Pimple scar treatment

Information for Patients (Gel)

TAZORAC Gel (PDF)

TAZORAC
(tazarotene) Gel, 0.05%
(tazarotene) Gel, 0.1%

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Please read this carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This does not take the place of talks with your doctor. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.

Uses:

TAZORAC Gel 0.05% is used in the treatment of stable plaque psoriasis covering up to 20% of body surface area.

TAZORAC Gel 0.1% is used in the treatment of stable plaque psoriasis covering up to 20% of body surface area and in the treatment of mild to moderately severe facial acne.

Before you use this medicine

You should be aware that:

(a) TAZORAC Gel should not be used if you are pregnant, attempting to become pregnant or at high risk of pregnancy. Consult your physician for adequate birth control measures if you are a female of childbearing potential. If you are able to become pregnant, take a pregnancy test within 2 weeks prior to beginning to use TAZORAC Gel to be sure you are not pregnant. If you have menstrual periods, begin taking TAZORAC Gel during a normal menstrual period. These actions help assure that you are not pregnant when you begin use.

(b) TAZORAC Gel should be used with caution if you are also using other topical agents with a strong skin drying effect, products with high concentrations of alcohol, astringents, spices, the peel of lime, medicated soaps or shampoos, permanent wave solutions, electrolysis, hair depilatories or waxes, or other preparations or processes that might dry or irritate the skin, unless otherwise instructed by your health care practitioner.

(c) TAZORAC Gel should not be used if you have sunburn, eczema or other chronic skin condition(s). TAZORAC Gel may cause severe irritation if applied to eczematous skin. If you have sunburn, you should wait until full recovery before using TAZORAC Gel.

(d) TAZORAC Gel should not be used if you are inherently sensitive to sunlight.

(e) TAZORAC Gel should not be used if you are taking other drugs that increase your sensitivity to sunlight (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides). Inform your physician if you are taking any other medications.

(f) You should use protective clothing and sunscreens with minimum SPF of 15 during the day when being treated with TAZORAC Gel. You should avoid direct sun exposure as much as possible and avoid sunlamps totally while being treated with TAZORAC Gel, unless advised otherwise by your doctor.

(g) If you have considerable sun exposure due to occupation, particular caution as described above should be exercised when using TAZORAC Gel.

(h) Weather extremes, such as wind or cold, may be more irritating to your skin while you are using TAZORAC Gel.

Before you use this medicine

Tell your doctor:

(a) If you are pregnant or are considering becoming pregnant.

(b) If you are breast-feeding. We do not know if tazarotene can pass through the milk to the baby. The potential harm to the baby is unknown.

(c) If you are allergic to any ingredients in this medicine.

(d) If you are already using other products that make your skin dry.

(e) If you have a skin condition called eczema.

(f) If you will be subject to excessive sun exposure.

(g) If you are taking vitamin A supplements.

How to use this product

• Read the directions on your prescription label carefully. Ask your doctor or pharmacist to explain anything that you do not understand
• If you become pregnant while using TAZORAC Gel, you should immediately discontinue its use and contact your doctor
• If you use a cream or lotion to soften or lubricate your skin, apply TAZORAC Gel after ensuring that there is no more cream or lotion on the skin
• With use of TAZORAC Gel, some people notice a feeling of itching, burning or stinging. If irritation is excessive, consult your health care provider, who may adjust your medication temporarily to a more comfortable level. Effectiveness of this medication when used less often than once daily has not been proven
• Do not cover treated areas with dressings or bandages
• Never use more TAZORAC Gel than instructed and never use it more often than instructed, as application of larger amounts of medication than recommended will not lead to more rapid or better results, and marked redness, peeling or discomfort may occur
• Wash your hands after applying the medication unless you are treating your hands for psoriasis. If the gel accidentally gets on areas you do not need to treat, wash it off
• Keep TAZORAC Gel away from your eyes, eyelids, and mouth. If it gets in contact with your eyes, wash them with large amounts of cool water, and contact a doctor if eye irritation persists

Missed doses

• If you forget or miss a dose of TAZORAC Gel, do not try to “make it up.” Return to your normal application schedule as soon as you can

