Sultacillin Dosage/Direction for Use

Ampicillin sodium/Sulbactam sodium IM/IV can be administered by either intravenous or intramuscular routes.
The following dilutions may be used. (See Table 1.)

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For intravenous administration, Ampicillin sodium/Sulbactam sodium IM/IV should be reconstituted with sterile water for injection or any compatible solution (see Instructions for use under Cautions for Usage.) To ensure complete dissolution, allow foaming to dissipate in order to visually inspect. The dose can be given by bolus injection over a minimum of 3 minutes or can be used in greater dilutions as intravenous infusion over 15-30 minutes. Ampicillin sodium/Sulbactam sodium parenteral may also be administered by deep intramuscular injection; if pain is experienced, 0.5% sterile solution for injection of lignocaine hydrochloride anhydrous may be used for reconstitution of the powder.
Use in Adults: The usual dosage range of Ampicillin sodium/Sulbactam sodium IM/IV is 1.5 g (1 g ampicillin and 0.5 g sulbactam) to 12 g (8 g ampicillin and 4 g sulbactam) per day in divided doses every 6 or 8 hours up to a maximum daily dosage of 12 g (8 g ampicillin and 4 g sulbactam). Less severe infections may be treated on an every-12-hours schedule. (See Table 2.)

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More or less frequent dosing may be indicated depending on the severity of the illness and the renal function of the patient. Treatment is usually continued until 48 hours after pyrexia and other abnormal signs have been resolved. Treatment is normally given for 5 to 14 days, but the treatment period may be extended or additional Ampicillin may be administered in severely ill cases.
In treating patients on restricted sodium intake, it should be noted that 1,500 mg (1 g ampicillin and 0.5 g sulbactam) of Ampicillin sodium/Sulbactam sodium IM/IV contains approximately 115 mg (5 mmol) of sodium. For the prophylaxis of surgical infections, 1.5 g (1g ampicillin and 0.5 g sulbactam). 3 g (2 g ampicillin and 1 g sulbactam) of Ampicillin sodium/Sulbactam sodium IM/IV should be given at induction of anesthesia, which allows sufficient time to achieve effective serum and tissue concentrations during the procedure. The dose may be repeated every 6-8 hours. Administration is usually stopped 24 hours after on the majority of surgical procedures, unless a therapeutic course of Ampicillin sodium/Sulbactam sodium IM/IV is indicated. In the treatment of uncomplicated gonorrhea, Ampicillin sodium/Sulbactam sodium IM/IV can be given as a single dose of 1.5 g (1 g ampicillin and 0.5 g sulbactam). Concomitant probenecid 1 g orally should be administered in order to prolong plasma concentrations of Ampicillin and Sulbactam.
Use in Children, Infant and Neonates: The dosage of Ampicillin sodium/Sulbactam sodium IM/IV for most infections in children, infants and neonates is 150 mg/kg/day (corresponding to ampicillin 100 mg/kg/day and sulbactam 50 mg/kg/day). In children, infants and neonates, dosing is usually every 6 or 8 hours in accordance with the usual practice for ampicillin. In neonates during the first week of life (especially preterms), the recommended dose is 75 mg/kg/day (corresponding to 50 mg/kg/day ampicillin and 25 mg/kg/day sulbactam) in divided doses every 12 hours.
Use in Patients with Renal Impairment: In patients with severe impairment of renal function (creatinine clearance <30 mL/min), the elimination kinetics of ampicillin and sulbactam are similarly affected and hence the plasma ratio of one to the other will remain constant. The dose of Ampicillin sodium/Sulbactam sodium IM/IV in such patients should be administered less frequently in accordance with the usual practice for ampicillin.