Lidex

Fluocinonide is a topical medicine used to treat psoriasis, eczema, dermatitis, and other skin conditions.

It's sold under the brand name Vanos.

Fluocinonide is a steroid. It works by preventing the release of certain substances in the body that cause inflammation.

The Food and Drug Administration (FDA) approved this prescription medicine in 1971. It's manufactured by various pharmaceutical companies.

Fluocinonide Warnings

Before using fluocinonide, tell your doctor if you have, or have ever had:

• Diabetes
• A skin infection
• Rosacea, perioral dermatitis, or another skin condition
• An immune disorder
• Circulation problems
• Glaucoma or cataracts (eye conditions)
• Cushing's syndrome (an adrenal gland disorder)
• A recent vaccination
• Measles
• Tuberculosis (TB)
• Chickenpox or shingles
• Intracranial hypertension (increased pressure in the head)
• Allergies to medicines

Tell your doctor if your condition doesn't improve, or if it worsens, after two weeks of treatment with fluocinonide.

This medicine should only be used for two weeks at a time.

Using too much fluocinonide — or using this medicine for a long period of time — may increase your risk of developing adrenal gland problems.

Tell your doctor right away if you experience any of the following symptoms:

• Blurred vision
• Dizziness or fainting
• Fast or irregular heartbeat
• Irritability, depression, or anxiety
• Unusual tiredness or weakness
• Increased thirst or urination
• Muscle weakness
• Unusual weight gain
• Facial swelling
• New or worsening high blood pressure
• Loss of appetite or weight loss

If you have diabetes, fluocinonide may affect your blood sugar levels. Be sure to monitor your condition carefully.

Let your healthcare provider know you're using fluocinonide before having any type of medical or dental procedure.

Talk to your doctor before receiving any vaccinations while using this medicine.

Steroids can affect growth in some children and teens. Talk to your doctor if this is a concern.

Don't use this medicine on a child under age 12 without consulting with a doctor.

Pregnancy and Fluocinonide

It's not known whether this medicine could harm an unborn baby if taken during pregnancy.

Tell your doctor if you become pregnant, or might become pregnant, while using fluocinonide.

It's also unknown whether fluocinonide passes into breast milk. Don't breastfeed a baby while using this medicine.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

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 Lidex. Ask your doctor or pharmacist for more information.

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

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Skin irritation.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

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

IN-5069/S

Applies to fluocinonide topical: compounding powder, topical cream, topical gel, topical ointment, topical solution

General

The most commonly reported side effects were burning, itching, irritation, and dryness.

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Local

Common (1% to 10%): Application site burning
Frequency not reported: Itching, dryness
Postmarketing reports: Discoloration, erythema, pruritus, swelling, pain, condition aggravated[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Intracranial hypertension (including bulging fontanelles, bilateral papilledema)
Postmarketing reports: Dizziness[Ref]

Dermatologic

Frequency not reported: Irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
Postmarketing reports: Acne, dry skin, rash, skin exfoliation, skin tightness[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Respiratory

Common (1% to 10%) Nasopharyngitis, nasal congestion[Ref]

Some side effects of Lidex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.