Halobetasol Topical application

It is very important that you use halobetasol 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.

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

halobetasol 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. halobetasol should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

Do not use halobetasol on the face, groin, or underarms unless directed to do so by your doctor.

To use:

• Wash your hands with soap and water before and after using halobetasol.
• Apply a thin layer of halobetasol to the affected area of the skin. Rub it in gently.
• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

Dosing

The dose of halobetasol 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 halobetasol. 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 topical dosage forms (cream and ointment):
  • For redness, itching, and swelling of the skin:
    • Adults—Apply to the affected area of the skin one or two times per day.
    • Children 12 years of age and older—Apply to the affected area of the skin one or two times per day.
    • Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of halobetasol, 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

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

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Do not keep outdated medicine or medicine no longer needed.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.

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by halobetasol.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of halobetasol or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater 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 you are using halobetasol: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using halobetasol and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

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

Along with its needed effects, a medicine 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:

• Blisters under the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dry skin
• flushing or redness of the skin
• hives or welts
• itching
• rash
• stinging
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• unusually warm skin

• Blistering, burning, crusting, dryness, or flaking of the skin
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth

Some side effects 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:

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• 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

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

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

Apply a thin layer to affected area once or twice a day

Comments:
-Treatment should be limited to two weeks.
-Use should be limited to 50 g a week.
-Use should be discontinued when control is achieved.
-Reassessment of diagnosis may be needed, if no improvement is seen in two weeks.
-This topical drug should not be used with occlusive dressings.

Use: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

12 years or older:
Apply a thin layer to affected area once or twice a day

Comments:
-Treatment should be limited to two weeks.
-Use should be limited to 50 g a week.
-Use should be discontinued when control is achieved.
-Reassessment of diagnosis may be needed, if no improvement is seen in two weeks.
-This topical drug should not be used with occlusive dressings.

Use: Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses

Data not available

Substance Name

Halobetasol

CAS Registry Number

66852-54-8

Drug Class

Corticosteroids, Topical

Glucocorticoids

Anti-Inflammatory Agents

LactMed Record Number

131

Last Revision Date

20150310

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