Details for: LEDERLE LEUCOVORIN
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02170493 | LEDERLE LEUCOVORIN | LEUCOVORIN (LEUCOVORIN CALCIUM) | 5 MG | TABLET | ORAL |
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
The medication is used -
- To diminish the toxicity and counteract the effect of impaired METHOTREXATE elimination.
- To treat the megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of pregnancy and infancy.
What it does
LEUCOVORIN is a reduced form of folic acid. LEUCOVORIN limits METHOTREXATE action on normal cells by competing with METHOTREXATE for the same transport processes into the cell. LEUCOVORIN rescues bone marrow and gastrointestinal cells from METHOTREXATE but has no apparent effect on preexisting METHOTREXATE nephrotoxicity.
When it should not be used
Do not take LEUCOVORIN
- if you are allergic (hypersensitive) to calcium folinate or any of the other ingredients of LEUCOVORIN OR
- If you have megaloblasic anaemia due to Vitamin B12 deficiency
What the medicinal ingredient is
LEUCOVORIN Calcium (also known as calcium folinate).
What the non-medicinal ingredients are
Non-medicinal ingredients are: Lactose, Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate and Starch Pregelatinized 1500.
What dosage form it comes in
Tablet: 5 mg LEUCOVORIN as LEUCOVORIN calcium
Warnings and precautions
In very rare cases sloughing of the skin, rarely leading to death, has been reported in patients receiving Leucovorin along with other medications known to have similar side-effects.
Leucovorin should only be used under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
BEFORE you use LEUCOVORIN talk to your doctor or pharmacist if:
- You have symptoms of gastrointestinal disorders.
- You are taking cytotoxic drugs (hydroxycarbamide cytarabine, mercaptopurine, thioguanine).
- You are epileptic and are being treated with phenobarbital, primidone, phenytoin and succinimides.
- If you are Pregnant or Nursing.
Interactions with this medication
LEUCOVORIN can interfere with the breakdown or metabolism of certain drugs. In particular, you should inform your doctor if you are taking any of the following:
- Cytotoxic drugs - 5-fluorouracil (5FU), Methotrexate (High doses of LEUCOVORIN may reduce the efficacy of Methotrexate. LEUCOVORIN may enhance the toxicity of fluorouracil.)
- Folic acid antagonists – cotrimxazole, pyrimethamine
- Anti-epileptic substances - phenobarbital, primidone, phenytoin and succinimides.
Proper use of this medication
Usual dose
Take your dose as prescribed by the physician.
Overdose
If you take too much LEUCOVORIN (Overdose):
- Immediately call your doctor or go to the nearest hospital emergency department
- Do this even if you have no signs of discomfort
- Always take the labelled medicine bottle with you, even if it is empty
Missed Dose
Not Applicable.
Side effects and what to do about them
Undesirable effects have been rarely reported.
Allergic sensitization, including anaphylactoid/anaphylactic reactions (including shock) and urticaria, has been reported following administration of folinic acid.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
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This is not a complete list of side effects. For any unexpected effects while taking LEUCOVORIN, contact your doctor or pharmacist.
How to store
Tablets should be stored at 15-30°C. Protect from light.
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 3 ways:
- Report online at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
- 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 1908C
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.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
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 obtained by contacting the sponsor, Pfizer Canada Inc., at: 1-800-463-6001 or at www.pfizer.ca
This leaflet was prepared by Pfizer Canada Inc.
Last revised: October 10, 2018