Sulbactam

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. …

• 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 mL to 100 mL of a compatible diluent as an intravenous infusion over 15 to 30 minutes (see DIRECTION FOR USE-Preparation for Intravenous Use section)
• Ampicillin and Sulbactam for Injection may be administered by deep intramuscular injection (see DIRECTIONS FOR USE-Preparation for Intramuscular Injection section)
• The recommended adult dosage of Ampicillin and Sulbactam for Injection is 1.5 g (ampicillin 1 g and sulbactam 0.5 g) to 3 g (ampicillin 2 g and sulbactam 1 g) every six hours
• This 1.5 g to 3 g range represents the total of ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to a range of 1 g ampicillin and 0.5 g sulbactam to 2 g ampicillin and 1 g sulbactam
• The total dose of sulbactam should not exceed 4 g per day
• Pediatric Patients 1 Year of Age or Older: The recommended daily dose of Ampicillin and Sulbactam for Injection
• In pediatric patients is 300 mg per kg of body weight administered via intravenous infusion in equally divided doses every 6 hours
• This 300 mg/kg/day dosage represents the total ampicillin content plus the sulbactam content of Ampicillin and Sulbactam for Injection, and corresponds to 200 mg ampicillin and 100 mg sulbactam per kg per day. …

• The safety and effectiveness of ampicillin and sulbactam for injection have been established for pediatric patients one year of age and older for skin and skin structure infections as approved
• In adults
• Use of ampicillin and sulbactam for injection
• In pediatric patients is supported by evidence from adequate and well-controlled studies
• In adults with additional data from pediatric pharmacokinetic studies, a controlled clinical trial conducted
• In pediatric patients and post-marketing adverse events surveillance (see CLINICAL PHARMACOLOGY , INDICATIONS AND USAGE , ADVERSE REACTIONS , DOSAGE AND …

• Patients should be counseled that antibacterial drugs including ampicillin and sulbactam for injection should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When ampicillin and sulbactam for injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. …

• 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)
• Ampicillin and sulbactam for injection is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with ampicillin and sulbactam for injection

Probenecid decreases the renal tubular secretion of ampicillin and sulbactam. Concurrent use of probenecid with ampicillin and sulbactam for injection may result in increased and prolonged blood levels of ampicillin and sulbactam. The concurrent administration of allopurinol and ampicillin increases substantially the incidence of rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients. There are no data with ampicillin and sulbactam for injection and allopurinol administered concurrently. …

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. Before therapy with a penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, and other allergens. …

Adult Patients: Ampicillin and sulbactam for injection is generally well tolerated. The following adverse reactions have been reported in clinical trials. Local Adverse Reactions Pain at IM injection site – 16% Pain at IV injection site – 3% Thrombophlebitis – 3% Phlebitis – 1.2% Systemic Adverse Reactions The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients. …

Pregnancy: Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) 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. …

Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Ampicillin may be removed from circulation by hemodialysis. The molecular weight, degree of protein binding and pharmacokinetics profile of sulbactam suggest that this compound may also be removed by hemodialysis.

Ampicillin and Sulbactam for Injection, USP sterile powder is to be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] prior to reconstitution. Sterile, Nonpyrogenic, Preservative-free. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.