국가: 캐나다
언어: 영어
출처: Health Canada
CLOBETASOL PROPIONATE
MYLAN PHARMACEUTICALS ULC
D07AD01
CLOBETASOL
0.05%
LOTION
CLOBETASOL PROPIONATE 0.05%
TOPICAL
20ML/60ML
Prescription
ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0110995001; AHFS:
APPROVED
2009-06-03
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 전체 문서 읽기