Halobetasol and tazarotene (Topical application)

Halobetasol and tazarotene combination topical is used to treat plaque psoriasis. Plaque psoriasis is a skin disease that causes 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 helps to reduce redness and the number and size of skin lesions.

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

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

If your symptoms do not improve within a few days or weeks, or if they get worse, contact your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant. If you think you may be pregnant while using this medicine, inform your doctor immediately.

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

Using too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. The risk is higher for children and patients who use large amounts for extended periods. Contact your doctor right away if you experience more than one of these symptoms while 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 likely to get sunburned, dry, or irritated. Do not use a sunlamp or tanning bed. Use a sunscreen or sunblock lotion with a sun protection factor (SPF) of at least 15 regularly. Wear protective clothing and hats and stay out of direct sunlight, especially between 10 a.m. and 3 p.m.

It is possible 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.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want your eyes 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.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. Here are important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how halobetasol and tazarotene combination topical affects children. Safety and effectiveness have not been proven.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of halobetasol topical.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could happen. In these 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

Some medicines should not be taken around mealtime or with certain foods because interactions may occur. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Adrenal gland problem or
• Diabetes or
• Eye or vision problems (e.g., cataracts, glaucoma)—Use with caution. May worsen these conditions.

• Broken skin at the application site or
• Liver failure—Use with caution. May increase the chance of side effects.

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor right away 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to help prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Duobrii

Available Dosage Forms:

• Lotion

Therapeutic Class: Corticosteroid, Very Strong

Pharmacologic Class: Halobetasol

Chemical Class: Retinoid

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.

• How long should you use Duobrii?
• What happens if you use too much Duobrii?