CLOBETASOL PROPIONATE spray

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Zydus Pharmaceuticals USA Inc.

Designació comuna internacional (DCI):

CLOBETASOL PROPIONATE

Composición:

CLOBETASOL PROPIONATE 0.05 g in 1 mL

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructed to use clobetasol propionate spray, 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 because safety has not been established and because numerically high rates of HPA axis suppression were seen with other clobetasol propionate topical formulations. [see Use in Specific Populations (8.4)] Clobetasol propionate spray, 0.05% should not be used on the face, axillae, or groin.  Clobetasol propionate spray, 0.05% should not be used if there is atrophy at the treatment site. Clobetasol propionate spray, 0.05% should not be used in the treatment of rosacea or perioral dermatitis. None. Risk Summary There are no available data on

Resumen del producto:

Clobetasol propionate spray, 0.05% is a clear, colorless liquid, filled in white HDPE bottle fitted with white polypropylene cap and are supplied as follows: 2 fl oz/59 mL NDC 68382-998-01 4.25 fl oz/125 mL NDC 68382-998-02 Storage Keep tightly closed. Store under controlled room temperature conditions 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or store above 86°F (30°C). Spray is flammable; avoid heat, flame or smoking when using this product.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SPRAY
ZYDUS PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOBETASOL
PROPIONATE SPRAY.
CLOBETASOL PROPIONATE SPRAY, FOR TOPICAL USE.
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol propionate spray, 0.05% is a corticosteroid indicated for
the topical treatment of moderate to
severe plaque psoriasis affecting up to 20% body surface area (BSA) 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. (1.2)
Spray directly onto the affected skin areas twice daily and rub in
gently. (2)
The total dosage should not exceed 50 g (59 mL or 2 fluid ounces) per
week. Do not use more than 26
sprays per application or 52 sprays per day. (2)
Treatment beyond 2 weeks should be limited to localized lesions of
moderate to severe plaque
psoriasis that have not sufficiently improved after the initial 2
weeks of treatment with clobetasol
propionatespray, 0.05%. (2)
Do not use for more than 4 weeks (2)
DOSAGE FORMS AND STRENGTHS
Spray, 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 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)
Clobetasol propionate spray, 0.05% may inc