Medication Guide App

calcitriol

Pronunciation

Generic Name: calcitriol (vitamin D3) (kal si TRYE ol)
Brand Name: Rocaltrol, Calcijex

What is calcitriol?

Calcitriol is vitamin D3. Vitamin D is important for the absorption of calcium from the stomach and for the functioning of calcium in the body.

Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

Calcitriol is also used to treat calcium deficiency (hypocalcemia) and metabolic bone disease in people who are receiving dialysis.

Calcitriol is also used to treat calcium deficiency in people with hypoparathyroidism (underactive parathyroid glands) caused by surgery, disease, or other conditions.

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

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

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

Drink plenty of fluids unless your doctor has told you to restrict your fluid intake.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.

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

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb calcitriol.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Calcitriol is only part of a complete program of treatment that may also include a special diet. Follow your diet and medication routines very closely. 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 calcitriol?

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

To make sure you can safely take calcitriol, tell your doctor about all of your medical conditions.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Calcitriol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take calcitriol?

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

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

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink plenty of fluids unless your doctor has told you to restrict your fluid intake.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to a serious electrolyte imbalance.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Calcitriol 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.

If you need to be on bed-rest or have any type of surgery, your dose or testing needs may change. Follow your doctor's instructions.

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

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.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking calcitriol?

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

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb calcitriol.

Calcitriol 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 using calcitriol and call your doctor at once if you have a serious side effect such as:

  • weakness, headache, drowsiness;

  • nausea, vomiting, stomach pain, constipation;

  • loss of appetite;

  • dry mouth, increased thirst;

  • metallic taste in your mouth;

  • urinating more than usual;

  • fast, slow, or uneven heart rate;

  • changes in behavior;

  • muscle pain, bone pain, muscle weakness, loss of height;

  • slow growth (in a child taking calcitriol); or

  • severe pain in your upper stomach spreading to your back.

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.

See also: Side effects (in more detail)

Calcitriol dosing information

Usual Adult Dose for Hypocalcemia:

Oral
Initial dose: 0.25 mcg orally once a day.
Maintenance dose: May increase by 0.25 mcg/dose at 4 to 8 week intervals.

Parenteral
Initial dose: 0.5 mcg IV 3 times a week.
Maintenance dose: May increase by 0.25 to 0.5 mcg/dose at 2 to 4 week intervals.

Usual Adult Dose for Renal Osteodystrophy:

Oral
Initial dose: 0.25 mcg orally once a day.
Maintenance dose: May increase by 0.25 mcg/dose at 4 to 8 week intervals.

Parenteral
Initial dose: 0.5 mcg IV 3 times a week.
Maintenance dose: May increase by 0.25 to 0.5 mcg/dose at 2 to 4 week intervals.

Usual Adult Dose for Hypoparathyroidism:

Initial dose: 0.25 mcg orally once a day in the morning.
Maintenance dose: May increase by 0.25 mcg/dose at 2 to 4 week intervals. Most patients respond to 0.25 to 2 mcg once a day.

Usual Adult Dose for Rickets:

1 mcg orally once a day

Usual Adult Dose for Secondary Hyperparathyroidism:

Predialysis patients: 0.25 mcg orally once a day in the morning.

Dialysis patients: 0.25 mcg orally once a day in the morning. Increase dose, if needed, by 0.25 mcg/dose at 2 to 4 week intervals. For some patients 0.25 mcg orally every other day may be enough. Most patients respond to doses of 0.25 to 1 mcg once a day. Alternatively, 0.5 to 4 mcg IV may be administered three times per week at the end of each dialysis.

Pulse oral therapy:
Study (n=5), patients on Continuous Ambulatory Peritoneal Dialysis:
5 mcg orally given twice per week.
Study (n=19), patients on hemodialysis:
4 mcg orally given twice per week.

Usual Pediatric Dose for Hypoparathyroidism:

Less than 1 year: 0.04 to 0.08 mcg/kg orally once a day.

1 to 5 years: 0.25 to 0.75 mcg orally once daily. May increase by 0.25 mcg/dose at 2 to 4 week intervals.

Greater than or equal to 6 years: 0.5 to 2 mcg. May increase by 0.25 mcg/dose at 2 to 4 week intervals.

