Properties
What is it?
International Nonproprietary Name - ampicillin, sulbactam Clinical-pharmacological group: Antibacterial agents → Beta-lactam antibiotics (penicillins and cephalosporins) → Combined preparations of ampicillin and sulbactam Composition: Each vial contains: Ampicillin sodium USP - equivalent to 0.5 g ampicillin. Sulbactam sodium USP - equivalent to 0.25 g sulbactam. Each vial contains: Ampicillin sodium USP - equivalent to 1.0 g ampicillin. Sulbactam sodium USP - equivalent to 0.5 g sulbactam. Indication Ampicillin/sulbactam is indicated for the treatment of intra-abdominal infections, obstetric and gynecological, skin and soft tissue, bone and joint, urinary tract, respiratory tract, ear, nose, and throat (E.N.T.) infections, gonorrhea, and surgical prophylaxis. Side effects Ampicillin/sulbactam is well tolerated. The only frequently characteristic side effect is pain at the injection site. Diarrhea and phlebitis are rarely observed. Precautions As with other beta-lactam antibiotics, this combination is used during pregnancy only when absolutely necessary. Low concentrations of ampicillin and sulbactam are excreted in milk, so caution should be exercised when taking Centram in nursing mothers. Contraindications The preparation is contraindicated in patients with a history of penicillin allergy and mononucleosis. Drug interactions Probenecid reduces the tubular secretion of Centram. Concomitant use may increase blood levels of ampicillin and sulbactam. Concomitant administration of allopurinol and ampicillin significantly increases the incidence of rash in patients receiving both drugs together, compared to patients receiving ampicillin alone. It is unknown whether this rash is caused by allopurinol or the presence of hyperuricemia in these patients. Concomitant administration of ampicillin/sulbactam and aminoglycosides is not recommended due to the reduction of in vitro activity of aminoglycosides by ampicillin. Recommended therapeutic doses: In adults, the daily dose ranges from 1.5 to 12 g (sulbactam from 0.5 g to 4 g and ampicillin from 1 to 8 g in concentration) divided into doses every 6-8 hours. For less severe infections, the interval between doses may be extended to 12 hours. In children, infants, and newborns, the recommended therapeutic dosage of this combination is 150 mg/kg/day. (sulbactam 50 mg/kg/day plus ampicillin 100 mg/kg/day). For the prophylaxis of surgical infections in adults. Centram 1.5 to 3 g is recommended - at the induction of anesthesia and may be repeated every 6-8 hours for 24 hours.