CLOBETASOL PROPIONATE spray

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Lupin Pharmaceuticals, Inc.

Az alkalmazás módja:

TOPICAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Clobetasol Propionate Spray, 0.05% is a clear, colorless liquid packed in white HDPE bottle with a white polypropylene cap and clean peel induction heat seal liner, available in the following sizes: 2 fl oz/59 mL NDC 68180-551-11 4.25 fl oz/125 mL NDC 68180-551-22 Storage: Keep tightly closed. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Do not freeze, refrigerate or store above 86°F (30°C). Spray is flammable; avoid heat, flame or smoking when using this product. Keep out of reach of children.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SPRAY
LUPIN PHARMACEUTICALS, INC.
----------
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 propionate spray, 0.05%. (2)
Do not use for more than 4 weeks (2)
DOSAGE FORMS AND STRENGTHS
Spray, 0.05% w/w (3)
CONTRAINDICATIONS
None .
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 may increase the risk