PATIENT INFORMATION
Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical
Suspension, 0.005%/0.064%
Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical
Suspension, 0.005%/0.064% with Applicator
Important: Taclonex® Topical Suspension is for use
on skin only (topical). Do not get Taclonex® Topical Suspension near or in your
mouth, eyes, or vagina.
There are other medicines that contain the same medicine
that is in Taclonex® Topical Suspension and are used to treat plaque psoriasis.
Do not use other products containing calcipotriene or a corticosteroid medicine
with Taclonex® Topical Suspension without talking to your doctor first.
What is Taclonex® Topical Suspension?
Taclonex® Topical Suspension is a prescription medicine
used on the skin only (topical use) to treat:
- plaque psoriasis of the scalp and body in adults 18 years
of age and older
- plaque psoriasis of the scalp in children from 12 to 17
years of age
It is not known if Taclonex® Topical Suspension is safe
and effective in children under 12 years of age.
What should I tell my doctor before using Taclonex®
Topical Suspension?
Before you use Taclonex® Topical Suspension, tell your
doctor about all of your medical conditions, including if you:
- have a calcium metabolism disorder
- have thinning-skin (atrophy) at the site to be treated
- are getting light therapy (phototherapy treatments) for
your psoriasis
- are pregnant or plan to become pregnant. It is not known
if Taclonex® Topical Suspension will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known
if Taclonex® Topical Suspension passes into your breast milk. You should not
use Taclonex® Topical suspension on your breast if you breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the counter medicines, vitamins, and herbal
supplements.
How should I use Taclonex® Topical Suspension?
See the “Instructions for Use” for detailed
information about the right way to use Taclonex® Topical Suspension Bottle or
Taclonex® Topical Suspension with Applicator.
- Use Taclonex® Topical Suspension exactly as your doctor
tells you to use it.
- Your doctor should tell you how much Taclonex® Topical
Suspension to use and where to use it.
- Your doctor will decide which type of Taclonex® Topical
Suspension to prescribe to you. Taclonex® Topical Suspension comes in:
- a carton containing a 60 g bottle or a carton containing
120 g (2 bottles of 60 g)
- an applicator, 60 g
- If you are 18 years of age or older, you should not use
more than 100 grams of Taclonex® Topical Suspension in 1 week.
- If you are 12 to 17 years of age, you should not use more
than 60 grams of Taclonex® Topical Suspension in 1 week.
- Do not use Taclonex® Topical Suspension longer than
prescribed. Using too much Taclonex® Topical Suspension, or using it too often,
or for too long can increase your risk for having serious side effects.
- Apply Taclonex® Topical Suspension to affected areas on
the skin 1 time a day for up to 8 weeks. You should stop treatment when your
plaque psoriasis is under control, unless your doctor gives you other
instructions.
- Do not apply Taclonex® Topical Suspension to the scalp in
the 12 hours before or after any chemical treatments to your hair. Since hair
treatments may involve strong chemicals, talk with your doctor first.
- If you accidentally get Taclonex® Topical Suspension on
your face or in your eyes, wash the area with water right away.
- Avoid using Taclonex® Topical Suspension on your face,
groin, or armpits (axilla), or if you have thinning of your skin (atrophy) at
the treatment site.
- Do not wash your hair, take a bath, or shower right after
applying Taclonex® Topical Suspension as the medicine will not work as well to
treat your psoriasis.
- Do not bandage or cover the treated skin area, unless
instructed by your doctor.
What should I avoid while using Taclonex® Topical
Suspension?
Avoid spending a long time in sunlight. Avoid tanning
booths and sun lamps.
What are the possible side effects of Taclonex®
Topical Suspension?
Taclonex® Topical Suspension may cause serious side
effects, including:
- too much calcium in your blood or urine
- adrenal gland problems
Your doctor may do blood and urine tests to check your calcium levels and
adrenal gland function while you are using Taclonex® Topical Suspension.
- skin problems such as
- thinning of your skin
- burning
- inflammation
- itching
- irritation
- dryness
- changes in skin color
- redness
- infection
- raised bumps on your skin
- eye irritation if you accidently get Taclonex® Topical
Suspension in your eyes
The most common side effects of Taclonex® Topical
Suspension are inflamed hair pores (folliculitis) and skin burning.
