er-ta-PEN-em

• Moderate to severe:
  • complicated intra-abdominal infections,
  • complicated skin and skin structure infections,
  • 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.

• 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.

• 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.
• Addition 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.

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).

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
• Lactation: Use during breast feeding only if benefit to patient outweighs potential risk to infant
• Pedi: Safety and effectiveness not established
• Geri: ↑sensitivity due to age-related ↓ in renal function.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS.

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

GU: vaginitis.

Local: phlebitis at IV site, pain at IM site.

Neuro: SEIZURES, headache.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

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

• 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).

• 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:
  Diluent: 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. 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.
• Y-Site Compatibility:
  • acyclovir
  • alfentanil
  • amifostine
  • amikacin
  • aminocaproic acid
  • aminophylline
  • amphotericin B lipid complex
  • amphotericin B liposome
  • argatroban
  • arsenic trioxide
  • atracurium
  • azithromycin
  • aztreonam
  • bivalirudin
  • bleomycin
  • bumetanide
  • buprenorphine
  • busulfan
  • butorphanol
  • calcium chloride
  • calcium gluconate
  • cangrelor
  • carboplatin
  • carmustine
  • chloramphenicol
  • cisatracurium
  • cyclophosphamide
  • cyclosporine
  • cytarabine
  • dacarbazine
  • dactinomycin
  • daptomycin
  • dexamethasone
  • dexmedetomidine
  • dexrazoxane
  • digoxin
  • diltiazem
  • diphenhydramine
  • docetaxel
  • dopamine
  • doxacurium
  • doxorubicin liposome
  • doxycycline
  • enalaprilat
  • ephedrine
  • epinephrine
  • eptifibatide
  • erythromycin
  • esmolol
  • etoposide phosphate
  • famotidine
  • fenoldopam
  • fluconazole
  • fludarabine
  • fluorouracil
  • foscarnet
  • fosfomycin
  • fosphenytoin
  • furosemide
  • ganciclovir
  • gemcitabine
  • gentamicin
  • glycopyrrolate
  • granisetron
  • haloperidol
  • heparin
  • hydrocortisone
  • hydromorphone
  • ifosfamide
  • insulin, regular
  • irinotecan
  • isoproterenol
  • ketorolac
  • labetalol
  • leucovorin calcium
  • levofloxacin
  • lidocaine
  • linezolid
  • lorazepam
  • magnesium sulfate
  • mannitol
  • melphalan
  • meperidine
  • meropenem/vaborbactam
  • mesna
  • methotrexate
  • methyldopate
  • methylprednisolone
  • metoclopramide
  • metronidazole
  • milrinone
  • mitomycin
  • morphine
  • moxifloxacin
  • nalbuphine
  • naloxone
  • nitroglycerin
  • nitroprusside
  • norepinephrine
  • octreotide
  • oxaliplatin
  • oxytocin
  • paclitaxel
  • pamidronate
  • pancuronium
  • pantoprazole
  • pemetrexed
  • pentobarbital
  • phenobarbital
  • phentolamine
  • phenylephrine
  • potassium acetate
  • potassium chloride
  • potassium phosphates
  • procainamide
  • propranolol
  • remifentanil
  • rocuronium
  • sodium acetate
  • sodium bicarbonate
  • sodium phosphates
  • streptozocin
  • succinylcholine
  • sufentanil
  • tacrolimus
  • telavancin
  • theophylline
  • thiotepa
  • tigecycline
  • tirofiban
  • tobramycin
  • trimethoprim/sulfamethoxazole
  • vancomycin
  • vasopressin
  • vecuronium
  • vinblastine
  • vincristine
  • vinorelbine
  • voriconazole
  • zidovudine
  • zoledronic acid
• Y-Site Incompatibility:
  • alemtuzumab
  • allopurinol
  • amiodarone
  • anidulafungin
  • caspofungin
  • chlorpromazine
  • dantrolene
  • daunorubicin hydrochloride
  • diazepam
  • dobutamine
  • doxorubicin hydrochloride
  • droperidol
  • epirubicin
  • hydralazine
  • hydroxyzine
  • idarubicin
  • isavuconazonium
  • midazolam
  • minocycline
  • mitoxantrone
  • nicardipine
  • ondansetron
  • pentamidine
  • phenytoin
  • prochlorperazine
  • promethazine
  • quinupristin/dalfopristin
  • thiopental
  • topotecan
  • verapamil
.

INVanz

Therapeutic Classification: anti-infectives

Pharmacologic Classification: carbapenems

(Generic available)

• Powder for injection (requires reconstitution): 1 g/vial;

(blood levels)

• 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 the physician 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.

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

• Risk for infection (Indications, Side Effects).

• 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.

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

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)