Temovate

• PharmaDerm, A division of Fougera Pharmaceuticals Inc.

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.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use this medicine to treat any condition that has not been checked by your doctor.

Avoid using clobetasol topical to treat skin on your face, underarms, or groin area without your doctor's advice.

Avoid getting this medicine in your eyes. If contact does occur, rinse with water. Do not use clobetasol topical on broken or infected skin. Also avoid using this medicine in open wounds.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe irritation of any treated skin;

• nausea, vomiting;

• fever; or

• a light-headed feeling, like you might pass out.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body, such as:

• blurred vision, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Common side effects may include:

• burning, itching, or irritation of treated skin;

• dry or cracking skin;

• redness or crusting around your hair follicles;

• spider veins;

• stretch marks;

• acne; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to 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:

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

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Clobetasol

This section provides information on the proper use of a number of products that contain clobetasol. It may not be specific to Temovate. Please read with care.

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 is for use on the skin only. Do not get it in 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 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 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 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.

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, the foam and scalp solution for more than 2 weeks unless your doctor has told you to.

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

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 two times per day.
    • Children 12 to 17 years of age—Apply to the affected area of the skin two 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 two times per day.
    • Children—Use is not recommended.
• For plaque psoriasis:
  • For topical dosage form (cream):
    • Adults—Apply to the affected area of the skin two 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 two 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 two 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 to the affected area of the skin two 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 two 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 two 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 at room temperature, away from heat 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 from freezing.

Applies to clobetasol topical: topical application cream, topical application emollient cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application shampoo, topical application solution, topical application spray

Along with its needed effects, clobetasol topical (the active ingredient contained in Temovate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clobetasol topical:

• Burning or stinging at the application site

• 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, encrusted, scaly and oozing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• hair loss
• redness and scaling around the mouth
• thinning of the hair
• thinning, weakness, or wasting away of the skin

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

• Cough
• sore throat

• Body aches or pain
• changes in skin coloring
• congestion or cough
• dryness or soreness of the throat
• headache
• 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
• unusual tiredness or weakness
• voice changes

• 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

Applies to clobetasol topical: compounding powder, topical cream, topical foam, topical gel, topical kit, topical lotion, topical ointment, topical shampoo, topical solution, topical spray

General

The most common side effect reported was skin discomfort.[Ref]

Endocrine

Postmarketing reports: Cushing's syndrome, adrenal suppression[Ref]

Dermatologic

Common (1% to 10%): Skin discomfort, acne/folliculitis, telangiectasia, skin atrophy, dry skin
Uncommon (0.1% to 1%): Local signs of irritation, pruritus, urticaria
Frequency not reported: Stria, purpura, contact dermatitis, pigmentation changes, pustular eruptions, hypertrichosis, irritant dermatitis
Postmarketing reports: Erythema, alopecia, pain of skin, skin exfoliation, chapped skin, scaling, induration/papulation,
lichenification, psoriasis (aggravation) plaque elevation, excoriation, rash, hair color changes, skin tightness[Ref]

Local

Frequency not reported: Itching[Ref]

Ocular

Common (1% to 10%): Eye stinging/burning
Postmarketing reports: Eye pain, blurred vision, eye irritation[Ref]

Other

Frequency not reported: Edema[Ref]

Gastrointestinal

Postmarketing reports: Nausea[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Nervous system

Common (1% to 10%): Headache
Postmarketing reports: Dizziness[Ref]

Some side effects of Temovate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.