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: SENTRAM 0.75g Each vial contains: Ampicillin sodium USP - equivalent to 0.5 g ampicillin. Sulbactam sodium USP - equivalent to 0.25 g sulbactam. SENTRAM 1.5 g Each vial contains: Ampicillin sodium USP - equivalent to 1.0 g ampicillin. Sulbactam sodium USP - equivalent to 0.5 g sulbactam. Indications Sentram 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 Sentram 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 should be used during pregnancy only when clearly needed. Low concentrations of ampicillin and sulbactam are excreted in milk, so caution should be exercised when administering Sentram to nursing mothers. Contraindications The preparation is contraindicated in patients with a history of penicillin allergy and mononucleosis. Drug interactions Probenecid reduces the renal tubular secretion of Sentram. Concomitant use may increase ampicillin and sulbactam levels in the blood. Concomitant administration of allopurinol and ampicillin significantly increases the incidence of rash in patients receiving both drugs together, compared to patients receiving only ampicillin. It is unknown whether this rash is caused by allopurinol or the presence of hyperuricemia in these patients. Concomitant administration of Sentram and aminoglycosides is not recommended due to the inactivation of aminoglycosides by ampicillin in vitro. Recommended therapeutic doses: In adults, the daily dose ranges from 1.5 to 12g (0.5g to 4g sulbactam and 1g to 8g ampicillin) administered in divided 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 for this combination is 150mg/kg/day. (50mg/kg/day sulbactam plus 100mg/kg/day ampicillin). For the prophylaxis of surgical infections in adults. Sentram 1.5 to 3g is recommended at the time of induction of anesthesia and may be repeated every 6-8 hours for 24 hours.