Embeline (Topical application)

Clobetasol topical is used to relieve redness, itching, swelling, or other discomfort caused by certain skin conditions. The solution is for scalp problems, the foam is for mild to moderate plaque psoriasis, the cream, lotion, and spray are for moderate to severe plaque psoriasis, and the foam and shampoo are for moderate to severe scalp psoriasis. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check you or your child's progress during regular visits for any side effects that may come from this medicine.

If your or your child's symptoms do not get better within a few days, or if they get worse, contact your doctor.

Using too much of this medicine or using it for a long time may increase the risk of adrenal gland problems. This risk is higher for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Contact your doctor right away if blurred vision, difficulty reading, or any other change in vision happens during or after treatment. Your doctor may want your eyes checked by an ophthalmologist (eye doctor).

Contact your doctor right away if you or your child develop a skin rash, burning, stinging, swelling, or irritation on the skin.

Make sure your doctor knows that you are using clobetasol cream, gel, or spray. You may need to stop using this medicine several days before having surgery.

Do not use clobetasol along with other topical corticosteroid-containing medicines, such as betamethasone, hydrocortisone, triamcinolone, Cortaid®, or Lotrisone®. Using these medicines together may cause serious side effects.

Do not use cosmetics or other skin care products on the treated areas.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the use of clobetasol topical cream, foam, gel, ointment, or scalp solution in children aged 12 and older. However, due to its potential toxicity, it should be used cautiously. Children can absorb large amounts through the skin, which may lead to serious side effects. If your child is using this medicine, follow your doctor's instructions very closely. The safety and effectiveness of clobetasol topical cream, foam, gel, ointment, or scalp solution have not been established in children under 12 years old, and its use is not recommended. The safety and effectiveness of clobetasol topical lotion, shampoo, or spray have not been established in children, and use is not recommended.

Studies have not been conducted on the effects of Impoyz™ cream in children. Its safety and effectiveness have not been confirmed, and use in children is not recommended.

Geriatric

Studies have not shown any specific problems that would limit the use of clobetasol topical in older adults. However, elderly patients may be more likely to experience unwanted effects, which could require careful monitoring and possible dose adjustments for those taking clobetasol topical cream, foam, gel, lotion, ointment, scalp solution, shampoo, or spray.

Interactions with Medicines

Some medicines should not be taken together, while others may be used together even if an interaction is possible. In such cases, your doctor may adjust the dose or suggest other precautions. It is crucial for your healthcare provider to know if you are taking any of the following medicines when using this medicine. The following interactions are significant and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose to avoid prescribing this medication or adjust your other medicines.

• Desmopressin

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

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best option for you. If both medicines are prescribed, your doctor may adjust the dose or how often you use one or both medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare provider the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, 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
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head) or
• Posterior subcapsular cataract—Use with caution. May worsen these conditions.

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

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

• Thinning of the skin at the application site—Impoyz™ cream should not be used in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Burning or stinging at the application site

Less common

• Burning sensation of the skin
• Dry skin
• Flushing or redness of the skin
• Itching, scaling, severe redness, soreness, or swelling of the skin
• Skin irritation
• Skin rash that is encrusted, scaly, and oozing
• Thinning of the skin with easy bruising, especially when used on the face or in skin folds (e.g., between the fingers)

Rare

• Thinning, weakness, or wasting away of the skin

Incidence not known

• Backache
• Blindness
• Blurred vision
• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• Change in vision
• Dry mouth
• Eye pain
• Facial hair growth in females
• Fractures
• Fruit-like breath odor
• Full or round face, neck, or trunk
• Hair loss
• Headache
• Hives
• Increased hunger
• Increased thirst
• Increased urination
• Irritability
• Loss of sexual desire or ability
• Menstrual irregularities
• Muscle wasting
• Nausea
• Redness and scaling around the mouth
• Stomach pain
• Sugar in the urine
• Sweating
• Tearing
• Thinning of the hair
• Troubled breathing
• Unexplained weight loss
• Unusual tiredness or weakness
• Vomiting

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Cough
• Sore throat

Less common

• Body aches or pain
• Changes in skin coloring
• Congestion
• Dryness of the throat
• Raised, dark red, wart-like spots on the skin, especially when used on the face
• Skin discomfort
• Stuffy or runny nose
• Tender, swollen glands in the neck
• Trouble swallowing
• Voice changes

Incidence not known

• Acne or pimples
• Burning and itching of the skin with pinhead-sized red blisters
• Increased hair growth on the forehead, back, arms, and legs
• Lightening of normal skin color
• Lightening of treated areas of dark skin
• Reddish purple lines on the arms, face, legs, trunk, or groin
• Softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

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

In the U.S.

