Desoximetasone (Topical application)

Desoximetasone (Topical application) is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. Desoximetasone topical spray is used to treat plaque psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits for any problems or side effects that may be caused by this medicine.

If your symptoms do not improve within a few days, or if they get worse, check with your doctor.

After applying this medicine to your child's skin, watch the child closely to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

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 for patients who use large amounts for a long time. Talk to your doctor if you have blurred vision, dizziness or fainting, fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Desoximetasone spray may cause serious skin reactions, which may happen if you cover the treated skin area or use the medicine for a long time. Check with your doctor right away if you or your child have thinning of the skin with easy bruising, reddish purple lines on the arms, face, legs, trunk, or groin areas, acne or pimples, darkening or lightening of skin color, blistering, burning, crusting, dryness, flaking of the skin, or itching, scaling, severe redness, soreness, or swelling of the skin.

Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Do not use desoximetasone together with other topical corticosteroid-containing medicines, including betamethasone, hydrocortisone, triamcinolone, Cortaid®, or Lotrisone®. Using these medicines together may cause serious unwanted effects.

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

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important things to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems that would limit the use of desoximetasone cream, gel, and ointment in children aged 10 and older, or desoximetasone spray in children. However, due to the potential toxicity of this medicine, it should be used with caution. Children and teenagers using this medicine should have regular check-ups with their doctor, as desoximetasone topical can be absorbed through the skin and may affect growth or cause other unwanted effects. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems that would limit the use of desoximetasone topical spray in elderly patients. However, older adults may have age-related liver, kidney, or heart problems that could require caution and dosage adjustments when using desoximetasone topical spray.

No information is available about how age affects the effects of desoximetasone topical in older patients.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cushing's syndrome (a disorder of the adrenal glands) or
• Diabetes or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May worsen these conditions.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site or
• Liver failure—The risk of side effects may be increased.

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:

Rare

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

Incidence not known

• Blindness
• Blistering, burning, crusting, dryness, or flaking of the skin
• Blurred vision
• Decreased vision
• Eye pain
• Headache
• Irritation
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Nausea or vomiting
• Redness and scaling around the mouth
• Tearing
• Thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g., 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:

Rare

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

Incidence not known

• 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.

In the U.S.

• Topicort
• Topicort LP

In Canada

• Desoxi
• Taro-Desoximetasone
• Topicort Mild

Available Dosage Forms:

• Ointment
• Cream
• Gel/Jelly
• Spray

Therapeutic Class: Corticosteroid, Strong

Pharmacologic Class: Adrenal Glucocorticoid

It is very important that you 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 should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only on the skin. Do not get it in your eyes, nose, mouth, or groin. Do not use the spray on your face or armpits unless your doctor tells you to. 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 skin conditions 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, including severe burns.

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.

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 2 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 2 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.