DESONIDE gel

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

KMM Pharmaceuticals, LLC

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Desonide Gel, 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 Desonide Gel, 0.05% for the minimum amount of time as necessary to achieve the desired results because of the potential for Desonide Gel, 0.05% to suppress the hypothalamicpituitary-adrenal (HPA) axis [see Warnings and Precautions ( 5.1)]. Treatment should not exceed 4 consecutive weeks [see Dosage and Administration ( 2)]. Desonide Gel, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Desonide Gel, 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some

제품 요약:

Desonide Gel, 0.05% is a translucent to opaque gel supplied in 60g tubes in cartons containing 1x 60g tube (NDC 52187-556-60). Storage: Store at controlled room temperature: 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Keep out of reach of children.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DESONIDE- DESONIDE GEL
KMM PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESONIDE GEL, 0.05%
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DESONIDE
GEL, 0.05%.
DESONIDE GEL, 0.05% FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1972
INDICATIONS AND USAGE
Desonide Gel, 0.05% 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
• Apply as a thin layer to the affected areas two times daily and
rub in gently. ( 2)
• Therapy should be discontinued when control is achieved. ( 2)
• If no improvement is seen within 4 weeks, reassessment of
diagnosis may be necessary. ( 2)
• Should not be used with occlusive dressings. ( 2)
• Treatment beyond 4 consecutive weeks is not recommended. ( 2)
• For topical use only. Not for oral, ophthalmic, or intravaginal
use. ( 2)
DOSAGE FORMS AND STRENGTHS
Gel, 0.05%; (0.5mg/g) desonide in a translucent to opaque gel (3)
CONTRAINDICATIONS
History of hypersensitivity to any of the components of the
preparation. (4)
WARNINGS AND PRECAUTIONS
• Topical corticosteroids can produce reversible hypothalamic
pituitary adrenal (HPA) axis suppression,
Cushing’s syndrome and unmask latent diabetes. ( 5.1)
• Systemic absorption may require evaluation for HPA axis
suppression. ( 5.1)
• 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)
• Local adverse reactions may include atrophy, striae, irritation,
acneiform eruptions, hypopigmentation,
and allergic contact dermatitis and may be more likely with occlusive
use or more potent corticosteroids. (
5.2, 5.4, 6)
• Children may be more susceptible to systemic toxicity when treated
with topical corticosteroids. ( 5.1,
8.4)
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 1%) are headache and