Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)
NORTHSTAR RX LLC
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2)] . Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] . Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product with the eyes and lips. In case of contact, rinse thoroughly with water all parts of the body that came in contact with the shampoo. None Teratogenic ef
Clobetasol Propionate Shampoo, 0.05%, is a clear to translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 16714-030-01 Storage: Keep tightly closed. Store 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SHAMPOO NORTHSTAR RX LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOBETASOL PROPIONATE SHAMPOO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL PROPIONATE SHAMPOO. CLOBETASOL PROPIONATE SHAMPOO, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1985 INDICATIONS AND USAGE Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older (1). Limitations of Use: Do not use on the face, axillae or groin. (1.2) Avoid any contact with the eyes and lips. (1.2) DOSAGE AND ADMINISTRATION Not for oral, ophthalmic, or intravaginal use. (2) Clobetasol propionate shampoo, 0.05% should be applied onto dry (not wet) scalp once a day in a thin film to the affected areas only, and left in place for 15 minutes before lathering and rinsing. Clobetasol propionate shampoo, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 4 weeks. (2) As with other corticosteroids, therapy should be discontinued when control is achieved. (2) Total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. (2) Clobetasol propionate shampoo should not be used with a shower cap or bathing cap. (2) DOSAGE FORMS AND STRENGTHS Shampoo, 0.05% (3) CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested. (5.1) Cushing's syndrome, hyperglycemia and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. (5.1) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (5.1) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1, 8.4) If irritation develops in the prese Læs hele dokumentet