Patient Medication Information: uses, side effects, how to take - Calcitriol Injection USP (Sterimax, 1 mcg)
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 nonmedicinal ingredients are:
Anhydrous dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate monohydrate, polysorbate 20, sodium ascorbate, sodium chloride.
What dosage forms it comes in:
Calcitriol Injection USP is supplied in 1 mL ampoules containing 1 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 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.
If you think you, or a person you are caring for, have taken too much Calcitriol Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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.
| 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 | ||||||
| Common | Elevated blood calcium | ✓ | |||||
| Allergic Reactions such as: | ✓ | ||||||
| ✓ | ||||||
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| ✓ | ||||||
| Dehydration such as: | ✓ | ||||||
| ✓ | ||||||
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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 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 Calcitriol Injection USP:
- 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/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.sterimaxinc.com); or by calling 1-800-881-3550