Amsubac Dosage/Direction for Use

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

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For IV administration, Ampicillin sodium & Sulbactam sodium should be reconstituted with sterile water for injection or any compatible solution. To ensure complete dissolution, allow foaming to dissipate to permit visual inspection. The dose can be given by bolus injection over a minimum of 3 min or can be used in greater dilutions as an IV infusion over 15-30 min. Ampicillin sodium & Sulbactam sodium parenteral may also be administered by deep IM injection; if pain is experienced, 0.5% sterile solution for injection of lignocaine HCl anhydrous may be used for reconstitution of the powder.
Adults: The usual dosage range of Ampicillin sodium & Sulbactam sodium is 1.5-12 g/day in divided doses every 6 or 8 hours up to a maximum daily dosage of sulbactam of 4 g. Less severe infections may be treated on an every-12-hr 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 resolved. Treatment is normally given for 5-14 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 1500 mg of Ampicillin sodium & Sulbactam sodium contains approximately 115 mg (5 mmol) of sodium.
For the prophylaxis of surgical infections, 1.5-3 g of Ampicillin sodium & Sulbactam sodium should be given at induction of anaesthesia, 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 the majority of surgical procedures, unless a therapeutic course of Ampicillin sodium & Sulbactam sodium is indicated.
In the treatment of uncomplicated gonorrhea, Ampicillin sodium & Sulbactam sodium can be given as a single dose of 1.5 g. Concomitant probenecid 1 g orally should be administered in order to prolong plasma concentrations of sulbactam and ampicillin.
Children, Infants, Neonates: The dosage of Ampicillin sodium & Sulbactam sodium for most infections in children, infants and neonates is 150 mg/kg/day (corresponding to sulbactam 50 mg/kg/day and ampicillin 100 mg/kg/day). In children, infants and neonates, dosing is usually every 6 or 8 hrs in accordance with the usual practice for ampicillin. In neonates during the 1st week of life (especially pre-terms), the recommended dose is 75 mg/kg/day (corresponding to 25 mg/kg/day sulbactam and 50 mg/kg/day ampicillin) in divided doses every 12 hrs.
Renal Impairment: In patients with severe impairment of renal function (creatinine clearance ≤30 mL/min), the elimination kinetics of sulbactam and ampicillin are similarly affected and hence the plasma ratio of one to the other will remain constant. The dose of Ampicillin sodium & Sulbactam sodium in such patients should be administered less frequently in accordance with the usual practice for ampicillin.
Incompatibilities: For IV administration, Ampicillin sodium & Sulbactam sodium should be reconstituted with sterile water for injection or any compatible solution. To ensure complete dissolution, allow foaming to dissipate to permit visual inspection. The dose can be given by bolus injection over a minimum of 3 min or can be used in greater dilutions as an IV infusion over 15-30 min. Sulbactam sodium/ampicillin sodium parenteral may also be administered by deep IM injection; if pain is experienced, 0.5% sterile solution for injection of lignocaine HCl anhydrous may be used for reconstitution of the powder.