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Ertapenem

Pronunciation

Pronunciation

(er ta PEN em)

Index Terms

  • Ertapenem Sodium
  • L-749,345
  • MK0826

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

INVanz: 1 g (1 ea)

Solution Reconstituted, Intravenous:

INVanz: 1 g (1 ea)

Brand Names: U.S.

  • INVanz

Pharmacologic Category

  • Antibiotic, Carbapenem

Pharmacology

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:

Children 3 months to 12 years: ~0.2 L/kg

Children 13-17 years: ~0.16 L/kg

Adults: ~0.12 L/kg

Metabolism

Non-CYP-mediated hydrolysis to inactive metabolite

Excretion

Urine (~80% as unchanged drug and metabolite); feces (~10%)

Time to Peak

IM: ~2.3 hours

Half-Life Elimination

Children 3 months to 12 years: ~2.5 hours

Children ≥13 years and Adults: ~4 hours

Protein Binding

Concentration dependent, primarily to albumin: 85% at 300 mcg/mL, 95% at <100 mcg/mL

Special Populations: Renal Function Impairment

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 ESRD, respectively.

Special Populations: Elderly

The total and unbound AUC increased 37% and 67%, respectively, in elderly patients relative to younger patients.

Special Populations: Children

Pharmacokinetic parameters in adolescents are comparable with adults. Plasma clearance is approximately 2-fold higher in infants ≥3 months and children when compared with adults. The half-life is ~2.5 hours in infants ≥3 months and children.

Use: Labeled Indications

Moderate-to-severe infections:

Acute pelvic infections: For the treatment of acute pelvic infections, including postpartum endomyometritis, septic abortion, and postsurgical gynecologic infections caused by Streptococcus agalactiae, Escherichia coli, Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus spp, or Prevotella bivia.

Community-acquired pneumonia: For the treatment of community-acquired pneumonia (CAP) caused by Streptococcus pneumoniae (penicillin-susceptible isolates only), including cases with concurrent bacteremia; Haemophilus influenzae (beta-lactamase-negative isolates only); or Moraxella catarrhalis.

Complicated intra-abdominal infections: For the treatment of complicated intra-abdominal infections caused by E. coli, Clostridium clostridioforme, Eubacterium lentum, Peptostreptococcus spp, B. fragilis, Bacteroides distasonis, Bacteroides ovatus, Bacteroides thetaiotaomicron, or Bacteroides uniformis.

Complicated skin and skin structure infections: For the treatment of 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. Ertapenem has not been studied in diabetic foot infections with concomitant osteomyelitis.

Complicated urinary tract infections: For the treatment of complicated urinary tract infections (UTIs), including pyelonephritis caused by E. coli, including cases with concurrent bacteremia or K. pneumoniae.

Prophylaxis of surgical-site infection in colorectal surgery: For the prophylaxis of surgical-site infection in adults following elective colorectal surgery.

Note: Methicillin-resistant Staphylococcus aureus, Enterococcus spp, penicillin-resistant strains of Streptococcus pneumoniae , Acinetobacter, and Pseudomonas aeruginosa, are resistant to ertapenem while most extended-spectrum beta-lactamase (ESBL)-producing bacteria remain sensitive to ertapenem.

Use: Unlabeled

Treatment of intravenous catheter-related bloodstream infection; treatment of prosthetic joint infection

Contraindications

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).

Dosing: Adult

Note: IV therapy may be administered for up to 14 days; IM for up to 7 days

Community-acquired pneumonia and complicated urinary tract infections (including pyelonephritis): IM, IV: 1 g once daily; duration of total antibiotic treatment: 10-14 days; duration includes possible switch to appropriate oral therapy after at least 3 days of parenteral treatment, once clinical improvement demonstrated. Note: The carbapenems, including ertapenem, are preferred agents for Enterobacter spp and Burkholderia pseudomallei, and are considered alternative agents for anaerobes in aspiration pneumonia (IDSA, 2007).

