FLUOCINOLONE ACETONIDE oil

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Amneal Pharmaceuticals LLC

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 to the increased risk of local adverse reactions [see Adverse Reactions (6) and Use in Specific Populations (8.4)] . None Pregnancy Category C: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide 0.01% topical oil. Therefore, fluocinolone acetonide 0.01% topical oil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide 0.01% topical oil is administered to a nursing woman. Systemic Adverse Reactions in Pediatric Patients HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see Warnings and Precautions (5.1)] . Evaluation in Peanut-Sensitive Pediatric Subjects A clinical study was conducted to assess the safety of fluocinolone acetonide 0.01% topical oil, which contains refined peanut oil, on subjects with known peanut allergies. The study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. Of the 13 subjects, 9 were Radioallergosorbent Test (RAST) positive to peanuts and 4 had no peanut sensitivity (controls). The study evaluated the subjects’ responses to both prick test and patch test utilizing peanut oil NF, fluocinolone acetonide 0.01% topical oil and histamine/saline controls. Subjects were also treated with fluocinolone acetonide topical oil 0.01% twice daily for 7 days. Prick test and patch test results for all 13 patients were negative to fluocinolone acetonide 0.01% topical oil and the refined peanut oil. One of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide 0.01% topical oil. The bulk peanut oil NF, used in fluocinolone acetonide 0.01% topical oil is heated at 475°F for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins [see Description (11)] . Evaluation in Pediatric Subjects 2 to 6 years old Open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. Subjects were treated with fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks. Baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. Morning pre-stimulation cortisol and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. At the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dL; normal: cortisol > 7 mcg/dL) but all had normal responses to 0.25 mg of ACTH stimulation (cortisol > 18 mcg/dL). Evaluation in Pediatric Subjects 3 months to 2 years old An open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the HPA axis by ACTH stimulation testing following use of fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks. All subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. Baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. Morning pre-stimulation and post-ACTH stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. All subjects had normal responses to 0.125 mg of ACTH stimulation (cortisol > 18 mcg/dL).

Dettagli prodotto:

Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is supplied in 4 fluid ounce bottles with a net content of 118.28 mL (NDC 65162-704-86 ). 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].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OIL
AMNEAL PHARMACEUTICALS LLC
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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 ONLYINITIAL U.S. APPROVAL: 1988
INDICATIONS AND USAGE
Fluocinolone Acetonide 0.01% Topical Oil is a corticosteroid indicated
for the (1)
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: (1)
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) (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) (3)
CONTRAINDICATIONS
None (4). (4)
WARNINGS AND PRECAUTIONS
Topical corticosteroids can produce reversible HPA axis suppression,
Cushing's syndrome,
hyperglycemia, and glycosuria. (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 likely with occlusive
use or more potent
corticosteroids (5.2, 5.3, 6.1)
C