Calcipotriene and Betamethasone Dipropionate

Name: Calcipotriene and Betamethasone Dipropionate

Patient information

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment
(calcipotriene, 0.005% and betamethasone dipropionate, 0.064%)

Read the Patient Information that comes with Taclonex® (calcipotriene and betamethasone dipropionate) Ointment before you start using it and each time you use the ointment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What is Taclonex® (calcipotriene and betamethasone dipropionate) Ointment and what is it used for?

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is a prescription medicine called a topical (skin-use only). Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is used on the skin to treat psoriasis vulgaris in adults. Taclonex® (calcipotriene and betamethasone dipropionate) Ointment contains

  • calcipotriene hydrate, which is somewhat similar to vitamin D, but not the same as vitamin D, and
  • betamethasone dipropionate, which is a strong (potent) corticosteroid.

It is very important that you use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment only as directed, in order to avoid serious side effects.

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is not recommended for use in children. Taclonex® (calcipotriene and betamethasone dipropionate) Ointment has not been studied in patients under the age of 18.

Who should not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment?

Do not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment if you:

  • have a calcium metabolism disorder
  • have one of the following types of psoriasis:
    • erythrodermic psoriasis o exfoliative psoriasis
    • pustular psoriasis
  • are allergic to anything in Taclonex® (calcipotriene and betamethasone dipropionate) Ointment. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before using Taclonex® (calcipotriene and betamethasone dipropionate) Ointment?

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® (calcipotriene and betamethasone dipropionate) Ointment
  • have thin-skin (atrophy) at the site to be treated. You should not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment
  • are getting phototherapy treatments for your psoriasis
  • are pregnant or planning to become pregnant. It is not known if Taclonex® (calcipotriene and betamethasone dipropionate) Ointment can harm your unborn baby. You and your doctor will have to decide if Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is right for you while pregnant
  • are breastfeeding. It is not known if Taclonex® (calcipotriene and betamethasone dipropionate) Ointment passes into your milk and if it can harm your baby

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

Taclonex® (calcipotriene and betamethasone dipropionate) 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® (calcipotriene and betamethasone dipropionate) Ointment?

  • Use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment exactly as directed by your doctor. Do not use more than the recommended weekly amount of 100 grams of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment.
  • Do not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on your face, under your arms or on your groin. Do not get any Taclonex® (calcipotriene and betamethasone dipropionate) Ointment in your eyes. Wash your face or eyes right away if you get Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on them.

Using Taclonex® (calcipotriene and betamethasone dipropionate) Ointment:

  • 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 push through the seal.
  • Apply Taclonex® (calcipotriene and betamethasone dipropionate) Ointment once a day to the areas of your skin affected by psoriasis. Gently rub Taclonex® (calcipotriene and betamethasone dipropionate) Ointment into your affected skin areas.
  • Do not bandage or tightly cover or wrap the treated skin area. Wear your usual clothes.
  • Only use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment as directed by your doctor. Taclonex® (calcipotriene and betamethasone dipropionate) Ointment is recommended for up to 4 weeks of treatment. Do not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment for more than 4 weeks unless prescribed by your doctor.
  • If you forget to use your Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, use it as soon as you remember. Then go on as before.
  • Wash your hands well after using Taclonex® (calcipotriene and betamethasone dipropionate) Ointment.

What are the possible side effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment?

The most common side effects are:

  • itching
  • rash
  • skin burning

Other less common side effects with Taclonex® (calcipotriene and betamethasone dipropionate) Ointment include:

  • redness of the skin
  •  inflamed hair pores (folliculitis)
  • psoriasis
  • skin irritation
  • change of skin color (at the site of application)
  • thinning of the skin (atrophy)
  • swollen fine blood vessels (this makes your skin appear red at the site of application)

Taclonex® (calcipotriene and betamethasone dipropionate) Ointment may cause serious side effects if you use too much or use it for too long. Taclonex® (calcipotriene and betamethasone dipropionate) Ointment can pass through your skin. Serious side effects may include:

  • too much calcium in your blood
  • 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® (calcipotriene and betamethasone dipropionate) 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® (calcipotriene and betamethasone dipropionate) Ointment. Ask your doctor or pharmacist for more information.

How should I store Taclonex® (calcipotriene and betamethasone dipropionate) Ointment?

