SILVERDERM CREAM

Country: Malaysia

Language: English

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

Active ingredient:

SILVER SULPHADIAZINE

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

SILVER SULPHADIAZINE

Units in package:

25gm mcg/mL; 25gm mcg/mL; 50 gm mcg/mL

Manufactured by:

T.O. CHEMICALS (1979) LTD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SILVERDERM CREAM
®
Silver Sulphadiazine (1g/100g)
1
WHAT IS IN THE LEAFLET
1.
What Silverderm Cream is used for
2.
How Silverderm Cream works
3.
Before you use Silverderm Cream
4.
How to use Silverderm Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Silverderm
Cream
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SILVERDERM CREAM
IS USED FOR
Silverderm Cream is used:
• To prevent and treat infection in burn
wounds
• As an aid to the short-term treatment in
other skin conditions, such as leg ulcers
• As an aid to prevent infection in skin
grafting.
HOW SILVERDERM CREAM
WORKS
Silver sulphadiazine has broad antimicrobial
activity against Gram-positive and Gram-
negative bacteria. It works by killing bacteria
or stopping their growth.
BEFORE YOU USE SILVERDERM CREAM_ _
-
_When you must not use it_
• Hypersensitive to silver sulphadiazine,
other sulphonamides or any of the other
ingredients in the preparation such as cetyl
alcohol and propylene glycol.
• Pregnant women approaching or at term
• Premature infants
• Newborn infants during the first 2 months
of life.
-
_Before you start to use it _
Please tell your doctor:
• If you have kidney or liver problem
• If you have extensive burns
• If you have glucose-6-phosphate
dehydrogenase (G6PD) deficiency
Absorption of propylene glycol which is
contained in Silverderm Cream may interfere
with some laboratory test results.
_If you are not sure whether you should start _
_taking this product, consult your doctor._
-
_Taking other medicines _
As the silver content of silver sulphadiazine
may inactivate topical proteolytic enzymes
and debriding agents (a type of medicine
used externally to clean and treat wounds),
their concomitant use may be inappropriate.
The effects of oral hypoglycaemic agents
(anti-diabetic medication) and phenytoin
(anticonvulsant medication) may be
potentiated when large areas of burns are
treated. Tell your

Summary of Product characteristics

SILVERDERM CREAM
Contains silver sulfadiazine 1.0% w/w.
DESCRIPTION
A white cream.
PROPERTIES
S
ilver
sulfadiazine
has
broad
antimicrobial
activity
against Gram-positive and Gram-negative bacteria
including _ Pseudomonas aeruginosa_ and some yeast
and
fungi.
Silver
sulfadiazine
acts
upon
the
cell
membrane
and
cell
wall
and
its
activity
is
not
antagonised by aminobenzoic acid (_p_-aminobenzoic
acid).
Silver sulfadiazine does not appear to be absorbed,
but when in contact with wound exudates, it reacts
with sodium chloride, sulfydryl groups and proteins,
resulting in the release of sulfadiazine.
When applied to second-degree burns particularly,
si
lver sulfadiazine may be systemically absorbed from
the site of application. Concentrations in blood of 10
to 20 micrograms (mcg) per ml have been reported
although
higher
concentrations
may
be
achieved
when extensive areas of the body are treated.
INDICATIONS
F
or
prevention
and
treatment
of
infection
in
burn
wounds. It has also been used as an aid to the short-
term treatment in other skin conditions, such as leg
ulcers where infections may prevent healing and as
an aid to prophylaxis of infection in skin grafting.
CONTRAINDICATIONS
_S_
_ILVERDERM CREAM_ is contraindicated in patients who
are hypersensitive to silver sulfadiazine or any of the
other
ingredients
in
the
preparation
such
as
cetyl
alcohol and propylene glycol.
Sulphonamide
therapy
is
known
to
increase
the
p
ossibility
of
kernicterus
and
because
of
that
_SILVERDERM CREAM_ should not be used on pregnant
women approaching or at term, on premature infants
or on newborn infants during the first 2 months of life.
SIDE EFFECTS / ADVERSE REACTIONS
Fre
quently
reported
adverse
reactions
include
burning,
skin
photosensitivity,
pruritus,
skin
rash
and
brown-grey skin discolouration.
When silver sulfadiazine is applied to extensive areas of
th
e
body
surface,
or
over
prolonged
periods,
sulfadiazine may be absorbed systemically and may
produce argyria and adverse reactions characteristic
of the sulphonamides. Some of th