CLOBETASOL PROPIONATE aerosol, foam

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Aleor Dermaceuticals Limited

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older. None. Risk Summary There are no available data on clobetasol propionate foam use in pregnant women to inform of a drug-associated risk for adverse developmental outcomes. Published data report a significantly increased risk of low birthweight with the use of greater than 300 grams of potent or very potent topical corticosteroid during a pregnancy. Advise pregnant women of the potential risk to a fetus and to use clobetasol propionate foam on the smallest area of skin and for the shortest duration possible (see Data). In animal reproduction studies, increased malformations, such as cleft palate and skeletal abnormalities, were observed after subcutaneous administration of clobetasol propionate to pregnant mice and rabbits. No comparison of anima

Prehľad produktov:

Clobetasol propionate foam, 0.05% contains 0.5 mg of clobetasol propionate, USP per gram. The white to off white foam is available as follows: 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]. FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION . Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C). Keep out of reach of children.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE AEROSOL, FOAM
ALEOR DERMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLOBETASOL
PROPIONATE FOAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR CLOBETASOL
PROPIONATE FOAM
CLOBETASOL PROPIONATE FOAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL:1985
INDICATIONS AND USAGE
Clobetasol propionate foam is a corticosteroid indicated for treatment
of moderate to severe plaque
psoriasis of the scalp and mild to moderate plaque psoriasis of
non-scalp regions of the body excluding
the face and intertriginous areas in patients 12 years and older. (1)
DOSAGE AND ADMINISTRATION
Apply a thin layer to the affected skin areas twice daily. (2)
Limit treatment to 2 consecutive weeks. (2)
Do not use more than 50 grams per week or more than 21 capfuls per
week. (2)
Discontinue therapy when control is achieved. (2)
Do not use with occlusive dressings unless directed by physician. (2)
Avoid use on the face, groin, or axillae, or if skin atrophy is
present at the treatment site. (2)
DOSAGE FORMS AND STRENGTHS
Foam, 0.05% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Clobetasol propionate foam can cause reversible HPA axis suppression
with the potential for
glucocorticosteroid insufficiency during and after withdrawal of
treatment. Risk factors include the use of
high-potency topical corticosteroid, use over a large surface area or
to areas under occlusion,
prolonged use, altered skin barrier, liver failure, and use in
pediatric patients. Modify use should HPA
axis suppression develop. (5.1, 8.4)
Clobetasol propionate foam may increase the risk of cataract and
glaucoma. If visual symptoms occur,
consider referral to an ophthalmologist. (5.2)
Clobetasol propionate foam is flammable. Avoid fire, flame, or smoking
during and immediately
following application. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (≥ 4%) are application site burning
and other application site reactions.
(6.1)