Pronunciation:

taz-AR-oh-teen

Brand Names:

• Arazlo
• Avage
• Fabior
• Tazorac

Dosage Forms:

• Lotion
• Cream
• Foam
• Gel/Jelly

Classifications:

Therapeutic—

Antiacne

Chemical—

Retinoid

Uses of This Medicine:

Tazarotene topical foam, gel, and lotion are used to treat acne. This medicine works to help clear acne on the face partly by keeping the skin pores clear (tiny openings on the skin).

Tazarotene topical 0.1% cream is used to help reduce fine facial wrinkles and certain types of dark and light spots on the face in patients who use a total skin care program and avoid sunlight.

Tazarotene topical cream and gel are used to treat psoriasis. Tazorac® gel is used to treat plaque psoriasis in up to 20% of the skin area involved. This medicine 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 tazarotene foam or gel in children younger than 12 years of age, tazarotene lotion in children younger than 9 years of age, tazarotene topical 0.1% cream in children younger than 17 years of age, and tazarotene cream in the pediatric population. Safety and efficacy have not been established in these age groups.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tazarotene cream or gel in the elderly.

Appropriate studies have not been performed on the relationship of age to the effects of tazarotene topical foam or lotion in the geriatric population. Safety and efficacy have not been established.

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:

• Eczema (skin disorder) or
• Sunburn—Tazarotene may cause skin irritation and should not be used in patients with these conditions.

• Skin cancer (including lentigo maligna), or history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed. 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 your skin to be irritated. You may need to use this medicine for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away.

To use the Avage® cream:

• At bedtime, gently wash your face with mild soap. Remove any makeup before applying the cream to the face. Rinse and pat your skin dry.
• Apply a pea-sized amount to lightly cover your face, including the eyelids, if desired. Do not get any cream into your eyes. If contact occurs, rinse with water.
• Wash your hands after applying the cream.
• You may apply a moisturizing sunscreen in the morning, and wear protective clothing while using this medicine.
• You can also use a cream or lotion to soften or moisturize your skin before or after you apply Avage® cream.

To use the Fabior™ foam:

• Wash your hands with soap and water before and after using this medicine.
• Before applying this medicine, wash the affected area of your skin with water and a mild cleanser or soap. Rinse well and pat dry.
• Wait at least 20 to 30 minutes before applying the cream or gel.
• Apply a small amount of the medicine to each affected area of the skin (eg, forehead, chin, cheeks, chest, shoulders, or other parts in the body), and gently rub it in.
• Do not cover the treated area with a bandage.
• If you are using Fabior™ foam, dispense a small amount of foam into your palm. Apply only enough foam to lightly cover the affected area(s) of the face and upper body. Gently rub it until the foam disappears.
• You may also use moisturizer as needed.

To use the Tazorac® gel:

• Wash your hands before and after using this medicine.
• Dry your skin before applying a thin layer of this medicine on the affected area at bedtime.
• You can also use a cream or lotion to soften or moisturize your skin 1 hour before you apply Tazorac® gel for psoriasis.

Do not apply this medicine to windburned or sunburned skin or on open wounds.

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 (0.1% cream):
  • For reducing fine facial wrinkles and certain types of dark and light spots on the face:
    • Adults and children 17 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, at bedtime.
    • Children younger than 17 years of age—Use and dose must be determined by the doctor.
• For topical dosage form (cream):
  • For psoriasis:
    • Adults—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime.
    • Children—Use and dose must be determined by the doctor.
• For topical dosage form (foam):
  • For acne:
    • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime.
    • Children younger than 12 years of age—Use and dose must be determined by the doctor.
• For topical dosage form (gel):
  • For acne:
    • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime.
    • Children younger than 12 years of age—Use and dose must be determined by the doctor.
  • For psoriasis:
    • Adults and children 12 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime.
    • Children younger than 12 years of age—Use and dose must be determined by the doctor.
• For topical dosage form (lotion):
  • For acne:
    • Adults and children 9 years of age and older—Apply a thin layer to the affected area(s) of the skin once a day, usually in the evening or at bedtime.
    • Children younger than 9 years of age—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 the Fabior™ foam. Do not spray or use it near heat, open flame, or while smoking. Do not puncture, break, or burn the can.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

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.

If you are using this medicine to treat acne on the face, your condition may seem to worsen at first before it begins to improve in about 4 weeks. Check with your doctor if your condition does not improve within 8 to 12 weeks.

If you are using this medicine to treat psoriasis, scaly patches on the skin may begin to improve in about 1 to 4 weeks but redness may take longer to improve. Check with your doctor if your condition becomes worse.

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.

Skin reactions such as dryness, redness, scaling, burning, or stinging can occur when you use this medicine. Use a moisturizer as needed to lessen these skin problems.

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.

Unless your doctor tells you otherwise, you should avoid skin products that can dry or irritate the skin. Some examples are:

• Any topical acne product or skin product containing a peeling agent (such as benzoyl peroxide).
• Hair products that are irritating, such as permanents or hair removal products.
• Skin products that cause sensitivity to the sun, such as those containing spices or limes.
• Skin products containing a large amount of alcohol, such as astringents, shaving creams, or after-shave lotions.
• Skin products that are too drying or abrasive, such as some cosmetics, soaps, or skin cleansers.

Ask your doctor before taking vitamin A supplements by mouth while using this medicine.

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

Burning or stinging of the skin (severe)

changes in color of the treated skin

deep grooves or lines in the skin

dryness, itching, peeling, or redness of the skin (severe)

pain or swelling of the treated skin

skin rash (in patients with psoriasis only)

Incidence not known

Blistering, crusting, or irritation of the skin

cracked, dry, scaly skin

flaking and falling off of the skin

swelling at or near the application site

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:

More common

Burning or stinging after application

dryness, itching, peeling, or redness of the skin (mild)

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.