AMPICILLIN sodium
SULBACTAM sodium
500 mg / 250 mg and 1g / 500 mg
Powder for Injection
(I.M. /I.V.)
FORMULATION:
Each vial contains:
Ampicillin (as Sodium) ..........................................…. 500 mg / 1 g
Sulbactam (as Sodium) ............................................ 250 mg/ 500 mg
INDICATIONS
Indicated for the treatment of infections due to beta-lactamase producing strains of H. influenza including those of the respiratory tract, bones, joints and soft-tissues. For polymicrobial infections with mixed aerobic and anaerobic such as diabetic foot, gynecologic infections, intra abdominal infections and urinary infections due to susceptible organisms.
PHARMACOLOGY:
Immediately after completion of a 15-minute intravenous infusion of Ampicillin and Sulbactam, peak serum concentrations of ampicillin and sulbactam are attained. Ampicillin serum levels are similar to those produced by the administration of equivalent amounts of ampicillin alone. Peak ampicillin serum levels ranging from 109 to 150 mcg/ mL are attained after administration of 2000 mg of ampicilin plus 1000 mg sulbactam and 40 to 71 mcg/mL after administration of 1000 mg ampicillin plus 500 mg sulbactam. The corresponding mean peak serum levels for sulbactam range from 48 to 88 mcg/mL and 21 to 40 mcg/mL, respectively. After an intramuscular injection of 1000 mg ampicillin plus 500 mg sulbactam, peak ampicillin serum levels ranging from 8 to 37 mcg/mL and peak sulbactam serum levels ranging from 6 to 24 mcg/mL are attained.
The mean serum half-life of both drugs is approximately 1 hour in healthy volunteers.
Approximately 75 to 85% of both ampicillin and sulbactam are excreted unchanged in the urine during the first 8 hours after administration of Ampicillin and Sulbactam to individuals with normal renal function. Somewhat higher and more prolonged serum levels of ampicillin and sulbactam can be achieved with the concurrent administration of
In patients with impaired renal function the elimination kinetics of ampicillin and sulbactam are similarly affected, hence the ratio of one to the other will remain constant whatever the renal function. The dose of Ampicillin and Sulbactam for Injection in such patients should be administered less frequently in accordance with the usual practice for ampicillin.
DOSAGE AND ADMINISTRATION:
The usual dose is ampicillin 500 mg with sulbactam 250 mg every 6 hours, doses may be doubled in severe infections or as prescribed by the physician.
CONTRAINDICATION:
Contraindicated in individuals with history of hypersensitivity reactions to any of the penicillins.
ADVERSE REACTION:
Pain in injection site; nausea, vomiting and diarrhea; phlebitis; thrombocytopenia, eosinophilia & leukopenia; rash and itching; sour mouth and tongue and black hairy tongue.
DRUG INTERACTIONS:
Erythromycin, tetracycline, chloramphenicol, allopurinol, methotrexate
STORAGE CONDITION:
Store at temperatures not exceeding 30oC.
AVAILABILITY
500 mg / 250 mg and 1 g/500 mg 10 mL tubular clear & colorless glass vial (USP Type I); Box of 1's
DIRECTION FOR RECONSTITUTION:
Each vial should be reconstituted with 8 mL of Sterile Water for Injection or 0.9% Sodium Chloride for Injection. Swirl until dissolve. For Single Use only. Discard any remaining portion.
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