Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) (NDC # 64980-330-04) is supplied in bottles containing 4 fluid ounces and with 2 shower caps. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL Rising® PHARMACEUTICALS NDC 64980-330-04 Fluocinolone Acetonide Topical Oil, 0.01% (SCALP OIL) FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC, or INTRAVAGINAL USE SHAKE WELL BEFORE USE Net Contents 118.28 mL (4 fl. oz.) Rx only fluocinolone scalp-carton.jpg fluocinolone-container label.jpg
- 16 HOW SUPPLIED / STORAGE AND HANDLING Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) (NDC # 64980-330-04) is supplied in bottles containing 4 fluid ounces and with 2 shower caps. Storage: Keep tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°- 30°C (59°-86°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL Rising® PHARMACEUTICALS NDC 64980-330-04 Fluocinolone Acetonide Topical Oil, 0.01% (SCALP OIL) FOR TOPICAL USE ONLY NOT FOR ORAL, OPHTHALMIC, or INTRAVAGINAL USE SHAKE WELL BEFORE USE Net Contents 118.28 mL (4 fl. oz.) Rx only fluocinolone scalp-carton.jpg fluocinolone-container label.jpg
Overview
Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1– methylethylidene) bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Fluocinolone acetonide topical oil, 0.01% is formulated with 48% refined peanut oil. The bulk refined peanut oil used in fluocinolone acetonide topical oil, 0.01% is heated between 232°C - 246°C (450°F - 475°F) for at least 15 minutes which should provide for adequate decomposition of allergenic proteins. structure.jpg
Indications & Usage
Fluocinolone acetonide topical oil, 0.01% is indicated for the treatment of psoriasis of the scalp in adults. Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults.
Dosage & Administration
Fluocinolone acetonide topical oil, 0.01% is for topical use only. Not for oral, ophthalmic, or intravaginal use. Wet or dampen hair and scalp thoroughly. Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours then wash hair with regular shampoo and rinse thoroughly. Use daily as needed. Discontinue fluocinolone acetonide topical oil, 0.01% when control of disease is achieved within 2 weeks, or contact the healthcare provider if no improvement is seen within 2 weeks. Do not use fluocinolone acetonide topical oil, 0.01% on the face unless directed by the healthcare provider. Do not apply to intertriginous areas due to the increased risk of local adverse reactions [see Adverse Reactions ( 6 )]. Do not apply to the diaper area; diapers or plastic pants may constitute occlusive use. [see Warnings and Precautions ( 5.1 )] Fluocinolone acetonide topical oil, 0.01% is not for oral, ophthalmic, or intravaginal use. ( 2 ) Do not use on face or intertriginous areas. ( 2 ) Apply a thin film of fluocinolone acetonide topical oil, 0.01% on the wet scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. ( 2 )
Warnings & Precautions
Endocrine System Adverse Reactions: o Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome, hyperglycemia, and glucosuria. ( 5.1 ) o Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression. Potent corticosteroids use on large areas, prolonged use or occlusive use, altered skin barrier, liver failure, and young age may increase systemic absorption. Modify use should HPA axis suppression develop. ( 5.1 ) Local Adverse Reactions: 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 , 6.1 ) Ophthalmic Adverse Reactions: May increase the risks of glaucoma and posterior subcapsular cataract. Avoid contact of fluocinolone acetonide topical oil, 0.01% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. ( 5.3 ) 5.1 Endocrine System Adverse Reactions Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Cushing's syndrome, hyperglycemia, and glucosuria can result from systemic absorption of topical corticosteroids. HPA axis suppression and Cushing's syndrome have been reported in patients receiving topical corticosteroids. Conditions which increase systemic absorption include the use of more potent corticosteroids, use over large surface areas, use over prolonged periods, use of occlusive dressings, altered skin barrier, liver failure, and young age. Use of more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure. Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. The ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids. 5.2 Local Adverse Reactions Local adverse reactions may occur with use of topical corticosteroids, including fluocinolone acetonide topical oil, 0.01%, and may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Some local adverse reactions may be irreversible. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria [see Adverse Reactions ( 6.1 )]. 5.3 Ophthalmic Adverse Reactions Use of topical corticosteroids may increase the risks of glaucoma and posterior subcapsular cataract. Glaucoma and cataracts have been reported in postmarketing experience with the use of topical corticosteroid products. Avoid contact of fluocinolone acetonide topical oil, 0.01% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation. 5.4 Allergic Contact Dermatitis Use of topical corticosteroids can cause allergic contact dermatitis. Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.5 Concomitant Skin Infections Use of topical corticosteroids may delay healing or worsen concomitant skin infections. Treat concomitant skin infections with an appropriate antimicrobial agent. If the infection persists unchanged, discontinue fluocinolone acetonide topical oil, 0.01% until the infection has been adequately treated. 5.6 Use in Peanut-Sensitive Individuals Use caution in prescribing fluocinolone acetonide topical oil, 0.01% for peanut-sensitive individuals [see Description ( 11 )]. Should signs of hypersensitivity present (wheal and flare reactions, pruritus, or other manifestations), or should disease exacerbations occur, discontinue fluocinolone acetonide topical oil, 0.01% immediately and institute appropriate therapy.
Contraindications
None. None.
Adverse Reactions
The following serious adverse reactions are discussed in more detail in other sections of the labeling: • Endocrine System Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Local Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.3 )] The most common adverse reactions in pediatric subjects treated for atopic dermatitis (≥5%) were cough (20%), rhinorrhea (13%), pyrexia (10%), telangiectasia (7%), nasopharyngitis (7%), and hypopigmentation (7%). ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying condition, 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. An open-label safety study was conducted in 29 pediatric subjects 3 months to 2 years old to assess the HPA axis by ACTH stimulation testing following use of the formulation of fluocinolone acetonide topical oil, 0.01% twice daily for 4 weeks. Fluocinolone acetonide topical oil, 0.01% is not approved for use in pediatric patients for the treatment of psoriasis of the scalp. The most common adverse reactions were reported in the study: Table 1: Adverse Reactions in ≥2% Pediatric Subjects 3 Months to 2 Years of Age Treated with the Formulation of Fluocinolone Acetonide Topical Oil, 0.01%, N=30* Adverse Reaction n (%) Cough 6 (20) Rhinorrhea 4 (13) Pyrexia 3 (10) Nasopharyngitis 2 (7) Hypopigmentation 2 (7) Abscess 1 (3) Atopic Dermatitis 1 (3) Eczema 1 (3) Hyperpigmentation 1 (3) Molluscum 1 (3) Rash 1 (3) Diarrhea 1 (3) Otitis Media 1 (3) URI 1 (3) Vomiting 1 (3) *Includes one subject who withdrew at Week 2 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Endocrine Disorders: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema
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