ertapenem

REMS

Complicated intra-abdominal infections.
Complicated skin and skin structure infections (including diabetic foot infections with osteomyelitis).
Community acquired pneumonia.
Complicated urinary tract infections (including pyelonephritis).
Acute pelvic infections (including postpartum endomyometritis, septic abortion, and postsurgical gynecologic infections).
Prophylaxis of surgical site infection following elective colorectal surgery.

Action ⬆ ⬇

Binds to bacterial cell wall, resulting in cell death. Ertapenem resists the actions of many enzymes that degrade most other penicillins and penicillin-like anti-infectives.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Active against the following aerobic gram-positive organisms: Staphylococcus aureus (methicillin-susceptible strains only), Staphylococcus epidermidis, Streptococcus agalactiae, S. pneumoniae (penicillin-susceptible strains only), and S. pyogenes.
Also active against the following gram-negative aerobic organisms: Escherichia coli, Haemophilus influenzae (beta-lactamase negative strains), Klebsiella pneumonia, Moraxella catarrhalis, and Providencia rettgeri.
Additional anaerobic spectrum includes Bacteroides fragilis, B. distasonis, B. ovatus, B. thetaiotamicron, B. uniformis, B. vulgatis, Clostridioides clostrioforme, Eubacterium lentum, Peptostreptococcus, Porphyromonas asaccharolytica, and Prevotella bivia.

Pharmacokinetics ⬆ ⬇

Absorption: 90% after IM administration; IV administration results in complete bioavailability.

Distribution: Enters breast milk.

Metabolism/Excretion: Mostly excreted by the kidneys.

Half-Life: 1.8 hr (↑ in renal impairment).

Time/Action Profile ⬆ ⬇

(blood levels)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	2 hr	24 hr
IV	rapid	end of infusion	24 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Cross-sensitivity may occur with penicillins, cephalosporins, and other carbapenems;
Hypersensitivity to lidocaine (may be used as a diluent for IM administration).

Use Cautiously in:

History of multiple hypersensitivity reactions;
Seizure disorders;
Renal impairment;
OB: Safety not established in pregnancy;
Lactation: Use during breastfeeding only if potential maternal benefit to patient justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: sensitivity due to age-related in renal function in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), diarrhea, nausea, vomiting

GU: vaginitis

Local: pain at IM site, phlebitis at IV site

Neuro: headache, SEIZURES

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Probenecid↓ excretion and ↑ levels.
May ↓ serum valproate levels (↑ risk of seizures).

Route/Dosage ⬆ ⬇

IV IM (Adults and Children ≥13 yrs): 1 g once daily for up to 14 days (IV) or 7 days (IM).
IV IM (Children 3 mo–12 yrs): 15 mg/kg twice daily (not to exceed 1 g/day) for up to 14 days (IV) or 7 days (IM).

Renal Impairment

IM IV (Adults ): CCr ≤30 mL/min/1.73 m²: 500 mg once daily.

Availability ⬆ ⬇

(Generic available)

Powder for injection: 1 g/vial

Assessment ⬆ ⬇

Assess for infection (vital signs; appearance of wound, sputum, urine, and stool; WBC) at beginning of and during therapy.
Obtain a history before initiating therapy to determine previous use of and reactions to penicillins, cephalosporins, or carbapenems. Persons with a negative history of penicillin sensitivity may still have an allergic response.
Obtain specimens for culture and sensitivity before initiating therapy. First dose may be given before receiving results.
Observe patient for signs and symptoms of anaphylaxis (rash, pruritus, laryngeal edema, wheezing). Discontinue the drug and notify healthcare professional immediately if these occur. Have epinephrine, an antihistamine, and resuscitative equipment close by in the event of an anaphylactic reaction.
Monitor bowel function. Diarrhea, abdominal cramping, fever, and bloody stools should be reported to health care professional promptly as a sign of Clostridioides difficile-associated diarrhea (CDAD). May begin up to several wk following cessation of therapy.

Lab Test Considerations:

May cause ↑ AST, ALT, serum alkaline phosphatase levels.
- May cause ↑ platelet and eosinophil counts.

Implementation ⬆ ⬇

IM: Reconstitute 1-g vial with 3.2 mL of 1% lidocaine without epinephrine. Shake well to form solution. Immediately withdraw contents and inject deep into large muscle mass. Use reconstituted solution within 1 hr.

IV Administration:

Intermittent Infusion: Reconstitution: Reconstitute 1-g vial with 10 mL of sterile water for injection or 0.9% NaCl using a 21-gauge or smaller diameter needle and shake well.Diluent: For adults and pediatric patients 13 yrs and older: further dilute in 50 mL of 0.9% NaCl. For pediatric patients 3 mo to 12 yr: immediately withdraw a volume equal to 15 mg/kg (not to exceed 1 g/day) and dilute in 0.9% NaCl to a final concentration of 20 mg/mL or less. Administer within 6 hr of reconstitution.
Rate: Infuse over 30 min.

Patient/Family Teaching ⬆ ⬇

Advise patient to report the signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools) and allergy.
Caution patient to notify health care professional if fever and diarrhea occur, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care professional. May occur up to several wk after discontinuation of medication. Consult health care professional before treating with antidiarrheals.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any new medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Resolution of the signs and symptoms of infection. Length of time for complete resolution depends on the organism and site of infection.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0006- Merck Sharp and Dohme Corp.
- 0006-3843- INVANZ
  - 0006-3843-71- 10 VIAL, SINGLE-DOSE in 1 TRAY (0006-3843-71) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

42023- Par Pharmaceutical Inc.
- 42023-221- ERTAPENEM
  - 42023-221-10- 10 VIAL, SINGLE-DOSE in 1 TRAY (42023-221-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)

42023- Par Pharmaceutical Inc.
- 42023-221- ERTAPENEM
  - 42023-221-85- 10 VIAL, SINGLE-DOSE in 1 TRAY (42023-221-85) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89)

44647- Savior Lifetec Corporation
- 44647-051- Ertapenem
  - 44647-051-10- 10 VIAL in 1 CARTON (44647-051-10) > 20 mL in 1 VIAL (44647-051-01)

55150- AuroMedics Pharma LLC
- 55150-282- Ertapenem
  - 55150-282-09- 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-09) > 1 INJECTION in 1 VIAL, SINGLE-DOSE

55150- AuroMedics Pharma LLC
- 55150-282- Ertapenem
  - 55150-282-20- 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) > 1 INJECTION in 1 VIAL, SINGLE-DOSE

60505- Apotex Corp
- 60505-6196- Ertapenem
  - 60505-6196-4- 10 VIAL in 1 CARTON (60505-6196-4) > 20 mL in 1 VIAL (60505-6196-0)

63323- Fresenius Kabi USA, LLC
- 63323-823- Ertapenem
  - 63323-823-20- 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-823-20) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (63323-823-01)

68001- BluePoint Laboratories
- 68001-408- Ertapenem
  - 68001-408-31- 10 VIAL in 1 CARTON (68001-408-31) > 20 mL in 1 VIAL (68001-408-29)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