Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Rising Pharmaceuticals, Inc.
FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. 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. 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 avo
Fluocinolone Aetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC #64980-331-04). Storage: Store at 25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL RISING PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (BODY OIL) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01%. FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (BODY OIL) FOR TOPICAL USE ONLY INITIAL U.S. APPROVAL: 1988 NDC 64980-331-04 FOR TOPICAL USE ONLY - NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE 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) DOSAGE AND ADMINISTRATION 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) DOSAGE FORMS AND STRENGTHS Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. (3) CONTRAINDICATIONS None (4). 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 Leggi il documento completo