Composition

Novactam Tablets:
Each tablet contains:
Sultamicillin (as sultamicillin tosylate) ........................ 375 mg
Novactam Dry Mix:
Each 5 ml after reconstitution contains:
Sultamicillin ...... ........................ 250 mg

Therapeutic Indications

Novactam is indicated for infections caused by susceptible microorganisms.
Typical indications are upper respiratory tract infections including sinusitis, otitis media and tonsillitis; lower respiratory tract infections including bacterial pneumonias and bronchitis.
Urinary tract infections and pyelonephritis; and gonococcal infections.
Skin and soft tissue infections.
Sultamicillin may also be indicated in patients requiring sulbactam/ampicillin therapy following initial treatment with Novactam IM/IV.

Dosage and Administration

Adults (including Elderly patients):
The recommended dose of Novactam is 375 mg-750 mg twice daily.
Children weighing less than 30 kg:
The dosage for most infections is Novactam 25-50 mg/kg/day in 2 divided doses depending on the severity of the infection and the physician's judgment.
Children weighing 30 kg or more:
The usual adult dose should be given.
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, Novactam can be given as a single oral dose of 2.25 grams (six Novactam 375 mg Tablets). Concomitant probenecid 1.0 gram should be administered in order to prolong plasma concentrations of sulbactam and ampicillin.
Cases of gonorrhoea 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.
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 Novactam in such patients should be administered less frequently in accordance with usual practice for ampicillin.
The reconstituted oral suspension must be stored under refrigeration and discarded after 14 days