Lidex-E

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluocinonide topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. For Vanos® cream, safety and efficacy have not been established in children younger than 12 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Vanos® cream in the elderly. However, elderly patients are more likely to have age-related medical problems, which may require caution in patients receiving Vanos® cream.

No information is available on the relationship of age to the effects of fluocinonide topical in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Vanos® cream should not be used in patients with these conditions.

This section provides information on the proper use of a number of products that contain fluocinonide. It may not be specific to Lidex-E. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

If you are using the Vanos® cream:

• Do not use it on the face, groin, or underarms unless directed to do so by your doctor.
• Do not use it for more than 2 weeks unless your doctor tells you otherwise.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.
• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (cream, gel, ointment, or solution):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two to four times per day.
    • Children—Apply to the affected area of the skin two to four times per day.
• For topical dosage form (cream):
  • For atopic dermatitis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin once a day.
    • Children younger than 12 years of age—Use is not recommended.
  • For psoriasis:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin one to two times per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use Lidex-E as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use. Do not wash your hands after use if putting this on your hand.
• Clean affected part before use. Make sure to dry well.
• Put a thin layer on the affected skin and rub in gently.
• Do not use coverings (bandages, dressings, make-up) unless told to do so by the doctor.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Dry skin.
• Burning.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Lidex-E Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Lidex-E Cream is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

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