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Drug Catalog - Product Detail

CLOBETASOL PROPIONATE LOTION LOT 0.0005 4OZ

NDC Mfr Size Str Form
00574-2103-04 PADAGIS 118 0.05% LOTION
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Description
11 DESCRIPTION Clobetasol Propionate Lotion, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. 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 CIFO 5 , and a molecular weight of 466.98 (CAS Registry Number 25122-46-7). The following is the chemical structure: Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobetasol Propionate Lotion, 0.05%, contains 0.5 mg of clobetasol propionate, in a white liquid composed of hypromellose, propylene glycol, mineral oil, polyoxyethylene glycol 300 isostearate, carbomer 1342, sodium hydroxide and purified water. chemical-structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Clobetasol Propionate Lotion, 0.05% is a white liquid, supplied in the following sizes: 2 fl oz/59 mL NDC 0574-2103-02 high density polyethylene bottles 4 fl oz/118 mL NDC 0574-2103-04 high density polyethylene bottles Store at USP controlled room temperature 68° to 77°F (20°-25°C), with excursions permitted between 59° and 86°F (15° - 30°C). Protect from freezing.
Indications & Usage
1 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) 1.1 Indication 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 of age is not recommended due to numerically high rates of HPA axis suppression [ see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ]. 1.2 Limitations of Use Clobetasol Propionate Lotion, 0.05%, should not be used on the face, axillae, or groin and should not be used if there is atrophy at the treatment site. Clobetasol Propionate Lotion, 0.05% should not be used in the treatment of rosacea or perioral dermatitis.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Clobetasol Propionate Lotion, 0.05% is for topical use only, and not for ophthalmic, oral or intravaginal use. Clobetasol Propionate Lotion, 0.05%, should be applied to the affected skin areas twice daily and rubbed in gently and completely. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Clobetasol Propionate Lotion, 0.05% contains a topical corticosteroid; therefore treatment should be limited to 2 consecutive weeks for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and up to 2 additional weeks in localized lesions (less than 10% body surface area) of moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment with Clobetasol Propionate Lotion, 0.05%. Unless directed by physician, Clobetasol Propionate Lotion, 0.05% should not be used with occlusive dressings. • 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 (50mL or 1.75 fl. oz.) per week. (2)