Topicort

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medication to treat any skin condition that has not been checked by your doctor.

Avoid getting this medication in your eyes. If this does happen, rinse with water. Do not use desoximetasone topical on broken or infected skin. Also avoid using this medication in open wounds.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing desoximetasone topical through your skin, such as:

• blurred vision, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Less serious side effects may include:

• mild skin itching, burning, peeling, or dryness;

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• swollen hair follicles;

• changes in color of treated skin;

• blisters, pimples, or crusting of treated skin; or

• stretch marks.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In the U.S.

• Topicort
• Topicort LP

In Canada

• Desoxi
• Taro-Desoximetasone
• Topicort Mild

Available Dosage Forms:

• Ointment
• Gel/Jelly
• Cream
• Spray

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

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

Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

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.

To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

Do not use this medicine on your face, armpits, or groin area unless your doctor tells you to.

To use the cream, gel, ointment, or spray:

• 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, wrap, or use diapers on the skin being treated unless directed to do so by your doctor.
• Do not use the spray for more than 4 weeks unless your doctor has told you to.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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, and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin two times a day.
    • Children—Use and dose must be determined by your doctor.
• For topical dosage form (spray):
  • For plaque psoriasis:
    • Adults—Apply to the affected area of the skin two times a day.
    • Children—Use and dose must be determined by your doctor.

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

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.

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

The spray bottle is flammable. Do not use it near heat, an open flame, or while smoking. Throw away any unused medicine after 30 days.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Flushing or redness of the skin
• redness, blistering, peeling, or loosening of the skin
• unusually warm skin

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning, itching, and pain in hairy areas, or pus at the root of the hair

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat skin rashes.
• It is used to treat psoriasis.

General

Systemic absorption of topical corticosteroids 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.

Because of the potential for systemic absorption, use of topical corticosteroids 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 corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.

Local Adverse Reactions with Topical Corticosteroids

Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible.

Allergic Contact Dermatitis with Topical Corticosteroids

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing.

Concomitant Skin Infections

Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Topicort® (desoximetasone cream USP) 0.05%, Topicort® (desoximetasone cream USP) 0.25%, or Topicort® (desoximetasone gel USP) 0.05% should be discontinued until the infection has been adequately treated.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions, especially under occlusive dressings.
5. Other corticosteroid-containing products should not be used with Topicort® (desoximetasone cream USP) 0.05%, Topicort® (desoximetasone cream USP) 0.25%, or Topicort® (desoximetasone gel USP) 0.05% without first consulting with the physician.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Desoximetasone was nonmutagenic in the Ames test.

Pregnancy

Pregnancy Category C

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 after dermal application in laboratory animals.

Desoximetasone has been shown to be teratogenic and embryotoxic in mice, rats, and rabbits when given by subcutaneous or dermal routes of administration in doses 3 to 30 times the human dose of Topicort® (desoximetasone cream USP) 0.25% and 15 to 150 times the human dose of Topicort® (desoximetasone cream USP) 0.05%, or Topicort® (desoximetasone gel USP) 0.05%.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, Topicort® (desoximetasone cream USP) 0.05%, Topicort® (desoximetasone cream USP) 0.25%, or Topicort® (desoximetasone gel USP) 0.05%, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

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

0.05%
CREAM

Topicort®

Desoximetasone Cream USP, 0.05%

FOR TOPICAL USE ONLY. NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE.

Keep this and all medications out of the reach of children.

NDC 51672-5205-1
15 g

Rx only

TaroPharma®

Applies to desoximetasone topical: compounding powder, topical cream, topical gel, topical ointment, topical spray

General

The most commonly reported side effects were application site dryness, application site irritation, and application site pruritus.[Ref]

Endocrine

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

Dermatologic

Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria[Ref]

Local

Common (1% to 10%): Application site dryness, application site irritation, application site pruritus
Frequency not reported: Burning, itching[Ref]

Metabolic

Frequency not reported: Hyperglycemia, latent diabetes mellitus[Ref]

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