CLOBETASOL PROPIONATE spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol Propionate Topical 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. The total dosage should not exceed 50 g (59 mL or 2 fl. oz.) per week. Do not use more than 26 sprays per application or 52 sprays per day. Treatment should be limited to 4 consecutive weeks. Patients should be instructed to use Clobetasol Propionate Topical 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. Clobetasol Propionate Topical Spray, 0.05% should not be used on the face, axillae, or groin. Clobetasol Propionate Topical Spray, 0.05% should not be used if there is atr

Product summary:

Clobetasol Propionate Topical Spray, 0.05% is a clear, colorless liquid, supplied in a white HDPE bottle with a white polypropylene cap and white LDPE liner in the following sizes: 2 fl oz/59 mL NDC 51672-1371-4 4.25 fl oz/125 mL NDC 51672-1371-8 Storage: Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SPRAY
TARO PHARMACEUTICALS U.S.A., INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL PROPIONATE TOPICAL
SPRAY, 0.05% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CLOBETASOL PROPIONATE
TOPICAL SPRAY, 0.05%.
CLOBETASOL PROPIONATE SPRAY, 0.05%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
Clobetasol Propionate Topical 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)
Clobetasol Propionate Topical Spray, 0.05% should be sprayed directly
onto the affected skin areas twice daily and
rubbed 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)
Clobetasol Propionate Topical Spray, 0.05% contains a super-high
potent topical corticosteroid; therefore treatment
should be limited to 4 weeks.
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 Propionate Topical Spray, 0.05%. (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