UNASYN ORAL TABLET 375 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

SULTAMICILLIN TOSYLATE

Available from:

PFIZER PRIVATE LIMITED

ATC code:

J01CR04

Dosage:

375 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

SULTAMICILLIN TOSYLATE 375 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

PFIZER GLOBAL SUPPLY JAPAN INC

Authorization status:

ACTIVE

Authorization date:

1990-06-29

Patient Information leaflet

Pfizer Confidential 
1.0 
TRADENAME OF MEDICINAL PRODUCT 

UNASYN 

2.0 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Sultamicillin is a double ester in which ampicillin and the beta-lactamase inhibitor sulbactam are 
linked  via  a  methylene  group.    Chemically  sultamicillin  is  the  oxymethylpenicillinate  sulphone 
ester of ampicillin and has a molecular weight of 594.7.  

3.0 
PHARMACEUTICAL FORM 

Sultamicillin is available as  film-coated tablets containing the tosylate salt equivalent to 375 mg 
sultamicillin  which  is  a  mutual  prodrug  of  sulbactam  and  ampicillin  yielding  the  equivalent  of 
147 mg sulbactam and 220 mg ampicillin.  

Sultamicillin is also available as a powder for oral suspension containing sultamicillin base that 
after reconstitution with water provides 250 mg sultamicillin
per 5 ml.  

4.0 
CLINICAL PARTICULARS 

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.

Summary of Product characteristics

UNASYN ORAL
Sultamicillin
1.
NAME OF THE MEDICINAL PRODUCT
UNASYN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sultamicillin is a double ester in which ampicillin and the
beta-lactamase inhibitor sulbactam
are linked via a methylene group. Chemically, sultamicillin is the
oxymethylpenicillinate
sulfone ester of ampicillin and has a molecular weight of 594.7.
3.
PHARMACEUTICAL FORM
Sultamicillin is available as film-coated tablets containing the
tosylate salt equivalent to 375 mg
sultamicillin, which is a mutual prodrug of sulbactam and ampicillin,
yielding the equivalent of
147 mg sulbactam and 220 mg ampicillin.
4.
CLINICAL PARTICULARS
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