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 - INJECTION
COMMON BRAND NAME(S): Zemplar
USES: Paricalcitol is a man-made active form of vitamin D, which is needed for building and keeping strong bones. Paricalcitol is used in patients with long-term kidney disease to treat or prevent high levels of a certain natural substance made by the body (parathyroid hormone). Too much parathyroid hormone can cause serious problems such as bone disorders.
Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. People with kidney disease cannot make enough of the active form of vitamin D. Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones.
HOW TO USE: Read the Patient Information Leaflet if one is available from your pharmacist before you start using paricalcitol. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.
This medication is given by injection into a vein during dialysis, usually by a health care professional. It is given as directed by your doctor, usually 3 times a week (every other day). The dosage is based on your condition, weight, laboratory tests, and response to treatment. Your doctor will do blood tests to find the best dose for you.
It is very important to follow the diet recommended by your doctor to get the most benefit from this medication and to prevent side effects. Do not take other supplements/vitamins (e.g., calcium, vitamin D) unless ordered by your doctor.
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.
This medication may raise your vitamin D and calcium levels too high. Tell your doctor immediately if any of these unlikely but serious effects of too much vitamin D/calcium occur: constipation, drowsiness, dry mouth, muscle/bone/joint pain, metallic taste in mouth, weakness, vomiting.
Tell your doctor immediately if any of these rare but serious side effects of very high vitamin D levels occur: loss of appetite, unusual weight loss, eye pain/redness/sensitivity to light, severe runny nose, stomach/abdominal pain.
Tell your doctor right away if you have any serious side effects, including: dizziness, fast/irregular/pounding heartbeat, swelling hands/ankles/feet, severe mental/mood changes (e.g., agitation, confusion), easy bleeding/bruising, bloody/tarry stool, vomit that looks like coffee grounds.
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.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Zemplar (paricalcitol tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high levels of calcium (hypercalcemia), high levels of vitamin D (hypervitaminosis D), regular use/abuse of alcohol, brain problems (e.g., seizures, brain injury), heart problems (e.g., arrhythmias, coronary artery disease), liver disease.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication contains alcohol, which may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Some products that may interact with this drug include: products that contain aluminum/magnesium (e.g., certain antacids, phosphate binders), corticosteroids (e.g., prednisone), digoxin, calcium supplements, other products that contain vitamin D or phosphate (e.g., ergocalciferol, sodium phosphate).
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Check the labels on all your prescription and nonprescription/herbal products (e.g., antacids, vitamins) because they may contain calcium, phosphate, or vitamin D. Ask your pharmacist about using those products safely.
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.
NOTES: Laboratory and/or medical tests (e.g., blood levels of aluminum, calcium, magnesium, phosphorus, and parathyroid hormone) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.
Information last revised January 2015. Copyright(c) 2015 First Databank, Inc.