"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
(clobetasol propionate) Spray
Important: For External Use Only For use on skin only. Do not get CLOBEX® spray near or in your eyes, mouth or vagina.
Read the Patient Information that comes with CLOBEX® 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® spray?
CLOBEX® 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® spray is for use on the skin only (topical).
- CLOBEX® 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® spray to your skin in 1 week.
You should not use CLOBEX® 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® spray in people under 18 years of age.
What should I tell my doctor before using CLOBEX® spray?
Before you use CLOBEX® spray, tell your doctor if you:
- have a skin infection. You may need medicine to treat the skin infection before you use CLOBEX® spray.
- plan to have surgery.
- have any other medical conditions.
- are pregnant or plan to become pregnant. It is not known if CLOBEX® spray will harm your unborn baby.
- are breast-feeding or plan to breast-feed. It is not known if CLOBEX® spray passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use CLOBEX® 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® spray?
- Use CLOBEX® spray exactly as your doctor tells you to use it.
- Your doctor should tell you how much CLOBEX® spray to use and where to apply it.
- CLOBEX® spray is for use on skin only. Do not get CLOBEX® spray near or in your eyes, mouth, or vagina.
- You should not use CLOBEX® spray on your face, under arms (armpits), or groin areas.
- Apply CLOBEX® spray 2 times each day.
- Apply only enough CLOBEX® spray to cover the affected skin areas. Rub in gently.
- Wash your hands after using CLOBEX® spray.
- Throw away any unused CLOBEX® 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® spray. Your doctor may tell you to apply CLOBEX® spray to certain areas of your skin for up to 2 more weeks if needed. You should not use CLOBEX® 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® spray?
- CLOBEX® spray is flammable. Avoid heat, flames or smoking while applying CLOBEX® spray to your skin.
What are the possible side effects of CLOBEX® spray?
- Clobex spray can pass through your skin. Too much Clobex 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.
The most common side effects with CLOBEX® 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.
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® 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® spray?
- Store CLOBEX® spray at 68°F to 77°F (20°C to 25°C).
- Do not store CLOBEX® spray above 86°F (30°C).
- Keep the bottle of CLOBEX® spray tightly closed.
- Do not freeze or refrigerate CLOBEX® spray.
- Keep away from heat or flame.
Keep CLOBEX® spray and all medicines out of the reach of children.
General information about CLOBEX® spray.
Medicines are sometimes prescribed for purposes other than those listed in patient information. Do not use CLOBEX® spray for a condition for which it was not prescribed. Do not give CLOBEX® 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® spray. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about CLOBEX® 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 1800-FDA-1088 or www.fda.gov/medwatch.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 9/14/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Clobex Spray Information
Clobex Spray - User Reviews
Clobex Spray User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.