Tranexamic Acid Injection BP (Sterimax): Uses, Side Effects and Dosage

What is Tranexamic Acid Injection BP used for?

Tranexamic Acid Injection BP is used in adults:

• to prevent or reduce bleeding from tooth extraction

How does Tranexamic Acid Injection BP work?

Tranexamic Acid Injection BP belongs to one of 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 BP?

Medicinal ingredient: Tranexamic Acid

Nonmedicinal ingredients: Water for injection

Tranexamic Acid Injection BP comes in the following dosage form:

Solution for Injection: 100 mg / mL of tranexamic acid.

Do not use Tranexamic Acid Injection BP 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 CYKLOKAPRON.
• 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 BP (solution for injection) is only for intravenous use. Do not administer Tranexamic Acid Injection BP 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 BP. 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 BP 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 BP will only be given if your healthcare professional has done blood tests to check 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 BP can cause the following:

• Allergic reaction: This can occur when Tranexamic Acid Injection BP is given intravenously (directly into your bloodstream). Your healthcare professional will closely monitor you after Tranexamic Acid Injection BP 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 BP for several weeks, you should get an eye check-up before you start taking Tranexamic Acid Injection BP and 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 BP 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 BP 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 BP. 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 BP, tell your healthcare professional right away.

Driving and using machines:

Tranexamic Acid Injection BP can cause dizziness. Before you drive or do tasks that require special attention, wait until you know how you respond to Tranexamic Acid Injection BP.

Tell your doctor or pharmacists about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Tranexamic Acid Injection BP:

• 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 BP:

• Solution for Injection: Your healthcare professional will prepare and give you Tranexamic Acid Injection BP solution for injection. You will receive Tranexamic Acid Injection BP 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 BP include:

• diarrhea;
• dizziness;
• headache;
• nausea;
• seizures;
• symptoms of low blood pressure (e.g., blurry vision, confusion, fainting, light-headedness, weakness); and
• vomiting.

What are possible side effects from using Tranexamic Acid Injection BP?

These are not all the possible side effects you may have when taking Tranexamic Adid Injection BP. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of Tranexamic Adid Injection BP 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

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:

• 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

Storage:

• Store the unopened vials at room temperature (15-30°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 the reach and sight of children.

If you want more information about Tranexamic Adid Injection BP:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for health 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.sterimaxinc.com), or by calling 1-800-881-3550.

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Last revised: SEP 08, 2022