Tranexamic Acid (Glotrek) 100mg/ml (500mg/5ml) Solution for Injection (IV) 5ml x 5 Ampoules

Certainly! Below is the detailed information for Tranexamic Acid (Glotrek) 100mg/ml (500mg/5ml) Solution for Injection (IV) 5ml x 5 Ampoules:

Product Description:

Tranexamic Acid (Glotrek) 100mg/ml Solution for Injection is a medication used to reduce excessive bleeding. The active ingredient, Tranexamic Acid, is an antifibrinolytic agent that works by inhibiting the breakdown of fibrin, which helps the blood clot more effectively. This helps prevent excessive bleeding in conditions where blood clotting is impaired or when there is a risk of significant blood loss. The solution is presented in 5ml ampoules, each containing 500mg of Tranexamic Acid.

Indications:

Tranexamic Acid (Glotrek) Solution for Injection is indicated for the following conditions:

• Management of Bleeding or Risk of Bleeding:

  • Heavy Menstrual Bleeding (Menorrhagia): For control of excessive menstrual bleeding.

  • Postoperative Bleeding: To prevent excessive bleeding following surgery, particularly in surgeries involving the heart, prostate, or gynecological procedures.

  • Trauma-induced Bleeding: Tranexamic Acid can be used in cases of trauma where bleeding is severe.

  • Bleeding Disorders: In patients with bleeding disorders, it helps to manage and prevent bleeding episodes.

  • Dental Procedures in Hemophilia Patients: Used to prevent bleeding in individuals with hemophilia undergoing dental work.

  • Other conditions requiring reduction of excessive bleeding (e.g., gastrointestinal bleeding, during and after surgical interventions, etc.).

Dosage:

The dosage of Tranexamic Acid (Glotrek) Solution for Injection depends on the severity of the condition being treated:

• For Acute Bleeding or Trauma:

  • Initial Dose (IV Injection): 10 to 15 mg/kg body weight, administered over 20–30 minutes. The total dose can be repeated every 6–8 hours, depending on the severity of bleeding.

  • Alternatively, an infusion may be given at a rate of 1–2 mg/min.

• For Surgical Bleeding Prevention:

  • The typical dose is 10 mg/kg body weight, injected slowly before surgery begins.

• For Heavy Menstrual Bleeding:

  • An initial dose of 500 mg to 1000 mg may be administered 2-3 times a day, depending on the patient's needs and medical advice.

Important Note: Always follow the dosage instructions provided by a healthcare professional. The dose may vary based on the patient's condition, age, and body weight.

Side Effects:

Common side effects of Tranexamic Acid (Glotrek) may include:

• Gastrointestinal Effects: Nausea, vomiting, and diarrhea.

• Headache and Dizziness: Some individuals may experience headaches or dizziness during or after administration.

• Allergic Reactions: Rash, itching, and in rare cases, severe allergic reactions such as anaphylaxis (difficulty breathing, swelling of the throat, etc.).

• Venous Thrombosis: Rarely, Tranexamic Acid may increase the risk of blood clots (thrombosis) in certain patients.

• Vision Problems: Blurred vision or changes in vision may occur, especially in high doses.

• Muscle or Joint Pain: In rare cases, muscle pain or joint pain may occur.

Serious but rare side effects include:

• Severe allergic reactions: Such as anaphylaxis, with symptoms of swelling, difficulty breathing, or chest tightness.

• Thromboembolic Events: Increased risk of deep vein thrombosis, pulmonary embolism, or stroke, especially if the patient has pre-existing risk factors for blood clots.

If any of these severe reactions occur, immediate medical attention should be sought.

Contraindications:

Tranexamic Acid (Glotrek) is contraindicated in the following situations:

• Hypersensitivity to Tranexamic Acid or any other component of the formulation.

• Active Thromboembolic Disorders: Patients with a history of or active deep vein thrombosis (DVT), pulmonary embolism (PE), or stroke should not use Tranexamic Acid, as it may exacerbate these conditions.

• Severe Renal Impairment: In patients with significant kidney dysfunction, the use of Tranexamic Acid should be avoided or closely monitored due to the risk of accumulation and toxicity.

• Subarachnoid Hemorrhage: Tranexamic Acid should not be used in patients with a subarachnoid hemorrhage, as it can increase the risk of complications.

• Active Bleeding in Certain Areas: Tranexamic Acid is contraindicated in patients with active bleeding from the upper urinary tract or genital tract, as well as from the eyes.

Precautions:

• Renal Impairment: Use with caution in patients with mild to moderate renal impairment. The dose may need to be reduced in such patients.

• History of Blood Clots: Careful monitoring is required for patients with a history of thromboembolic events, as Tranexamic Acid may increase the risk of clot formation.

• Pregnancy and Lactation: Tranexamic Acid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk, so caution should be exercised if administering to breastfeeding mothers.

• Concurrent Use with Other Antithrombotic Drugs: Tranexamic Acid should be used with caution in combination with other drugs that affect blood clotting (such as anticoagulants), as this can lead to a higher risk of blood clotting issues.

This medication should be used strictly according to a healthcare provider’s instructions, and patients should notify their doctor of any existing conditions or medications that might affect its safety or effectiveness.

This overview should provide a comprehensive understanding of Tranexamic Acid (Glotrek) Solution for Injection. Always consult with a healthcare provider before starting or changing a medication regimen.