CLOBETASOL PROPIONATE spray

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Versapharm Incorporated

INN（国際名）:

CLOBETASOL PROPIONATE

構図:

CLOBETASOL PROPIONATE 0.05 g in 1 mL

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. 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 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 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. Clob

製品概要:

Clobetasol Propionate 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 61748-380-02 4.25 fl oz/125 mL NDC 61748-380-04 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 freeze, refrigerate or store above 30°C. Spray is flammable; avoid heat, flame or smoking when using this product.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SPRAY
VERSAPHARM INCORPORATED
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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:
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DOSAGE AND ADMINISTRATION
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•
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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
de ve lops.(5.1)
Children may be more susceptible to systemic toxicity from use of
topical corticosteroids.(5.1,8.4)
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)
Clobetasol Propionate Spray, 0.05% is flammable, keep away from heat
or flame.(5.5)
ADVERSE REACTIONS
In controlled, clinical trials with Clobetasol Propionate Spray,
0.05%, the most common adverse reactions (incidence > 2%)
were burning, pruritus, nasopharyngitis, upper respiratory tract
infection. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT