Desonate

Desonate is part of the drug classes:

• Corticosteroids, moderately potent group II

• Antiinflammatory Corticosteroids

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:

• 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

• 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 (e.g., between the fingers)

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:

• Body aches or pain
• chills
• cough
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Cold flu-like symptoms
• congestion
• cough
• hoarseness
• irritability
• noisy breathing
• shortness of breath
• tender, swollen glands in the neck
• tightness in the chest
• trouble with swallowing
• voice changes
• wheezing

• 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.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled clinical studies of 425 Desonate treated subjects and 157 Vehicle-treated subjects, adverse events occurred at the application site in 3% of subjects treated with Desonate and the incidence rate was not higher compared with vehicle-treated subjects. The most common local adverse events in Desonate treated subjects were application site burning in 1% (4/425) and rash in 1% (3/425) followed by application site pruritus in <1% (2/425).

Adverse events that resulted in premature discontinuation of study drug in Desonate treated subjects were telangiectasia and worsening of atopic dermatitis in one subject each. Additional adverse events observed during clinical trials for patients treated with Desonate included headache in 2% (8/425) compared with 1% (2/157) in those treated with vehicle.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic or photoco-carcinogenic potential of Desonate or the effect of desonide on fertility. Desonide revealed no evidence of mutagenic potential based on the results of an in vitro genotoxicity test (Ames assay) and an in vivo genotoxicity test (mouse micronucleus assay). Desonide was positive without S9 activation and was equivocal with S9 activation in an in vitro mammalian cell mutagenesis assay (L5178YITK+ mouse lymphoma assay). A dose response trend was not noted in this assay.

In two randomized vehicle-controlled clinical studies, subjects 3 months to 18 years of age with mild to moderate atopic dermatitis were treated twice daily for 4 weeks with either Desonate or vehicle. Treatment success was defined as achieving clear or almost clear on the Investigator's Global Severity Score (IGSS) with at least a 2-point change (decrease) from the subject's baseline IGSS when compared to the Week 4 IGSS. The results of the 2 clinical trials are summarized in Table 1:

Use Desonate exactly as directed on the label, or as it has been prescribed by your doctor. Do not use Desonate in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Desonate can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions. Do not use Desonate on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using Desonate over a long treatment period.

Contact your doctor if your condition does not improve after 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

An overdose of Desonate is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use Desonate gel on broken or infected skin. Also avoid using this medicine in open wounds.

Do not use Desonate to treat any condition that has not been checked by your doctor.

It is not likely that other drugs you take orally or inject will have an effect on topically applied Desonate. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to desonide topical: compounding powder, topical cream, topical foam, topical gel, topical kit, topical lotion, topical ointment

General

The most commonly reported side effects were headache, insomnia, impetigo, skin infection, and rash.[Ref]

Endocrine

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

Hypersensitivity

Postmarketing reports: Allergic reaction including facial edema[Ref]

Dermatologic

Common (1% to 10%): Impetigo, skin infection, rash
Frequency not reported: Folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
Postmarketing reports: Pruritus, skin disorder[Ref]

Local

Frequency not reported: Burning, itching, irritation, dryness[Ref]

Other

Common (1% to 10%): Flu syndrome aggravated[Ref]

Nervous system

Common (1% to 10%): Headache, insomnia[Ref]

Metabolic

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

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