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.

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.

Drug-drug:

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

(Generic available)

Powder for injection: 1 g/vial

IV IM (Adults and Children ≥13 yr): 1 g once daily for up to 14 days (IV) or 7 days (IM).
IV IM (Children 3 mo–12 yr): 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.

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.

Therapeutic Classification: anti-infectives

Pharmacologic Classification: carbapenems

Absorption: 90% absorbed following IM administration. IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Mostly excreted by the kidneys.

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

(plasma concentrations)

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

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to report signs of superinfection (black, furry overgrowth on 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.
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 women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

NDC Code

0006- Merck Sharp & Dohme LLC
- 0006-3843- INVANZ
  - 0006-3843-71- 10 VIAL, SINGLE-DOSE in 1 PACKAGE (0006-3843-71) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

0143- Hikma Pharmaceuticals USA, Inc.
- 0143-9398- ertapenem sodium
  - 0143-9398-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)

0143- Hikma Pharmaceuticals USA Inc.
- 0143-9429- Ertapenem
  - 0143-9429-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9429-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9429-01)

0409- Hospira, Inc.
- 0409-3510- Ertapenem
  - 0409-3510-22- 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21)

16714- NorthStar RxLLC
- 16714-889- ERTAPENEM SODIUM
  - 16714-889-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (16714-889-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (16714-889-01)

42023- ENDO USA, Inc.
- 42023-221- ERTAPENEM
  - 42023-221-10- 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)

42023- ENDO USA, Inc.
- 42023-221- ERTAPENEM
  - 42023-221-85- 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-85) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-89)

43598- Dr.Reddys Laboratories Inc.,
- 43598-901- ERTAPENEM SODIUM
  - 43598-901-58- 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11)

44567- WG Critical Care, LLC
- 44567-820- ertapenem
  - 44567-820-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (44567-820-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (44567-820-01)

44647- Savior Lifetec Corporation
- 44647-005-
  - 44647-005-10- 2 BAG in 1 DRUM (44647-005-10) / 5 kg in 1 BAG (44647-005-05)

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)

51810- Qilu Antibiotics Pharmaceutical Co., Ltd.
- 51810-504- Ertapenem
  - 51810-504-02- 10 VIAL, SINGLE-DOSE in 1 CARTON (51810-504-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (51810-504-01)

55150- Eugia US 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- Eugia US LLC
- 55150-282- Ertapenem
  - 55150-282-20- 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE

59651- Aurobindo Pharma Limited
- 59651-190-
  - 59651-190-37- 50 kg in 1 DRUM (59651-190-37)

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)

68083- Gland Pharma Limited
- 68083-351- Ertapenem
  - 68083-351-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)

69806- Merck Sharp & Dohme Corp.
- 69806-0003-
  - 69806-0003-0- 1 DRUM in 1 BOX (69806-0003-0) / 1 BAG in 1 DRUM / 40 kg in 1 BAG

72266- Fosun Pharma USA Inc
- 72266-159- Ertapenem
  72266-159-05- 5 VIAL, SINGLE-DOSE in 1 CARTON (72266-159-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72266-159-01)

72266- Fosun Pharma USA Inc
- 72266-159- Ertapenem
  - 72266-159-10- 10 VIAL, SINGLE-DOSE in 1 CARTON (72266-159-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72266-159-01)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