CLOBETASOL PROPIONATE lotion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Tilgjengelig fra:

Paddock Laboratories, LLC

INN (International Name):

CLOBETASOL PROPIONATE

Sammensetning:

CLOBETASOL PROPIONATE 0.5 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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.

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE LOTION
PADDOCK LABORATORIES, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE LOTION, 0.05% SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLOBETASOL
PROPIONATE LOTION, 0.05%.
CLOBETASOL PROPIONATE LOTION, 0.05%, FOR TOPICAL USE ONLY
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). (1)
Limitations of Use: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Lotion, 0.05%. (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)
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. (5.2) (5)
ADVERSE REACTIONS
The most common adverse reactions (incidence > 1%) are skin atrophy,
telangiectasia, discomfort skin and skin dry (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PERRIGO, MINNEAPOLIS,
MN 55427 1-866-634-9120 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MED