UNASYN TABLET

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SULTAMICILLIN TOSYLATE

Available from:

PFIZER (MALAYSIA) SDN. BHD.

INN (International Name):

SULTAMICILLIN TOSYLATE

Units in package:

20 Tablet Tablets; 100Tablet Tablets

Manufactured by:

Pfizer Global Supply Japan Inc.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
UNASYN
®
TABLET
Sultamicillin (375 mg)
1
WHAT IS IN THIS LEAFLET
1.
What UNASYN is used for
2.
How UNASYN works
3.
Before you use UNASYN
4.
How to use UNASYN
5.
While you are using UNASYN
6.
Side Effects
7.
Storage and Disposal of
UNASYN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT UNASYN IS USED FOR
UNASYN is indicated for infections
caused by susceptible
micro-organisms which include:
-
upper respiratory tract infections
including sinus infection, middle
ear infection and tonsils
inflammation
-
lower respiratory tract infections
including inflammation of the lungs
and inflammation of the bronchial
tubes
-
kidneys and urinary tract infections
-
skin and soft tissues infections
-
gonococcal infections (a sexually
transmitted disease)
UNASYN tablets may also be used in
individuals who have been treated
with injections of UNASYN and who
have to further continue treatment
with the same medicine by mouth.
HOW UNASYN WORKS
UNASYN contains the active
substance sultamicillin. Inside the
body, sultamicillin is split into two
substances, sulbactam and ampicillin.
Together, these two substances are
able to kill various types of bacteria.
BEFORE YOU USE UNASYN
-
_When you must not use it_
Do not use UNASYN
-
if you are allergic to sultamicillin
or any penicillin, or any of the
other ingredients of this medicine
_Pregnancy and lactation_
UNASYN crosses the placenta and
reaches the foetus. If necessary, your
doctor will assess the benefits of
treatment with this medicine
compared to the possible risks.
Do not take UNASYN if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
-
_Before you start to use it_
Tell your doctor if you have:
-
allergic reactions to penicillins,
cephalosporins, carbapenems,
beta lactams and other allergens
-
any kidney or liver problems or if
you develop any signs and
symptoms of liver disease
-
hereditary problems of galactose
intolerance,

Summary of Product characteristics

Pfiz\b 
\bntial
1
UNAS\b
L
Sultamicillin
1. NAME OF THE MEDICINAL PRODUCT
UNASYN
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sultamicillin is a doubl\b \b\br in which ampicillin and th\b b\ba -lactamas\b inhibitor sulbactam
ar\b link\b via a m\b,\bn\b group. Ch\b7 sultamicillin is th\b oxym\b,1\bnicillinat\b
sulfon\b\bst\b 1
,\bcular w\b-,0%3).
3. PH ARMACEUTICAL FORM
Sultamicillin is availabl\b as film -coat\b tabl\b containing th\b tosylat\b salt \bC!\bnt to 375
mg sultamicillin ,which is a mutual prodrug of sulbactam and ampicillin ,yi\b
- th\b
\bC!\bnt of 147 mg sulbactam and 220 mg ampicillin.
Sultamicillin is also availabl\b as a powd\b for oral susp\b containing sultamicillin bas\b that ,
aft\b  \bconstitution with wat\br ,provid\b#0-1\br 5 ml.
4. CLINICAL PARTICULARS
4.1 Therapeutic Indications
Sultamicillin is indicat\b for inf\b caus\b by susc\b1"\b micro -organisms. Typical
indications ar\b11\br r\b1   \bctions including sinusitis, otitis m\b

*
low\b r\b1   tract inf\b including bact\b  pn\b and bronchitis; urinary tract
inf\b
1\blon\b1, *A
\b inf\b
-\bctions.
Sultamicillin may also b\b indicat\b in pati\b r\bC - sulbactam/ampicillin th\b 1
following initial tr\b\bnt with sulbactam/ampicillin IM/IV.
4.2 Posology and Method of Administration
Th\b r\b\bnd\b dos\b of sultamicillin in adults (including \b
\brly pati\b is 375 -750 mg
orally twic\b
.
In both adults and childr\bn ,tr\b\bnt is usually continu\b until 48 hours aft\b pyr\bB and oth\b
abnormal signs hav\b r\b!\bd. Tr\b\bnt is normally giv\b for 5 -14 days, but th\b tr\b\bnt
p\b 
"\b \bB\bnd\b
\bc\b .
In th\b tr\b\bnt of uncomplicat\b
- ,\ba, sultamicill in can b\b-!\bn as a singl\b oral dos\b
2.25 g (six 375 mg tabl\b) Concomitant prob\b\bcid 1.0 g should b\b administ\b \bd in ord\b