July 29, 2016
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Taclonex Scalp

"Subtle signs of joint involvement detectable using magnetic resonance imaging (MRI) of the hand helped identify a subset of patients with psoriasis who were at high risk of developing psoriatic arthritis (PsA), researchers report in an article pu"...

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Taclonex Scalp




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

Application of Taclonex® Topical Suspension to your scalp - Illustration

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

Assembled Taclonex® Topical Suspension with Applicator - Illustration

Parts of Your Taclone® Topica Suspension with Applicator

Parts of Your Taclone® Topica Suspension with Applicator - Illustration

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.

Check expiration date - Illustration

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.

Remove the cartridge cap - Illustration

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.

TACLONEX® (calcipotriene and betamethasone dipropionate) Figure 5 Illustration

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.

Prime the applicator - Illustration

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.

Apply to the affected area - Illustration

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.

Use the spreading surfaces of the applicator head -  Illustration

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

Use applicator nozzle to apply to scalp and hairline - Illustration

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.

Clean your Taclonex® Topical Suspension with Applicator - Illustration

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.

Cover the applicator - Illustration

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.

Estimate the amount of remaining Taclonex® Topical Suspension - Illustration

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.

Check expiration date -  Illustration

Step 13: Remove cover by lifting the tab at rear.

TACLONEX® (calcipotriene and betamethasone dipropionate) Figure 14 Illustration

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.

Last reviewed on RxList: 7/6/2016
This monograph has been modified to include the generic and brand name in many instances.

Taclonex Scalp - User Reviews

Taclonex Scalp User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Taclonex Scalp sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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