Vanos Information
Vanos (Fluocinonide) Indications And Usage
Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Vanos (Fluocinonide) Cream 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.
Vanos (Fluocinonide) Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Vanos (Fluocinonide) Dosage And Administration
For topical use only. Vanos (Fluocinonide) Cream is not for ophthalmic, oral, or intravaginal use.
For psoriasis, apply a thin layer of Vanos (Fluocinonide) Cream 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 Vanos (Fluocinonide) Cream 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 []
For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Vanos (Fluocinonide) Cream once or twice daily to the affected areas as directed by a physician.
Vanos (Fluocinonide) Dosage Forms And Strengths
Cream, 0.1%.
Each gram of Vanos (Fluocinonide) Cream contains 1 mg of fluocinonide in a white to off-white cream base.
Vanos (Fluocinonide) Contraindications
Vanos (Fluocinonide) Warnings And Precautions
Systemic absorption of topical corticosteroids, including Vanos (Fluocinonide) Cream, 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 Vanos (Fluocinonide) Cream for longer than 2 weeks may suppress the immune system [].
HPA axis suppression has been observed with Vanos (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 [
Because of the potential for systemic absorption, use of topical corticosteroids, including Vanos (Fluocinonide) Cream, 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 Vanos (Fluocinonide) Cream. Pediatric patients may be more susceptible than adults to systemic toxicity from equivalent doses of Vanos (Fluocinonide) Cream due to their larger skin surface-to-body-mass ratios [].
Vanos (Fluocinonide) Adverse Reactions
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 Vanos (Fluocinonide) Cream for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows:
Safety in patients 12 to 17 years of age was similar to that observed in adults.
The following adverse reactions have been identified during post approval use of Vanos (Fluocinonide) Cream:
Administration Site Conditions:
Immune System Disorders:
Nervous System Disorders:
Skin and Subcutaneous Tissue Disorders:
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.
Vanos (Fluocinonide) Use In Specific Populations
Safety and efficacy of Vanos (Fluocinonide) Cream in pediatric patients younger than 12 years of age have not been established; therefore use in pediatric patients younger than 12 years of age is not recommended.
HPA axis suppression was studied in 4 sequential cohorts of pediatric patients with atopic dermatitis covering at least 20% of the body surface area, treated once daily or twice daily with Vanos (Fluocinonide) Cream. The first cohort of 31 patients (mean 36.3% BSA) 12 to
HPA axis suppression has not been evaluated in patients with psoriasis who are less than 18 years of age.
Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA-axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and absence of response to cosyntropin (ACTH) stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Vanos (Fluocinonide) Overdosage
Topically applied Vanos (Fluocinonide) Cream can be absorbed in sufficient amounts to produce systemic effects [].
Vanos (Fluocinonide) Description
Vanos (Fluocinonide) Cream, 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 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is CHFO and it has a molecular weight of 494.58.
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 Vanos (Fluocinonide) Cream contains 1 mg micronized fluocinonide in a cream base of propylene glycol USP, dimethyl isosorbide, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate NF, purified water USP, carbopol 980 NF, diisopropanolamine, and anhydrous citric acid USP.
Vanos (Fluocinonide) Clinical Pharmacology
Vasoconstrictor studies performed with Vanos (Fluocinonide) Cream in healthy subjects indicate that it is in the super-high range of potency as compared with other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
Application of Vanos (Fluocinonide) Cream twice daily for 14 days in 18 adult subjects with plaque-type psoriasis (10–50% BSA, mean 19.6% BSA) and 31 adult subjects (17 treated once daily; 14 treated twice daily) with atopic dermatitis (2–10% BSA, mean 5% BSA) showed demonstrable HPA-axis suppression in 2 subjects with psoriasis (with 12% and 25% BSA) and 1 subject with atopic dermatitis (treated once daily, 4% BSA) where the criterion for HPA-axis suppression is a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (ACTH) [].
HPA-axis suppression following application of Vanos (Fluocinonide) Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to
Vanos (Fluocinonide) Clinical Studies
Two adequate and well-controlled efficacy and safety studies of Vanos (Fluocinonide) Cream have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with Vanos (Fluocinonide) Cream for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2.
No efficacy studies have been conducted to compare Vanos (Fluocinonide) Cream, 0.1% with any other topical corticosteroid product, including fluocinonide cream 0.05%.
Vanos (Fluocinonide) How Supplied/storage And Handling
Vanos (Fluocinonide) Cream is white to off-white in color and is supplied in tubes as follows:
Vanos (Fluocinonide) Patient Counseling Information
Patients using Vanos (Fluocinonide) Cream should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects:
Vanos (Fluocinonide)
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