Duofilm Solution

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

Lactic Acid; SALICYLIC ACID

متاح من:

DKSH MALAYSIA SDN. BHD.

INN (الاسم الدولي):

Lactic Acid; SALICYLIC ACID

الوحدات في الحزمة:

15 ml

المصنعة من قبل:

Delpharm Bladel B.V.

نشرة المعلومات

DUOFILM SOLUTION
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Salicylic acid 16.7% w/w; Lactic acid 15.0% w/w
WHAT IS IN THIS LEAFLET
1.
What Duofilm Solution is used for
2.
How Duofilm Solution works
3.
Before you use Duofilm Solution
4.
How to use Duofilm Solution
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Duofilm
Solution
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DUOFILM SOLUTION IS USED FOR
Duofilm Solution is indicated in the
treatment of warts, corns and calluses.
HOW DUOFILM SOLUTION WORKS
Duofilm
Solution
contains
two
medicines called salicylic acid and lactic
acid. It works by softening the skin of a
wart, corn and callus, causing it to peel
off.
Duofilm Solution is used in the treatment
of warts, corns and calluses.
BEFORE YOU USE DUOFILM SOLUTION
-
_When you must not use it _
Do not use Duofilm Solution:
•
if you are allergic (hypersensitive) to
salicylic acid, lactic acid or any other
ingredients of Duofilm Solution.
•
if the wart, verruca, corn or callus or
skin
surrounding
it,
is
red,
irritated,
broken or infected.
•
on moles, birthmarks, or warts with
hairs growing from them, red edges or
that are of an unusual colour.
•
on warts that are on your face, genital
(sex) area or mucous membranes such
as eyes, nose or mouth.
•
on warts that cover an area of the body
more than 5 cm
2
(approximately the
size of a postage stamp).
•
for diabetics or those suffering from
poor blood circulation or poor sense of
feeling (nerve damage) to the hands or
feet.
•
for infants under 2 years old
•
for children or teenagers showing any
signs
of
fever
(raised
temperature),
who have a viral infection (such as the
flu or chickenpox) or who have just
recovered from any of these illnesses.
There is no information about the safety
of Duofilm Solution in pregnant women.
Duofilm
Solution
is
not
recommended
for use during pregnancy.
The ingredients of Duofilm Solution may
pass into breast milk. Breast-feeding is
not recommended

خصائص المنتج

1.
Product Name
Duofilm Solution
2.
Qualitative And Quantitative Composition
Salicylic acid 16.7% w/w
Lactic acid 15.0% w/w
Excipient:
Flexible collodion (contains pyroxylin, colophony, virgin
castor oil, ethanol and ether).
This product contains Ethanol 90%.
3.
Product Description
A yellowish to amber coloured clear viscous liquid with a
strong odour ether.
4.
Pharmacodynamics
ATC Code
Pharmacotherapeutic group: Wart and anti-corn
preparations.
ATC code: D11AF
Mechanism of Action
Topically applied salicylic acid is keratolytic. The keratolytic
activity produces desquamation by solubilising the
intercellular cement in the stratum corneum resulting in the
shedding of skin scales.
Lactic acid affects the keratinisation process, reducing the
hyperkeratosis which is characteristic of warts, corns and
calluses. At high concentrations it can cause epidermolysis,
leading to the destruction of the keratotic tissue, and in the
case of warts, of the causative virus. It also has antiseptic
properties.
Flexible collodion provides a viscous vehicle that allows
accurate application of the active ingredients to the wart, corn
or callus. It also forms a film that helps to hydrate and promote
the destruction of hyperkeratotic tissue.
5.
Pharmacokinetics
Absorption
Salicylic acid is absorbed through the skin; where detectable,
maximum plasma levels are found 6 to 12 hours after
application. Systemic absorption of salicylic acid has been
reported to range from 9% to 25% after topical application of
other salicylic acid-containing preparations. The extent of
absorption is variable depending on the duration of contact and
the vehicle. Despite percutaneous absorption, the systemic
exposure is low given the low dose topically administered to
small, localised areas of hyperkeratotic tissue.
Human abdominal skin in a flow-through diffusion system
was used to assess the in vitro percutaneous absorption of
lactic acid. At a pH of 3, the amount of radioactivity detected
in the receptor fluid, stratum corneum, epidermis, and
dermis was 3.6,