Pronunciation:

DES-oh-nide

Brand Names:

• Desonate
• Desowen
• LoKara
• Tridesilon
• Verdeso
• Pms-Desonide

Dosage Forms:

• Gel/Jelly
• Ointment
• Cream
• Lotion
• Foam

Classifications:

Therapeutic—

Corticosteroid, Strong

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Desonide topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (eg, atopic dermatitis). This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of desonide topical foam or gel in children 3 months of age and older. 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 the foam and gel forms, safety and efficacy have not been established in infants younger than 3 months of age. The safety and efficacy of desonide topical cream, lotion, and ointment have not been established in children and use is not recommended.

Older adults—

No information is available on the relationship of age to the effects of desonide topical cream, ointment, or lotion in geriatric patients.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desonide topical foam or gel in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving desonide topical foam or gel.

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.

Other 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.

Other interactions—

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
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head) or
• Posterior subcapsular cataracts—Use with caution. May make these conditions worse.

• Infection of the skin at or near the application site or
• Large sores, broken skin, or severe skin injury at the application site—Use with caution. May increase risk for more side effects.

• Skin infection (eg, bacteria, fungi, virus)—Must be treated first before using this medicine.

Proper Use of This Medicine:

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 into 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 come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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.

Do not use the topical gel on the groin or underarms unless directed to do so by your doctor, and do not use this form for more than 4 weeks.

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

• 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.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
• 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.

To use the foam:

• Wash your hands with soap and water before and after using this medicine.
• Shake the can well before using it.
• Do not put the foam directly onto your face. Turn the can upside down and place a small amount of medicine in your hands. Massage it gently into the affected areas of the face until the medicine has dried. For areas other than the face, you may put it directly on the affected area.
• Do not wash or rinse the treated area right after applying the medicine.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• Do not use this medicine near heat, an open flame, or while smoking.

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 atopic dermatitis:
  • For topical dosage forms (foam or gel):
    • Adults—Apply a thin layer to the affected area of the skin 2 times a day.
    • Children 3 months of age and older—Apply a thin layer to the affected area of the skin 2 times a day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
• For redness, itching, and swelling of the skin:
  • For topical dosage forms (cream, ointment, or lotion):
    • Adults—Apply to the affected area of the skin 2 or 3 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.

Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If your or your child's symptoms do not improve within a few days or after 4 weeks, 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.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

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 be checked by an ophthalmologist (eye doctor).

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

Make sure your doctor knows that you are using desonide foam. You may need to stop using this medicine several days before having surgery.

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

Side Effects of This Medicine:

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:

Less common

Blistering, burning, crusting, dryness, or flaking of the skin

burning, itching, redness, skin rash, swelling, or soreness at the application site

flushing or redness of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

peeling of the skin

raised, dark red, wart-like spots on the skin, especially when used on the face

stinging and burning

unusually warm skin

Incidence not known

Blindness

blurred vision or other change in vision

decreased vision

eye pain

headache

loss of vision

nausea

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 (eg, between the fingers)

vomiting

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:

More common

Body aches or pain

chills

cough

difficulty with breathing

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

Less common

Hoarseness

irritability

noisy breathing

tender, swollen glands in the neck

tightness in the chest

trouble with swallowing

voice changes

Incidence not known

Acne or pimples

burning and itching of the skin with pinhead-sized red blisters

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

lightening of normal skin color

lightening of treated areas of dark skin

reddish purple lines on the arms, face, legs, trunk, or groin

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.