País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
DESONIDE (UNII: J280872D1O) (DESONIDE - UNII:J280872D1O)
Almirall, LLC
DESONIDE
DESONIDE 0.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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
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.
New Drug Application
VERDESO- DESONIDE AEROSOL, FOAM ALMIRALL, LLC ---------- 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 Leia o documento completo