FLUOCINOLONE ACETONIDE- fluocinolone acetonide_oil

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Topical corticosteroids can be absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may increase percutaneous absorption. The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids may be necessary due to the fact that circulating levels are often below the level of detection. Once absorbed through the skin, topical corticosteroids are metabolized, primarily in the liver, and are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile. Fluocinolone Acetonide 0. 01% Topical Oil is in the low to medium range of potency as compared with other topical corticosteroids in vasoconstrictor studies.

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. 3 Do not use in the diaper area. 3 Do not use on the face, axillae, or groin. 4 Fluocinolone Acetonide 0. 01% Topical Oil (Body Oil) is indicated for the topical treatment of atopic dermatitis in adult patients. 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. 01% Topical Oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. 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) Use in Specific Populations (8.

Fluocinolone Acetonide 0. 01% Topical Oil (Body Oil) is not for oral, ophthalmic, or intravaginal use. The dosing of Fluocinolone Acetonide 0. 01% Topical Oil (Body Oil) is different for adult and pediatric patients. 01% Topical Oil is not for oral, ophthalmic, or intravaginal use. ( 2 Adult patients: Apply to affected areas 3 times daily. 1 Pediatric patients: Moisten skin and apply to affected areas twice daily for up to 4 weeks. 2 Apply Fluocinolone Acetonide 0. 01% Topical Oil as a thin film to the affected areas three times daily Moisten skin and apply Fluocinolone Acetonide 0. 01% Topical Oil as a thin film to the affected areas twice daily for up to four weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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 Seton Pharmaceuticals at 1-800-510-3401 or FDA at 1-800-FDA-1088 or www. gov/medwatch. An open-label study was conducted in 58 children with moderate to severe atopic dermatitis (2 to 12 years old) to evaluate the safety of Fluocinolone Acetonide 0. 01% Topical Oil when applied to the face twice daily for 4 weeks. The following adverse reactions were reported: Incidence of Adverse Reactions (%), N=58 Adverse Reaction (AR) The number of individual adverse reactions reported does not necessarily reflect the number of individual subjects, since one subject could have multiple reporting of an adverse reaction. # of subjects (%) Day 14 Day 28 End of Treatment Day 56 Four Weeks Post Treatment Any AE 15 (26) 6 (10) 7 (12) 7 (12) Telangiectasia 5 (9) 3 (5) 4 (7) 2 (4) Erythema 3 (5) 3 (5) Itching 3 (5) 3 (5) Irritation 3 (5) 3 (5) Burning 3 (5) 3 (5) Hypopigmentation 2 (4) 2 (4) Shiny skin 1 (2) 1 (2) Secondary atopic dermatitis 1 (2) 1 (2) Papules and pustules 1 (2) 1 (2) Keratosis pilaris 1 (2) 1 (2) Folliculitis 1 (2) 1 (2) Facial herpes simplex 1 (2) 1 (2) Acneiform eruption 1 (2) 1 (2) Ear infection 1 (2) 1 (2) An open-label safety study was conducted in 29 children to assess the HPA axis by ACTH stimulation testing following use of Fluocinolone Acetonide 0. 01% Topical Oil twice daily for 4 weeks. The following adverse reactions were reported in the study [See Use in Specific Populations (8. 4) Adverse Reactions (%), N=30 Includes one subject who withdrew at Week 2 Adverse Reaction # of subjects (%) Diarrhea 1 (3) Vomiting 1 (3) Pyrexia 3 (10) Abscess 1 (3) Molluscum 1 (3) Nasopharyngitis 2 (7) URI 1 (3) Otitis media 1 (3) Cough 6 (20) Rhinorrhea 4 (13) Atopic dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Hypopigmentation 2 (7) Rash 1 (3).

None None ( 4.

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. 1 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. 2 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 0. 01% Topical Oil 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 use. 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) 8. 3 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. 6 µg/dL; normal: cortisol > 7µg/dL) but all had normal responses to 0. 25 mg of ACTH stimulation (cortisol > 18 µg/dL). 4 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. 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 µg/dL).

OVERDOSAGE
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects, including under conditions of normal use. [See Warnings and Precautions (5.1) Use in Specific Populations (8.4)
NONCLINICAL TOXICOLOGY
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of Fluocinolone Acetonide 0.01% Topical Oil. Studies have not been performed to evaluate the mutagenic potential of fluocinolone acetonide, the active ingredient in Fluocinolone Acetonide 0.01% Topical Oil. Some corticosteroids have been found to be genotoxic in various genotoxicity tests (i.e. the in vitro in vivo in vitro

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