sulbactam/durlobactam

REMS

Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to sulbactam, durlobactam, or any beta-lactam antibiotic.

Use Cautiously in:

Renal impairment (↓ dose if CCr <45 mL/min);
CCr ≥130 mL/min;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Consider age-related ↓ in renal function in determining dose in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: arrhythmia

F and E: hypokalemia

GI: ↑liver enzymes, diarrhea, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), constipation

GU: acute kidney injury

Hemat: anemia, thrombocytopenia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Probenecid may ↓ renal excretion and ↑ levels of sulbactam; concurrent use not recommended.

Availability ⬆ ⬇

Lyophilized powder for injection: sulbactam 1 g/vial + durlobactam 0.5 g/vial (2 vials supplied)

Route/Dosage ⬆ ⬇

IV (Adults ): CCr 45–129 mL/min: Sulbactam 1 g/durlobactam 1 g every 6 hr for 7–14 days. CCr ≥130 mL/min: Sulbactam 1 g/durlobactam 1 g every 4 hr for 7–14 days.

Renal Impairment

IV (Adults ): CCr 30–44 mL/min: Sulbactam 1 g/durlobactam 1 g every 8 hr for 7–14 days. CCr 15–29 mL/min: Sulbactam 1 g/durlobactam 1 g every 12 hr for 7–14 days. CCr <15 mL/min (at baseline before initiating therapy): Sulbactam 1 g/durlobactam 1 g every 12 hr for first 3 doses; then sulbactam 1 g/durlobactam 1 g every 24 hr to complete a total treatment course of 7–14 days. CCr <15 mL/min (after initiating therapy): Sulbactam 1 g/durlobactam 1 g every 24 hr for 7–14 days.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Sulbactam is a beta-lactam antibiotic and a beta-lactamase inhibitor that inhibits Acinetobacter baumannii-calcoaceticus complex penicillin-binding proteins. Durlobactam is a beta-lactamase inhibitor that protects sulbactam from being degraded by certain serine-beta-lactamases.

Therapeutic effects:

Bactericidal action against susceptible bacteria.

Spectrum:

Active against the following gram-negative pathogen:
- Acinetobacter baumannii-calcoaceticus complex.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: Beta lactams, beta lactamase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Undergoes minimal metabolism. Primarily excreted by the kidneys, with 75–85% of sulbactam and 78% of durlobactam being excreted as unchanged drug.

Half-Life: Sulbactam: 2–3 hr; Durlobactam: 2–3 hr.

Time/Action Profile ⬆ ⬇

( plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	6 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Advise patient to report rash or signs of superinfection (furry overgrowth on the tongue, vaginal itching or discharge, loose or foul-smelling stools).
Advise patient that serious allergic reaction may occur and to notify health care provider immediately if rash, swelling of face or airway, or difficulty breathing occur.
Caution patient to notify health care provider if fever and diarrhea occur, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care provider. May occur up to several weeks after discontinuation of medication.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

sul-BAK-tam/der-low-BAK-tam

Code ⬆

NDC Code

68547- La Jolla Pharmaceutical Company
- 68547-111- Xacduro
  - 68547-111-10- 1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30)

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Indications ⬇