Patient Medication Information: uses, side effects, how to take - Heparin Sodium Injection USP (Pfizer Canada, 10000 Unit)
ABOUT THIS MEDICATION
What the medication is used for
Heparin Sodium Injection is indicated for:
- treatment to stop your blood from clotting in many surgical and non-surgical situations
- preventing and stopping the spread of blood clots in your veins
- preventing and stopping the spread of blood clots to your lungs
- treatment of some disorders of blood clotting
- prevention of blood clotting during surgery
- prevention and treatment of blood clots in your arteries
What it does
Heparin stops reactions that lead to the clotting of blood and the formation of clots. Once an active blood clot has developed, larger amounts of heparin can inhibit further clotting.
Peak levels of heparin are achieved 2-4 hours following intravenous administration, although there are considerable individual variations.
When it should not be used
BEFORE you use Heparin Sodium Injection, talk to your doctor if you have:
- severe reduction of blood platelets
- an uncontrollable active bleeding state (see WARNINGS AND PRECAUTIONS), except when this is due to disseminated intravascular coagulation
- a hypersensitivity or allergy to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see What the important nonmedicinal ingredients are.
This Heparin Sodium Injection formulation contains benzyl alcohol and should not be given to neonates, premature and low birth weight infants.
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What the medicinal ingredient is
Heparin sodium
What the important nonmedicinal ingredients are
Sodium chloride
Benzyl alcohol as preservative
What dosage form it comes in
Heparin Sodium Injection is available as:
- 10 000 units per mL: vials of 10 000 units in 2 mL (1 mL fill) with preservative
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Fatal bleeding has occurred in infants and children due to medication errors in which 1 mL Heparin Sodium Injection vials were confused with 1 mL “catheter lock flush’ vials.
Bleeding can occur at virtually any site in patients receiving heparin.
Increased resistance to heparin is frequently encountered in fever, blood clot, vein inflammation associated with a blood clot, infection with blood clotting tendencies, heart attack, cancer and in patients after surgery.
Heparin sodium should be used with extreme caution in disease states in which there is an increased danger of bleeding. Some of the conditions in which an increased danger of bleeding exists are:
- Infections of the heart and heart valves. Severe high blood pressure.
- During and immediately following (a) spinal tap, spinal or epidural anesthesia or (b) major surgery, especially involving the brain, spinal cord, or eye.
- Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia (low platelets) and some vascular purpuras.
- Ulcers of the stomach and continuous tube drainage of the stomach or small intestine.
- Menstruation, liver disease with impaired blood clotting.
Heparin sodium should be used with caution in patients at risk of increased potassium levels.
Excessive administration of potassium-free solutions may result in significant low concentrations of potassium in the blood.
Heparin is not intended for Intramuscular Use.
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Allergic reaction to this drug might happen, stop the medication and consult your doctor.
Platelet count should be tested and monitored.
This Heparin Sodium Injection formulation contains benzyl alcohol and should be given with caution to pregnant and nursing women.
INTERACTIONS WITH THIS MEDICATION
Certain medications may intensify the anticoagulant effect (e.g., blood thinning effect) of Heparin Sodium Injection. Therefore, it is important for you to advise your doctor if you are taking any medications such as the following:
- other drugs used to reduce blood clotting including warfarin, dextran, alteplase or streptokinase
- acetylsalicylic acid (Aspirin)
- non-steroidal anti-inflammatory drugs (NSAIDs); drugs used to treat painful and/or inflammatory conditions of muscles or joints including ibuprofen, celecoxib or indomethacin
- hydroxychloroquine; drug used to treat malaria
- Andexanet alpha can cause unresponsiveness to Heparin Sodium.
The following may interact with ONDEXXYA:
- ONDEXXYA treatment should be avoided if anticoagulation with heparin might become necessary.
ONDEXXYA causes unresponsiveness to heparin.
PROPER USE OF THIS MEDICATION
If you think you, or a person you are caring for, have taken too much Heparin Sodium Injection USP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms.
Usual dose
The product should be administered under the supervision of a qualified health professional who is experienced in the use of anticoagulant agents and in the management of patients with venous thrombosis, pulmonary embolism, acute and chronic consumptive coagulopathies and peripheral arterial embolism. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Side effects may include:
- irritation at the injection site
- mild pain at the injection site
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- bruising at the injection site
- chills
- fever
- skin rash
- asthma
- runny nose
- tearing from eyes
- headache
- nausea
- vomiting
If the above symptoms become bothersome consult your doctor.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
COMMON Hemorrhage; bleeding | √ | ||
| Thrombocytopenia; low levels of platelets in the blood | √ | ||
| Osteoporosis after prolonged treatment | √ | ||
RARE Allergic reactions | √ | ||
This is not a complete list of side effects. For any unexpected effects while taking Heparin Sodium Injection, contact your doctor or pharmacist immediately.
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
- Talk to your healthcare professional;
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- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication 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 www.pfizer.ca or by calling 1-800-463-6001.