Clobex Spray: Uses, Side Effects and Dosage

What is CLOBEX SPRAY used for?

CLOBEX SPRAY is used in adults for the treatment of plaque type psoriasis.

How does CLOBEX SPRAY work?

CLOBEX SPRAY contains the medicinal ingredient clobetasol propionate. It belongs to a group of medicines called topical corticosteroids or topical steroids. Topical corticosteroids reduce inflammation by decreasing the body’s immune response. This can relieve symptoms such as redness, scaling, and itching. CLOBEX SPRAY is not to be used for more than 4 weeks.

What are the ingredients in CLOBEX SPRAY?

Medicinal ingredient: clobetasol propionate

Non-medicinal ingredients: alcohol, isopropyl myristate, sodium lauryl sulphate, and undecylenic acid

CLOBEX SPRAY comes in the following dosage form:

Spray, 0.05% w/w

Do not use CLOBEX SPRAY:

• if you are allergic to clobetasol propionate, any other corticosteroids or to any of the other ingredients in CLOBEX SPRAY.
• if you have skin areas affected by a bacterial, mycobacterial (including tuberculosis of the skin), parasitic or fungal infection.
• if you have a viral infection (such as herpes simplex, chickenpox or vaccinia).
• on wounds that have become ulcers.

• in children under 2 years of age.

• on or near the eyes or eyelids (risk of glaucoma or cataracts).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you use CLOBEX SPRAY. Talk about any health conditions or problems you may have, including if you:

• have a weak immune response. Tell your healthcare professional if you suspect an infection has occurred as corticosteroids can make infections more likely and may mask their signs.
• have rosacea or acne.
• have plaques around your mouth, underarms, anus, or genitals.
• think you have a fungal or bacterial infection. Tell your healthcare professional before you use CLOBEX SPRAY, because you may need other medicines to treat the infection.
• have liver problems.
• have diabetes.
• have eye problems, such as glaucoma or cataracts.
• have adrenal gland problems. CLOBEX SPRAY can affect how your adrenal glands work.
• use other oral or topical medication containing corticosteroids or medication intended to suppress your immune system (e.g. for autoimmune disease or after an organ transplant). Combining CLOBEX SPRAY with these medicines may result in serious infections.
• are less than 18 years of age. Children are at a greater risk of side effects, including adrenal suppression and may experience a decrease in the speed of their growth.

• are pregnant or trying to become pregnant.

• are breastfeeding or planning to breastfeed.

Other warnings you should know about:

• Do not use CLOBEX SPRAY for more than 4 weeks.

• Adrenal Suppression:

  • Too much CLOBEX SPRAY passing through your skin can shut down your adrenal glands (adrenal suppression). 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. Using CLOBEX SPRAY for longer than 4 weeks, over large areas of skin, on broken skin or on the face, underarms or groin can also increase your chances of developing adrenal suppression.
  • If your adrenal glands shut down, they may not start working right away after you stop using CLOBEX SPRAY, which will make it hard for your body to respond properly to stress or illness. It can also cause the symptoms of Cushing’s syndrome. This is due to too much cortisol (a hormone) in your blood. It has also caused high levels of blood sugar (hyperglycemia) and high levels of sugar in the urine. Your healthcare professional may do special blood and urine tests to check your adrenal gland function, hormone levels and sugar levels while you are using CLOBEX SPRAY.
  • Covering the treated area can increase the amount of medicine absorbed through your skin. This may increase your chance of developing adrenal suppression. You should not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.

• Immunosuppression: CLOBEX SPRAY can suppress your immune system. This may:

  • hide symptoms of infections
  • reactivate dormant infections
  • cause infections due to lowered body resistance

Tell your healthcare professional if you suspect an infection has occurred while you are using CLOBEX SPRAY.

• Surgery: Before you have any surgery, including at the dentist’s office, tell your healthcare professional that you are using CLOBEX SPRAY.
• Vision Problems: If you experience symptoms such as increased eye pressure, blurred vision, or other visual disturbances, tell your healthcare professional. Corticosteroids, like CLOBEX SPRAY, can cause eye problems.
• Allergic Contact Dermatitis: You may develop contact dermatitis (allergic skin reaction) while using CLOBEX SPRAY. Tell your healthcare professional if your skin condition is not healing or gets worse.

Tell your healthcare professional about all the medicines you take and skin products you use, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

There are no known interactions with this medication.

How to use CLOBEX SPRAY:

• Use CLOBEX SPRAY only as directed by your healthcare professional in order to avoid serious side effects. Do not use more of it; do not use it more often, or for a longer period of time than your healthcare professional has told you.
• Do not use CLOBEX SPRAY for longer than 4 weeks. If your skin condition has not improved in 2 weeks, talk to your healthcare professional.
• As with other corticosteroids, stop using CLOBEX SPRAY once your plaques have healed.
• CLOBEX SPRAY is for external, topical use only.
• Before applying CLOBEX SPRAY, wash the area to be treated with a mild cleanser, pat dry, and wait several minutes.
• Do not apply CLOBEX SPRAY to your face, groin or armpits.
• Do not cover the treated skin area with a bandage or other covering unless your healthcare professional tells you to.
• Do not get CLOBEX SPRAY on or near your lips. If you get CLOBEX SPRAY on your lips, rinse your face with cold water right away. If you accidentally swallow CLOBEX SPRAY, call your regional poison control centre immediately.
• Do not use CLOBEX SPRAY near your eyes or eyelids (risk of glaucoma and cataracts). If you get CLOBEX SPRAY in your eye, flush it with cold water right away. If your eyes keep stinging after rinsing them well with water, tell your healthcare professional right away.
• CLOBEX SPRAY is flammable. Avoid using it near sources of heat or open flame.

Usual dose:

Adults: Apply to the affected skin areas twice daily, once in the morning and once at night. Rub in gently and completely. Use only enough to cover the affected areas. Maximum single dose: ¾ tsp or 23 sprays. Do not cover more than 20% of your body surface area.

Maximum weekly dose: 50 mL (one bottle).

How to apply CLOBEX SPRAY:

Please read the following instructions before using CLOBEX SPRAY. 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.

Step 1: 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.

Step 2: Push down on the Pump Top to spray CLOBEX SPRAY (see Fig.4).

Step 3: Spray only enough to cover affected area (see Fig. 5). Rub in gently to ensure even coverage. Wash your hands after applying CLOBEX SPRAY.

Overdose:

Missed dose:

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 healthcare professional.

What are possible side effects from using CLOBEX SPRAY?

These are not all possible side effects you may have when using CLOBEX SPRAY. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• burning, pain
• dry skin, skin irritation
• itching, rash, redness
• thinning of the skin
• swelling of the skin
• darkening of the skin around the plaque being treated
• inflammation and infection of the hair follicles (folliculitis)
• spider veins
• stretch marks
• acne
• excessive hair growth

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

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 out of reach and sight of children.

If you want more information about CLOBEX SPRAY:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the Galderma Canada Inc. website: https://www.galderma.com/canada, or by calling 1-800-467-2081.

Last revised: May 12, 2022