Ultravate

Common Side Effects of Halobetasol

Tell your doctor if the following side effects become severe or don't go away:

• Burning
• Stinging
• Redness
• Itching

Serious Side Effects of Halobetasol

Tell your doctor immediately if you experience any of the symptoms listed in the Halobetasol Warnings section above, or the following serious side effects:

• Severe burning, itching, or redness
• Skin thinning or discoloration
• Severe skin rash
• Swelling
• Nausea or vomiting
• Excessive hair growth
• Acne
• Inflamed hair follicles
• Irregular menstrual periods (in women)
• Changes in sexual function
• Signs of a skin infection, which may include redness, swelling, or oozing of the skin
• Symptoms of anaphylaxis, which may include rash, hives, itching, difficulty breathing, tightness in the chest, or swelling of the face, mouth, lips, or tongue

Ultravate is a prescription medication used to treat swelling, inflammation, and itching associated with skin conditions such as eczema and dermatitis. This topical (applied to skin) medication belongs to a group of drugs called glucocorticoids (also referred to as steroids) which reduce inflammation, pain, swelling, redness, and itching.

Ultravate comes in cream and ointment forms. It is usually applied in a thin layer to the affected skin once or twice daily for up to 2 weeks.

Common side effects include skin reactions such as burning, itching, or stinging.

Ultravate is a prescription medication used for the relief of the inflammation and itchiness caused by a variety of skin conditions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ultravate is part of the drug class:

• Corticosteroids, potent group III

In the U.S.

• Ultravate
• Ultravate X

Available Dosage Forms:

• Cream
• Lotion
• Ointment

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Halobetasol

Halobetasol topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

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

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 halobetasol topical 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 use is not recommended.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of halobetasol topical in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• 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.

• 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—The chance of side effects may be increased.

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

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 this medicine.

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 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 more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine 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.

Ultravate® contains halobetasol propionate, a synthetic corticosteroid for topical dermatological use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agent.

Chemically halobetasol propionate is 21-chloro-6α, 9-difluoro-11β, 17-dihydroxy-16β-methylpregna-1, 4-diene-3-20-dione, 17-propionate, C25H31ClF2O5. It has the following structural formula:

Halobetasol propionate has the molecular weight of 485. It is a white crystalline powder insoluble in water.

Each gram of Ultravate Cream contains 0.5 mg/g of halobetasol propionate in a cream base of cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, (and) methylisothiazolinone and water.

Each gram of Ultravate Ointment contains 0.5 mg/g of halobetasol propionate in a base of aluminum stearate, beeswax, pentaerythritol cocoate, petrolatum, propylene glycol, sorbitan sesquioleate, and stearyl citrate.