unbound AUC increased 4.4- and 7.6-fold in those with advanced renal impairment and end-stage renal disease, respectively.
Older adult: The total and unbound AUC increased 37% and 67%, respectively, in elderly patients relative to younger patients.
Anti-infective considerations:
Parameters associated with efficacy:
Time dependent; associated with time free drug concentration (fT) > minimum inhibitory concentration (MIC).
Organism specific:
Gram-negative organisms (E. coli, K. pneumoniae): Goal: ≥40% fT > MIC (bactericidal) (DeRyke 2011).
S. pneumoniae: Goal: ≥30% fT > MIC (bactericidal) (Xuan 2002).
Population specific:
Critically ill patients in the ICU: Minimum goal: ≥50% fT > MIC; preferred goal: ≥100% fT > MIC (Abdul-Aziz 2020; Al-Shaer 2020; Roberts 2014); some experts favor ≥100% fT > 4 times the MIC (Guilhaumou 2019).
Expected drug exposure in normal renal function:
Cmax (peak): Single dose:
Infants and children 3 to 23 months of age: IV: 15 mg/kg (maximum dose: 1 g): 103.8 mg/L.
Children 2 to 12 years of age: IV: 15 mg/kg (maximum dose: 1 g): 113.2 mg/L.
Adolescents 13 to 17 years of age: IV: 1 g: 155.9 mg/L.
Adults:
IV: 1 g: 155 mg/L.
IM: 1 g: 67 mg/L.
Postantibiotic effect: Minimal bacterial killing continues after ertapenem concentration falls below the MIC of targeted pathogen and varies based on the organism:
S. aureus: ~1.5 hours (Odenholt 1998).
S. pneumoniae: ~2.4 hours (Odenholt 1998).
Gram-negative organisms (Enterobacter cloacae, E. coli, H. influenzae): ≤0.7 hours (Odenholt 1998).
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