Fluocinolone Acetonide Oil

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderate to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area. ( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. Safety and effectiveness in pediatric patients younger than 3 months of age have not been established. 1.3 Limitations of Use Apply the least amount of fluocinolone acetonide topical oil, 0.01% needed to cover the affected areas. As with other corticosteroids, fluocinolone acetonide topical oil, 0.01% should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone acetonide topical oil, 0.01% should not be used on the face, axillae, or groin unless directed by the physician. Application to intertriginous areas should be avoided due to the increased risk of local adverse reactions. [see Adverse Reactions (6) and Use in Specific Populations (8.4) ] . Dosage and administration 2 DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use. The dosing of fluocinolone acetonide topical oil, 0.01% is different for adult and pediatric patients. Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. ( 2 ) Adult patients: Apply to affected areas 3 times daily. ( 2.1 ) Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. ( 2.2 ) 2.1 Adult Patients with Atopic Dermatitis Apply fluocinolone acetonide topical oil, 0.01% as a thin film to the affected areas three times daily. 2.2 Pediatric Patients with Atopic Dermatitis Moisten skin and apply fluocinolone acetonide topical oil, 0.01% as a thin film to the affected areas twice daily for up to four weeks. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (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 , 5.3 , 6.1 ) Children may be more susceptible to systemic toxicity from equivalent doses. ( 5.1 , 8.4 ) 5.1 Hypothalamic-Pituitary-Adrenal Axis Suppression Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing’s syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticosteroids. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, and use of occlusive dressings. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. [See Use in Specific Populations (8.4) ] 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may occur with use of topical corticosteroids and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reaction