Ampicillin and sulbactam

Impaired Renal Function In patients with impairment of 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 and according to the following recommendations: [See table below.] When only serum creatinine is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance.

The serum creatinine should represent a steady state of renal function. [See table below.]

DOSAGE AND ADMINISTRATION 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 DIRECTIONS FOR USE - Preparation for Intravenous Use section).

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.