Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Akorn
CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE .5 mg in 1 mL
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 e
Clobetasol Propionate Shampoo, 0.05%, is a translucent, colorless to pale yellow viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 50383-979-04 Storage: Keep tightly closed. Store at USP controlled room temperature 68˚ to 77˚F (20˚ to 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ to 30˚C).
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SHAMPOO AKORN ---------- 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 ONLY 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) (1) Limitations of Use: (1) (1) • • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS Shampoo, 0.05% (3) (3) CONTRAINDICATIONS None (4) (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) (5) Cushing’s syndrome, hyperglycemia and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. (5.1) (5) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. (5.1) (5) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. (5.1, 8.4) (5) If irritation develops in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of clobetasol propionate shampoo should be discontinued until the infection has been adequately controlled. (5.3) (5) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions include: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria. (5.4) (5) (5) ADVERSE REACTIONS The most Pročitajte cijeli dokument