Taclonex Ointment

Generic name: betamethasone and calcipotriene topical
Drug class: Topical antipsoriatics

Medically reviewed by  A Ras MD.

What is Taclonex Ointment?

Taclonex Ointment is a prescription medicine that is for use on the skin only (a topical medicine). Taclonex Ointment is used to treat plaque psoriasis in patients 12 years of age and older.

Taclonex Ointment has not been studied in patients under the age of 12 years.

Description

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 0.005%/0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only.

Calcipotriene hydrate is a synthetic vitamin D3 analogue.

Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3,H2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene hydrate is a white to almost white crystalline compound.

Betamethasone dipropionate is a synthetic corticosteroid.

Betamethasone dipropionate has the chemical name 9-fluoro-11(beta), 17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

Betamethasone dipropionate is a white to almost white odorless powder.Each gram of Taclonex® Ointment contains 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum.

What is the most important information I should know about Taclonex?

Taclonex Ointment is for use on the skin only (topical use only). Do not use Taclonex Ointment on the face, under arms or on groin area. Do not swallow Taclonex Ointment. Another product, Taclonex Topical Suspension contains the same medicine that is in Taclonex Ointment and is used to treat plaque psoriasis on the scalp. If you use both medicines to treat your plaque psoriasis, be sure to follow your doctor’s directions carefully so that you do not use too much of one or both of these medications.

Who should not use Taclonex?

Do not use Taclonex Ointment if you:

• have thin skin (atrophy) at the site to be treated
• are allergic to anything in Taclonex Ointment. See the end of this leaflet for a complete list of ingredients.

What should I tell my healthcare provider before using Taclonex?

Tell your doctor about all of your health conditions, including if you:

• have a skin infection. Your skin infection should be treated before starting Taclonex Ointment.
• have a calcium metabolism disorder
• have one of the following types of psoriasis:
  • erythrodermic psoriasis
  • exfoliative psoriasis
  • pustular psoriasis
• are getting phototherapy treatments (light therapy) for your psoriasis
• are pregnant or planning to become pregnant. It is not known if Taclonex Ointment can harm your unborn baby. You and your doctor will have to decide if Taclonex Ointment is right for you while pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Taclonex Ointment passes into your milk and if it can harm your baby. If you use Taclonex Ointment while breastfeeding, use Taclonex Ointment on the smallest area of skin and for the shortest time needed. If you use Taclonex Ointment, do not apply Taclonex Ointment to your nipple or areola to avoid getting Taclonex Ointment into your baby’s mouth.

Tell your doctor about all the medicines you take, including prescription, and nonprescription medicines, vitamins and herbal supplements.

Taclonex Ointment and some other medicines can interact with each other. Especially tell your doctor if you use:

• other corticosteroid medicines
• other medicines for your psoriasis

How should I use Taclonex?

• Use Taclonex Ointment exactly as prescribed by your doctor.
• If you are 18 years of age or older, you should not use more than 100 grams of Taclonex Ointment in 1 week.
• If you are 12 to 17 years of age, you should not use more than 60 grams of Taclonex Ointment in 1 week.
• Apply Taclonex Ointment once a day to the areas of your skin affected by psoriasis. Gently rub Taclonex Ointment into your affected skin areas.
• Only use Taclonex Ointment as directed by your doctor. Taclonex Ointment is recommended for up to 4 weeks of treatment. Do not use Taclonex Ointment for more than 4 weeks unless prescribed by your doctor.
• Do not use Taclonex Ointment on the face, under arms or on groin area. If you accidentally get Taclonex Ointment on the face or in the eyes wash the area with water right away.
• If you forget to use Taclonex Ointment, use it as soon as you remember. Then go on as before.
• Wash your hands well after applying Taclonex Ointment.
• If you are breastfeeding, do not use Taclonex Ointment on the breast while nursing.

Using Taclonex Ointment:
Do not bandage or tightly cover the treated skin area.

Remove the cap and check that the aluminum seal covers the tube before the first use. To break the seal, turn the cap over and punch through the seal.

What should I avoid while using Taclonex?

Avoid spending a long time in the sunlight. Avoid tanning booths and sunlamps. Use sunscreen if you have to be in the sunlight. Talk to your doctor if you get a sunburn.

What are the possible side effects of Taclonex?

The most common side effects are:

• itching
• rash

Other less common side effects with Taclonex Ointment include:

• redness of the skin
• skin irritation
• skin burning
• inflamed hair pores (folliculitis)
• change of skin color (at the site of application)
• rash with pus-filled papules
• thinning of the skin (atrophy)
• swollen fine blood vessels (this makes your skin appear red at the site of application)

Taclonex Ointment may cause serious side effects. Serious side effects are more likely to happen if you use too much Taclonex Ointment, use it for too long, or use it with other topical medicines that contain corticosteroids, calcipotriene, or certain other ingredients. Check with your doctor before using other topical medicines. Taclonex Ointment can pass through your skin. Serious side effects may include:

• too much calcium in your blood or urine
• adrenal gland problems

Your doctor may do special blood and urine tests to check your calcium levels and adrenal gland function while you are using Taclonex Ointment.
Call your doctor about any side effect that bothers you or that does not go away.

These are not all of the side effects with Taclonex Ointment. Ask your doctor or pharmacist for more information.

Vision problems. Taclonex Ointment may increase your chance of developing cataract(s) and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with Taclonex Ointment.

General information about the safe and effective use of Taclonex

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex Ointment for a condition for which it was not prescribed. Do not give Taclonex Ointment 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 Ointment. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex Ointment that is written for health professionals.

How should I store Taclonex?

• Store Taclonex Ointment at room temperature, 68°F – 77°F (20°C – 25°C); Make sure the cap on the tube is tightly closed.
• Taclonex Ointment has an expiration date (exp.) marked on the tube. Do not use the ointment after this date.
• Keep Taclonex Ointment and all medicines out of the reach of children and pets.

What are the ingredients in Taclonex?

Active ingredients in ointment: calcipotriene hydrate, betamethasone dipropionate.
Inactive ingredients in ointment: butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, white petrolatum.