Instructions specific to treatment of psoriasis

• If you bathe or shower before using TAZORAC Gel, be sure the skin is dry before application. Apply a thin film of the gel to your psoriasis lesions once a day before going to bed
• Carefully avoid application to apparently uninvolved skin. TAZORAC Gel may be more irritating to nonlesional skin
• If you need to treat your hands, avoid contact with your eyes
• Usually your psoriasis plaques and scales will begin to improve in about one to four weeks, but the redness may take longer to improve. Continue to use TAZORAC Gel as directed by your doctor
• Contact your doctor if your psoriasis becomes worse

Instructions specific to treatment of acne

• Gently clean and dry your face before using TAZORAC Gel. Apply TAZORAC Gel once a day, before going to bed, to entire areas of the face where you have acne lesions. Use enough gel to cover the entire affected area with a thin film
• Follow your doctor’s directions for other routine skin care and the use of make-up. Talk to your doctor about the use of sunscreens and cosmetics, especially those that dry your skin
• Usually, your acne will begin to improve in about 4 weeks. Continue to use TAZORAC Gel for up to 12 weeks as directed by your doctor
• Contact your doctor if your acne becomes worse

Possible side effects of TAZORAC Gel

For patients with psoriasis, the most common side effects of TAZORAC Gel 0.05% and 0.1% are itching, burning/stinging, red skin, worsening of psoriasis, irritation, and skin pain.

For patients with acne, the most common side effects of TAZORAC Gel 0.1% are peeling, burning/stinging, dry skin, red skin, and itching.

Tell your doctor if these side effects become problems. Your doctor may wish to adjust your dose of TAZORAC Gel. However, effectiveness of TAZORAC Gel when used less often than once a day has not been proven.

While you take TAZORAC Gel, weather extremes, such as wind or cold, may irritate your skin more than usual.

Warnings

TAZORAC Gel should not be used if you are allergic to any of its ingredients. TAZORAC Gel contains tazarotene as the active ingredient, and the following inactive ingredients: ascorbic acid, benzyl alcohol, butylated hydroxyanisole, butylated hydroxytoluene, carbomer 934P, edetate disodium, hexylene glycol, poloxamer 407, polyethylene glycol 400, polysorbate 40, purified water, and tromethamine.

TAZORAC Gel should not be used if you are pregnant, attempting to become pregnant or at high risk of pregnancy. Women of childbearing potential should use adequate birth-control measures when TAZORAC Gel is used.

If TAZORAC Gel is swallowed by accident, contact your doctor or a poison control center.

Do not use TAZORAC Gel after the expiration date found on the bottom seal of the tube.

This medicine is for your use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their skin problem appears to be the same as yours.

Retinoids should not be used on eczematous skin, as they may cause severe irritation. Do not use TAZORAC Gel until your doctor has confirmed that your eczema has fully recovered.

Because of increased burning susceptibility, exposure to sunlight (including sunlamps) should be avoided or minimized during the use of TAZORAC Gel, unless prescribed differently by your doctor.

You should use sunscreens (minimum SPF of 15) and protective clothing when using TAZORAC Gel. Be certain that you use these precautions if you expect to experience considerable sun exposure or if you are sensitive to sunlight.

If you have a sunburn, do not use TAZORAC Gel until you have fully recovered.

Do not use TAZORAC Gel if you are also taking drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides), unless you have discussed taking both drugs with your doctor, because of the increased possibility of a more severe reaction.

The safety of use over more than 20% of body surface area has not been established in psoriasis or acne.

Instructions for use and handling

Keep tube tightly closed when not in use. Store it in a safe place where children cannot reach it. TAZORAC Gel should be stored at 25 C (77 F): excursion permitted to 15-30 C (59-86 F).

General advice about prescription medicines

This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use TAZORAC Gel for a condition for which it was not prescribed. Do not use TAZORAC Gel after the expiration date on the bottom seal of the tube.

Where can I get more information about TAZORAC Gel?

You can contact Allergan by calling 800-433-8871. You can ask your doctor or pharmacist for the information about TAZORAC Gel that is written for health professionals.

If you have questions about psoriasis

Information is available from:
The National Psoriasis Foundation
6600 SW 92nd Avenue, Suite 300, Portland, OR 97223-7195
Telephone (800) 723-9166, or on the World Wide Web at http://www.psoriasis.org

marks owned by Allergan, Inc.

ALLERGAN
Irvine, California 92612, USA January 2004
2004 Allergan, Inc.
Printed in USA

8606X, 8607XA

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