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Details for: TARO-CALCITRIOL

Company: TARO PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02485710TARO-CALCITRIOLCALCITRIOL0.25 MCGCAPSULEORAL
02485729TARO-CALCITRIOLCALCITRIOL0.5 MCGCAPSULEORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Taro-Calcitriol is indicated in the management of

  • Calcium deficiency (hypocalcemia) and bone disease in patients with chronic renal failure undergoing dialysis
  • Calcium deficiency (hypocalcemia) in patients with hypoparathyroidism (underactive parathyroid glands).
  • Rickets (type of bone disease).
What it does

Taro-Calcitriol helps patients with kidney or bone disease (e.g. rickets) who cannot make enough of the active form of vitamin D in the body to meet their needs. Taro-Calcitriol supplies this form of vitamin D which the body can use to meet requirements.

When it should not be used
  • If you are allergic to the medicinal ingredient calcitrol, vitamin D, other vitamin D products or other forms of vitamin D or to any of the nonmedicinal ingredients in this formulation (see What the non-medicinal ingredients are).
  • If you have hypercalcemia (high levels of calcium in the blood).

What the medicinal ingredient is

Calcitriol

What the non-medicinal ingredients are

Butylhydroxyanisole, butylhydroxytoluene, medium-chain triglycerides, gelatin, liquid sorbitol, glycerol, methyl paraben, propyl paraben, ferric oxide (red), ferric oxide (yellow) in 0.25 mcg strength only, titanium dioxide, triethyl citrate, shellac glaze, iron oxide black, propylene glycol and ammonium hydroxide.

What dosage form it comes in

Capsules 0.25 mcg: Peach colored, oval, soft gelatin capsule imprinted with '967' in black ink, containing clear, colorless to slightly yellowish oily liquid.
Capsules 0.50 mcg: Brown colored, oval, soft gelatin capsule imprinted with '968' in black ink, containing clear, colorless to slightly yellowish oily liquid.

Warnings and precautions

BEFORE you use Taro-Calcitriol talk to your doctor or pharmacist if:

  • you are allergic to vitamin D or other forms of vitamin D products or to any ingredient of Taro-Calcitriol.
  • you have a history of kidney disease.
  • you are undergoing dialysis.
  • you have a history of heart disease.
  • you are using cardic glycosides (e.g.digitalis).
  • you are pregnant or planning to become pregnant during treatment.
  • you are breastfeeding or planning to breastfeed. Taro-Calcitriol may be released in human breast milk. Discuss with your doctor.
  • you are taking any other drugs including nonprescription drugs, other vitamin D products, or other forms of vitamin D or any other vitamins or supplements.
Interactions with this medication

Drugs that may interact with Taro-Calcitriol include: digitalis, bile acid sequestrants (including cholestyramine and sevelamer) and mineral oil, anticonvulsants (e.g. phenytoin, phenobarbital), calcium supplements, corticosteroids, ketoconazole, magnesiumcontaining drugs (e.g. some antacids), thiazides.

Proper use of this medication

The effectiveness of Taro-Calcitriol therapy is based on the assumption that each patient is receiving an adequate daily intake of calcium.

To ensure that you receive an adequate daily intake of calcium, your doctor may either prescribe a calcium supplement or instruct appropriate dietary measures. Your doctor may monitor your blood levels of calcium and phosphorus.

Be sure to drink plenty of fluids to maintain good hydration, important during Taro-Calcitriol treatment.

Usual Dose

Dosage is based on your medical condition and response to therapy. Your doctor may start you on a low dose and adjust the dose slowly to find the best dose for you. Follow your doctor's directions carefully.

Overdose

If you think you have taken too much Taro-Calcitriol, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Take you missed dose as soon as you remember. Skip taking the missed dose if it is almost time for the next scheduled dose. No extra medicine should be taken to make up the missed dose.

Side effects and what to do about them

The most common side effect of Taro-Calcitriol is hypercalcemia -high calcium levels in the blood (see Serious Side Effects table below for symptoms). Common side effects include nausea, vomiting, stomach cramps, itching and sleeplessness.

Other side effects include agitation, sleeplessness, lack of feeling, weakness, constipation, upper abdominal pain, redness or itching of the skin, excessive thirst, fever and joint pain. If these side effects become bothersome or persist, contact your doctor.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Very Common
Higher blood calcium levels than normal.

Possible symptoms:

Early symptoms:
weakness, headache, drowsiness, nausea, irregular heartbeat, excessive thirst, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, abdominal pain or stomach ache.

Late symptoms:
frequent urination (including needing to urinate at night), excessive thirst, urinary tract infections, anorexia, weight loss, conjunctivitis, inflammation of the pancreas, sensitivity to light, runny nose, itching, feeling feverish, decreased sex drive, too much protein in the urine, high cholesterol, elevated liver function tests, excessive calcium in tissues, high blood pressure, irregular heartbeat, and rarely, loss of contact with reality.
   
Common
Headache Abdominal pain - Rash Urinary tract infection    
Uncommon
Decreased appetite Vomiting    
Not Known
Allergic reactions - Possible symptoms: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.    
Difficulty in understanding Growth retardation Excessive urination Calcium deposits on the skin Weight loss    

This is not a complete list of side effects. For any unexpected effects while taking, Taro-Calcitriol contact your doctor or pharmacist.

How to store

Capsules should be stored a 15-25 C. Store in the original container. Protect from light and moisture. Keep blister in the outer carton. Keep out of sight and reach of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Taro-Calcitriol:

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website www.taro.ca, or by calling 1- 800-268-1975.
This leaflet was prepared by:

Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Date Prepared: February 11, 2019

Date modified: