Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Ingenus Pharmaceuticals, LLC
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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. None. Risk Summary There are no available data on Clobetasol propionate foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use Clobetasol propionate foam on the smallest area of skin and for the shortest duration possible (see Data ). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of anim
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 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.
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE AEROSOL, FOAM INGENUS PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOBETASOL PROPIONATE FOAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL PROPIONATE FOAM. CLOBETASOL PROPIONATE FOAM, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1985 RECENT MAJOR CHANGES Warnings and Precautions, _Ophthalmic Adverse Reactions_ (5.2) 04/2018 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. (1) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Foam, 0.05% (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Clobetasol propionate foam can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. (5.1, 8.4) Clobetasol propionate foam may increase the risk of cataract and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. (5.2) Clobetasol propionate foam is flammable. Avoid fire, flame, or smoking during and immediately following application. (5.4) ADVERSE REACTIONS Most common advers Olvassa el a teljes dokumentumot