Tell your doctor if you have any side effect that bothers
you or that does not go away.
These are not all of the possible side effects of
Taclonex® Topical Suspension. For more information, ask your doctor or
pharmacist.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1800-FDA-1088.
How should I store Taclonex® Topical Suspension?
- Store Taclonex® Topical Suspension at room temperature
between 68°F to 77°F (20°C to 25°C).
- Do not refrigerate Taclonex® Topical Suspension.
- Bottle: Keep the bottle in the outer carton when not in
use.
- Bottle and Applicator: Discard unused Taclonex® Topical
Suspension 6 months after it has been opened.
Keep Taclonex® Topical Suspension and all medicines
out of the reach of children.
General information about Taclonex® Topical
Suspension.
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use Taclonex®
Topical Suspension for a condition for which it was not prescribed. Do not give
Taclonex® Topical Suspension to other people, even if they have the same
symptoms you have. It may harm them.
This leaflet summarizes the most important information
about Taclonex® Topical Suspension. If you would like more information, talk
with your doctor. You can ask your pharmacist or doctor for information about
Taclonex® Topical Suspension that is written for health professionals.
What are the ingredients in Taclonex® Topical
Suspension?
Active ingredients: calcipotriene hydrate and
betamethasone dipropionate.
Inactive ingredients: hydrogenated castor oil,
polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, butylhydroxytoluene
and mineral oil.
Instructions for Use
Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical
Suspension, 0.005%/0.064%Bottle
Important: Taclonex® Topical Suspension is for use
on skin only (topical). Do not get Taclonex® Topical Suspension near or in your
mouth, eyes, or vagina.
Read this Instructions for Use before you start using
Taclonex® Topical Suspension and each time you get a refill. There may be
new information. This information does not take the place of talking with your
doctor about your medical condition or treatment.
How to apply Taclonex® Topical Suspension to your
body:
Follow your doctor's instructions of how much Taclonex® Topical
Suspension to use and where to use it. Apply Taclonex® Topical Suspension
directly to areas affected by plaque psoriasis and gently rub in. Wash your
hands after applying Taclonex® Topical Suspension, unless you are treating
areas on your hands.
How to apply Taclonex® Topical Suspension to your
scalp:
You do not need to wash your hair before you apply
Taclonex® Topical Suspension.
Step 1: Shake the bottle before use. Remove the
cap from the bottle. (See Figure A).
Step 2: Locate the area to treat using your
fingers and part your hair. (See Figure B).
Figure A, B, C and D
Step 3: Squeeze a drop of Taclonex® Topical
Suspension to your fingertip. (See Figure C).
Step 4: Use your fingers to apply the drop of
Taclonex® Topical Suspension directly to scalp affected by plaque psoriasis.
Gently rub in. (See Figure D).
Step 5: After applying Taclonex® Topical
Suspension, put the cap back on the bottle.
Step 6: Wash your hands after applying Taclonex® Topical
Suspension. Do not wash your hair right after you apply Taclonex® Topical
Suspension to your scalp.
How should I store Taclonex
Topical Suspension?
- Store the Taclonex® Topical® Suspension at room
temperature between 68°F to 77°F (20°C to 25°C).
- Do not refrigerate Taclonex® Topical Suspension.
- Keep bottle in the outer carton when not in use.
- Discard unused Taclonex® Topical Suspension 6 months
after it has been opened
Keep Taclonex® Topical Suspension and all medicines
out of the reach of children.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.
Instructions for Use
Taclonex®
(TAK-lo-NEKS)
(calcipotriene and betamethasone dipropionate) Topical
Suspension, 0.005%/0.064% with Applicator
Important: Taclonex® Topical Suspension is for use
on skin only (topical). Do not get Taclonex® Topical Suspension near or in your
mouth, eyes, or vagina.
Read this Instructions for Use before you start using
Taclonex® Topical Suspension with Applicator and each time you get a
refill. There may be new information. This information does not take the place
of talking with your doctor about your medical condition or treatment.
Do not share the Taclonex® Topical Suspension or
the Applicator with other people.
Assembled Taclonex® Topical Suspension with Applicator
Parts of Your Taclone® Topica Suspension with
Applicator
Preparing your Taclonex®
Topical Suspension with
Applicator:
Step 1: Check the expiration date on the cartridge
label.
