Drug Catalog - Product Detail
CLOBETASOL PROPIONATE 0.0005 FOAM 100GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50742-0304-01 | INGENUS PHARMACEUTICALS | 100 | 0.05% | FOAM |
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Description
11 DESCRIPTION Clobetasol propionate foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C 25 H 32 ClFO 5 , a molecular weight of 466.97. The following is the chemical structure: Clobetasol propionate is a white to cream-colored crystalline powder, practically insoluble in water. Each gram of Clobetasol propionate foam contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant. Chemical Structure
How Supplied
16. HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Clobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white aerosol foam is available as follows: • 50 g aluminum can NDC 50742-304-50 • 100 g aluminum can NDC 50742-304-01 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Apply a thin layer of Clobetasol propionate foam to the affected skin areas twice daily. Clobetasol propionate foam is a super-high-potency topical corticosteroid; therefore, limit treatment to 2 consecutive weeks. Patients should not use greater than 50 grams per week or more than 21 capfuls per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1 )] . Therapy should be discontinued when control is achieved. Clobetasol propionate foam should not be used with occlusive dressings unless directed by a physician. Clobetasol propionate foam is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid contact with eyes. Wash hands after each application. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Apply a thin layer to the affected skin areas twice daily. ( 2 ) Limit treatment to 2 consecutive weeks. ( 2 ) Do not use more than 50 grams per week or more than 21 capfuls per week. ( 2 ) Discontinue therapy when control is achieved. ( 2 ) Do not use with occlusive dressings unless directed by physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 )