Fluocinonide

LIDEX (fluocinonide) Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

LIDEX (fluocinonide) Cream 0.05% is supplied in

15 g Tube -NDC 99207-511-13
30 g Tube -NDC 99207-511-14
60 g Tube -NDC 99207-511-17
120 g Tube -NDC 99207-511-22

Store at room temperature. Avoid excessive heat, above 40°C (104°F).

Manufactured for: MEDICIS, The Dermatology Company®., Scottsdale, AZ 85258. Effective May 2001.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

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 C26H32F2O7 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 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.

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 VANOS Cream 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

Safety in patients 12 to 17 years of age was similar to that observed in adults.

Postmarking Experience

The following adverse reactions have been identified during post approval use of VANOS Cream:

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.

VANOS®
(VAN-os)
(fluocinonide) Cream 0.1%

Important: For skin use only. Do not get VANOS Cream in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Read the Patient Information that comes with VANOS Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your condition or treatment.

What is VANOS Cream?

VANOS Cream is a prescription corticosteroid medicine used on the skin (topical) to treat adults and children 12 years and older with certain skin conditions that cause red, flaky, and itchy skin.

• You should not use VANOS Cream for longer than 2 weeks in a row.
• You should not use more than 60 grams of VANOS Cream or more than half of the 120 gram tube in 1 week.
• Vanos Cream should not be used:
• if you have skin swelling or redness on the nose of face (rosacea)
• for a scaly or bumpy rash around your mouth (perioral dermatitis)
• on your face, underarms, or groin area

It is not known if VANOS Cream is safe and effective in children under 12 years of age.

What should I tell my doctor before using VANOS Cream?

Before using VANOS Cream, tell your doctor if you:

• have had irritation or other skin reaction to a steroid medicine in the past
• adrenal gland problems
• plan to have surgery
• are pregnant or plan to become pregnant. It is not known if VANOS Cream will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or plan to breastfeed. It is not known if VANOS Cream passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use Vanos Cream.

Tell your doctor about all the medicine you take including prescriptions and non-prescriptions medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a corticosteroid medicine by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist when you get a new medicine.

How should I use VANOS Cream?

• See "What is VANOS Cream?"
• Use VANOS Cream exactly as your doctor tells you.
• This medicine is for use on the skin only. Do not use VANOS Cream in your eyes, mouth or vagina.
• Wash your hands after you use VANOS Cream.
• Do not use VANOS Cream for longer than 2weeks in a row.
• Talk to your doctor if your skin does not get better after 2 weeks of treatment with VANOS Cream.
• Do not bandage or cover the skin treated with VANOS Cream unless your doctor tells you to.

What are the possible side effects with VANOS Cream?

VANOS Cream may cause side effects, including:

• Symptoms of a disorder where the adrenal gland does not make enough of certain hormones (adrenal insufficiency) during treatment or after stopping treatment. Your doctor may do blood tests to check you for adrenal insufficiency while you are using VANOS Cream. Tell your doctor if you have any of these symptoms of adrenal insufficiency:
  • tiredness that worsens and does not go away
  • nausea or vomiting
  • dizziness or fainting
  • muscle weakness
  • irritability and depression
  • loss of appetite
  • weight loss
• Cushing's syndrome, when the body is exposed to too much of the hormone cortisol. Your doctor may do tests to check for this. Symptoms can include:
  • weight gain, especially around your upper back and midsection
  • slow healing of cuts, insect bites and infections
  • tiredness and muscle weakness
  • depression, anxiety and irritability
  • roundness of your face (moon face)
  • new or worsening high blood pressure

The most common side effect of VANOS Cream is burning of your skin treated with VANOS Cream.

Talk to your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with VANOS Cream. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Medicis at 1-800-900-6389.

How should I store VANOS Cream?

• Store VANOS Cream at room temperature, between 59°F to 86°F (15°C to 30°C).
• Keep the tube tightly closed.

Keep VANOS Cream and all medicines out of the reach of children.

General information about VANOS Cream

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use VANOS Cream for a condition for which it was not prescribed. Do not give VANOS Cream to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about VANOS Cream. If you would like more information, talk with your doctor. You can also ask your pharmacist or doctor for information about VANOS Cream that is written for healthcare professionals.

What are the ingredients in VANOS Cream?

Active ingredient: fluocinonide 0.1%

Inactive ingredients: propylene glycol, dimethyl isosorbide, glyceryl stearate (and) PEG-100 stearate, glyceryl monostearate, purified water, carbopol 980, diisopropanolamine, and anhydrous citric acid.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Common side effects include:

• burning
• itching
• irritation
• dryness

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with fluocinonide. Ask your doctor or pharmacist for more information.

You may report side effects to FDA at 1-800-FDA-1088.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinonide topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Your pharmacist can provide more information about fluocinonide topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Mechanism of Action

Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of Fluocinonide Cream in corticosteroid responsive dermatoses is unknown.

Pharmacodynamics

Vasoconstrictor studies performed with 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 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 (ACTH1–24) [see Warnings and Precautions (5.1)].

HPA-axis suppression following application of Fluocinonide Cream, 0.1% (once or twice daily) was also evaluated in 123 pediatric patients from 3 months to <18 years of age with atopic dermatitis (mean BSA range 34.6% – 40.0%). HPA-axis suppression was observed in 4 patients in the twice-daily groups. Follow-up testing 14 days after treatment discontinuation demonstrated a normally responsive HPA axis in all 4 suppressed patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties. May depress the formation, release, and activity of endogenous chemical mediators of inflammation (kinins, histamine, liposomal enzymes, prostaglandins) through the induction of phospholipase A2 inhibitory proteins (lipocortins) and sequential inhibition of the release of arachidonic acid. Fluocinonide is fluorinated corticosteroid considered to be of high potency.

Absorption

Dependent on formulation, amount applied and nature of skin at application site; may be increased with inflammation or occlusion

Metabolism

Hepatic

Excretion

Primarily urine; bile