Classification Antibiotic penicillin

See also Anti-Infectives and Penicillins.

Content: The Powder for Injection contains either 1 g ampicillin sodium and 0.5 g sulbactam sodium or 2 g ampicillin sodium and 1 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. tv2, 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-lac-tamase-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 Acineto-bacter calcoaceticus; (b) intra-ab-dominal 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-produc-ing organisms are susceptible to this product; thus, additional antibiotics do not have to be used. Contraindications: Hypersensitiv-ity to penicillins.

Special Concerns: Safety and efficacy in children less than 12 years of age have not been established. 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. Drug Interactions: See also Anti-Infectives and Penicillins. How Supplied: See Content

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