Clobetasol

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

clobetasol (clobetasol propionate)

Saatavilla:

Arpimed LLC

INN (Kansainvälinen yleisnimi):

clobetasol (clobetasol propionate)

Annos:

0,5mg/g

Lääkemuoto:

cream for topical use

Prescription tyyppi:

Prescription

Valmisteyhteenveto

SUMMARY PRODUCT CHARACTERISTIC (SPC)
CLOBETASOL
0.05% CREAM FOR TOPICAL USE
1.1 BRAND NAME – CLOBETASOL
1.2 INTERNATIONAL NON-PROPERTY NAME - CLOBETASOL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of Clobetasol 0.05% cream contains:
_ACTIVE INGREDIENT:_ clobetasol propionate – 0.5 mg;
_For a full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM
Cream.
White odorless cream.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clobetasol is a very potent topical corticosteroid indicated for
adults, elderly and children over 1
year for the short term treatment only of more resistant inflammatory
and pruritic manifestations of
steroid
responsive
dermatoses
unresponsive
to
less
potent
corticosteroids.
These
include
the
following:
- Psoriasis (excluding widespread plaque psoriasis)
- Recalcitrant dermatoses
- Lichen planus
- Discoid lupus erythematosus
- Other skin conditions which do not respond satisfactorily to less
potent steroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous
Creams are especially appropriate for moist or weeping surfaces.
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice a
day until improvement occurs (in the more responsive conditions this
may be within a few days),
then reduce the frequency of application or change the treatment to a
less potent preparation. Allow
adequate time for absorption after each application before applying an
emollient.
Repeated short courses of clobetasol propionate may be used to control
exacerbations.
In more resistant lesions, especially where there is hyperkeratosis,
the effect of clobetasol can be
enhanced, if necessary, by occluding the treatment area with polythene
film. Overnight occlusion
only is usually adequate to bring about a satisfactory response.
Thereafter improvement can usually
be maintained by application without occlusion.
If the condition worsens or does not improve within 2-4 weeks,
treatment and diagnosis