calcipotriene 0.005 %-betamethasone 0.064 % topical cream

Generic name:
Betamethasone/calcipotriene (calcipotriol) - topical

Pronunciation
(BAY-ta-METH-a-sone/KAL-si-poe-TRYE-een/KAL-si-poe-TRYE-ol)

Brand name(s)
Enstilar , Taclonex

This medication is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition. Healthy skin lowers your risk for infection and protects you against the environment. This product contains 2 drugs. Betamethasone is a very strong corticosteroid drug that works by decreasing swelling, redness, and itching. Calcipotriene is a form of vitamin D. It is also known as calcipotriol in other countries. It works by slowing down the growth of skin cells so that they don't build up into thickened, scaly skin patches.

This product should not be used if you have certain types of psoriasis (skin patches with pus-filled blisters, psoriasis over most of your body with intense redness/shedding/oozing). Consult your doctor for more information.

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Apply a thin layer to the affected area(s) as directed by your doctor, usually once daily. Rub it in gently and completely. Wash your hands after using, unless you are using this medication to treat the hands. Avoid getting any medication in the eyes or mouth. If this occurs, rinse right away with water. Do not apply this product to the face, underarms, or groin area. Do not use this medication for more than 4 weeks if you are using the ointment or foam (or 8 weeks if you are using the cream) unless directed by your doctor.

If you are using the ointment, because of the increased risk of side effects, adults should not use more than 100 grams of the ointment per week unless directed and closely monitored by the doctor. Also, children and teenagers should not use more than 60 grams of the ointment per week.

If you are using the foam, shake the can before using. Do not use more than 60 grams of the foam every 4 days.

If you are using the cream, do not use more than 100 grams of the cream per week.

Do not bandage, wrap, or cover the treated area unless your doctor instructs you to do so. Do not apply this medication to large areas of damaged skin or use it in skin folds. Do not apply more of this medication than prescribed or use it more often or for longer than directed. Doing so may increase the amount of medication that is absorbed into your bloodstream, an effect that may increase your risk of side effects.

Tell your doctor if your condition does not get better or if it gets worse. It may take a week to see any improvement and several weeks to see the full benefit of this medication.

Itching, burning, redness, or irritation of the skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• skin thinning/discoloration/"stretch marks"
• small red bumps on the skin (folliculitis)
• worsening of psoriasis

This product may rarely cause an increase in the level of calcium in your blood. Tell your doctor right away if you notice any of the following unlikely but serious side effects:

• mental/mood changes
• unexplained constipation

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur:

• unusual/extreme tiredness
• weight loss
• headache
• swelling ankles/feet
• increased thirst/urination
• vision problems

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to betamethasone or calcipotriene; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain mineral imbalance (high calcium blood level)
• thin skin in the areas to be treated

If you have a skin infection or a skin reaction other than psoriasis (such as bacterial skin infection, chickenpox, herpes simplex), it should be treated before you start this medication. Betamethasone and other corticosteroid drugs can slow down your body's response to antibiotic drugs and make it more difficult to clear an infection.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Your doctor may direct you to limit or avoid phototherapy while you use this product. Ask your doctor for details.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as adrenal gland function tests) may be done while you are using this medication, especially if you use it for an extended period of time or apply it over large areas of the body. Consult your doctor for more details.

Try to identify and reduce the triggers that may worsen your psoriasis (such as stress, skin injury). Discuss with your doctor additional ways to control symptoms, such as using a moisturizer to treat dry, itching skin.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Also, check the product instructions about how long you may store the product once it has been opened. The foam product is flammable. Avoid smoking during and right after applying the foam. Do not puncture the foam can or expose to high heat or open flame. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.