Unasyn

Unasyn Dosage/Direction for Use

sultamicillin

ampicillin + sulbactam

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Film-coated tablet: The recommended dose of sultamicillin in adults (including elderly patients) is 375-750 mg twice daily.
In both adults and children, 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 if necessary.
In the treatment of uncomplicated gonorrhoea, sultamicillin can be given as a single oral dose of 2.25 g (three 750 mg tablets). Concomitant probenecid 1.0 g should be administered in order to prolong plasma concentrations of sulbactam and ampicillin.
Cases of gonorrhea with a suspected lesion of syphilis should have dark field examinations before receiving sultamicillin and monthly serological tests for a minimum of four months.
It is recommended that there be at least 10 days treatment for any infection caused by hemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Use in Children and Infants: The dosage for most infections in children weighing less than 30 kg is sultamicillin 25-50 mg/kg/day orally in two divided doses, depending on the severity of the infection and the physician's judgment. For children weighing 30 kg or more, the usual adult dose should be given.
Use in Patients with 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 sultamicillin in such patients should be administered less frequently in accordance with the usual practice for ampicillin.
Powder for injection: Sulbactam sodium/ampicillin sodium IM/IV can be administered by either intravenous or intramuscular routes. The following dilutions may be used: See Table 1.

Click on icon to see table/diagram/image

For intravenous administration, sulbactam sodium/ampicillin 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 an intravenous infusion over 15-30 minutes.
Pfizer sulbactam sodium/ampicillin 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 sulbactam sodium/ampicillin sodium IM/IV is 1.5 g to 12 g per 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-hours schedule. (See Table 2.)

Click on icon to see table/diagram/image

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 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 of sulbactam sodium/ampicillin sodium IM/IV contains approximately 115 mg (5 mmol) of sodium.
For the prophylaxis of surgical infections, 1.5-3 g of sulbactam sodium/ampicillin 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 the majority of surgical procedures, unless a therapeutic course of sulbactam sodium/ampicillin sodium IM/IV is indicated.
In the treatment of uncomplicated gonorrhea, sulbactam sodium/ampicillin sodium IM/IV can be given as a single dose of 1.5 g. Concomitant probenecid 1.0 g orally should be administered in order to prolong plasma concentrations of sulbactam and ampicillin.
Use in Children, Infants and Neonates: The dosage of sulbactam sodium/ampicillin sodium IM/IV 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 hours in accordance with the usual practice for ampicillin.
In neonates during the first 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 hours.
Use in Patients with 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 sulbactam sodium/ampicillin sodium IM/IV in such patients should be administered less frequently in accordance with the usual practice for ampicillin.
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