Intra-abdominal infection: IM, IV: 1 g once daily for 5-14 days; Note: 2010 IDSA guidelines recommend a treatment duration of 4-7 days (provided source controlled) for community-acquired, mild-to-moderate intra-abdominal infections (Solomkin, 2010)

Pelvic infections (acute): IM, IV: 1 g once daily for 3-10 days

Prophylaxis of surgical site following colorectal surgery: IV: 1 g as a single dose given 1 hour preoperatively

Skin and skin structure infections (excluding diabetic foot infections with osteomyelitis): IM, IV: 1 g once daily for 7-14 days. Notes: For diabetic foot infections, recommended treatment duration is up to 4 weeks depending on severity of infection and response to therapy (Lipsky, 2012).

Intravenous catheter-related bloodstream infection (off-label use): IV 1 g once daily (Note: Carbapenems, including ertapenem, are preferred agents for extended-spectrum β-lactamase [ESBL]-positive Escherichia coli and Klebsiella, Enterobacter, and Serratia [IDSA, 2009].)

Prosthetic joint infection: Enterobacter spp (off-label use): IV: 1 g every 24 hours for 4-6 weeks (Osmon, 2013)

Skin and soft tissue necrotizing infections (off-label use): IV: 1 g once daily 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 (IDSA [Stevens, 2014]).

Surgical site infection (intestinal or genitourinary tract surgery) (off-label use): IV: 1 g once daily (IDSA [Stevens, 2014]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: IV therapy may be administered for up to 14 days; IM therapy for up to 7 days

Infants ≥3 months and Children:

Community-acquired pneumonia and complicated urinary tract infections (including pyelonephritis): IM, IV: 15 mg/kg twice daily (maximum: 1 g daily); duration of total antibiotic treatment: 10-14 days (Note: Duration includes possible switch to appropriate oral therapy after at least 3 days of parenteral treatment, once clinical improvement demonstrated.)

Intra-abdominal infection: IM, IV: 15 mg/kg twice daily (maximum: 1 g daily) for 5-14 days

Pelvic infections (acute): IM, IV: 15 mg/kg twice daily (maximum: 1 g daily) for 3-10 days

Skin and skin structure infections: IM, IV: 15 mg/kg twice daily (maximum: 1 g daily) for 7-14 days

Skin and soft tissue necrotizing infections (off-label use): IV: 15 mg/kg every 12 hours 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 (IDSA [Stevens, 2014]).

Adolescents:

Community-acquired pneumonia, complicated urinary tract infections (including pyelonephritis): Refer to adult dosing.

Intra-abdominal infection: Refer to adult dosing.

Pelvic infections (acute): Refer to adult dosing.

Skin and skin structure infections (excluding diabetic foot infections with osteomyelitis): Refer to adult dosing.

Dosing: Renal Impairment

Children: No data available for pediatric patients with renal insufficiency.

Adults:

CrCl >30 mL/minute/1.73 m2: No dosage adjustment necessary.

CrCl ≤30 mL/minute/1.73 m2 and ESRD: 500 mg/day

Hemodialysis: When the daily dose is given within 6 hours prior to hemodialysis, a supplementary dose of 150 mg is required following hemodialysis. If ertapenem is given at least 6 hours prior to hemodialysis, no supplementary dose is needed.

CAPD: IV: 500 mg daily (Cardone, 2011)

Dosing: Hepatic Impairment

Adjustments cannot be recommended (lack of experience and research in this patient population).

Reconstitution

IM: Reconstitute 1 g vial with 3.2 mL of 1% lidocaine HCl injection (without epinephrine). Shake well.

IV: Reconstitute 1 g vial with 10 mL of sterile water for injection, 0.9% sodium chloride injection, or bacteriostatic water for injection. Shake well. For adults, transfer dose to 50 mL of 0.9% sodium chloride injection; for children, dilute dose with NS to a final concentration ≤20 mg/mL.

Administration

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: Infuse over 30 minutes

Dietary Considerations

Some products may contain sodium.

Compatibility

Stable in NS; per manufacturer do not mix with other medications or use diluents containing dextrose.

Y-site administration: Incompatible with anidulafungin, caspofungin

Storage

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.

