Silkaderm solution for topical use

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tretinoin

Available from:

Arpimed LLC

ATC code:

D10AD01

INN (International Name):

tretinoin

Dosage:

0,5mg/ml

Pharmaceutical form:

solution for topical use

Units in package:

30ml glass bottle

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2018-09-12

Summary of Product characteristics

SUMMARY
PRODUCT
CHARACTERISTIC
{SPC}
SILKADEBM
0.05%
solution
for
foPical
use
COMPO$ITION
Each
mt
of
$ILKAIIERM
solution contains:
s€tive
ingrcdient:
ffetinoin
-
0.5
mg;
furctive
ingredients,:
a-tocopheryl
acetate
(viamin
E),
propylene
glycol,
etlranol 96%.
PHARMACOLOGICAL
GROUP
AND
ATC
CODE
Dermatological
drug
retinoid;
D
I
0AD0l
.
PHARMACEUTICAL
FORM
Soluticn
for
topical
use.
A
transparent,
yellow
tiquid.
PHARMACOLOCY
Tretinoin
is
a
retinoid
and
is the acid
form
of
vitamin
A'
Tretinoin
is
used
prirnarity in
the
topical
featmsnt
of
acne
vulgaris
when
comedones,
papules,
and
pustules
predaminate-
lt
appears
ta
stimulate
mitosis
ald
turnover
of
follicular
epithelial
cells
end
reduce
their
cahesiveness
thereby
facilitating
the
extr*sion
of
existing
cornedones
and
preventing
the
farmation of
new
ones.
It
also appears
to
have
a
thinning
effect
on
the
stratum corneum.
PHARMACOKINETICS
Absorption
does
not
sesm
to
cccur to
any
great
extent
with
topical
use.
USES AIYD
ADMINISTRATION
Silkaderm
is
used
prim*rily
in
the
topical
treatment
of
aene
vulgaris
when
comedones,
papules,
and
pustules
predominate.
Silkaderm
is
also
use{
for
tlre
treatment
of
mottled hyperpigmentation,
roughness,
and
fine
wrinkling
of
photodamaged
skin.
Administration
Silkaderm
is
applied
topically
to the
skin.
Patients should
be
instrueted
carefully
in
proper
use
of
the
drug
ineluding
associated
precautions.
The skin should
be
cleansed
to
remove
excsssive
oiliness
and
dried
15
ts
30
minutes before
applying
tretinoin
lightly,
once
sr
fwice
daily
according
to
response
and
irritatioll;
some
patients
may
require
less
frequent
applications.
Other
topical
preparations
{including
skin
moisturisen)
should
not
be
applied
at the
same
time
as
ketinoin
is
applied,
and
eaution
is required
if
other local irritants
are
used
concurrently,
There
may
be
apparent
exacerbafions
of
the
acne
during
early
treatrnent
and
a
therapeutic rcsponse
may
not
be
evident
far 6
to
I
weeks.
When
fhe
condition
has
resolved
maintenance
therapy
should be
less
fiequent.
For
the treatmen