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Calcipotriene and Betamethasone: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
50 mcg/g, 0.5 mg/g
Brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Calcipotriene and Betamethasone

What is Calcipotriene and Betamethasone Dipropionate Ointment?

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

Calcipotriene and Betamethasone Dipropionate Ointment has not been studied in patients under the age of 12 years.

Who should not use Calcipotriene and Betamethasone Dipropionate Ointment?

Do not use Calcipotriene and Betamethasone Dipropionate Ointment if you:

  • have thin skin (atrophy) at the site to be treated
  • are allergic to anything in 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 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 Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate Ointment can harm your unborn baby. You and your doctor will have to decide if Calcipotriene and Betamethasone Dipropionate Ointment is right for you while pregnant.

  • are breastfeeding or plan to breastfeed. It is not known if Calcipotriene and Betamethasone Dipropionate Ointment passes into your milk and if it can harm your baby. If you use Calcipotriene and Betamethasone Dipropionate Ointment while breastfeeding, use Calcipotriene and Betamethasone Dipropionate Ointment on the smallest area of skin and for the shortest time needed. If you use Calcipotriene and Betamethasone Dipropionate Ointment, do not apply Calcipotriene and Betamethasone Dipropionate Ointment to your nipple or areola to avoid getting Calcipotriene and Betamethasone Dipropionate Ointment into your baby's mouth.

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

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 Calcipotriene and Betamethasone Dipropionate Ointment?

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

Using Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate Ointment?

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 Calcipotriene and Betamethasone Dipropionate Ointment?

The most common side effects are:

  • itching
  • rash

Other less common side effects with Calcipotriene and Betamethasone Dipropionate 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)

Calcipotriene and Betamethasone Dipropionate Ointment may cause serious side effects. Serious side effects are more likely to happen if you use too much Calcipotriene and Betamethasone Dipropionate 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. Calcipotriene and Betamethasone Dipropionate 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 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 Calcipotriene and Betamethasone Dipropionate Ointment. Ask your doctor or pharmacist for more information.

Vision problems. Calcipotriene and Betamethasone Dipropionate 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 Calcipotriene and Betamethasone Dipropionate Ointment.

How should I store Calcipotriene and Betamethasone Dipropionate Ointment?

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

General information about Calcipotriene and Betamethasone Dipropionate Ointment

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Calcipotriene and Betamethasone Dipropionate Ointment for a condition for which it was not prescribed. Do not give Calcipotriene and Betamethasone Dipropionate 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 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 Calcipotriene and Betamethasone Dipropionate Ointment that is written for health professionals.

What are the ingredients in Calcipotriene and Betamethasone Dipropionate Ointment?

Active ingredients: calcipotriene hydrate, betamethasone dipropionate.

Inactive ingredients: butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, white petrolatum.

Manufactured by:

LEO Laboratories Ltd. (LEO Pharma)

Dublin 12, Ireland

Distributed by:

Prasco Laboratories

Mason, OH 45040 USA

Revised: 03/2020

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA AUTHORIZED GENERIC 021852 · View the label on DailyMed

Revision date stated in the text: March 2020

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Calcipotriene and Betamethasone

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Corticosteroid, Vitamin D Analog
Active ingredients Calcipotriene monohydrate 50 mcg/g, Betamethasone dipropionate 0.5 mg/g
Dosage form Ointment
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) LEO PHARMA AS
FDA approval NDA AUTHORIZED GENERIC 021852NDA authorized generic Approved January 9, 2006
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Taclonex with the same TE code
Manufacturers 5 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mcg/g, 0.5 mg/g – 60 g in 1 tube / 1 in 1 carton NDC 66993-938-61
50 mcg/g, 0.5 mg/g – 100 g in 1 tube / 1 in 1 carton NDC 66993-938-65

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.