VERDESO- desonide aerosol, foam

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

DESONIDE (UNII: J280872D1O) (DESONIDE - UNII:J280872D1O)

Предлага се от:

Almirall, LLC

INN (Международно Name):

DESONIDE

Композиция:

DESONIDE 0.5 mg in 1 g

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

VERDESO® (desonide) Foam, 0.05% is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Patients should be instructed to use VERDESO Foam for the minimum amount of time necessary to achieve the desired results because of the potential for VERDESO Foam to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Treatment should not exceed 4 consecutive weeks. None. Risk Summary There are no available data on VERDESO Foam use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, topical administration of a desonide cream, 0.05% formulation during organogenesis caused malformations characteristic of corticosteroids in rats and in rabbits (see Data) . The available data do not allow the calculation of relevant comparisons between the systemic exposure of desonide observed in animal studies to the systemic exposure that would be expected in humans aft

Каталог на резюме:

VERDESO Foam is a white to off-white aerosol foam supplied in 100-g (NDC 16110-111-00) aluminum cans. Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F). WARNING: FLAMMABLE. AVOID FIRE, FLAME, OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Contents under pressure. Do not puncture or incinerate. Do not expose containers to heat, and/or store at temperatures above 120°F (49°C). Avoid contact with eyes or other mucous membranes. Keep out of reach of children.

Статус Оторизация:

New Drug Application

Данни за продукта

VERDESO- DESONIDE AEROSOL, FOAM
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VERDESO FOAM SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VERDESO FOAM.
VERDESO (DESONIDE) FOAM, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1972
INDICATIONS AND USAGE
VERDESO Foam is a corticosteroid indicated for the topical treatment
of mild to moderate atopic
dermatitis in patients 3 months of age and older. (1)
DOSAGE AND ADMINISTRATION
VERDESO Foam should be applied to the affected area(s) twice daily.
(2)
Discontinue therapy when control has been achieved. (2)
If no improvement is seen within 4 weeks, reassess diagnosis. (2)
Unless directed by a physician, do not use with occlusive dressings.
(2)
VERDESO Foam is not for oral, ophthalmic, or intravaginal use. (2)
The safety and efficacy of VERDESO Foam has not been established
beyond 4 weeks of use. (2)
DOSAGE FORMS AND STRENGTHS
Foam, 0.05% (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
VERDESO Foam has been shown to produce reversible HPA axis
suppression. (5.1, 8.4, 14)
Systemic effects of topical corticosteroids may also include
manifestations of Cushing's syndrome,
hyperglycemia, facial swelling, glycosuria, withdrawal syndrome, and
growth retardation in children. (5.1)
Because of the potential for systemic absorption, use of topical
corticosteroids may require that
patients be periodically evaluated for HPA axis suppression. (5.1,
5.5)
Modify use should HPA axis suppression develop. (5.1)
Potent corticosteroids, use on large areas, prolonged use, or
occlusive use may increase systemic
absorption. (5.1)
Pediatric patients may be more susceptible to systemic toxicity. (5.1,
8.4, 12.2)
Concomitant therapy with topical corticosteroids should be used with
caution because a cumulative
effect may occur. (5.1)
Discontinue use if irritation develops. (5.2)
Topical corticosteroids may increase the risk of cataracts and
glaucoma. If visual symptoms occur,
consider referral to an opht