ampicillin/sulbactam

REMS

Treatment of the following infections:
- Skin and skin structure infections, soft-tissue infections,
- Otitis media,
- Intra-abdominal infections,
- Sinusitis,
- Respiratory infections,
- Genitourinary infections,
- Meningitis,
- Septicemia.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to penicillins or sulbactam;
History of cholestatic jaundice or hepatic impairment with ampicillin/sulbactam.

Use Cautiously in:

Severe renal impairment (↓ dosage if CCr <30 mL/min);
Epstein-Barr virus infection, acute lymphocytic leukemia, or cytomegalovirus infection (↑ risk of rash);
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash, ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, ERYTHEMA MULTIFORME, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, urticaria

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

Hemat: blood dyscrasias

Local: pain at injection site, phlebitis

Neuro: SEIZURES (HIGH DOSES)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND MYOCARDIAL ISCHEMIA [WITH OR WITHOUT MI]), superinfection

Interactions ⬆ ⬇

Drug-drug:

Probenecid↓ renal excretion and ↑ levels of ampicillin—therapy may be combined for this purpose.
May potentiate the effect of warfarin.
Concurrent allopurinol therapy (↑ risk of rash).
May ↓ levels and effectiveness of hormonal contraceptives.

Availability ⬆ ⬇

(Generic available)

Powder for injection: 1.5 g/vial (1 g ampicillin with 500 mg sulbactam); 3 g/vial (2 g ampicillin with 1 g sulbactam); 15 g/vial (10 g ampicillin with 5 g sulbactam)

Route/Dosage ⬆ ⬇

Dosage based on ampicillin component
IM IV (Adults and Children ≥40 kg): 1–2 g ampicillin every 6–8 hr (not to exceed 12 g ampicillin/day).
IM IV (Children ≥1 yr): 100–200 mg ampicillin/kg/day divided every 6 hr; Meningitis: 200–400 mg ampicillin/kg/day divided every 6 hr; maximum dose: 8 g ampicillin/day.
IM IV (Infants >1 mo): 100–150 mg ampicillin/kg/day divided every 6 hr.

Renal Impairment

IM IV (Adults , Children, and Infants): CCr 15–29 mL/min: Administer every 12 hr; CCr 5–14: Administer every 24 hr.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to bacterial cell wall, resulting in cell death; spectrum is broader than that of penicillin. Addition of sulbactam increases resistance to beta-lactamases, enzymes produced by bacteria that may inactivate ampicillin.

Therapeutic effects:

Bactericidal action.

Spectrum:

Active against:
- Streptococci,
- Pneumococci,
- Enterococci,
- Haemophilus influenzae,
- Escherichia coli,
- Proteus mirabilis,
- Neisseria meningitidis,
- N. gonorrhoeae,
- Shigella,
- Salmonella,
- Bacteroides fragilis,
- Moraxella catarrhalis.
Use should be reserved for infections caused by beta-lactamase–producing strains.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: aminopenicillins beta lactamase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed from IM sites.

Distribution: Ampicillin diffuses readily into bile, blister and tissue fluids. Poor CSF penetration unless meninges are inflamed.

Metabolism/Excretion: Ampicillin is variably metabolized by the liver (12–50%). Renal excretion is also variable. Sulbactam is eliminated unchanged in urine.

Protein Binding: Ampicillin: 28%; sulbactam: 38%.

Half-Life: Ampicillin: 1–1.8 hr; sulbactam: 1–1.3 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	1 hr	6–8 hr
IV	immediate	end of infusion	6–8 hr

Patient/Family Teaching ⬆ ⬇

Advise patient to report rash, signs of superinfection (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.
Rep: Caution patients taking oral contraceptives to use an alternative or additional nonhormonal method of contraception while taking ampicillin/sulbactam and until next menstrual period. Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Instruct the patient to notify health care professional if symptoms do not improve.

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Indications ⬇