Patient Medication Information: uses, side effects, how to take - Taro-Calcitriol
ABOUT THIS MEDICATION
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 non- prescription drugs, other vitamin D products, or other forms of vitamin D or any other vitamins or supplements.
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 important 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 forms 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.
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, magnesium- containing 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 adult 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.
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.
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.
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
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your | ||
| 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 | √ | √ | |
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
| Only if severe | In all cases | |||
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. | √ | ||
of the skin, excessive thirst, fever and joint pain. If these side effects become bothersome or persist, contact your doctor.
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 IT
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 side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting
(https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. 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.
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1
TARO is a registered trademark of Taro Pharmaceuticals Inc.
Date Prepared: February 11, 2019