দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
REMEDYREPACK INC.
TOPICAL
PRESCRIPTION DRUG
Clobetasol propionate lotion, 0.05% is a super-high potent topical corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses only in patients 18 years of age or older. Treatment should be limited to 2 consecutive weeks. For moderate to severe plaque psoriasis, treatment may be extended for an additional 2 weeks for localized lesions (less than 10% body surface area) that have not sufficiently improved after the initial 2-week treatment. Any additional benefits of extending treatment should be weighed against the risk of hypothalamic-pituitary-adrenal (HPA) axis suppression before prescribing for more than 2 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 lotion, 0.05% for the minimum amount of time necessary to achieve the desired results [ see Dosage and Administration (2) ]. Use in patients under 18 years
Clobetasol Propionate Lotion, 0.05% is a white lotion supplied in the following sizes: 4 fl oz (118 mL) high density polyethylene bottles NDC: 70518-2068-00 PACKAGING: 1 in 1 CARTON, 118 mL in 1 BOTTLE, TYPE 0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE LOTION REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CLOBETASOL PROPIONATE LOTION, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL PROPIONATE LOTION. CLOBETASOL PROPIONATE LOTION, FOR TOPICAL USE INITIAL U.S. APPROVAL: 1985 INDICATIONS AND USAGE Clobetasol propionate lotion, 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, in patients 18 years of age or older ( 1.1). Limitations of Use: Do not use on the face, axillae or groin. ( 1.2) Do not use if atrophy is present at the treatment site. ( 1.2) Do not use for rosacea or perioral dermatitis. ( 1.2) DOSAGE AND ADMINISTRATION Not for oral, ophthalmic, or intravaginal use. ( 2) Clobetasol propionate lotion, 0.05% should be applied directly onto the affected skin areas twice daily and rubbed in gently. ( 2) Clobetasol propionate lotion, 0.05% contains a super-high potent topical corticosteroid; therefore treatment should be limited to 2 weeks. For moderate to severe plaque psoriasis, treatment may be extended for additional 2 weeks for localized lesions (<10% body surface area) that have not sufficiently improved. ( 2) Total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. ( 2) DOSAGE FORMS AND STRENGTHS Lotion, 0.05% w/w ( 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 cortico সম্পূর্ণ নথি পড়ুন