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|Paricalcitol Capsules

Paricalcitol Capsules

Paricalcitol Capsules is used for:

Preventing and treating high levels of parathyroid hormone in the blood due to long-term kidney disease.

Paricalcitol Capsules is a vitamin D compound. It works by blocking the formation and release of parathyroid hormone (PTH).

Do NOT use Paricalcitol Capsules if:

• you are allergic to any ingredient in Paricalcitol Capsules
• you have high levels of vitamin D or calcium in the blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Paricalcitol Capsules:

Some medical conditions may interact with Paricalcitol Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems, hardening or narrowing of the arteries (arteriosclerosis), or high blood phosphate levels

Some MEDICINES MAY INTERACT with Paricalcitol Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digitalis medicines (eg, digoxin) because risk of toxicity may be increased by Paricalcitol Capsules
• Clarithromycin, HIV protease inhibitors (eg, ritonavir, saquinavir), imidazole antifungals (eg, ketoconazole, itraconazole), nefazodone, telithromycin, or voriconazole because side effects of Paricalcitol Capsules may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Paricalcitol Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Paricalcitol Capsules:

Use Paricalcitol Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Paricalcitol Capsules may be taken with or without food.
• If you take cholestyramine, do not take it at the same time you take Paricalcitol Capsules. Talk with your doctor about how you should take cholestyramine with Paricalcitol Capsules.
• If you miss a dose of Paricalcitol Capsules and you are taking it once daily, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
• If you miss a dose of Paricalcitol Capsules and you are taking it three times weekly, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Paricalcitol Capsules.

Important safety information:

• Paricalcitol Capsules may cause lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Paricalcitol Capsules. Using Paricalcitol Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Carefully follow the diet instructions given to you by your health care provider, including instructions on vitamin D and phosphorus restrictions and calcium supplementation.
• Before you begin taking any new prescription or nonprescription medicine, including vitamin or mineral products, read the ingredients to see if it contains vitamin D or phosphorus. If it does or if you are uncertain, contact your doctor or pharmacist.
• Avoid excessive use of aluminum-containing products (eg, antacids) while using Paricalcitol Capsules.
• LAB TESTS, including blood calcium, phosphorus, and PTH levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Paricalcitol Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Paricalcitol Capsules, discuss with your doctor the benefits and risks of using Paricalcitol Capsules during pregnancy. It is unknown if Paricalcitol Capsules is excreted in breast milk. Do not breast-feed while you are using Paricalcitol Capsules.

Possible side effects of Paricalcitol Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; diarrhea; feeling unwell; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black tarry or bloody stools; chest pain; depression; fever or chills; irregular heartbeat; muscle cramps or spasms; pounding in the chest; stomach pain; swelling of the hands or feet; trouble breathing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. High vitamin D levels, which can be dangerous, may occur if Paricalcitol Capsules is used in higher doses than necessary. Symptoms may include bone or muscle pain; decreased sex drive; dizziness; fever; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste in mouth; persistent or severe constipation, headache, nausea, or vomiting; seizures; sensitivity to sunlight (eyes); unexplained runny nose; unusual drowsiness; unusually dry mouth; vision changes; weakness; weight loss.

Store Paricalcitol Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Paricalcitol Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Paricalcitol Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Paricalcitol Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Paricalcitol Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.