Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Zemplar

Descriptions


Paricalcitol is used to treat and prevent hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). This hormone controls the concentrations of calcium and phosphorus in your blood. Paricalcitol helps lower the amount of PTH which lowers the calcium and phosphorus concentrations.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

  • Capsule, Liquid Filled

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of paricalcitol in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of paricalcitol in the elderly.

Pregnancy

Information about this paricalcitol-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ketoconazole

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone disease or
  • Heart rhythm problems (e.g., arrhythmia) or
  • Hypercalciuria (high calcium in the urine) or
  • Hyperphosphatemia (high phosphate in the blood) or
  • Seizures—Use with caution. May make these conditions worse.
  • Hypercalcemia (high calcium in the blood) or
  • Vitamin D overdose—Should not be used in patients with these conditions.

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Carefully follow your doctor's instructions about any special diet. Do not use vitamin D, phosphate, or calcium supplements, or antacids containing aluminum without asking your doctor.

Your doctor may tell you to limit your dietary intake of phosphate. Foods that are high in phosphate include beans, beer, chocolate, cheese, cola soft drinks, ice cream, milk, nuts, peas, whole grain products, and yogurt.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules):
    • For hyperparathyroidism in patients with chronic kidney disease:
      • Adults—At first, 1 to 2 micrograms (mcg) once a day or 2 to 4 mcg three times a week (taken not more than every other day) as directed by your doctor. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not take other medicines unless they have been discussed with your doctor. Taking other medicines (especially digoxin, Lanoxin®) together with paricalcitol may require your doctor to change the dose of one of the medicines or paricalcitol.

This medicine may increase the calcium in your blood (hypercalcemia). The symptoms of high calcium may include abdominal or stomach pain; confusion; constipation; depression; dry mouth; headache; incoherent speech; increased urination; loss of appetite; metallic taste; muscle weakness; nausea; thirst; unusual tiredness; vomiting; or weight loss. If you have any of these symptoms, check with your doctor immediately.

This medicine may increase the aluminum in your blood and may cause harm to your bones if used in combination with any products containing aluminum (e.g., antacids or phosphate binders). Ask your doctor before you take any of these products.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  1. Blurred vision
  2. cough or hoarseness
  3. difficulty with swallowing
  4. dizziness
  5. fever or chills
  6. headache
  7. hives
  8. itching
  9. lower back or side pain
  10. nervousness
  11. pain
  12. painful or difficult urination
  13. pounding in the ears
  14. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  15. shortness of breath
  16. skin rash
  17. slow or fast heartbeat
  18. swelling
  19. tightness in the chest
  20. unusual tiredness or weakness
  21. wheezing

Less common

  1. Abdominal or stomach pain
  2. abnormal growth filled with fluid or semisolid material
  3. ammonia-like breath odor
  4. anxiety
  5. bladder pain
  6. bloating or swelling of the face, arms, hands, lower legs, or feet
  7. bloody or cloudy urine
  8. burning, tingling, numbness or pain in the hands, arms, feet, or legs
  9. chest pain or discomfort
  10. cold sweats
  11. coma
  12. confusion
  13. convulsions
  14. cool, pale skin
  15. decreased urine
  16. depression
  17. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  18. drowsiness
  19. dry mouth
  20. fainting
  21. frequent urge to urinate
  22. general feeling of discomfort or illness
  23. increase in heart rate
  24. increased hunger
  25. increased thirst
  26. irregular heartbeat
  27. joint pain
  28. lightheadedness
  29. loss of appetite
  30. muscle aches and pains
  31. nausea or vomiting
  32. nightmares
  33. numbness or tingling in the hands, feet, or lips
  34. pain or discomfort in the arms, jaw, back, or neck
  35. rapid breathing
  36. rapid weight gain
  37. runny nose
  38. sensation of pins and needles
  39. shakiness
  40. shivering
  41. slurred speech
  42. sneezing
  43. sore throat
  44. stabbing pain
  45. sunken eyes
  46. sweating
  47. thirst
  48. trouble sleeping
  49. troubled breathing
  50. unusual weight gain or loss
  51. weight loss
  52. wrinkled skin

Incidence not known

  1. Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  2. slow or irregular breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  1. Abdominal or stomach cramps
  2. constipation
  3. depression
  4. high urine levels of calcium
  5. incoherent speech
  6. increased urination
  7. metallic taste
  8. muscle cramps in the hands, arms, feet, legs, or face
  9. muscle weakness
  10. tremor

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  1. Acid or sour stomach
  2. back pain
  3. belching
  4. bloody nose
  5. bruising
  6. change in vision
  7. cough producing mucus
  8. difficulty with moving
  9. feeling of constant movement of self or surroundings
  10. heartburn
  11. impaired vision
  12. indigestion
  13. lack or loss of strength
  14. large, flat, blue, or purplish patches in the skin
  15. leg cramps
  16. muscle pain or stiffness
  17. pain or tenderness around the eyes and cheekbones
  18. pain, swelling, or redness in the joints
  19. sensation of spinning
  20. sores on the skin
  21. stomach discomfort, upset, or pain
  22. stuffy nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.