SOLAGÉ SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRETINOIN; MEQUINOL

Διαθέσιμο από:

GLAXOSMITHKLINE INC

Φαρμακολογική κατηγορία (ATC):

D11AX56

INN (Διεθνής Όνομα):

MEQUINOL, COMBINATIONS

Δοσολογία:

0.01%; 2%

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

TRETINOIN 0.01%; MEQUINOL 2%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

30ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CELL STIMULANTS AND PROLIFERANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0242765001; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-03-04

Αρχείο Π.Χ.Π.

_ _
_2010-05-20/131-pristine-english-Solagé.doc _
_Page 1 of 27_
PRODUCT MONOGRAPH
SOLAGÉ
®
(MEQUINOL 2% / TRETINOIN 0.01%)
TOPICAL SOLUTION
AGENT FOR THE TREATMENT OF SOLAR LENTIGINES AND
RELATED HYPERPIGMENTED LESIONS
GlaxoSmithKline Inc
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
www.stiefel.ca
Date of Preparation:
June 8, 2010
Control No.: 139132
_©_
_2010 GlaxoSmithKline Inc., All Rights Reserved _
_®_
_SOLAGÉ used under license by GlaxoSmithKline Inc. _
_ _
_2010-05-20/131-pristine-english-Solagé.doc _
_Page 2 of 27_
PRODUCT MONOGRAPH
SOLAGÉ
®
(MEQUINOL 2% / TRETINOIN 0.01%)
Topical Solution
THERAPEUTIC CLASSIFICATION
Agent for the treatment of solar lentigines and
related hyperpigmented lesions
ACTION AND CLINICAL PHARMACOLOGY
Solar lentigines and related hyperpigmented lesions are localized,
pigmented, macular lesions
of the skin, usually on the areas of the body which have been
chronically exposed to sunlight.
These lesions are characterized by increased numbers of active
melanocytes and increased
melanin production.
The exact mechanism of action of mequinol as a depigmenting agent is
unknown.
Mequinol is a substrate for the enzyme tyrosinase and acts as a
competitive inhibitor of the
formation of melanin precursors.
The exact mechanism of action of tretinoin also is unknown. It is
believed that the therapeutic
effect of topically-applied tretinoin is due to its ability to inhibit
melanogenesis by inhibiting the
induction of tyrosinase thus decreasing melanin content in the
epidermis. Tretinoin is also
believed to act as a regulator in controlling differentiation of
various cell types.
The percutaneous absorption of tretinoin was approximately 4.4 % and
systemic concentrations
did not increase over endogenous levels, following the assessment of
the percutaneous
absorption of tretinoin and the systemic exposure to tretinoin and
mequinol in healthy subjects
(n=8) after two weeks of twice daily topical treatment with SOLAGÉ
®
. Approximately 0.8 mL of
SOLAGÉ
®
was applied to a 400 cm
2
a