Clobex Spray - Consumer Medicine Information
|Condition:||Psoriasis vulgaris (Plaque Psoriasis), Psoriasis|
|Ingredients:||Clobetasol propionate, alcohol, isopropyl myristate, isopropyl myristate, undecylenic acid|
Clobetasol Propionate Solution
About This Medication
What the Medication is Used For
- the treatment of moderate to severe plaque type psoriasis in adults, aged 18 years and older.
What it Does
Clobex Spray works to reduce redness, scaling, and itching that occur with psoriasis.
When it Should not be Used
Do not use if you are allergic to clobetasol propionate or to any other ingredients in Clobex Spray or any other corticosteroids. Ask your doctor or pharmacist if you need a list of other corticosteroids.
Do not use if you have untreated tubercular and other bacterial, fungal, or viral infections (such as herpes simplex, chicken pox, or vaccinations).
What the Medicinal Ingredient Is
What the Important Nonmedicinal Ingredients Are
Clobex Spray contains alcohol.
Nonmedicinal ingredients: alcohol, isopropyl myristate, sodium lauryl sulphate, and undecylenic acid
What Dosage Forms it Comes In
Clobex Spray is a spray formulation for the skin that comes in 59 mL (50 g) bottles. Each gram of spray contains 0.5 mg of clobetasol propionate.
Warnings and Precautions
BEFORE you use Clobex Spray talk to your doctor or pharmacist if:
- you are less than 18 years of age. Clobex Spray is not recommended for use by children under 18 years of age.
- you have acne rosacea or acne vulgaris
- you need to have surgery for any reason
- you have plaques around your mouth, underarms, anus, or genitals.
- you are pregnant, think you are pregnant, plan to be pregnant, or are nursing an infant. Your doctor will decide with you whether the benefits in using Clobex Spray will be greater than the risks. If possible, delay treatment with Clobex Spray until after the baby is born.
Clobex Spray is not for long-term use. Use Clobex Spray for the minimum amount of time necessary. Intermittent use of this product has not been studied. Not to be used with occlusive dressing or to be applied to a large area and its use may cause reversible adrenal suppression (shut down of adrenal glands).
Interactions With This Medication
There are no known interactions with this medication, but please tell your doctor or pharmacist about other medications, that you are taking or are planning to take, including non-prescription drugs, vitamins, and natural health products.
Proper use of This Medication
Apply twice daily, once in the morning and once at night. Use only enough to cover the affected areas. Make sure that you use Clobex Spray exactly as directed by your doctor.
Before applying Clobex Spray, wash the area to be treated with a mild cleanser, pat dry, and wait several minutes.
How to use Clobex Spray
Please read the following instructions before using Clobex (clobetasol propionate) Spray, 0.05%. The terms described in the figure below (Fig.1) will help you understand these instructions.
When you receive Clobex Spray the Directional Spray Nozzle is in the “locked” position (see Fig. 2).
To use Clobex Spray follow Steps 1 through 3.
Grip the sides of the Pump Top with one hand and use your second hand to point the Directional Spray Nozzle where you want the spray to go (see Fig. 3). The spray will be delivered through the nozzle opening at the end of the Directional Spray Nozzle.
Push down on the Pump Top to spray Clobex Spray (see Fig.4).
Spray only enough to cover affected area. Rub gently to ensure even coverage. Do not apply Clobex Spray to your face, underarms or groin and avoid contact with eyes and lips (see Fig. 5).
The maximum recommended single dose should not exceed 3.6 mL (about ¾ of a teaspoon), or 23 sprays (each pump spray is about 0.16 mL).
Single application not to exceed 20% body surface area.
Wash your hands after applying Clobex Spray.
DO NOT APPLY MORE THAN THE PRESCRIBED AMOUNT (50 g or one complete bottle of spray) per week maximum.
Not to be used with occlusive dressings.
Stop using Clobex Spray as soon as your plaques have healed. After four weeks, you must stop using the product, even if you are not completely healed, and speak to your doctor.
Clobex Spray is for external use only. Avoid getting it in your eyes and mouth.
Clobex Spray is flammable. Avoid using it near sources of heat or open flame.
If you or a child accidentally swallows Clobex Spray or experiences an overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you forget to apply Clobex Spray at the scheduled time, use it as soon as you remember. Then go back to your regular schedule. If it is about time for your next dose, apply just that one dose, and continue with your regular schedule the next day. Do not make up the missed dose. If you miss several doses, tell your doctor.
Side Effects and What to do About Them
The most common side effects with Clobex Spray include burning or itching at the site of application. Other possible side effects include dry skin, thinning of skin, pain, or darkening of the skin around the plaque being treated. Usually, these side effects are mild.
Clobex Spray can pass through your skin. Too much Clobex Spray passing through your skin can shut down your adrenal glands. This may happen if you use too much Clobex Spray or if you use it for too long, but it can happen with correct use. If your adrenal glands shut down, they may not start working right away after you stop using Clobex Spray. Shutting down of the adrenal glands can cause nausea, vomiting, fever, low blood pressure, heart attack and even death because your body cannot adequately respond to stress or illness. Your doctor may do special blood and urine tests to check your adrenal gland function while you are using Clobex Spray.
Serious Side Effects, how Often They Happen and What to do About Them
|Symptom / effect
||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Common||Burning or irritation at the site||√|
This is not a complete list of side effects. For any unexpected effects while taking Clobex Spray, contact your doctor or pharmacist.
How to Store It
Store at room temperature (15 - 30°C). Do not refrigerate. Keep tightly closed. The spray is flammable, and must be kept away from heat or flame.
Keep in a safe place out of the reach of children.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Galderma Canada Inc., at: 1-800-467-2081