MYLAN-CLOBETASOL SCALP APPLICATION LOTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CLOBETASOL PROPIONATE

Tilgængelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

D07AD01

INN (International Name):

CLOBETASOL

Dosering:

0.05%

Lægemiddelform:

LOTION

Sammensætning:

CLOBETASOL PROPIONATE 0.05%

Indgivelsesvej:

TOPICAL

Enheder i pakken:

20ML/60ML

Recept type:

Prescription

Terapeutisk område:

ANTI-INFLAMMATORY AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0110995001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2009-06-03

Produktets egenskaber

PRODUCT MONOGRAPH
MYLAN-CLOBETASOL SCALP APPLICATION
(Clobetasol 17-propionate 0.05% w/w in aqueous-alcohol base)
(60 ml bottles)
Topical Corticosteroid
Mylan Pharmaceuticals ULC
85 Advance Road Etobicoke,
Ontario M8Z 2S6
DATE OF PREPARATION:
June 5, 2009
DATE OF REVISION:
Control#: 129665
2
NAME OF DRUG
MYLAN-CLOBETASOL SCALP APPLICATION
(Clobetasol 17-propionate 0.05 %w/w)
(60 mL bottles)
THERAPEUTIC CLASSIFICATION
Topical Corticosteroid
ACTIONS AND CLINICAL PHARMACOLOGY
MYLAN-CLOBETASOL SCALP APPLICATION (Clobetasol 17-propionate) is a
very potent
topical corticosteroid with anti-inflammatory, antipruritic, and
vasoconstrictive actions.
Pharmacokinetics
In man, the extent of percutaneous absorption of topical
corticosteroids, including clobetasol
17-propionate, is determined by many factors, including the vehicle,
the integrity of the
epidermal barrier, and the use of occlusive dressing.
As with all topical corticosteroids, clobetasol 17-propionate can be
absorbed from normal
intact skin. Inflammation and/or other disease processes in the skin
may increase
percutaneous absorption. Occlusive dressings substantially increase
the percutaneous
absorption of topical corticosteroids.
3
Once absorbed through the skin, topical corticosteroids enter
pharmacokinetic pathways similar to
systemically administered corticosteroids. Corticosteroids are bound
to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then
excreted by the kidneys. Some of the topical
corticosteroids, including clobetasol 17-propionate and its
metabolites, are also excreted in the bile.
Bioavailability
The relative potency of corticosteroids is usually assayed by the
vasoconstriction test which reflects the potency of
the steroid molecule, its topical activity as well as its
bioavailaility from the particular formulation. The
vascoconstrictor response of MYLAN-CLOBETASOL SCALP APPLICATION was
compared with
Dermovate Scalp Application as well as a placebo in a randomised and
double blind study involving