Calcitriol Injection USP (Sterimax, 2 mcg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

The management of hypocalcemia (low calcium levels) in patients undergoing chronic renal dialysis.

What it does:

Calcitriol Injection USP helps to regulate calcium levels in the blood.

When it should not be used:

You should not use Calcitriol Injection USP if you:

• Are allergic to calcitriol, or vitamin D or its analogues and derivatives, or any of the non-medicinal ingredients in Calcitriol Injection USP
• Have high calcium levels (hypercalcemia)
• Have high vitamin D levels (vitamin D toxicity)

What the medicinal ingredient is:

Calcitriol

What the important nonmedicinal ingredients are:

Anhydrous dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate monohydrate, polysorbate 20, sodium ascorbate, sodium chloride.

For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.

What dosage forms it comes in:

Calcitriol Injection USP is supplied in 1 mL ampoules containing 1 mcg or 2 mcg of calcitriol.

WARNINGS AND PRECAUTIONS

BEFORE you use Calcitriol Injection USP talk to your doctor or pharmacist if:

• You are allergic to vitamin D or to any ingredient of Calcitriol Injection USP

• You are on digitalis

  • You are pregnant or nursing

  • If you are taking other vitamin D products or its derivatives

The safety and effectiveness of Calcitriol Injection USP in children under 18 years of age have not been established.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Calcitriol Injection USP include:

• Digitalis
• Anti-seizure medications (e.g., diphenylhydantoin and barbiturates)
• Antacids containing magnesium
• Corticosteroids
• Thiazide diuretics (e.g., hydrochlorothiazide)

PROPER USE OF THIS MEDICATION

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

To ensure that each patient receives an adequate daily intake of calcium, the physician may either prescribe a calcium supplement or instruct the patient in appropriate dietary measures.

Usual dose:

The dose will be decided by your doctor and be given through a catheter three times per week at the end of hemodialysis. You should also take your prescribed daily dose of calcium and follow the instructions on diet and supplement intake.

Overdose:

If you think you have been given more Calcitriol Injection USP than you should have, talk to your doctor or nurse or contact a poison control centre.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effect of Calcitriol Injection USP is hypercalcemia (high calcium levels).

Early symptoms (within first few months of use of drug) of hypercalcemia and vitamin D toxicity include: weakness, headache, feeling sleepy, nausea, irregular heart beat, excessive thirst, vomiting, dry mouth, constipation, abdominal pain, loss of appetite, discomfort or unpleasant sensation in the upper abdomen, muscle pain, bone pain, and metallic taste.

Late symptoms (with continued [chronic] use of drug): too much protein in your urine, loss of appetite, feeling indifferent or lack

of emotion, abnormal heart beat, swelling or infection near your

eyelid, decreased sex drive, loss of water/not enough water in

your body, abnormal changes in bone and muscle development,

deposit of calcium salt in tissues, excessive nitrogen in your urine, elevated liver function tests, high cholesterol, high blood pressure,

feeling too hot, too much calcium in your kidneys, needing to

urinate at night, inflammation of the pancreas, sensitivity to light,

excessive thirst, increased need to urinate, itching, loss of contact

with reality, runny nose, changes in sensation such as pain, touch,

pressure and temperature sensation, urinary tract infections, and

weight loss.

If these side effects do not go away or if you experience other side effects which are not listed above, talk to your doctor right away.

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

HOW TO STORE IT

Store between 15°C and 30°C. Protect from light, excessive heat, and freezing.

REPORTING SUSPECTED 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 3 ways:

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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 0701D

  Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.sterimaxinc.com

or by contacting the sponsor, SteriMax Inc., at:

1-800-881-3550

Last revised: March 10, 2016