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Paricalcitol (Oral route)

Pronunciation:

par-i-KAL-si-tol

Brand Names:

  • Zemplar

Dosage Forms:

  • Capsule, Liquid Filled

Classifications:

Therapeutic—

Antithyroid Agent

Pharmacologic—

Vitamin D (class)

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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
Blurred vision
cough or hoarseness
difficulty with swallowing
dizziness
fever or chills
headache
hives
itching
lower back or side pain
nervousness
pain
painful or difficult urination
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
shortness of breath
skin rash
slow or fast heartbeat
swelling
tightness in the chest
unusual tiredness or weakness
wheezing
Less common
Abdominal or stomach pain
abnormal growth filled with fluid or semisolid material
ammonia-like breath odor
anxiety
bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
burning, tingling, numbness or pain in the hands, arms, feet, or legs
chest pain or discomfort
cold sweats
coma
confusion
convulsions
cool, pale skin
decreased urine
depression
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
fainting
frequent urge to urinate
general feeling of discomfort or illness
increase in heart rate
increased hunger
increased thirst
irregular heartbeat
joint pain
lightheadedness
loss of appetite
muscle aches and pains
nausea or vomiting
nightmares
numbness or tingling in the hands, feet, or lips
pain or discomfort in the arms, jaw, back, or neck
rapid breathing
rapid weight gain
runny nose
sensation of pins and needles
shakiness
shivering
slurred speech
sneezing
sore throat
stabbing pain
sunken eyes
sweating
thirst
trouble sleeping
troubled breathing
unusual weight gain or loss
weight loss
wrinkled skin
Incidence not known
Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
slow or irregular breathing

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

Symptoms of overdose
Abdominal or stomach cramps
constipation
depression
high urine levels of calcium
incoherent speech
increased urination
metallic taste
muscle cramps in the hands, arms, feet, legs, or face
muscle weakness
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
Acid or sour stomach
back pain
belching
bloody nose
bruising
change in vision
cough producing mucus
difficulty with moving
feeling of constant movement of self or surroundings
heartburn
impaired vision
indigestion
lack or loss of strength
large, flat, blue, or purplish patches in the skin
leg cramps
muscle pain or stiffness
pain or tenderness around the eyes and cheekbones
pain, swelling, or redness in the joints
sensation of spinning
sores on the skin
stomach discomfort, upset, or pain
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.


Last Updated: 4/4/2014

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