Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Morton Grove Pharmaceuticals, Inc.
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in children under 12 years of age. Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.
Clobetasol Propionate Topical Solution, USP 0.05%, a colorless, hazy solution, is supplied in plastic squeeze bottles, 25 mL (NDC 60432-133-25), and 50 mL (NDC 60432-133-50). Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). Do not refrigerate. Do not use near an open flame.
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION MORTON GROVE PHARMACEUTICALS, INC. ---------- CLOBETASOL PROPIONATE TOPICAL SOLUTION, USP 0.05% (POTENCY EXPRESSED AS CLOBETASOL PROPIONATE) FOR USE ON THE SCALP FOR DERMATOLOGIC USE ONLY- NOT FOR OPHTHALMIC USE. DESCRIPTION Clobetasol propionate topical solution contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is 21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4- diene-3,20-dione 17-propionate, and it has the following structural formula: Clobetasol propionate has the molecular formula C H ClFO and a molecular weight of 466.98. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate topical solution contains clobetasol propionate 0.05% (0.5 mg/g) in a base composed of purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium hydroxide. It may also contain hydrochloric acid to adjust pH. CLINICAL PHARMACOLOGY The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects. Topical corticosteroids such as clobetasol propionate are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of 25 32 5 pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Clobetasol propionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects Belgenin tamamını okuyun