Verdeso: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

VERDESO™ Foam is used for the treatment of mild to moderate atopic dermatitis for up to 4 weeks in patients 1 year of age and older.

What it does:

VERDESO™ Foam contains desonide. Desonide is topical corticosteroid which reduces redness, inflammation and itching.

When it should not be used:

Do not use VERDESO™ Foam if you:

• are allergic to desonide, other corticosteroids, or to any of the other ingredients of VERDESO™ Foam.
• have bacterial, fungal, parasitic, viral skin infection (e.g. herpes simplex, chickenpox), tuberculous or syphilis skin lesions, or skin reaction following a recent vaccination
• have acne, rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus-filled bumps (pustules)), itchy skin which is not inflamed.

Do not apply VERDESO™ Foam in, or near the eye.

What the medicinal ingredient is:

desonide

What the nonmedicinal ingredients are:

The foam contains white petrolatum, light mineral oil, isopropyl myristate, cyclomethicone, anhydrous citric acid, cetyl alcohol, polyoxyl 20 cetostearyl ether, potassium citrate (monohydrate), propylene glycol, purified water, sorbitan monolaurate, and phenoxyethanol as a preservative.

What dosage forms it comes in:

VERDESO™ (desonide) Foam, 0.05% w/w. Each 1 g of VERDESO™ Foam contains 0.5 mg of desonide.

WARNINGS AND PRECAUTIONS

Topical corticosteroids, when used over large areas, on sensitive areas such as the face, in skin-fold areas like the armpit and groin or broken skin, for prolonged periods, or under airtight dressings, are more likely to be absorbed into the bloodstream and cause side effects. Apply only enough to cover the affected areas. VERDESO™ should not be applied over large areas unless advised by a physician.

Inform your doctor if you have previously used corticosteroids.

Before using VERDESO™ Foam, talk to your doctor or pharmacist if:

• you have any skin disease around a leg ulcer; use of a topical corticosteroid may increase the risk of an allergic reaction or an infection around the ulcer.
• you have other inflammatory skin diseases in the leg as a result of impaired circulation (such as stasis dermatitis).

• you are pregnant or planning to become pregnant.

• you do use VERDESO™ Foam while breast feeding, do not apply it on your breasts to ensure the infant does not accidentally get it in their mouth.
• you have problems with your kidney and liver. You may need to use a smaller amount of VERDESO™ or use it less often.

While using VERDESO™ Foam, talk to your doctor or pharmacist if:

• you develop any skin infection
• you have an allergic reaction
• you develop significant skin irritation
• you experience skin thinning or softening

Care should be taken when applying VERDESO™ Foam to the face, or in skin-fold areas, such as the groin and the armpit since these areas are more prone to skin thinning.

Use the smallest amount of VERDESO™ Foam necessary to cover the affected area.

Children absorb larger amounts of topical corticosteroids and therefore, may be more likely to develop side effects. Children may need to use a smaller amount of VERDESO™.

VERDESO™ Foam should not be used with airtight dressings.

Avoid getting VERDESO™ Foam in the eye, or other mucous membranes. Absorption in the body may cause increased pressure in the eye (glaucoma), or a cloudy lens in the eye (cataracts).

VERDESO™ Foam is not recommended for use in children under 1 year of age.

If you are over 65 years of age, use VERDESO™ Foam with caution. You may need to use a smaller amount of VERDESO™ or use it less often.

The propellant in VERDESO™ Foam is extremely flammable. Avoid fire, open flame, spark or smoking during and immediately following application.

INTERACTIONS WITH THIS MEDICATION

Some medicines may affect how VERDESO™ Foam works and may make it more likely that you will have side effects. Some of these medicines may include:

• Ritonavir (for HIV).
• Itraconazole (for fungal infections).

Tell your doctor or pharmacist about all your other medications, including medicines that you bought without a prescription and natural health products.

PROPER USE OF THIS MEDICATION

For topical use only and not for ophthalmic, oral or intravaginal use.

Apply a thin layer of VERDESO™ Foam to the affected area(s) twice daily, morning and evening.

Treatment should be limited to 4 consecutive weeks.