Drug Interactions

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Probenecid: May increase the serum concentration of Ertapenem. Monitor therapy

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. Consider therapy modification

Tacrolimus (Systemic): Ertapenem may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

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. Consider therapy modification

Adverse Reactions

>10%: Gastrointestinal: Diarrhea (6% to 12%)

1% to 10%:

Cardiovascular: Edema (3%), chest pain (<2%), phlebitis (<2%), thrombophlebitis (<2%), hypotension (1% to 2%)

Central nervous system: Headache (2% to 7%), altered mental status (eg, agitation, confusion, disorientation, mental acuity decreased, somnolence, stupor) (3% to 5%), insomnia (3%), dizziness (2%), hypothermia (infants, children, and adolescents <2%)

Dermatologic: Diaper rash (infants and children 5%), skin rash (2% to 3%), pruritus (1% to 2%), genital rash (infants, children, and adolescents <2%), skin lesion (infants, children, and adolescents <2%)

Gastrointestinal: Vomiting (2% to 10%), nausea (6% to 9%), abdominal pain (4% to 5%), constipation (2% to 4%), decreased appetite (infants, children, and adolescents <2%)

Genitourinary: Erythrocyturia (1% to 3%), vaginitis (1% to 3%)

Hematologic & oncologic: Thrombocythemia (4% to 7%), decreased neutrophils (3% to 6%), decreased hemoglobin (5%), decreased hematocrit (3%), leukocyturia (2% to 3%), leukopenia (<2%), eosinophilia (1% to 2%)

Hepatic: Increased serum ALT (8% to 9%), increased serum AST (7% to 8%), increased serum alkaline (4% to 7%)

Infection: Herpes simplex infection (infants, children, and adolescents <2%)

Local: Infused vein complication (4% to 7%)

Neuromuscular & skeletal: Arthralgia (infants, children, and adolescents <2%)

Otic: Otic infection (infants, children, and adolescents <2%)

Respiratory: Cough (≤4%), dyspnea (1% to 3%), nasopharyngitis (infants, children, and adolescents <2%), rhinitis (infants, children, and adolescents <2%), rhinorrhea (infants, children, and adolescents <2%), upper respiratory tract infection (infants, children, and adolescents 2%), wheezing (infants, children, and adolescents <2%)

Miscellaneous: Fever (2% to 5%)

≤1% (Limited to important or life-threatening): Anaphylactoid reaction, anaphylaxis, anuria, asthma, asystole, atrial fibrillation, bradycardia, bronchoconstriction, cardiac arrest, cardiac arrhythmia, cardiac failure, cholelithiasis, Clostridium difficile associated diarrhea, delirium, DRESS syndrome, extravasation, gastrointestinal hemorrhage, gout, heart murmur, hemoptysis, hyperglycemia, hyperkalemia, hypertension, hypoxemia, impaired consciousness, intestinal obstruction, jaundice, oral candidiasis, oliguria, pancreatitis, pleural effusion, prolonged prothrombin time, renal insufficiency, seizure, septicemia, septic shock, subdural hematoma, tachycardia, thrombocytopenia, tissue necrosis, ventricular tachycardia

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity reactions, including anaphylaxis, have been reported (some without a history of previous allergic reactions to beta-lactams).

• CNS effects: Carbapenems have been associated with CNS adverse effects, including confusional states and seizures (myoclonic); use caution with CNS disorders (eg, brain lesions and history of seizures) and adjust dose in renal impairment to avoid drug accumulation, which may increase seizure risk.

• Superinfection: Use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

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:

• Elderly: 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.

Monitoring Parameters

Periodic renal, hepatic, and hematopoietic assessment during prolonged therapy; neurological assessment

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic effects were not observed in animal reproduction studies. Ertapenem is approved for the treatment of postpartum endomyometritis, septic abortion, and postsurgical infections. Information related to use during pregnancy has not been located.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, diarrhea, headache, or injection site irritation. Have patient report immediately to prescriber severe dizziness, syncope, illogical thinking, considerable asthenia, mood changes, dyspnea, excessive weight gain, edema, vaginitis, or signs of pseudomembranous colitis (rare) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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