Tuesday, 2 October 2012

paricalcitol


Generic Name: paricalcitol (PAR i KAL si tol)

Brand Names: Zemplar


What is paricalcitol?

Paricalcitol is a man-made form of vitamin D. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.


Paricalcitol is used to treat or prevent hyperparathyroidism (overactive parathyroid gland) in people with chronic kidney failure.


Paricalcitol may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about paricalcitol?


Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have high levels of calcium or vitamin D in your blood.

Before taking paricalcitol, tell your doctor if you have high blood pressure, liver disease, or an electrolyte imbalance.


Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.


While using paricalcitol, you may need blood tests at your doctor's office. Visit your doctor regularly.


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.


Paricalcitol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.


What should I discuss with my healthcare provider before taking paricalcitol?


Do not use this medication if you have ever had an allergic reaction to vitamin D, or if you have:

  • high levels of calcium in your blood (hypercalcemia); or




  • high levels of vitamin D in your body (vitamin D toxicity).



If you have any of these other conditions, you may need a paricalcitol dose adjustment or special tests:



  • high blood pressure;




  • liver disease; or




  • an electrolyte imbalance.




FDA pregnancy category C. It is not known whether paricalcitol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Your paricalcitol dose needs may change if you are breast-feeding a baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take paricalcitol?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Paricalcitol is sometimes taken daily, and sometimes taken every other day. Follow your doctor's instructions carefully.


Your doctor may occasionally change your dose to make sure you get the best results.


You may take this medication with or without food.


While using paricalcitol, you may need blood tests at your doctor's office. Visit your doctor regularly.


Paricalcitol is only part of a complete program of treatment that may also include a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.


Store at room temperature away from moisture, light, and heat.

See also: Paricalcitol dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vitamin D can cause serious or life-threatening side effects.

Overdose symptoms may include headache, weakness, drowsiness, dry mouth, nausea, vomiting, constipation, muscle or bone pain, metallic taste in the mouth, weight loss, itchy skin, changes in heart rate, loss of interest in sex, confusion, unusual thoughts or behavior, feeling unusually hot, severe pain in your upper stomach spreading to your back, or fainting.


What should I avoid while taking paricalcitol?


Do not take other vitamin or mineral supplements unless your doctor has told you to.

Avoid using calcium supplements or antacids without your doctor's advice. Use only the specific type of supplement or antacid your doctor recommends.


Paricalcitol side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking paricalcitol and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;




  • chest pain, feeling short of breath;




  • feeling like you might pass out;




  • swelling, rapid weight gain;




  • pain or burning when you urinate;




  • dry mouth, drowsiness, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions);




  • nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;




  • early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).



Less serious side effects may include:



  • dizziness, spinning sensation;




  • back pain, mild muscle or joint pain;




  • stomach pain, indigestion;




  • diarrhea;




  • sore throat, cough, runny or stuffy nose; or




  • mild itching or skin rash.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Paricalcitol Dosing Information


Usual Adult Dose for Secondary Hyperparathyroidism:

Chronic kidney disease (CKD) stage 3 and 4:
Initial: dosage based on baseline intact parathyroid hormone level (iPTH):
iPTH iPTH >500 pg/mL: 2 mcg orally once a day or 4 mcg orally three times a week.

Maintenance: dose may be adjusted at 2 to 4 week intervals based on relation of subsequent iPTH levels to baseline iPTH level:
If iPTH levels remain the same, increase, or decrease by less than 30%: increase daily dose by 1 mcg or increase 3 times a week dose by 2 mcg.
If iPTH levels decrease by >= 30% and If iPTH levels decrease by > 60% or iPTH level If patient is on lowest dose on the daily regimen and a dose reduction is necessary, decrease dose to 1 mcg 3 times a week. If a further dose reduction is necessary, withhold the drug as needed and restart at a lower dose when feasible.


Chronic kidney disease (CKD) Stage 5 with dialysis:
Initial: 0.04 to 0.1 mcg/kg administered as an IV bolus dose no more frequently than every other day at any time during dialysis.

Maintenance:
If parathyroid hormone (PTH) levels remain the same or increase, an additional increase in paricalcitol dosage is necessary.
If PTH levels have decreased If PTH levels have decreased by >30% but If PTH levels have decreased more than 60%, decrease the paricalcitol dose.
If PTH levels are 1.5 to 3 times the upper limit of normal, maintain the current dose.
When using paricalcitol injection, the dosage may be increased by 2 to 4 mcg at 2- to 4-week intervals as necessary to produce the desired results. In clinical studies, doses as high as 0.24 mcg/kg (16.8 mcg) have been safely administered.


What other drugs will affect paricalcitol?


Tell your doctor about all other medicines you use, especially:



  • cholestyramine (Prevalite, Questran);




  • conivaptan (Vaprisol);




  • digoxin (Lanoxin);




  • imatinib (Gleevec);




  • isoniazid (for treating tuberculosis);




  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);




  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);




  • an antidepressant such as nefazodone;




  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or




  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir).



This list is not complete and other drugs may interact with paricalcitol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More paricalcitol resources


  • Paricalcitol Side Effects (in more detail)
  • Paricalcitol Dosage
  • Paricalcitol Use in Pregnancy & Breastfeeding
  • Paricalcitol Drug Interactions
  • Paricalcitol Support Group
  • 0 Reviews for Paricalcitol - Add your own review/rating


  • paricalcitol Advanced Consumer (Micromedex) - Includes Dosage Information

  • Paricalcitol Professional Patient Advice (Wolters Kluwer)

  • Paricalcitol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Paricalcitol Monograph (AHFS DI)

  • Zemplar Prescribing Information (FDA)

  • Zemplar Consumer Overview



Compare paricalcitol with other medications


  • Secondary Hyperparathyroidism


Where can I get more information?


  • Your pharmacist can provide more information about paricalcitol.

See also: paricalcitol side effects (in more detail)


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