Pronunciation:

hal-oh-BAY-ta-sol PROE-pee-oh-nate, taz-AR-oh-teen

Brand Names:

• Duobrii

Dosage Forms:

• Lotion

Classifications:

Therapeutic—

Corticosteroid, Very Strong

Pharmacologic—

Halobetasol

Chemical—

Retinoid

Uses of This Medicine:

Halobetasol and tazarotene combination topical is used to treat plaque psoriasis. Plaque psoriasis is a skin disease with red patches and white scales that do not go away.

Halobetasol is a corticosteroid that helps relieve redness, itching, swelling, or other discomfort caused by certain skin conditions. Tazarotene works by making the skin less red and reducing the number and size of lesions of the skin.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of halobetasol and tazarotene combination topical in the pediatric population. Safety and efficacy have not been established.

Older adults—

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

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other 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.

Other interactions—

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:

• Adrenal gland problem or
• Diabetes or
• Eye or vision problems (eg, cataracts, glaucoma)—Use with caution. May make these conditions worse.

• Broken skin at the application site or
• Liver failure—Use with caution. The chance of side effects may be increased.

• Eczema (skin disorder) or
• Sunburn—Should not be used in patients with these conditions. May increase risk of skin burning and irritation.

• Skin infection—Must be treated first before using this medicine.

Proper Use of This Medicine:

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 only on the skin. Do not get it into your eyes, nose, mouth, groin, or vagina, or apply it on your face or under your arms. If it does get on these areas, rinse it off right away with water.

To use:

• Wash your hands with soap and water before and after using this medicine.
• Make sure your skin is dry before you use the medicine.
• 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.

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.

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 form (lotion):
  • For plaque psoriasis:
    • Adults—Apply to the affected area of the skin once a day.
    • Children—Use and dose must be determined by the doctor.

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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

To make sure you are not pregnant when you start using this medicine, you may need to start using it during a normal menstrual period. Also, you must have a negative pregnancy test within 2 weeks before you start using this medicine.

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 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.

Avoid exposing your skin to wind, cold weather, and sunlight, even on cloudy days. Your skin will be more prone to sunburn, dryness, or irritation. Do not use a sunlamp or tanning bed. Use a sunscreen or sunblock lotion with a sun protection factor (SPF) of at least 15 on a regular basis. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 a.m. and 3 p.m.

It is likely that your skin may become irritated with normal use of this medicine. You should not stop using tazarotene unless your skin becomes too red, dry, puffy, or otherwise irritated. If severe irritation occurs, contact your doctor.

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 be checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

Blistering, burning, crusting, drying, or flaking of the skin

itching, scaling, severe redness, soreness, or swelling of the skin

Less common

Breakdown, weakness, falling off, or wasting away of the skin

burning, itching, and pain in hairy areas, pus at the root of the hair

skin scrape or irritation

thinning of skin with easy bruising, especially when used on the face or areas where the skin may touch or rub together

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

Pain at the application site

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.