FLUOCINOLONE ACETONIDE oil

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Padagis Israel Pharmaceuticals Ltd

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 avoide

Tuoteyhteenveto:

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC 45802-887 -26). Storage: Store at 25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
PADAGIS ISRAEL PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINOLONE
ACETONIDE TOPICAL OIL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FLUOCINOLONE ACETONIDE TOPICAL OIL.
FLUOCINOLONE ACETONIDE TOPICAL OIL, 0.01% (BODY OIL)
FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1988
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%).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at
1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 10/2022
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,
hyperglycemia, and glucosuria. (5.1)
Systemic absorption may require evaluation for
hypothalamic-pituitary-adrenal (HPA) axis
suppression. (