Ultravate X (Topical application)

Halobetasol topical is used to help reduce redness, itching, swelling, or other discomfort from certain skin conditions. It is also used to treat plaque 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 that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

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

Using too much of this medicine 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 blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Halobetasol lotion may cause serious skin reactions, which may occur if you cover the treated skin area or use the medicine for a long time. Check with your doctor right away if you or your child have thinning of the skin with easy bruising, reddish purple lines on the arms, face, legs, trunk, or groin areas, acne or pimples, darkening or lightening of skin color, blistering, burning, crusting, dryness, flaking of the skin, or itching, scaling, severe redness, soreness, or swelling of the skin.

Check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

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

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

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine compared to the benefits it will provide. Here are some important points to consider:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, inform your healthcare professional about any other allergies you may have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of halobetasol topical in children aged 12 and older. However, due to the toxicity of this medicine, it should be used carefully. Children can absorb large amounts through their skin, which can lead to serious side effects. If your child is using this medicine, follow your doctor’s instructions closely. Safety and effectiveness have not been established in children younger than 12 years, and use is not recommended.

Geriatric

Studies have not shown any specific problems that would limit the use of halobetasol topical in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together with caution. In those cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

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

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

• Perioral dermatitis (skin condition) or
• Rosacea (skin condition)—This medicine should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

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

Less common

• Blisters under the skin
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dry skin
• flushing or redness of the skin
• headache
• hives or welts, itching, skin rash
• raised, dark red, wart-like spots on the skin, especially when used on the face
• 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

Incidence not known

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

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:

Less common

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

Incidence not known

• Burning, itching, and pain in hairy areas, or pus at the root of the hair
• earache
• fever
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• muscle aches
• painful blisters on the trunk of the body
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness or swelling in the ear
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

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.

In the U.S.

• Bryhali
• Lexette
• Ultravate
• Ultravate X

Available Dosage Forms:

• Lotion
• Foam
• Cream
• Ointment

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Halobetasol

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 should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only on the skin. Do not get it into your eyes, nose, mouth, or groin, or apply it on your face or under your arms. Do not use it on skin areas that have cuts, scrapes, or burns. Do not apply the lotion to your nipple or areola, if you are breastfeeding. If it does get on these areas, rinse it off right away with water.

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.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Shake the aerosol foam can just before using.
• Apply a thin layer of this medicine 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 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 topical dosage forms (cream or ointment):For redness, itching, and swelling of the skin: Adults and children 12 years of age and older—Apply to the affected area of the skin 1 or 2 times a day. Children younger than 12 years of age—Use is not recommended.
• For topical dosage form (foam or lotion): For plaque psoriasis: Adults and children 12 years of age and older—Apply to the affected area of the skin 2 times a day for up to 2 weeks. Children younger than 12 years of age—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.

Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

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