IMPORTANT: 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.
BETAMETHASONE/CALCIPOTRIENE (CALCIPOTRIOL) – TOPICAL
COMMON BRAND NAME(S): Taclonex
USES: 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.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist. This medication is for use on the skin only. Apply a thin layer to the affected area(s), usually once daily or as directed by your doctor. 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. If this occurs, rinse eyes immediately with water. Do not apply this product to the face, underarms, or groin area. Do not use this medication for more than 4 weeks unless directed by your doctor. Because of the increased risk of side effects, adults should not use more than 100 grams of this product per week unless directed and closely monitored by the doctor. 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. Inform your doctor if your condition does not improve or if it worsens. It may take a week to see any improvement and 4 weeks to see the full benefit of this medication.
SIDE EFFECTS: Itching, burning, redness, or irritation of the skin may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: skin thinning/discoloration/”stretch marks”, swelling/inflammation of the hair pores (folliculitis), worsening of psoriasis. This product may infrequently cause an increase in the level of calcium in your blood. Tell your doctor immediately 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: 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. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: 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 (e.g., 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. Before using this medication, tell your doctor or pharmacist your medical history. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors. Your doctor may direct you to limit or avoid phototherapy while you use this product. Discuss this further with your doctor. 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. Therefore, 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 slow down a child’s growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child’s height can be checked. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other corticosteroids (e.g., prednisone, hydrocortisone), other products containing calcipotriene (calcipotriol). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: This medication may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as adrenal gland function tests) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug 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 (e.g., stress, skin injury). Discuss with your doctor additional ways to control symptoms, such as using a moisturizer to treat dry, itching skin.
MISSED DOSE: 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 and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store the US product in its tightly capped tube at room temperature between 68-77 degrees F (20-25 degrees C). Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Store the Canadian product in the refrigerator or at room temperature between 41-77 degrees F (5-25 degrees C). However, refrigerating the product may make it more difficult to apply. If you are using this product on delicate skin, it is best to store this medication at room temperature so it is easier to rub it in. Keep all medicines 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 for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).
Information last revised February 2011. Copyright(c) 2011 First Databank, Inc.