Usual Pediatric Dose for Rickets:

Vitamin D dependent rickets: 1 mcg orally once a day.

Vitamin D resistant rickets (familial hypophosphatemia): Initial: 0.015 to 0.02 mcg/kg orally once daily; maintenance: 0.03 to 0.06 mcg/kg orally once daily; maximum dose: 2 mcg once daily.

Usual Pediatric Dose for Hypocalcemia:

Hypocalcemia secondary to hypoparathyroidism:
Neonates: 1 mcg orally once daily for the first 5 days of life, or 0.02 to 0.06 mcg/kg/day.

Hypocalcemic tetany:
Neonates: 0.05 mcg/kg IV once daily for 5 to 12 days or 0.25 mcg orally once daily followed by 0.01 to 0.10 mcg/kg/day divided in 2 doses daily
(maximum daily dose: 2 mcg).

Management of hypocalcemia in patients with chronic kidney disease (CKD): Indicated for therapy when serum levels of 25(OH)D are greater than 30 ng/mL (75 nmol/L) and serum levels of intact parathyroid hormone (iPTH) are above the target range for the stage of CKD; serum levels of corrected total calcium are less than 9.5 to 10 mg/dL and serum levels of phosphorus are less than age appropriate upper limits of normal (ULN).

Children and Adolescents: CKD Stages 2 to 4:

Less than 10 kg: 0.05 mcg orally every other day.
10 to 20 kg: 0.1 to 0.15 mcg orally daily.
Greater than 20 kg: 0.25 mcg orally daily.

If iPTH decrease is less than 30% after 3 months of therapy and serum levels of calcium and phosphorus are within the target ranges based upon the CKD Stage, increase dosage by 50%.

If iPTH decrease is less than the target range for CKD stage, hold calcitriol therapy until iPTH increases to above target range; resume therapy at half the previous dosage (if dosage is less than 0.25 mcg capsule or 0.05 mcg liquid, use every other day therapy).

If serum levels of total corrected calcium exceed 10.2 mg/dL, hold calcitriol therapy until serum calcium decreases to less than 9.8 mg/dL; resume therapy at half the previous dosage (if dosage is less than 0.25 mcg capsule or 0.05 mcg liquid, use every other day therapy).

If serum levels of phosphorus increase to greater than the age appropriate upper limits, hold calcitriol therapy (initiate or increase phosphate binders until the levels of serum phosphorus decrease to age appropriate limits); resume therapy at half the previous dosage.

Children and Adolescents with CKD Stage 5: Serum calcium times phosphorus product (Ca x P) should not exceed 65 mg(2)/dL(2) for infants and children less than 12 years of age and 55 mg(2)/dL(2) for adolescents, serum phosphorus should be within target, serum calcium less than 10 mg/dL.

iPTH 300 to 500 pg/mL: 0.0075 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 0.25 mcg daily.

iPTH greater than 500 to 1000 pg/mL: 0.015 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 0.5 mcg daily.

iPTH greater than 1000 pg/mL: 0.025 mcg/kg orally or IV per dialysis session (3 times/week); not to exceed 1 mcg daily.

Dosage adjustment: If iPTH decrease is less than 30% after 3 months of therapy and serum levels of calcium and phosphorus are within the target ranges based upon the CKD Stage 5, increase dosage by 50%.

What other drugs will affect calcitriol?

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

  • digoxin (digitalis, Lanoxin, Lanoxicaps);

  • cholestyramine (Questran, Prevalite);

  • ketoconazole (Nizoral);

  • lanthanum (Fosrenol);

  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Solfoton);

  • steroids such as prednisone, fluticasone (Advair, Flovent), mometasone (Asmanex, Nasonex), dexamethasone (Cortastat, DexPak, Decadron) and others; or

  • a (water pill) diuretic such as hydrochlorothiazide (HCTZ, Esidrix, Hydrodiuril, Microzide,Oretic), chlorothiazide (Diuril), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others.

This list is not complete and other drugs may interact with calcitriol. 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.

Where can I get more information?

  • Your pharmacist can provide more information about calcitriol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02. Revision Date: 2010-12-15, 5:01:39 PM.

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