Clobex Spray (Clobetasol Propionate Spray) Drug Information: Medication Guide and Patient Information

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May 26, 2012

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Psoriasis facts

Psoriasis is a chronic inflammatory skin disease.
Psoriasis has no known cause.
The tendency toward developing psoriasis is inherited in genes.
Psoriasis is not contagious.
Psoriasis gets better and worse spontaneously and can have periodic remissions (clear skin).
Psoriasis is controllable with medication.
Psoriasis is currently not curable.
There are many promising therapies, including newer biologic drugs.
Future research for psoriasis is promising.

What is psoriasis?

Psoriasis is a noncontagious skin condition that produces red, dry plaques of thickened skin. The dry flakes and skin scales are thought to result from the rapid proliferation of skin cells that is triggered by abnormal lymphocytes from the blood . Psoriasis commonly affects the skin of the elbows, knees, and scalp.

Some people have such mild ps...

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PATIENT INFORMATION

CLOBEX®
(KLO-bex)
(clobetasol propionate) Spray

Important: For External Use Only For use on skin only. Do not get CLOBEX® (clobetasol propionate spray) spray near or in your eyes, mouth or vagina.

Read the Patient Information that comes with CLOBEX® (clobetasol propionate spray) spray before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What is CLOBEX® (clobetasol propionate spray) spray?

CLOBEX® (clobetasol propionate spray) spray is a prescription corticosteroid medicine used to treat adults with moderate to severe plaque psoriasis that affects up to 20% of the body's skin surface. CLOBEX® (clobetasol propionate spray) spray is for use on the skin only (topical).

CLOBEX® (clobetasol propionate spray) spray should only be used for the shortest amount of time needed to treat your plaque psoriasis.
Do not use more than 26 sprays for each application or more than 52 sprays in 1 day.
You should not apply more than 59 mL (2 fluid ounces) of CLOBEX® (clobetasol propionate spray) spray to your skin in 1 week.

You should not use CLOBEX® (clobetasol propionate spray) spray:

on your face, under arms (armpits), or groin areas
if you have thinning of the skin (atrophy) at the treatment site
to treat rosacea or perioral dermatitis (a rash around the mouth)

Do not use CLOBEX® (clobetasol propionate spray) spray in people under 18 years of age.

What should I tell my doctor before using CLOBEX® (clobetasol propionate spray) spray?

Before you use CLOBEX® (clobetasol propionate spray) spray, tell your doctor if you:

have a skin infection. You may need medicine to treat the skin infection before you use CLOBEX® (clobetasol propionate spray) spray.
plan to have surgery.
have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if CLOBEX® (clobetasol propionate spray) spray will harm your unborn baby.
are breast-feeding or plan to breast-feed. It is not known if CLOBEX® (clobetasol propionate spray) spray passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use CLOBEX® (clobetasol propionate spray) spray.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids. Ask your doctor or pharmacist if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use CLOBEX® (clobetasol propionate spray) spray?

Use CLOBEX® (clobetasol propionate spray) spray exactly as your doctor tells you to use it.
Your doctor should tell you how much CLOBEX® (clobetasol propionate spray) spray to use and where to apply it.
CLOBEX® (clobetasol propionate spray) spray is for use on skin only. Do not get CLOBEX® (clobetasol propionate spray) spray near or in your eyes, mouth, or vagina.
You should not use CLOBEX® (clobetasol propionate spray) spray on your face, under arms (armpits), or groin areas.
Apply CLOBEX® (clobetasol propionate spray) spray 2 times each day.
Apply only enough CLOBEX® (clobetasol propionate spray) spray to cover the affected skin areas. Rub in gently.
Wash your hands after using CLOBEX® (clobetasol propionate spray) spray.
Throw away any unused CLOBEX® (clobetasol propionate spray) spray.
Do not bandage or cover your treated areas unless your doctor tells you to.
Tell your doctor if your skin condition is not getting better after 2 weeks of using CLOBEX® (clobetasol propionate spray) spray. Your doctor may tell you to apply CLOBEX® (clobetasol propionate spray) spray to certain areas of your skin for up to 2 more weeks if needed. You should not use CLOBEX® (clobetasol propionate spray) spray for more than 4 weeks unless your doctor tells you to. This can increase your risk of serious side effects.

What should I avoid while using CLOBEX® (clobetasol propionate spray) spray?

CLOBEX® (clobetasol propionate spray) spray is flammable. Avoid heat, flames or smoking while applying CLOBEX® (clobetasol propionate spray) spray to your skin.

What are the possible side effects of CLOBEX® (clobetasol propionate spray) spray?

Clobex spray (clobetasol propionate spray) can pass through your skin. Too much Clobex spray (clobetasol propionate spray) passing through your skin can shut down your adrenal glands. Your doctor may need to do blood tests to check for adrenal gland function while you are using Clobex spray (clobetasol propionate spray) .

The most common side effects with CLOBEX® (clobetasol propionate spray) spray include:

burning at treated site
upper respiratory tract infection
runny nose
sore throat
dry, itchy, and reddened skin

If you go to another doctor for illness, injury or surgery, tell that doctor you are using Clobex spray (clobetasol propionate spray) .

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of CLOBEX® (clobetasol propionate spray) spray. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CLOBEX® (clobetasol propionate spray) spray?

Store CLOBEX® (clobetasol propionate spray) spray at 68°F to 77°F (20°C to 25°C).
Do not store CLOBEX® (clobetasol propionate spray) spray above 86°F (30°C).
Keep the bottle of CLOBEX® (clobetasol propionate spray) spray tightly closed.
Do not freeze or refrigerate CLOBEX® (clobetasol propionate spray) spray.
Keep away from heat or flame.

Keep CLOBEX® (clobetasol propionate spray) spray and all medicines out of the reach of children.

General information about CLOBEX® (clobetasol propionate spray) spray.

Medicines are sometimes prescribed for purposes other than those listed in patient information. Do not use CLOBEX® (clobetasol propionate spray) spray for a condition for which it was not prescribed. Do not give CLOBEX® (clobetasol propionate spray) spray to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about CLOBEX® (clobetasol propionate spray) spray. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX® (clobetasol propionate spray) spray that is written for health professionals.

What are the ingredients of CLOBEX® spray?

Active ingredient: clobetasol propionate

Inactive ingredients: alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Patient Information has been approved by the U.S. Food and Drug Administration.Revised 1/2011

Last reviewed on RxList: 2/25/2011
This monograph has been modified to include the generic and brand name in many instances.