Details for: TAZORAC GEL
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02230785 | TAZORAC | TAZAROTENE | 0.1 % | GEL | TOPICAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
TAZORAC® is a topical drug for the treatment of plaque psoriasis and acne. It is applied to the skin.
What it does
TAZORAC® is a preserved gel that contains tazarotene as the active ingredient which is a retinoid. The exact mechanisms of action for psoriasis and acne are not known. It is thought to act by helping skin cells to grow normally as well as having an anti-inflammatory effect in psoriasis and acne.
When it should not be used
TAZORAC®
should not be used by women who are or may become
pregnant. If this drug is used during pregnancy, treatment should be
stopped and discussed with your doctor.
Do not use TAZORAC® if you have a skin condition called
seborrheic dermatitis, a red, itchy, flaky, scaly inflammation of the
skin.
Do not use TAZORAC®
if you are allergic to tazarotene or any of
the non-medicinal ingredients (see “What the important
nonmedicinal ingredients are” section).
What the medicinal ingredient is
Tazarotene
What the non-medicinal ingredients are
Benzyl alcohol 1.0% (w/w) as a preservative; ascorbic acid, butylated hydroxyanisole, butylated hydroxytoluene as antioxidants; carbomer 934P, edetate disodium, hexylene glycol, purified water, poloxamer 407, polyethylene glycol 400, polysorbate 40, and tromethamine
What dosage form it comes in
Gel, 0.05% and 0.1% w/w
Warnings and precautions
Weather extremes, such as wind or cold, may be more irritating to
patients using TAZORAC®
BEFORE you use TAZORAC® talk to your doctor or
pharmacist:
- if you are pregnant or plan to become pregnant while using this drug
- if you are breast feeding or planning to breast feed
- if you are already using other products that make your skin dry (see INTERACTIONS WITH THIS MEDICATION)
- if you have a skin condition called eczema. TAZORAC® may cause severe irritation if applied to eczematous skin
- Avoid contact with the eyes and mucous membranes, eyes, lips and nose. In case of accidental contact, rinse thoroughly with large amounts of water.
- TAZORAC® may cause skin irritation, burning or itching. Contact your doctor if these effects become troublesome
- This product may harm the fetus. Avoid pregnancy during TAZORAC® treatment.
- Use adequate birth control measures during treatment. Your doctor may request a pregnancy test in the 2 week period before TAZORAC® treatment. (see Warnings, Use in Pregnancy section of the Product Monograph)
- If you become pregnant while using TAZORAC® , stop treatment immediately and contact your doctor.
Interactions with this medication
Tell your doctor about all the medications you are taking, including
those without a prescription.
Medications that may interact with TAZORAC® include:
- medications that are applied to the skin and cosmetics that have a strong drying effect. It is also advisable to "rest" a patient's skin until the effects of such preparations subside before use of TAZORAC® begins.
- medications that make you sensitive to the sun (e.g. thiazides (diuretics), antibiotics (tetracyclines, fluoroquinolones), sulfonamides )).
Proper use of this medication
For external use only.
Psoriasis:
Usual adult dose and dose for children above the age of 12:
If you bathe or shower, be sure the skin is dry before applying
TAZORAC®
. Apply a thin film of the gel to your psoriasis lesions
once a day before going to bed.
Avoid application to normal skin. TAZORAC®
is sometimes more
irritating to normal skin.
If you need to treat your hands, avoid contact with your eyes.
Usually, you will notice an improvement in your psoriasis after
about one week. Continue to use TAZORAC®
as directed by your
doctor. Contact your doctor if your psoriasis becomes worse.
Acne:
Usual adult dose and dose for children above the age of 12:
Clean your skin gently. After it is dry, apply TAZORAC®
once a
day, before going to bed, to the areas 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 cosmetics,
especially those that dry your skin.
Usually, your acne will begin to improve in about 4 weeks.
Continue to use TAZORAC®
as directed by your doctor.
Contact your doctor if your acne becomes worse.
General directions for use:
Your doctor may have told you to use TAZORAC®
in a different
way to that recommended in this leaflet. If so, follow your doctor’s
instructions about when and how to use the gel. Read the directions
on your prescription label carefully. Ask your doctor or pharmacist
to explain anything that you do not understand.
If you use a cream or lotion to lubricate your skin, apply it to your
skin before applying TAZORAC®
.
Remove the cap and check that the seal is not broken before you
first use the gel. To break the seal, use the back of the cap.
Do not cover treatment areas with dressings or bandages.
Excessive use of TAZORAC® will not provide faster or better
results, and severe irritation or discomfort could 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.
This medicine was prescribed to treat your specific medical problem
and is for your use only. Do not share it with others. It may harm
them even if their skin problem appears to be the same as yours.
Overdose
Missed Dose
If you forget a dose of TAZORAC® , do not try to “make it up.”, simply return to your normal application schedule as soon as you can.
Side effects and what to do about them
| Very common | Occurs in more than 1 out of 10 patients |
| Common | Occurs in between 1 and 10 out of every 100 patients |
Like all medicines, TAZORAC®
can have side effects. Most of the
side effects are not serious. If these persist or cause you concern,
consult your doctor.
Psoriasis:
Very common
- Burning and redness of the skin
- Itchy and irritated skin
- Skin pain
- Worsening of psoriasis
- Skin peeling
- Dry skin
- Skin swelling
- Rash
- Stinging sensation of the skin
Very common
- Burning, peeling and redness of the skin
- Dry and itchy skin
- Irritation of the skin
- Stinging sensation of the skin
How to store
TAZORAC® should be stored at room temperature (15 - 25ºC).
Do not use TAZORAC®
after the expiration date found on the
crimp of the tube.
Keep the tube tightly closed when not in use. Store it in a safe place
where children cannot reach it or see it.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health
professionals can be obtained by contacting the sponsor, Allergan
Inc, at: 1-800-668-6424
This leaflet was prepared by Allergan Inc.
Last revised: June 29, 2015
©
2015 Allergan Inc., Markham, ON L6G 0B5.
®Marks owned by Allergan Inc. All rights reserved.