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Ampicillin/​Sulbactam

    Brands

    DEA Class; Rx

    Common Brand Names; Unasyn

    • Penicillins, Amino

    Parenteral antibiotic combining ampicillin with sulbactam (a beta-lactamase inhibitor); sulbactam enhances ampicillin’s spectrum to include many beta-lactamase-producing bacteria; similar coverage to oral amoxicillin-clavulanic acid combination; main uses of ampicillin-sulbactam: intra-abdominal infections, gynecologic infections, and skin and soft-tissue infection; not indicated for meningitis.

    Indicated for the treatment of skin and skin structure infections, including animal or human bite wounds, diabetic foot ulcer, pyomyositis, and surgical incision site infections.

    For the treatment of gynecologic infections, including pelvic inflammatory disease (PID) and tubo-ovarian abscess.
    For the treatment of intraabdominal infections, including peritonitis, appendicitis, intraabdominal abscess, and peritoneal dialysis-related peritonitis.
    For the treatment of community-acquired pneumonia (CAP) and pleural empyema.
    For surgical infection prophylaxis.
    For the treatment of infective endocarditis.
    Indicated for Endocarditis (Off-label)

    Hypersensitivity to drug or components

    Patients with previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin sulbactam

    • IM injection site pain (16%)
    • Diarrhea (3%)
    • IV injection site pain (3%)
    • Thrombophlebitis (3%)
    • Rash ( < 2%)
    • Abdominal distention
    • Black, “hairy” tongue
    • Candidiasis
    • Chest pain
    • Chills
    • Dysuria
    • Edema
    • Epistaxis
    • Erythema
    • Fatigue
    • Flatulence
    • Glossitis
    • Headache
    • Itching
    • Malaise
    • Mucosal bleeding
    • Nausea
    • Pseudomembranous colitis
    • Seizure
    • Tightness in throat
    • Thrombocytopenia
    • Urine retention
    • Vomiting

    Use caution in patients with allergy to cephalosporins and carbapenems

    Adjust dose in renal failure

    Prolonged use is associated with fungal or bacterial superinfection

    Hepatic dysfunction, including hepatitis and cholestatic jaundice reported; hepatic toxicity is usually reversible; however, deaths have occurred; monitor hepatic function at regular intervals in patients with hepatic impairment

    A generalized dull red maculopapular rash may occur in 5-10% of children 3-14 days after initiating therapy; carefully evaluate the rash to differentiate a nonallergic ampicillin rash from a hypersensitivity reaction; it normally begins on the trunk and spreads over most of the body; it may be most intense at pressure areas, elbows, and knees

    Hepatotoxicity reported; monitor hepatic function at regular intervals in patients with hepatic impairment

    A high percentage of patients with infectious mononucleosis have developed rash during therapy; therapy is not recommended in these patients

    May cause severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome (SJS), dermatitis exfoliative, erythema multiforme, and acute generalized exanthematous pustulosis (AGEP); if patients develop skin rash monitor closely and discontinued therapy if lesions progress

    Pregnancy category: B

    Lactation: Excreted in breast milk; use caution

    Adults

    12 g/day (8 g ampicillin and 4 g sulbactam) IV/IM.

    Geriatric

    12 g/day (8 g ampicillin and 4 g sulbactam) IV/IM.

    Adolescents

    200 mg/kg/day ampicillin component (300 mg/kg/day ampicillin; sulbactam) IV is recommended in the FDA-approved labeling; however, doses up to 400 mg/kg/day ampicillin component (600 mg/kg/day ampicillin; sulbactam) IV have been used off-label (Max: 8 g/day ampicillin [12 g/day ampicillin; sulbactam]).

    Children

    200 mg/kg/day ampicillin component (300 mg/kg/day ampicillin; sulbactam) IV is recommended in the FDA-approved labeling; however, doses up to 400 mg/kg/day ampicillin component (600 mg/kg/day ampicillin; sulbactam) IV have been used off-label (Max: 8 g/day ampicillin [12 g/day ampicillin; sulbactam]).

    Infants

    Safety and efficacy have not been established; however, doses up to 400 mg/kg/day ampicillin component (600 mg/kg/day ampicillin; sulbactam) IV have been used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses up to 100 mg/kg/day ampicillin component (150 mg/kg/day ampicillin; sulbactam) IV have been used off-label.

    Ampicillin sodium/sulbactam sodium

    powder for solution

    • 1.5g (ampicillin 1g/sulbactam 0.5g)
    • 3g (ampicillin 2g/sulbactam 1g)
    • 15g (ampicillin 10g/sulbactam 5g)