• Clobevate
• Clobex
• Cormax
• Cormax Scalp Application
• Embeline
• Embeline E
• Embeline Scalp Application
• Olux
• Olux/Olux-E Complete Pack
• Olux-E
• Temovate
• Temovate E

In Canada

• Clobetasol Propionate
• Dermovate
• Dermovate Scalp Application
• Med Clobetasol Scalp Application
• Ratio-Clobetasol

Available Dosage Forms:

• Foam
• Ointment
• Cream
• Gel/Jelly
• Shampoo
• Solution
• Lotion
• Emollient Cream
• Spray

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Clobetasol

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

To help clear up your skin or scalp problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor first before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use this medicine on the face, groin, or underarms, or if you have skin thinning, unless directed to do so by your doctor.

To use the cream, foam, gel, lotion, ointment, or spray:

• Wash your hands with soap and water before and after using this medicine.
• Apply or spray a thin layer of this medicine to the affected area of the skin. Rub it in gently.
• With the lotion, protect the skin from water, clothing, or anything that causes rubbing until the medicine has dried. Also, shake the lotion well before using it.
• With the foam, do not dispense directly from the can into your hands, unless the hands are the affected area.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.
• Do not use Clobex® spray or Impoyz™ cream for more than 2 weeks unless your doctor told you to.

To use the foam, scalp solution, or shampoo:

• Wash your hands with soap and water before and after using this medicine.
• Apply a thin layer of this medicine to the affected area of the scalp. Rub it in gently.
• Do not cover the scalp (eg, shower cap, bathing cap) while it is being treated.
• With the shampoo, do not wet your hair before using it. And if the shampoo gets on any part of your body other than your scalp, rinse the area well with water.
• Do not use the shampoo for more than 4 weeks, and the foam and scalp solution for more than 2 weeks unless your doctor told you to.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For redness, itching, and swelling of the skin: For topical dosage forms (cream, gel, or ointment): Adults—Apply to the affected area of the skin 2 times per day. Children 12 to 17 years of age—Apply to the affected area of the skin 2 times per day. Children younger than 12 years of age—Use is not recommended. For topical dosage form (lotion): Adults—Apply to the affected area of the skin 2 times per day. Children—Use is not recommended.
• For plaque psoriasis: For topical dosage form (cream): Impoyz™: Adults—Apply to the affected area of the skin 2 times per day. Children—Use is not recommended. Temovate®: Adults and children older than 16 years of age—Apply to the affected area of the skin 2 times per day. Children younger than 16 years of age—Use is not recommended. For topical dosage form (foam): Adults—Apply to the affected area of the skin 2 times per day, once in the morning and once at night. Children 12 to 17 years of age—Apply to the affected area of the skin 2 times per day, once in the morning and once at night. Children younger than 12 years of age—Use is not recommended. For topical dosage form (spray): Adults—Spray directly to the affected area of the skin 2 times per day. Children—Use is not recommended.
• For scalp problems: For topical dosage forms (foam or scalp solution): Adults—Apply to the affected area of the scalp 2 times per day, once in the morning and once at night. Children 12 to 17 years of age—Apply to the affected area of the scalp 2 times per day, once in the morning and once at night. Children younger than 12 years of age—Use is not recommended. For topical dosage form (shampoo): Adults—Apply to the affected area of the scalp once a day. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the foam can or spray bottle at room temperature, away from heat, flames, smoke, and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Store the Temovate® E cream at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep Temovate® E cream and Impoyz™cream from freezing.

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