Do not use if expired. The expiration date on the
cartridge refers to the last day of that month.
Write the date that you assembled the applicator on the
cartridge label. Do not use the applicator more than 6 months after this date.
Step 2: Remove the cartridge cap.
Hold the cartridge upright on a flat surface and twist
the cap counter-clockwise to remove. Avoid tipping the cartridge as this may
result in spilling the product.
Throw away (discard) the cartridge cap after removing.
Step 3: Attach the applicator head tightly.
Keep the cartridge upright and align the applicator head.
Screw the applicator head clockwise until the applicator
head feels tightly sealed. Avoid touching the applicator nozzle. You will hear
clicking sounds until it is tightly sealed.
Note: Do not take apart (disassemble) the applicator.
If you try to take the applicator apart, you may break the applicator.
Step 4: Prime the applicator before first use.
Hold the applicator while squeezing the lever with one
hand. Gently push up on the center of the plunger with your thumb of your other
hand, until you see the medicine come out at the nozzle tip.
Note: If you travel in an airplane with your assembled
Taclonex® Topical Suspension with Applicator, you may need to pump the lever a
few times to re-prime before applying.
Applying Taclonex® Topical Suspension with Applicator
to the affected area:
Step 5: Apply to the affected area.
Place the applicator nozzle close to the affected area
and press the lever one or more times to dispense the Taclonex® Topical
Suspension.
Release the lever fully between each pump to get a full
dispense.
One full pump delivers a consistent amount of Taclonex® Topical
Suspension.
Step 6: Use the spreading surfaces of the applicator
head.
Use the spreading surfaces to gently massage Taclonex® Topical
Suspension into the affected skin.
Be careful not to press the lever when spreading.
Step 7: Use applicator nozzle to apply to scalp and
hairline.
Locate the area to treat using your fingers and part your
hair.
Use the applicator nozzle directly on the scalp or
hairline. Press lever to dispense medicine and use the applicator
Step 8: After applying, check that the affected areas
are fully treated with Taclonex® Topical Suspension.
If needed, ask someone to help you apply Taclonex® Topical
Suspension to areas you cannot reach or see.
Wash your hands after use if you or someone
helping you gets Taclonex® Topical Suspension on the fingers, unless you are
treating areas on your hands. Do not wash your hair right after you apply
Taclonex® Topical Suspension to your scalp.
After using Taclone® Topica Suspension with
Applicator:
Step 9: Clean your Taclonex® Topical Suspension with
Applicator after each use.
Following use, wipe the applicator head with one side of
a clean, dry tissue for 3 seconds. After wiping, fold the tissue and use the
other dry side of the tissue to wipe the applicator head again for an
additional 3 seconds. Make sure that no product remains on the applicator head.
Avoid pumping the applicator while cleaning.
Note: Do not wash the applicator with water,
detergents, or other products. Do not use moist or wet materials to wipe the
applicator.
Step 10: Cover the applicator.
Put the cover on after each use to keep the applicator
head clean.
Make sure you hear the cover click in place to prevent
dispensing the product during storage and transportation.
Step 11: Estimate the amount of remaining Taclonex® Topical
Suspension.
To estimate the amount of remaining Taclonex® Topical
Suspension, look in the bottom of the cartridge to see the plunger position.
Before using Taclonex® Topical Suspension with
Applicator again
Step 12: Check expiration date on the cartridge label
before each use. Do not use if expired or 6 months after opening the
cartridge.
Step 13: Remove cover by lifting the tab at rear.
How should I store Taclonex®
Topical Suspension with Applicator?
- Store the Taclonex® Topical Suspension at room
temperature between 68°F to 77°F (20°C to 25°C).
- Do not refrigerate Taclonex® Topical Suspension.
- Use Taclonex® Topical Suspension within 6 months after it
has been opened.
Keep Taclonex® Topical Suspension with Applicator and
all medicines out of the reach of children.
How should I throw away (dispose of) the Taclonex® Topical
Suspension with Applicator?
- The Applicator should be thrown away (disposed of) when
it is empty or has passed the expiration date.
- Ask your pharmacist for instructions on how to throw away
(dispose of) the Taclonex® Topical Suspension with Applicator.
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.