Tranexamic Acid Injection

Active Ingredients: Tranexamic Acid

Tranexamic Acid Injection is used for the short-term control and prevention of excessive or heavy bleeding during certain dental procedures in patients with hemophilia. This drug may also be used to reduce bleeding and the need for blood replacement therapy associated with trauma or orthopedic surgery.

Tranexamic acid is classified in the family of medicines called antifibrinolytics. It is a synthetic derivative of the amino acid lysine. It works by stopping blood clots from breaking down.

Tranexamic Acid Injection is available in two formulations, 250mg/5ml and 500mg/5ml. The solution is packaged in ampoules, which are available in packs of 10 or 100.

This medication is produced and exported by AdvaCare Pharma. Tranexamic Acid Injections are manufactured in our facilities in China, India, and the USA. Our factories comply with WHO guidelines and standards, and we regularly inspect these facilities to ensure they meet these high standards.

AdvaCare Pharma, a US-owned pharmaceutical company, is a manufacturer of Tranexamic Acid with GMP-compliant manufacturing facilities located worldwide. We conduct frequent GMP, third-party and internal facility inspections to ensure that our manufactured injectable treatments exceed the stringent requirements of importing countries and our distributors.

As a renown Tranexamic Acid manufacturer and global supplier of 120+ pharmaceutical injection products, our global reach extends to over 65 markets ensuring that pharmaceutical distributors, hospitals, pharmacies, NGOs and government institutions receive the quality-assured treatments they need.

What is Tranexamic Acid used for?

It is used to control bleeding caused by dental procedures for patients with hemophilia. It is also used to reduce bleeding associated with trauma or orthopedic surgery.

Tranexamic acid is also used (off-label) in severely bleeding patients requiring massive transfusion protocols (MTP) or when hyper-fibrinolysis is demonstrated and in dermatology for the improvement of melasma and as a maintenance treatment of hereditary angioedema and urticaria.

How are Tranexamic Acid Injections used?

This medication is manufactured as a solution to be injected into a vein. It is to be administered by a healthcare professional in the hospital or clinic setting.

Before administration, the solution should be carefully inspected for any visual particles or discoloration.

Diluted mixtures of tranexamic acid can be kept for up to 4 hours at room temperature.

After use, any unused portion of the medicine should be discarded.

How should Tranexamic Acid Injections be stored?

Any unused ampoules of tranexamic acid should be stored in a dark location below 25°C. Do not freeze this medicine.

What dose should be given?

Refer to a doctor or pharmacist for guidelines on dosage. The exact dosage is based on medical condition, response to the treatment, age, and weight.

Who can use Tranexamic Acid?

Tranexamic Acid Injection can be administered to adults and children, but caution is advised for specific groups of patients.

Pregnant Tranexamic acid should only be administered to pregnant women if the benefits outweigh the risks. Human data has shown that tranexamic acid is transmitted through the placenta. There is a possible risk of fetal and/or neonatal functional issues, including neonatal sepsis and cephalohematoma. Low birth weight and pre-term birth have also been reported in additional clinical studies.

Breastfeeding Tranexamic acid should only be administered if the benefits outweigh the risks. Published reports indicate that tranexamic acid is excreted into human milk. There is no known risk of infant harm based on limited human data, and there is not sufficient human data to assess the effects on milk production.

Children No significant pharmacokinetic differences have been reported for pediatric patients when compared with adults, though the benefits should be weighed against the risks when treating children under 2 years old. It is recommended to reduce the dose for children under 2 years old who also have mild or moderate renal impairment. This drug is not recommended for children with severe renal impairment.

Geriatric Human data does not suggest pharmacokinetic differences in elderly versus younger patients. It should be noted that tranexamic acid is largely excreted by the kidneys. As older patients are more likely to have renal insufficiency, it is advised to express caution when selecting the appropriate dose. In addition, some clinicians may find it useful to monitor renal function during treatment.

Other warnings

Caution should be expressed when treating patients during cardiovascular surgery or those with DIC, upper urinary tract bleeding, a history of thromboembolism, or a history of seizures.

For patients with renal impairment, it is recommended to follow the renal dosing guidelines, as lower doses are necessary, as blood levels of the drug are increased in this population.

Dose reductions are not necessary for patients with hepatic impairment, as tranexamic acid is excreted unchanged.

There is an increased risk of venous or arterial thrombosis associated with tranexamic acid. Avoid concomitant use with factor IX, as there is an increased risk of thrombosis. In addition, patients taking hormonal contraception should be advised to use non-hormonal options during therapy.

This medication is intended for intravenous use only. It should be noted that accidental injection into the neuraxial system may cause seizures or cardiac arrhythmias.

As with all pharmaceuticals, some unwanted effects can occur from the use of Tranexamic Acid Injection.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor.

Before treatment, consult your doctor regarding any medications you are taking to address potential drug interactions.

This medication may not be suitable for people with certain conditions, so it is important to consult with a doctor if you have any health conditions. Some conditions that may need additional consideration include kidney disease, bladder/kidney infection, or leukemia.

Driving and operating machinery should be avoided during treatment with tranexamic acid, as it is known to cause dizziness as a side effect.

Tranexamic acid can be mixed with most solutions intended for infusion, including electrolytes, carbohydrates, amino acids, and Dextran. Heparin can be added to this medication. It should be noted that tranexamic acid is not compatible with blood or penicillin antibiotics.

Tranexamic acid combined with recombinant factor VIII increases clot resistance to accelerated fibrinolysis in severe hemophilia A

This study evaluates whether the clot stability in hemophiliacs could be improved by treatment with tranexamic acid (TXA) in combination with recombinant factor VIII (rFVIII).

Baseline blood samples were taken from eight males with severe hemophilia A. A bolus injection of rFVIII was administered to elevate the functional level of FVIII to approximately 50%. After a 10-minute interval, blood was collected, followed by an intravenous injection of TXA. Another blood sample was obtained after an additional 10 minutes. Thrombelastography using minimal tissue factor activation was utilized to determine whole blood clotting profiles, assessing both clot initiation and propagation. Clot stability was evaluated at clot termination using parameters such as maximum clot firmness and area under the elasticity curve.

The results showed that rFVIII enhanced clot formation, while TXA did not affect this parameter. Assessments involving tissue-plasminogen activator demonstrated that rFVIII tripled the maximum clot firmness, whereas the presence of TXA resulted in an additional quadrupling of this increase.

The conclusion is that simultaneous treatment with TXA and rFVIII significantly improves clot stability in patients with hemophilia A.