Clobex

Before using clobetasol, tell your doctor or pharmacist if you are allergic to it; or to any other steroids (e.g., hydrocortisone, dexamethasone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: poor blood circulation, diabetes, other skin/scalp conditions (e.g., rosacea, perioral dermatitis), immune system problems.Do not use if there is an infection or sore in the area to be treated.Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk when applied to the scalp/skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.

Clobex is a brand name medication included in a group of medications called Corticosteroids, very potent group IV. For more information about Clobex see its generic Clobetasol

• Galderma Laboratories, L.P.

You should not use clobetasol topical if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have:

• any type of skin infection.

Steroids can increase the glucose (sugar) levels in your blood or urine. Tell your doctor if you have diabetes.

FDA pregnancy category C. It is not known whether clobetasol topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether clobetasol topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Clobetasol topical should not be given to a child younger than 12 years old. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of clobetasol topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of clobetasol topical cream, foam, gel, ointment, or scalp solution in children 12 years of age and older. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully. Safety and efficacy have not been established in children younger than 12 years of age and the use of clobetasol topical cream, foam, gel, ointment, or scalp solution is not recommended. The safety and efficacy of clobetasol topical lotion, shampoo, or spray have not been established in children and use is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clobetasol topical in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution in patients receiving clobetasol topical cream.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Nadroparin
• Pixantrone

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acne vulgaris (skin problem) or
• Perioral dermatitis (skin problem) or
• Rosacea (skin problem)—Should not be used in patients with these conditions.

• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Diaper dermatitis—Olux® foam should not be used in patients with this condition.

• Infection of the skin at or near the place of application or
• Large sores, broken skin, or severe skin injury at the place of application or
• Liver failure—The chance of side effects may be increased.

Spray, 0.05% w/w. Each gram of Clobex® Spray, 0.05% contains 0.5 mg of clobetasol propionate in a clear, colorless liquid.

Clobex® (clobetasol propionate) Spray, 0.05% contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Clobetasol propionate is 21-chloro-9-fluoro-11β, 17-dihydroxy-16β -methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32CIFO5, and a molecular weight of 466.97 (CAS Registry Number 25122-46-7).

The following is the chemical structure:

Clobetasol propionate is a white to almost white crystalline powder that is practically insoluble in water. Each gram of Clobex® Spray, 0.05% contains 0.5 mg of clobetasol propionate, in a clear, colorless liquid composed of alcohol, isopropyl myristate, sodium lauryl sulfate, and undecylenic acid.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clobetasol propionate was not carcinogenic to rats when topically applied for 2 years at concentrations up to 0.005% which corresponded to doses up to 11 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis).

Clobetasol propionate at concentrations up to 0.001% did not increase the rate of formation of ultra violet light-induced skin tumors when topically applied to hairless mice 5 days per week for a period of 40 weeks.
Clobetasol propionate was negative in the in vitro mammalian chromosomal aberration test and in the in vivo mammalian erythrocyte micronucleus test

The effect of subcutaneously administered clobetasol propionate on fertility and general reproductive toxicity was studied in rats at doses of 0, 12.5, 25, and 50 μg/kg/day. Males were treated beginning 70 days before mating and females beginning 15 days before mating through day 7 of gestation. A dosage level of less than 12.5 μg/kg/day clobetasol propionate was considered to be the no-observed-effect-level (NOEL) for paternal and maternal general toxicity based on decreased weight gain and for male reproductive toxicity based on increased weights of the seminal vesicles with fluid. The female reproductive NOEL was 12.5 μg/kg/day (ratio of animal dose to proposed human dose of 0.03 on a mg/m2/day basis) based on reduction in the numbers of estrous cycles during the pre-cohabitation period and an increase in the number of nonviable embryos at higher doses.

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

Important: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 information 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 a rash around the mouth (perioral dermatitis)

It is not known if Clobex® Spray is safe and effective in children under 18 years of age. Clobex® Spray should not be used in children 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, underarms (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 and completely.
• 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.

See the "Instructions for Use" at the end of the Patient Information for detailed information about the right way to apply Clobex® Spray.

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 cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working.

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.

You may also report side effects to Galderma Laboratories, L.P. at 1-866-735-4137

How should I store Clobex® Spray?

• Store Clobex® Spray at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not store Clobex® Spray above 86°F (30°C).
• Do not freeze or refrigerate Clobex® Spray.
• Keep the bottle of Clobex® Spray tightly closed.
• 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 a Patient Information leaflet. 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.

Instructions for Use

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

Important:For use on skin only. Do not get Clobex® Spray near or in your mouth, eyes, or vagina.

Read the Instructions for Use that comes with Clobex® Spray before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Parts of Clobex® Spray (See Figure A)

Figure A

When you receive Clobex® Spray the Directional Spray Nozzle is in the “locked” position with the nozzle pointing downwards. (See Figure B)

Front View Side View
Figure B

How to apply Clobex® Spray:

Step 1: To unlock the Directional Spray Nozzle, hold the Clobex® Spray bottle and sides of the Pump Top with one hand. Use your other hand to turn the Directional Spray Nozzle to either the right or the left. (See Figure C) The spray will come out through the opening at the end of the Directional Spray Nozzle.

Figure C

Step 2: To apply Clobex® Spray, point the Directional Spray Nozzle to the affected area. To spray, push down on the Pump Top. Apply Clobex® Spray to the affected area as instructed by your doctor. (See Figure D)

Figure D

Step 3: Spray only enough Clobex® Spray to cover the affected area, for example, the elbow. (See Figure E) Rub in Clobex® Spray gently and completely.

Figure E

• You should not apply Clobex® Spray to your face, underarms or groin. Avoid contact with your eyes and lips.

• To apply to your scalp, part your hair at the area where Clobex® Spray is to be applied. Spray directly on the affected area, and then rub in gently and completely. (See Figure F)

Figure F

• Repeat Steps 2 and 3 to apply Clobex® Spray to other affected areas as instructed by your doctor.

Step 4: After applying Clobex® Spray, return the Directional Spray Nozzle to the “locked” position. (See Figure G)

Figure G

Step 5: Wash your hands after applying Clobex® Spray.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Marketed by:
GALDERMA LABORATORIES, L.P., Fort Worth, Texas 76177 USA

Manufactured by: CPL, Mississauga, Ontario, Canada L5N 6L6

Made in Canada.

P52061-0

Or

Manufactured by: G Production Inc., Baie d'Urfé, QC, H9X 3S4 Canada

P51011-0

Revised 03/2013

GALDERMA is a registered trademark.
US Patent Nos: 5,972,920; 5,990,100 and foreign patents pending.