Classes
DEA Class; Rx
Common Brand Names; Unasyn
- Penicillins, Amino
Description
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.
Indications
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.
Contraindications
Hypersensitivity to drug or components
Patients with previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin sulbactam
Adverse Effects
- 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
Warnings
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 and Lactation
Pregnancy category: B
Lactation: Excreted in breast milk; use caution
Maximum Dosage
12 g/day (8 g ampicillin and 4 g sulbactam) IV/IM.
12 g/day (8 g ampicillin and 4 g sulbactam) IV/IM.
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]).
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]).
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.
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.
How supplied
Ampicillin sodium/sulbactam sodium
powder for solution
- 1.5g (ampicillin 1g/sulbactam 0.5g)
- 3g (ampicillin 2g/sulbactam 1g)
- 15g (ampicillin 10g/sulbactam 5g)