FLUOCINONIDE cream

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLUOCINONIDE (UNII: 2W4A77YPAN) (FLUOCINONIDE - UNII:2W4A77YPAN)

Sẵn có từ:

Bryant Ranch Prepack

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4) ]. Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. Fluocinonide cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. None. Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Therefore, fluocinonide

Tóm tắt sản phẩm:

Fluocinonide Cream USP, 0.1% is white to off white cream, free from lumps and foreign matter with no phase separation. Filled in aluminum tube fitted with white color cap and supplied as follows: NDC: 63629-2508-1: 120 grams Cream 0.1% in a TUBE Store at controlled room temperature: 15° to 30°C (59° to 86°F). Keep the tube tightly closed.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLUOCINONIDE- FLUOCINONIDE CREAM
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINONIDE CREAM
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FLUOCINONIDE CREAM.
FLUOCINONIDE CREAM USP, 0.1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the
relief of the inflammatory and pruritic
manifestations of corticosteroid responsive dermatoses in patients 12
years of age or older. (1)
Limitation of Use:
Treatment beyond 2 consecutive weeks is not recommended and the total
dosage should not exceed
60 g per week because of the potential for the drug to suppress the
hypothalamic-pituitary-adrenal
(HPA) axis. (1)
Avoid use on the face, groin, or axillae. (1.2)
Avoid use in perioral dermatitis or rosacea.
DOSAGE AND ADMINISTRATION
For topical use only. Fluocinonide cream is not for ophthalmic, oral,
or intravaginal use. (2)
PSORIASIS: apply a thin layer once or twice daily to the affected skin
areas. (2) ATOPIC DERMATITIS: apply
a thin layer once daily to the affected skin areas. (2) CORTICOSTEROID
RESPONSIVE DERMATOSES, OTHER
THAN PSORIASIS OR ATOPIC DERMATITIS: apply a thin layer once or twice
daily to the affected areas. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.1% (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Fluocinonide cream has been shown to suppress the HPA axis. Systemic
absorption of fluocinonide
cream may produce reversible hypothalamic- pituitary-adrenal (HPA)
axis suppression, Cushing's
syndrome, hyperglycemia 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 (5.3)
Local adverse reactions with topical steroids may include atrophy,
striae, irritation, acneiform eruptions,
hypopigmentation and allergic conta