Details for: TAZORAC
Company: ALLERGAN INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02243894 | TAZORAC | TAZAROTENE | 0.05 % | CREAM | 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, acne and photodamage, to treat the signs and symptoms of premature aging due to overexposure to the sun such as the fine wrinkling, skin dryness, irregular or mottled pigmentation and liver spots on the skin.
What it does
TAZORAC® is a preserved cream that contains tazarotene as the active ingredient which is a retinoid. The exact mechanism of action is 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® must not be used by women who are or may
become pregnant. If you become pregnant during TAZORAC®
treatment, stop using TAZORAC®
and contact your doctor
immediately.
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,
retinoid compounds 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, carbomer 934P, carbomer 1342, edetate disodium, medium chain triglycerides, mineral oil, purified water, sodium thiosulphate, sorbitan monooleate, and sodium hydroxide to adjust the pH
What dosage form it comes in
Cream, 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 skin products that make your skin dry (see INTERACTIONS WITH THIS MEDICATION)
- if you have recently undergone a skin procedure such as skin peeling, dermabrasion or other similar procedure, allow your skin to heal before starting TAZORAC®
- if you have a skin condition called eczema. TAZORAC® may cause severe irritation if applied to eczematous skin
- if you are sensitive to sunlight
- 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. There are rare reports of birth defects in babies born to women who have used topical retinoids during pregnancy, but retinoids have not been proven as a cause. 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.
Medication that may interact with TAZORAC® include:
- medications that are applied to the skin and cosmetics that have a strong drying effect such as those containing alcohol, astringents, spices, lime peel, medicated soaps or shampoos, permanent wave solution, electrolysis, hair depilatories or waxes, or other products or processes that may dry or irritate the skin. Your doctor may tell you to stop using these products and allow your skin to heal before starting TAZORAC® treatment.
- medications that make you sensitive to the sun (e.g. thiazides (diuretics), antibiotics (tetracyclines, fluoroquinolones), phenotiazines, and sulfonamides )). Your doctor may advise that these medications should not be used during TAZORAC® treatment.
Proper use of this medication
For external use only.
For all uses:
Wash your hands after applying the medication unless you are
treating your hands for psoriasis. If the cream accidentally gets
on areas you do not need to treat, wash it off to help prevent skin
irritation.
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 cream to your psoriasis
lesions once a day before going to bed.
If you use a cream or lotion to soften or moisten your skin, apply
emollients first, at least 1 hour before TAZORAC®
. Apply
TAZORAC®
only after ensuring that the first cream or lotion
has absorbed into the skin.
Avoid application to normal skin. TAZORAC®
is sometimes
more irritating to normal skin.
You may notice an improvement in your psoriasis as early as one
week after starting TAZORAC®
treatment. 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®
0.1%
once a day in the evening to the affected areas. Use enough
cream 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.
Your acne may begin to improve as early as 4 weeks after
starting TAZORAC®
treatment. Continue to use TAZORAC®
as directed by your doctor.
Contact your doctor if your acne becomes worse.
Photodamage – The signs and symptoms of premature aging
due to overexposure to the sun:
Usual adult dose and dose for children above the age of 12:
Remove makeup (if present) before applying TAZORAC®
. If
you wash your face prior to applying TAZORAC®
, you should
allow your skin to dry first. Apply a pea-sized amount to lightly
cover the entire face. Apply with special care around eyelids if
desired. Do not spot treat. TAZORAC®
should be applied
once per day.
When treating the eyelid, wrinkles around the eye (Crow’s feet)
and mouth, special care must be taken to minimize contact with
the eyes, lips and mucous-producing areas.
Follow your doctor’s directions for other routine skin care and
the use of make-up. It is recommended to use a sunscreen with
an SPF of at least 15 during the day, but you should talk to your
doctor about the use of sunscreens, moisturizers, and cosmetics.
In general, facial moisturizers may be used as frequently as
desired. If emollients or moisturizers are used, they can be
applied either before or after tazarotene cream, but whichever
one is applied first should be allowed to absorb into the skin
before the next one is applied.
Although results will vary, you may begin to see improvement in
about 2 weeks for mottled pigmentation, 8 weeks for fine
wrinkling and varying times for other signs and symptoms.
Continue to use TAZORAC®
as directed by your doctor.
Contact your doctor if your photodamage 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 cream.
Read the directions on your prescription label carefully. Ask
your doctor or pharmacist to explain anything that you do not
understand.
Remove the cap and check that the seal is not broken before you
first use the cream. 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.
TAZORAC® was prescribed by your doctor 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
- Inflammation and pain of the skin
- Peeling of the skin
- Worsening of psoriasis
- Eczema
- Rash
- Stinging sensation of the skin
Very common
- Burning, peeling and redness of the skin
- Dry skin
- Itchy and irritated skin
- Stinging
Very common
- Burning, peeling and redness of the skin
- Dry skin
- Inflammation of the skin
- Itchy and irritated skin
- Stinging sensation of the skin
- Acne
- Rash
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: December 8, 2015
©
2015 Allergan Inc., Markham, ON L6G 0B5.
®Marks owned by Allergan Inc. All rights reserved.