Paricalcitol 1mcg Capsules

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.

PARICALCITOL - ORAL

(pear-ih-KAL-sit-ole)

COMMON BRAND NAME(S): Zemplar

USES: Paricalcitol is used to treat and prevent high levels of a certain natural substance made by the body (parathyroid hormone) in patients with long-term kidney disease. In these patients, the high level of parathyroid hormone is caused by a low level of calcium and a certain kind of vitamin D. Too much parathyroid hormone can cause serious problems such as bone disorders. Paricalcitol is a man-made form of vitamin D. It helps to reduce parathyroid hormone levels and may help your body absorb calcium and phosphorus.

HOW TO USE: Take this medication by mouth with or without food, usually once daily or 3 times a week or as directed by your doctor. If you are taking this medication 3 times a week, do not take it more often than every other day. Dosage is based on your laboratory tests and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication on a schedule other than every day (e.g., 3 times a week), it may help to mark your calendar with a reminder. It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent serious side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.

SIDE EFFECTS: 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: fast/slow/irregular heartbeat, seizures, weakness, loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, nausea/vomiting, drowsiness, stomach/abdominal pain, increased thirst, change in the amount of urine. Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., psychosis). 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 taking paricalcitol, tell your doctor or pharmacist if you are allergic to it; or to other vitamin D products; 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: high levels of calcium (hypercalcemia), high levels of vitamin D (hypervitaminosis D). Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat, coronary artery disease), seizures. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because a very serious interaction may occur: other vitamin D products (e.g., ergocalciferol). If you are currently using any of the medications listed above, tell your doctor or pharmacist before starting paricalcitol. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: products that contain aluminum (e.g., certain antacids, phosphate binders), corticosteroids (e.g., prednisone), digoxin, drugs affecting liver enzymes that remove paricalcitol from your body (such as azole antifungals including ketoconazole/itraconazole, macrolide antibiotics including clarithromycin, nefazodone, HIV protease inhibitors including indinavir/ritonavir), thiazide diuretics (e.g., hydrochlorothiazide). Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, vitamins) because they may contain aluminum, calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely. Certain medications can decrease the absorption of vitamin D (bile acid sequestrants such as cholestyramine/colestipol, mineral oil, orlistat). Therefore, separate your doses of these medications as far as possible from your doses of vitamin D (at least 2 hours apart, longer if possible). It may be easiest to take vitamin D at bedtime if you are also taking these other medications. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications. This medication may interfere with certain laboratory tests (including cholesterol tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. 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: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: weakness, headache, loss of appetite, nausea, vomiting, stomach cramps, drowsiness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (e.g., calcium, phosphorus, parathyroid hormone levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take 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 at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. 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.

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.