产品特点
SUMMARY PRODUCT CHARACTERISTIC (SPC)
SILKADERM 0.05% CREAM
TRADE NAME – Silkaderm
INTERNATIONAL NON-PROPERTY NAME – Tretinoin
DOSAGE FORM – Cream for topical use
COMPOSITION
EACH GRAM OF SILKADERM 0.05% CREAM CONTAINS:
_ACTIVE INGREDIENT: _tretinoin - 0.5 mg;
_INACTIVE _
_INGREDIENTS: _
glyceryl
stearate
SE,
cetearete
12,
cetearete
20,
liquid
parafin,
glycerin,
cetostearyl alcohol, methylparaben, propylparaben, diazolidinyl urea,
disodium edetate, butyl hydroxy
toluene, propylene glycol, dimethicone, water purified.
PHARMACOLOGICAL GROUP AND ATC CODE
Dermatological drug, retinoid; D10AD01.
PHARMACOLOGY
Tretinoin is a retinoid and is the acid form of vitamin A.
Tretinoin is used primarily in the topical treatment of ACNE VULGARIS
when comedones, papules, and
pustules predominate. It appears to stimulate mitosis and turnover of
follicular epithelial cells and
reduce their cohesiveness thereby facilitating the extrusion of
existing comedones and preventing the
formation of new ones. It also appears to have a thinning effect on
the stratum corneum.
PHARMACOKINETICS
Absorption does not seem to occur to any great extent with topical
use. Tretinoin is the only metabolite
of retinol, which is normally present in plasma
USES
SILKADERM is used primarily in the topical treatment of ACNE VULGARIS
(both as monotherapy and in
combination therapy). ADMINISTRATION_ _
SILKADERM is applied topically to the skin. Patients should be
instructed carefully in proper use of the
drug, including associated precautions.
The skin should be cleansed to remove excessive oiliness and dried 15
to 30 minutes before applying
tretinoin lightly, once or twice daily according to response and
irritation; some patients may require
less frequent applications. Other topical preparations (including skin
moisturisers) should not be
applied at the same time as tretinoin is applied, and caution is
required if other local irritants are used
concurrently.
There
may
be
apparent
exacerbations
of
the
acne
during
early
treatment
and
a
therapeutic
response
m
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