FLUOCINOLONE ACETONIDE oil

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Disponible desde:

Versapharm Incorporated

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
VERSAPHARM INCORPORATED
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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
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
Fluocinolone Acetonide Topical Oil, 0.01% is not for oral, ophthalmic,
or intravaginal use. (2)
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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
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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