Patient Medication Information: uses, side effects, how to take - Tranexamic Acid Injection (Jamp Pharma)
What is Tranexamic Acid Injection used for?
Tranexamic Acid Injection is used in adults to prevent or reduce bleeding from tooth extraction.
How does Tranexamic Acid Injection work?
Tranexamic Acid Injection belongs to a group of medicines called antifibrinolytic agents. It works by blocking the breakdown of blood clots, which helps to prevent or reduce bleeding.
What are the ingredients in Tranexamic Acid Injection?
Medicinal ingredient: Tranexamic acid.
Non-medicinal ingredients: Water for injection.
Tranexamic Acid Injection comes in the following dosage forms:
Solution: 100 mg/mL of tranexamic acid.
Do not use Tranexamic Acid Injection if:
- you have a history or are at a higher risk for thrombosis (blood clots in the veins or arteries). This includes diseases where a blood clot breaks loose and blocks another blood vessel (e.g., deep vein thrombosis, pulmonary embolism, and cerebral thrombosis).
- you are allergic to tranexamic acid or to any other ingredients in Tranexamic Acid Injection.
- you have a colour vision problem that is not genetic.
- you have blood in the urine.
- you have bleeding in the space between your brain and the surrounding membrane (subarachnoid haemorrhage).
The Tranexamic Acid Injection is only for intravenous use. Do not administer Tranexamic Acid Injection using other routes of administration as this can cause serious adverse events including death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Tranexamic Acid Injection. Talk about any health conditions or problems you may have, including if you:
- have kidney problems.
- have irregular menstrual bleeding where the cause is not known.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. Tranexamic Acid Injection can pass into breast milk and affect your unborn baby.
are taking any of the following:
- anticoagulants (used to prevent blood clots and thin the blood);
- hormonal birth control methods (e.g., “the pill”); or
- tamoxifen (used to treat breast cancer).
- have a condition known as disseminated intravascular coagulation (DIC; excessive blood clotting). Tranexamic Acid Injection will only be given if your healthcare professional has done blood tests to check that you are suitable, otherwise other anti-clotting medicines may be a better option for you.
- are obese.
- have diabetes.
- have polycystic ovary syndrome (a condition that produces high levels of a male hormone called androgen causing irregular or no periods).
- have a history of cancer of the uterine (endometrial cancer) in a close relative.
- are on estrogen therapy.
- are over the age of 65 years old.
- are at a higher risk for blood clots in the veins or arteries (e.g., a history of blood clots or a family history of blood clotting conditions).
Other warnings you should know about:
Taking Tranexamic Acid Injection can cause the following:
- Allergic reaction: This can occur when Tranexamic Acid Injection solution for injection is given intravenously (directly into your bloodstream). Your healthcare professional will closely monitor you after Tranexamic Acid Injection administration.
- Seizures (fits)
- Thromboembolism (blood clot in a vein or artery)
- Vision problems: This can include blurred vision, loss of vision, and impaired colour vision. If you are prescribed to take Tranexamic Acid Injection for several weeks, you should get an eye check-up before you start taking Tranexamic Acid Injection at regular intervals. These check-ups will assess the sharpness of your vision, colour vision, and field of vision. If you notice any change in your vision, especially in your colour vision, tell your healthcare professional right away.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Pregnancy:
- Tranexamic Acid Injection can pass through the placenta and harm your unborn baby. If you are able to get pregnant, plan to become pregnant, are pregnant, or are taking hormonal birth control methods, there are specific risks that you must first discuss with your healthcare professional.
- Tranexamic Acid Injection can affect hormonal birth control methods such as “the pill” and can cause unwanted serious effects. Therefore, you should use a non-hormonal birth control method while you are taking Tranexamic Acid Injection. If you have any questions about this, talk to your healthcare professional.
- If you become pregnant or think you are pregnant while taking Tranexamic Acid Injection, tell your healthcare professional right away.
Driving and using machines:
Tranexamic Acid Injection can cause dizziness. Before you drive or do tasks that require special attention, wait until you know how you respond to Tranexamic Acid Injection.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Tranexamic Acid Injection:
- medicines used to help your blood clot;
- hormonal birth control (e.g., “the pill”);
- anticoagulants used to prevent blood clots and thin the blood;
- hydrochlorothiazide, a diuretic that is typically used to treat high blood pressure;
- desmopressin, a medicine used to treat diabetes;
- sulbactam-ampicillin, an antibiotic used to treat bacterial infections;
- carbazochrome, a medicine used to help your blood clot;
- ranitidine, a medicine used to lower the amount of stomach acid;
- nitroglycerin, a medicine used to treat or prevent chest pain.
How to take Tranexamic Acid Injection:
Your healthcare professional will prepare and give you Tranexamic Acid Injection solution for injection. You will receive Tranexamic Acid Injection through your veins (i.e., “intravenously” or “IV”) by slow injection as a bolus IV dose over 5 minutes or as an IV drip. They will ensure that the correct route of administration (IV) is used to give your dose. Other routes of administration are NOT to be used as this can cause serious adverse events including death.
Usual dose:
Your healthcare professional will decide the best dose based on weight.
Overdose:
Symptoms of an overdose with Tranexamic Acid Injection include:
- diarrhea;
- dizziness;
- headache;
- nausea;
- seizures;
- symptoms of low blood pressure (e.g., blurry vision, confusion, fainting, light-headedness, weakness); and
- vomiting.
| If you think you, or a person you are caring for, have taken too much Tranexamic Acid Injection, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
What are possible side effects from using Tranexamic Acid Injection?
These are not all the possible side effect you may have when taking Tranexamic Acid Injection. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Tranexamic Acid Injection may include:
- diarrhea;
- dizziness, especially if the injection is given too quickly;
- nausea (feeling sick);
- vomiting.
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 | ||
| RARE | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach, vomiting, hives, rash, or swelling of the face, lips, tongue or throat. | √ | ||
Eye problems: blurred vision, changes to the sharpness of vision, loss of vision, or colour vision change, changes to the field of vision, or sudden loss of eyesight in one eye. | √ | ||
Seizures (fit): loss of consciousness with uncontrollable shaking. | √ | ||
| Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, or possible irregular heartbeat. | √ | ||
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 | ||
|---|---|---|---|
| Thromboembolism (blood clot in a vein or artery, including in the brain, limbs, and heart): arm or leg pain, tenderness or swelling, skin that is red or warm, coldness, tingling, numbness, pale skin, muscle pain, muscle spasms, weakness, dizziness, numbness, weakness on one side of the body, and problems with talking, writing, or understanding language. | √ | ||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing, difficulty speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking, or loss of balance. | √ | ||
| Acute renal cortical necrosis (death of the tissue in the outer part of the kidney): red or dark brown urine, blood in urine, lower back pain, fever, changes in blood pressure, or urine flow is reduced or stopped. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light- headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up and after fast injection). | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
Storage:
- Store the unopened vials at room temperature (15°C to 30°C). After dilution, the mixture should be immediately used. However, if needed, the mixture can be stored at 2°C to 8°C for up to 24 hours. If the mixture is not used within 24 hours of preparation, it should be discarded.
- Keep out of reach and sight of children.
If you want more information about Tranexamic Acid Injection:
- Talk to your healthcare professional.
Find the full Product Monograph that is prepared for healthcare professionals and includes the 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.jamppharma.com) or by calling at 1-866-399-9091.
JAMP Pharma Corporation,
1310 rue Nobel,
Boucherville, Quebec,
J4B 5H3, Canada