CLOBETASOL PROPIONATE lotion

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Akorn

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 to

Proizvod sažetak:

Clobetasol Propionate Lotion, 0.05% is a white liquid, supplied in the following sizes: 2 fl oz/59 mL NDC 50383-978-02 high density polyethylene bottles 4 fl oz/118 mL NDC 50383-978-04 high density polyethylene bottles Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from freezing.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE LOTION
AKORN
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE LOTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CLOBETASOL PROPIONATE LOTION.
CLOBETASOL PROPIONATE LOTION, FOR TOPICAL USE
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)
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Lotion, 0.05% w/w (3) (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 HI-TECH PHARMACAL CO.,
INC. AT 1- 800-
262-9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING