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Samjin
[Natrapharm]
Regulatory Class: Rx
C: Per 750 mg inj Ampicillin Na 500 mg, sulbactam Na 250 mg. Per 1.5 g inj Ampicillin Na 1,000 mg, sulbactam Na 500 mg
I: Treatment of infections due to β-lactamase-producing H. influenzae including those of the resp tract, bones, joints & soft tissues; polymicrobial infections w/ mixed aerobic & anaerobic eg, diabetic foot, gynecologic infections, intra-abdominal infections & UTI due to susceptible organism.
D: IV/IMAdult 1.5-12 g daily in divided doses every 6 or 8 hr up to a max daily dose of sulbactam 4 g. Less severe infections May be treated on 12-hrly schedule. Mild infections 1.5 g daily. Moderate infections Up to 6 g daily. Severe infections Up to 12 g daily. Prophylaxis of surgical infections 1.5-3 g at induction of anesth. May be repeated every 6-8 hr; administration is usually stopped 24 hr after the majority of surgical procedures. Treatment of uncomplicated gonorrhea 1.5 g as single dose. Concomitantly administer probenecid 1 g orally to prolong plasma conc of ampicillin & sulbactam. Childn ≥1 yr 300 mg/kg via IV infusion in equally divided doses every 6 hr. Childn weighing ≥40 kg According to adult recommendations & total dose of sulbactam should not exceed 4 g daily. The course of IV therapy should not routinely exceed 14 days.
CI: Hypersensitivity to penicillins. Mononucleosis.
SP: History of hypersensitivity reactions to cephalosporins, multiple allergens. Monitor Clostridium difficile-associated diarrhea; watery & bloody stools (w/ or w/o stomach cramps & fever) even as late as ≥2 mth after having taken the last dose. Discontinue if superinfections occur. Not for treatment of viral infections (eg, common cold). Pregnancy & lactation. Childn (for intra-abdominal infections).
AR: Diarrhea/loose stool; nausea, vomiting, epigastric distress & abdominal cramps. Inj site pain (especially w/ IM inj); phlebitis or inj site reaction after IV inj. Anaphylactoid reaction & anaphylactic shock; hemolytic anemia, thrombocytopenia, eosinophilia, leukopenia; transient elevations of ALT & AST transaminases, bilirubinemia, abnormal hepatic function & jaundice.
INT: Decreased renal tubular secretion by probenecid. Increased risk of rashes w/ allopurinol. Mutual inactivation w/ aminoglycosides (in vitro). Additive alterations in platelet aggregation & coagulation tests w/ anticoagulants. Interfered bactericidal effect w/ bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides & tetracyclines). Reduced OC effectiveness. Decreased clearance of methotrexate.
P/P: 750 mg powd for inj 1's. 1.5 g powd for inj 1's.
