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Ampicillin sodium/Sulbactam sodium
Ampicillin sodium/Sulbactam sodium (Unasyn)
Ampicillin sodium/Sulbactam sodium
(am-pih-SILL-in/sull-BACK-tam)
Pregnancy Category: B Unasyn (Rx)

Classification: Antibiotic, penicillin

See Also: See also Anti-Infectives and Penicillins.

Content: The Powder for Injection contains either 1 g ampicillin sodium and 0.5 g sulbactam sodium, 2 g ampicillin sodium and 1 g sulbactam sodium, or 10 g ampicillin and 5 g sulbactam sodium.

Action/Kinetics: For details, see Ampicillin oral. Sulbactam is present in this product because it irreversibly inhibits beta-lactamases, thus ensuring activity of ampicillin against beta-lactamase-producing microorganisms. Thus, sulbactam broadens the antibiotic spectrum of ampicillin to those bacteria normally resistant to it. Peak serum levels, after IV infusion: 15 min. t1/2, both drugs: about 1 hr. From 75%-85% of both drugs is excreted unchanged in the urine within 8 hr after administration.

Uses: Infections caused by beta-lactamase-producing strains of the following: (a) skin and skin structure infections caused by Staphylococcus aureus, Escherichia coli, Klebsiella species (including K. pneumoniae), Proteus mirabilis, Bacteroides fragilis, Enterobacter species, and Acinetobacter calcoaceticus; (b) intra-abdominal infections caused by E. coli, Klebsiella species (including K. pneumoniae), Bacteroides (including B. fragilis and Enterobacter) (c) gynecologic infections caused by E. coli and Bacteroides (including B. fragilis). NOTE: Mixed infections caused by ampicillin-susceptible organisms and beta-lactamase-producing organisms are susceptible to this product; thus, additional antibiotics do not have to be used.

Special Concerns: Safety and efficacy in children 1 year of age and older have not been established for intra-abdominal infections or for IM administration.

Side Effects: At site of injection: Pain and thrombophlebitis. GI: Diarrhea, N&V;, flatulence, abdominal distention, glossitis. CNS: Fatigue, malaise, headache. GU: Dysuria, urinary retention. Miscellaneous: Itching, chest pain, edema, facial swelling, erythema, chills, tightness in throat, epistaxis, substernal pain, mucosal bleeding, candidiasis.

Laboratory Test Alterations: AST, ALT, alkaline phosphatase, LDH, creatinine, BUN; also, basophils, eosinophils, lymphocytes, monocytes, platelets. Serum albumin and total proteins, H&H;, RBCs, WBCs, and platelets. Presence of RBCs and hyaline casts in urine.

Overdose Management: Symptoms: Neurologic symptoms, including convulsions. Treatment: Both ampicillin and sulbactam may be removed by hemodialysis.

How Supplied: See Content

Dosage
•IV, IM
Adults: 1 g ampicillin/0.5 g sulbactam to 2 g ampicillin/1 g sulbactam q 6 hr, not to exceed 4 g sulbactam daily. Doses must be decreased in renal impairment. Children, over 40 kg: Use adult doses; total sulbactam dose should not exceed 4 g/day. Children, one year and older but less than 40 kg: 200 mg ampicillin/kg/day and 100 mg sulbactam/kg/day in divided doses q 6 hr.