FLUOCINOLONE ACETONIDE OIL- fluocinolone acetonide oil

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Rising Pharmaceuticals, Inc.

INN (International Adı):

FLUOCINOLONE ACETONIDE

Kompozisyon:

FLUOCINOLONE ACETONIDE 0.11 mg in 1 mL

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 avo

Ürün özeti:

Fluocinolone Aetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces. It is labeled as Body Oil (NDC #64980-331-04). Storage: Store at 25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUOCINOLONE ACETONIDE OIL- FLUOCINOLONE ACETONIDE OIL
RISING PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOCINOLONE ACETONIDE
TOPICAL OIL, 0.01% (BODY OIL) 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
NDC 64980-331-04
FOR TOPICAL USE ONLY - NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE
INDICATIONS AND USAGE
Fluocinolone Acetonide Topical Oil, 0.01% 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 Topical Oil, 0.01% 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 Topical Oil, 0.01% (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