Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinonide Cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g (NDC 45802- 151 -94) Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.; Fluocinol Pak TM Packaged in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Rev. 38106 Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING Fluocinonide Cream USP, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g (NDC 45802- 151 -94) Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.
- Fluocinol Pak TM Packaged in the USA by: PureTek Corporation Panorama City, CA 91402 For questions or information call toll-free: 877-921-7873 Rev. 38106 Carton
Overview
Fluocinonide Cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6α, 9-Difluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione, cyclic 16, 17-acetal with acetone, 21-acetate. Its chemical formula is C 26 H 32 F 2 O 7 and it has a molecular weight of 494.52. It has the following chemical structure: Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream USP, 0.1% contains 1 mg fluocinonide in a cream base of carbopol 980, citric acid, diisopropanolamine, glycerin, glyceryl monostearate, glyceryl stearate, isostearic acid, PEG-100 stearate, polyethylene glycol monomethyl ether, propylene glycol, and water. Chemical Structure
Indications & Usage
Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. (1) Avoid use on the face, groin, or axillae. (1.2) Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ]. 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Dosage & Administration
For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [ see Clinical Studies (14) ]. For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream USP, 0.1% once or twice daily to the affected areas as directed by a physician. For topical use only. Fluocinonide Cream USP, 0.1% is not for ophthalmic, oral, or intravaginal use. Psoriasis: apply a thin layer once or twice daily to the affected skin areas. Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas.
Warnings & Precautions
Fluocinonide Cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of Fluocinonide Cream USP, 0.1% may produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, hyperglycemia and unmask latent diabetes (5.1) Systemic absorption may require evaluation for 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 (5.3) Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids (5.3) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4) 5.1 Effect on Endocrine System Systemic absorption of topical corticosteroids, including Fluocinonide Cream USP, 0.1%, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In addition, the use of Fluocinonide Cream USP, 0.1% for longer than 2 weeks may suppress the immune system [ see Nonclinical Toxicology (13.1) ]. HPA axis suppression has been observed with fluocinonide cream, 0.1%, applied once or twice daily in 2 out of 18 adult patients with plaque-type psoriasis, 1 out of 31 adult patients with atopic dermatitis and 4 out of 123 pediatric patients with atopic dermatitis [ see Use in Specific Population (8.4) and Clinical Pharmacology (12.2) ]. Because of the potential for systemic absorption, use of topical corticosteroids, including Fluocinonide Cream USP, 0.1%, may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An 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 gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic absorption of topical corticosteroids. Studies conducted in pediatric patients demonstrated reversible HPA axis suppression after use of fluocinonide cream, 0.1%. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of fluocinonide cream, 0.1% due to their larger skin surface-to-body-mass ratios [ See Use in Specific Populations (8.4) ]. 5.2 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasis, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.3 Concomitant Skin Infections If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Fluocinonide Cream USP, 0.1% should be discontinued until the infection has been adequately controlled. 5.4 Allergic Contact Dermatitis If irritation develops, Fluocinonide Cream USP, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
Contraindications
None. None
Adverse Reactions
The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion. To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream, 0.1% for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Adverse Reaction Fluocinonide Cream once daily (n=216) Fluocinonide Cream twice daily (n=227) Vehicle Cream once or twice daily (n=211) Headache 8 (3.7%) 9 (4.0%) 6 (2.8%) Application Site Burning 5 (2.3%) 4 (1.8%) 14 (6.6%) Nasopharyngitis 2 (0.9%) 3 (1.3%) 3 (1.4%) Nasal Congestion 3 (1.4%) 1 (0.4%) 0 Safety in patients 12 to 17 years of age was similar to that observed in adults. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream, 0.1%: Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated. Immune System Disorders: hypersensitivity. Nervous System Disorders: headache and dizziness. Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation and skin tightness. Because these 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.
Storage & Handling
Store at controlled room temperature: 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Keep the tube tightly closed.
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