FLUOCINONIDE- fluocinonide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

FLUOCINONIDE

Composition:

FLUOCINONIDE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 USP, 0.1% 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 USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae. None. There are no adequate and well-controlled studies in pregnant women. Therefore, Fluocinonide Cream USP, 0.1% sh

Product summary:

Fluocinonide Cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g (NDC 45802-151-94) 60 g (NDC 45802-151-96) 120 g (NDC 45802-151-53) Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINONIDE- FLUOCINONIDE CREAM
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINONIDE CREAM USP, 0.1% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOCINONIDE CREAM
USP, 0.1%.
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: (1)
• 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)
• Avoid use in perioral dermatitis or rosacea. (1)
DOSAGE AND ADMINISTRATION
For topical use only. Fluocinonide Cream USP, 0.1% 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: (2)
apply a thin layer once or twice daily to the affected areas. (2)
DOSAGE FORMS AND STRENGTHS
Cream, 0.1% (3) (3)
CONTRAINDICATIONS
None (4) (4)
WARNINGS AND PRECAUTIONS
• Fluocinonide Cream USP, 0.1% has been shown to suppress the HPA
axis. Systemic absorption of Fluocinonide Cream
USP, 0.1% may produce reversible hypothalamic-pituitary-adrenal (HPA)
axis suppression, Cushing’s syndrome,
hyperglycemia and unmask latent diabetes (5)
• Systemic absorption may require evaluation for HPA axis
suppression (5)
• Modify use should HPA axis suppression develop (5)
• Potent corticosteroids, use on large areas, prolonged use or
occlusive use may increase systemic absorption (5)
• Local adverse reactions with topical steroids may inc