Fluocinonide

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.

1.1Indication

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 ) ].

1.2Limitation of Use

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 ( 4 ) None.

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 contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids ( 5.3 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids ( 5.1 , 8.4 )