  • Taclonex® (calcipotriene and betamethasone dipropionate) Ointment should be stored between 68-77°F (20-25°C); excursions permitted between 59-86°F (15-30°C). Make sure the cap on the tube is tightly closed.
  • Taclonex® (calcipotriene and betamethasone dipropionate) Ointment has an expiry date marked on the tube. Do not use the ointment after this date.
  • Keep Taclonex® (calcipotriene and betamethasone dipropionate) Ointment out of the reach of children and pets.

General information about Taclonex® (calcipotriene and betamethasone dipropionate) Ointment

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Taclonex® (calcipotriene and betamethasone dipropionate) Ointment for a condition for which it was not prescribed. Do not give 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® (calcipotriene and betamethasone dipropionate) Ointment. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Taclonex® (calcipotriene and betamethasone dipropionate) Ointment that is written for health professionals.
  • Additional consumer information is available on (800) 521-8813.

What are the ingredients in Taclonex® (calcipotriene and betamethasone dipropionate) Ointment?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate

Inactive ingredients: mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol, white petrolatum.

Calcipotriene and Betamethasone dipropionate Brand Names

Calcipotriene and Betamethasone dipropionate may be found in some form under the following brand names:

  • Taclonex

What should i avoid while using betamethasone and calcipotriene (taclonex, taclonex scalp)?

Avoid applying this medicine to more than one-third of your skin surface at any one time.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Betamethasone and calcipotriene topical can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use this medicine on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. Also avoid using this medication in wounds or on areas of infection. Wait until these conditions have healed before using betamethasone and calcipotriene topical.

Where can i get more information?

Your pharmacist has more information about betamethasone and calcipotriene topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.05. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Side effects

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Taclonex® (calcipotriene and betamethasone dipropionate) Ointment in 2448 patients, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known (See PRECAUTIONS). The effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Taclonex® (calcipotriene and betamethasone dipropionate) Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most patients received once daily application, and the median weekly dose was 24.5 g.

The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex® (calcipotriene and betamethasone dipropionate) Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.

  Taclonex® (calcipotriene and betamethasone dipropionate)
Ointment
N=2448
Calcipotriene
N=3197
Betamethasone
dipropionate
N=1164
Vehicle
N=470
Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4)
Preferred Term # of subjects (%)
Pruritus 75 (3.1) 183 (5.7) 38 (3.3) 43 (9.1)
Headache 69 (2.8) 75 (2.3) 44 (3.8) 12 (2.6)
Nasopharyngitis 56 (2.3) 77 (2.4) 34 (2.9) 9 (1.9)
Psoriasis 30 (1.2) 47 (1.5) 14 (1.2) 5 (1.1)
Rash scaly 30 (1.2) 40 (1.3) 0 (0.0) 1 (0.2)
Influenza 23 (0.9) 34 (1.1) 14 (1.2) 6 (1.3)
Upper respiratory 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6)
tract infection 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1)
Erythema Application site 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
pruritus 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1)
Skin irritation 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1)
Pain Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3)

Adverse Events Reported by ≥ 1% of Subjects by Preferred Term

A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects

  Taclonex® (calcipotriene and betamethasone dipropionate)
Ointment
N=2448
Calcipotriene
N=3197
Betamethasone
dipropionate
N=1164
Vehicle
N=470
Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76 (16.2)
Preferred Term # of subjects (%)
Pruritus 69 (2.8) 170 (5.3) 31 (2.7) 41 (8.7)
Rash scaly 29 (1.2) 38 (1.2) 0 (0.0) 0 (0.0)
Application site pruritus 12 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
Erythema 9 (0.4) 36 (1.1) 2 (0.2) 4 (0.9)
Skin irritation 9 (0.4) 51 (1.6) 8 (0.7) 5 (1.1)
Burning sensation 6 (0.2) 25 (0.8) 3 (0.3) 5 (1.1)

For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex® (calcipotriene and betamethasone dipropionate) Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).

In a separate study, patients (N=207) with at least moderate disease severity were given Taclonex® (calcipotriene and betamethasone dipropionate) Ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the patients: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of a serious flare-up of psoriasis was reported.

Development of pustular psoriasis has been reported as an adverse reaction during and following use of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment.

Read the entire FDA prescribing information for Taclonex (Calcipotriene and Betamethasone Dipropionate)

Read More »
  • Clobex
  • Tazorac
  • Ultravate X

© Taclonex Patient Information is supplied by Cerner Multum, Inc. and Taclonex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

(web3)