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:

Seton Pharmaceuticals

INN (International Name):

fluocinolone acetonide

Composition:

fluocinolone acetonide 0.11 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is indicated for the topical treatment of atopic dermatitis in adult patients. Fluocinolone Acetonide 0.01% Topical Oil (Body 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

Product summary:

Fluocinolone Acetonide 0.01% Topical Oil is supplied in bottles containing 4 fluid ounces. It is labeled as Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) (NDC # 13925-506-04 ). Storage: Store at 25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
SETON PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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)
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 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 allergic
contact dermatitis and may be more