The number of times you use VERDESO™ Foam may be reduced as your skin gets better. However, it is important to not stop using VERDESO™ Foam suddenly or your skin condition could flare up again. If your condition worsens or no improvement is seen within 2-4 weeks, contact your doctor.

How to use VERDESO™ Foam

	For proper dispensing of foam, shake the can before use. Remove the cap. Before applying VERDESO™ Foam for the first time, break the tiny plastic seal at the base of the nozzle by gently pushing it back away from the seal.
	Turn the can upside down, and depress the actuator. To apply VERDESO™ Foam on the affected areas of your face: Do not dispense VERDESO™ foam directly onto the face. Squirt a small amount of VERDESO™ Foam, enough to cover the affected areas with a thin layer, into the palm of your hand. Gently massage the foam into the affected areas of your face until it disappears.
	To apply VERDESO™ Foam on affected areas (other than your face): Squirt a small amount of VERDESO™ foam, enough to cover the affected areas with a thin layer, directly onto the affected areas. Gently massage the foam into the affected areas until it disappears.
	Use enough VERDESO™ Foam to cover the affected areas with a thin layer.
	Avoid contact with the eyes and lips; if contact, rinse thoroughly with water.

A moisturizer should be used as maintenance therapy.

Remember to wash your hands (excluding affected areas of the hands) after use.

VERDESO™ Foam should be used for the minimum amount of time required to achieve the desired results, but always use VERDESO™ Foam exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

Missed Dose:

If you forget to apply VERDESO™ Foam on a given time, you should apply VERDESO™ Foam to the affected area as soon as possible and then continue taking your next doses as before (i.e., do not take any extra doses).

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Side effects with VERDESO™ Foam include:

Common:

• reactions at the application site, burning, redness
• skin thinning or softening

Uncommon:

• itching, dryness, skin colour changes at the application site
• dermatitis (a type of eczema) at the application sites
• Bacterial infection of the skin and tissues beneath the skin (cellulitis)
• irritability, sleep disorder
• dry skin

Side effects with the use of topical corticosteroids, including VERDESO™, include:

• pain at the application site, burning, itching, skin irritation, dryness
• Inflammation of hair follicles, abnormal hair growth, hair loss
• stretch marks
• Secondary infection
• Acne
• allergic contact dermatitis
• rash on the skin around the mouth or lips
• heat rash (miliaria)
• skin thinning, loss of skin color (hypopigmentation)
• worsening of condition
• rash or hives
• skin pain
• facial swelling
• flaking skin

• superficial ulcers and blisters

  Serious side effects such as Cushing’s syndrome may be associated with absorption in the body of topical corticosteroids (for example, from long-term, improper or excessive use). Symptoms include: increased weight, moon face / rounding of the face and obesity. Other side effects may include weight loss, fatigue, nausea, diarrhea and abdominal pain (steroid withdrawal syndrome). Also, look out for delayed weight gain and slow growth in children.

  Other symptoms that may only show in blood tests or when your doctor gives you a medical examination are: decreased hormone cortisol levels in your blood, increased sugar levels in your blood or urine, high blood pressure, cloudy lens in the eye (cataract), increased pressure in the eye (glaucoma), as well as weakening of the bones through gradual mineral loss (osteoporosis) and additional tests may be needed after your medical examination to confirm whether you have osteoporosis.

  Patients should report any signs of local or systemic adverse reactions to their doctor.

This is not a complete list of side effects. For any unexpected effects while taking VERDESO™ Foam, contact your doctor or pharmacist.

HOW TO STORE IT

Store upright at controlled room temperature 20 – 25° C. Keep container tightly closed when not in use. Avoid storage in an inverted position. Keep out of reach and sight of children.

DANGER

EXTREMELY FLAMMABLE. AVOID FIRE, OPEN FLAME, SPARK OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 49°C. Do not place in hot water or near radiators, stoves or other sources of heat.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.stiefel.ca or by contacting the sponsor,

GlaxoSmithKline, Inc.

7333 Mississauga Road

Mississauga, Ontario

L5N 6L4

1-800-387-7374

Last revised: July 29, 2013

©2013 GlaxoSmithKline Inc. All Rights Reserved.

™ VERDESO used under license by GlaxoSmithKline Inc.