Generic Name: Fluocinonide

VanosLidex is used for: Treating certain skin disorders. It may also be used for other conditions as determined by your doctor. Lidex is a corticosteroid. It works by reducing the actions of chemicals in the body that cause inflammation. Do NOT use Lidex if: you are allergic to any ingredient in LidexContact your doctor or health care provider right away if any of these apply to you. Before using Lidex: Some medical conditions may interact with Lidex.

Drug Interactions

There may be other drugs that can interact with Lidex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. How to use Lidex: Use Lidex as directed by your doctor. Check the label on the medicine for exact dosing instructions. An extra patient leaflet is available with Lidex. Talk to your pharmacist if you have questions about this information. Wash and dry your hands before using.

Apply a thin film of medicine to the affected area and rub it gently. Do not apply to skin that is broken, irritated, or red. Do not apply to the face, underarms, or groin unless directed by your doctor. If you are using Lidex cream, do not cover the treated skin area with a bandage or other covering unless directed by your doctor. If you are using Lidex lotion, you may cover the treated skin area with a clean cotton gauze bandage. Do not apply to open wounds. If applying near the eyes, avoid getting this medication in your eyes since this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you do get medication in these areas, flush with plenty of water. Use Lidex on a regular schedule to get the most benefit from it. Using Lidex at the same time each day will help you remember to use it. Continue using Lidex until your doctor tells you to stop. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, and flu). Consult your doctor if you have been exposed to an infection or for more details. Do not take it by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina; rinse with water. Do not apply other skin products on the areas you treat with Lidex unless directed by your doctor.

Pharmacokinetics

Absorption:

Cream and ointment—Topical application results in minimal absorption of fluocinonide. Systemic absorption is further decreased when applied under occlusive dressings or plastic wraps.

Lotion—Minimal systemic absorption following topical application.

Metabolism and Excretion:

Metabolized in the liver to inactive metabolites which are excreted in the urine. The onset of Action: Topical—Cream and lotion: 1–2 hours; Ointment: 6–8 hours.Duration of Action: Topical—Up to 24 hours.

Half-life:Serum: 6–8 hours.

Protein Binding >99%.

Fluocinonide cream and ointment USP, 0.05% contain:

The active component fluocinonide in a cream base consists of cetyl alcohol, Cyclomethicone, glycerin, glyceryl monostearate SE, PEG-100 stearate, polysorbate 60, propylene glycol, purified water and sorbitan stearate or in an ointment base consisting of mineral oil and white petrolatum. Inactive ingredients: Fluocinonide cream also contains benzyl alcohol and trolamine. Fluocinonide ointment also contains ceresin wax and lanolin alcohols.

Clinical Pharmacology

Fluocinonide is a high potency synthetic corticosteroid possessing anti-inflammatory, antipruritic and vasoconstrictive properties.

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic following dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on the teratogenic effects of topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Side Effects

The most frequently reported side effects are burning, itching, irritation, and dryness of the skin. These side effects are usually mild and do not require discontinuation of therapy.

Cream and ointment—Fluocinonide cream and ointment USP, 0.05% are white to off-white in color, smooth in texture, and supplied in 15 g tubes.

Lotion—Fluocinonide lotion USP, 0.05% is colorless to a light yellow solution supplied in 60 mL bottles.

Do not take it by mouth. Topical medicine is for use only on the skin. Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina; rinse with water.

Do not apply other skin products on the areas you treat with Lidex unless directed by your doctor.

Dosage and Administration

The usual dose is:

Adults and Children 12 Years of Age and Older—Apply a thin film of cream or ointment to the affected area 2 to 4 times daily depending on the severity of the condition. If an infection develops, appropriate antimicrobial therapy should be instituted. After the condition improves, reduce the frequency of application to once or twice daily as maintenance therapy.

Overdose

There have been no reports of overdose with topical fluocinonide.

For external use only. Avoid contact with the eyes, nose, mouth, rectum, or vagina. If this occurs, rinse thoroughly with water. If irritation develops, discontinue use and institute appropriate therapy as indicated. If pregnant or nursing a baby: Ask a health professional before use.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Storage

Store at 20° to 25°C (68° to 77°F) see USP Controlled Room Temperature. Protect from freezing.