FLUOCINOLONE ACETONIDE oil

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinolone Acetonide 0.01% Topical Oil is indicated for the topical treatment of atopic dermatitis in adult patients. Fluocinolone Acetonide 0.01% Topical Oil 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 0.01% Topical Oil needed to cover the affected areas. As with other corticosteroids, Fluocinolone Acetonide 0.01% Topical Oil should be discontinued when control of disease is achieved. Contact the physician if no improvement is seen within 2 weeks. Fluocinolone Acetonide 0.01% Topical Oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. Fluocinolone Acetonide 0.01% Topical Oil should not be used on the face, axillae, or groin unless directed by the physician.  Application to intertriginous areas should be avoided due

Product summary:

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is supplied in 4 fluid ounce bottles with a net content of 118.28 mL ( NDC 42291-285-04 ). Storage: Store upright at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AVKARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL
(BODY OIL)
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINOLONE ACETONIDE 0.01%
TOPICAL OIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR FLUOCINOLONE ACETONIDE
0.01% TOPICAL OIL.
FLUOCINOLONE ACETONIDE 0.01% TOPICAL OIL, (BODY OIL)
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 0.01% Topical Oil 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 0.01% topical oil 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 0.01% Topical Oil (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 aller