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UNASYN ORAL TABLET 375 MG [SIN04892P]
Active ingredients: UNASYN ORAL TABLET 375 MG
Last updated 26 October 2025
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Product Info
UNASYN ORAL TABLET 375 MG
[SIN04892P]
Product information
Active Ingredient and Strength | SULTAMICILLIN TOSYLATE - 375 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | PFIZER GLOBAL SUPPLY JAPAN INC - JAPAN |
Registration Number | SIN04892P |
Licence Holder | PFIZER PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J01CR04 |
4.1 Therapeutic Indications
Sultamicillin is indicated for infections caused by susceptible micro‑organisms. 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; skin and soft tissue infections and gonococcal infections.
Sultamicillin may also be indicated in patients requiring sulbactam/ampicillin therapy following initial treatment with sulbactam/ampicillin IM/IV.
4.2 Posology and Method of Administration
The recommended dose of sultamicillin in adults (including elderly patients) is 375–750 mg orally 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 gonorrhea, sultamicillin can be given as a single oral dose of 2.25 g (six 375 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 judgement. 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 usual practice for ampicillin.
4.3 Contraindications
The use of sultamicillin is contraindicated in individuals with a history of an allergic reaction to any of the penicillins.