Ampicillin / Sulbactam

What it is and how it works

Mechanism of Action Ampicillin is similar to benzyl penicillin in its bactericidal action against susceptible organisms during the stage of active multiplication. It acts through the inhibition of cell wall mucopeptide biosynthesis. Ampicillin has a broad spectrum of bactericidal activity against many gram-positive and gram-negative aerobic and anaerobic bacteria. (Ampicillin is, however, degraded by beta-lactamases and therefore the spectrum of activity does not normally include organisms which produce these enzymes).

Indications

INDICATIONS AND USAGE Ampicillin and sulbactam for injection is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus , Escherichia coli , * Klebsiella spp. * (including K. pneumoniae * ), Proteus mirabilis , * Bacteroides fragilis , * Enterobacter spp., * and Acinetobacter calcoaceticus . * NOTE: For information on use in pediatric patients see PRECAUTIONS, Pediatric Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli , Klebsiella spp. (including K. pneumoniae * ), Bacteroides spp. (including B. fragilis ), and Enterobacter spp. * Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli , * and Bacteroides spp. * (including B. fragilis * ). * Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Ampicillin and sulbactam for injection may be administered by either the IV or the IM routes. For IV administration, the dose can be given by slow intravenous injection over at least 10 to 15 minutes or can also be delivered in greater dilutions with 50 to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes. Ampicillin and sulbactam for injection may be administered by deep intramuscular injection (see DIRECTIONS FOR USE, Preparation for Intramuscular Injection section).

Contraindications

CONTRAINDICATIONS The use of ampicillin and sulbactam for injection is contraindicated in individuals with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins).

Warnings and precautions

WARNINGS Hypersensitivity Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more apt to occur in individuals with a history of penicillin hypersensitivity and/or hypersensitivity reactions to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.

Pregnancy

Pregnancy Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to ampicillin and sulbactam for injection. There are, however, no adequate and well-controlled studies in pregnant women.

Storage and supply

Storage Conditions Ampicillin and Sulbactam for Injection, USP powder should be stored at or below 86°F (30°C), prior to reconstitution. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Source: Ampicillin And Sulbactam (Ampicillin And Sulbactam) — US FDA prescribing information, 2025-04-25, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.