Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)
Versapharm Incorporated
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 avoid
Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC 61748-204-04). Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL VERSAPHARM INCORPORATED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% 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 RECENT MAJOR CHANGES Indication and Usage, Pediatric Patients with Atopic Dermatitis (1.2) 11/2007 INDICATIONS AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a corticosteroid indicated for the • • Limitations of Use: • • • DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic, or intravaginal use. (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 • • • • • • ADVERSE REACTIONS The most common adverse reactions (≥ 5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT VERSAPHARM INC. - AN AKORN COMPANY AT 1-800-262- 9010 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 12/2018 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) 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) 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) Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyp Lue koko asiakirja