Tranexamic Acid (Aneptil) 500mg/5ml Solution for Injection I.M/I.V 5 x 5ml Ampoule

Product Description:

Tranexamic Acid (Aneptil) 500mg/5ml Solution for Injection (IM/IV) is a medication that is used to treat and prevent excessive bleeding. Tranexamic acid is an antifibrinolytic agent that works by inhibiting the breakdown of fibrin, a protein involved in blood clotting. This helps to stabilize blood clots and reduce bleeding in conditions where bleeding is excessive or abnormal. Aneptil 500mg/5ml Solution comes in a 5ml ampoule, and it can be administered through intramuscular (IM) or intravenous (IV) injection.

Tranexamic acid is commonly used in clinical settings to control bleeding after surgery or trauma, in conditions like heavy menstrual bleeding, and in some types of bleeding disorders.

Indications:

Tranexamic Acid (Aneptil 500mg/5ml Solution for Injection is indicated for the following conditions:

1. Management of excessive bleeding:

   • Postoperative bleeding: To control bleeding after surgeries (e.g., dental procedures, heart surgery, or orthopedic surgery).

   • Trauma: In cases of traumatic bleeding where blood loss needs to be controlled.

2. Menorrhagia (heavy menstrual bleeding):

   • To reduce the severity of bleeding in women with heavy menstrual periods.

3. Bleeding in specific medical conditions:

   • Hemophilia: To manage bleeding episodes in patients with hemophilia.

   • Hereditary angioedema: To prevent or treat bleeding associated with this condition.

   • Nasal bleeding (epistaxis) and other mucosal bleeding.

4. Dental surgeries:

   • To prevent excessive bleeding during dental extractions in patients with conditions like hemophilia.

Dosage and Administration:

Dosage:

• Adults:

  • Intravenous (IV): Typically, the dosage is 10-15mg/kg body weight, administered 2-3 times daily. For example, for a patient weighing 70kg, the dose would be 700-1050mg, given in divided doses.

  • Intramuscular (IM): If administered intramuscularly, the dose remains the same but should be given slowly and carefully, following the healthcare provider’s instructions.

  • Postoperative bleeding: 1g (10ml of solution) every 8 hours for up to 3-5 days, depending on the severity of bleeding.

  • Menorrhagia: 1g (10ml) 3 times daily for up to 5 days during menstruation.

• Children:

  • IV: The dose for children is usually 10-15mg/kg body weight administered 2-3 times a day, adjusted according to the clinical response.

Administration:

• The intravenous injection should be given slowly over 10-20 minutes to avoid complications like hypotension or dizziness.

• The intramuscular injection should be administered cautiously to avoid tissue irritation or injection site reactions.

Side Effects:

Although Tranexamic Acid (Aneptil) is generally well-tolerated, some patients may experience side effects. Common and serious side effects include:

Common Side Effects:

1. Gastrointestinal:

   • Nausea

   • Vomiting

   • Diarrhea

   • Stomach cramps or bloating

2. Cardiovascular:

   • Dizziness or light-headedness, especially after rapid IV administration.

   • Hypotension (low blood pressure) when given too quickly by IV.

3. Headache:

   • This can occur as a result of changes in the body’s clotting activity.

4. Skin:

   • Rash or mild skin irritation at the injection site.

5. Musculoskeletal:

   • Muscle pain or weakness in rare cases.

Serious Side Effects (rare but require immediate medical attention):

1. Thrombosis (blood clots):

   • Deep vein thrombosis (DVT)

   • Pulmonary embolism (PE): Blood clots that travel to the lungs, which can be life-threatening.

2. Allergic reactions:

   • Anaphylaxis (severe allergic reaction): Swelling of the face, lips, tongue, or throat, causing difficulty breathing.

3. Visual disturbances:

   • Blurred vision or color vision changes (due to optic nerve damage, though very rare).

4. Severe abdominal pain or discomfort, especially when taking oral forms for a prolonged period.

Contraindications:

Tranexamic Acid (Aneptil) should not be used in the following situations:

1. Hypersensitivity:

   • Known allergy to tranexamic acid or any of its components.

2. Active or history of blood clotting disorders:

   • Current deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral thrombosis, or any active thromboembolic disorder (due to an increased risk of clot formation).

3. Severe renal impairment:

   • Severe kidney disease (e.g., creatinine clearance <30 mL/min) should be avoided due to reduced elimination of the drug from the body, increasing the risk of side effects.

4. Subarachnoid hemorrhage:

   • Patients with active bleeding, especially from a brain hemorrhage (e.g., subarachnoid hemorrhage), should avoid tranexamic acid as it may increase the risk of rebleeding.

5. Pregnancy and breastfeeding:

   • Pregnancy: Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus.

   • Breastfeeding: It is not fully known if the drug passes into breast milk. Caution is recommended when using it during lactation.

Precautions:

1. Renal function:

   • Renal impairment (moderate to severe) requires careful dose adjustment, as the drug is eliminated via the kidneys.

2. Thromboembolic conditions:

   • Patients with a history of thromboembolic disorders (e.g., venous thromboembolism) should be closely monitored during treatment with tranexamic acid.

3. Concomitant use with hormonal therapy:

   • Caution is recommended when tranexamic acid is used with medications that increase the risk of clot formation, such as oral contraceptives or hormone replacement therapy (HRT).

4. Monitoring:

   • Prolonged use should be monitored for potential development of thrombosis, particularly in patients with increased risk factors for clotting disorders.

Drug Interactions:

• Oral contraceptives: Increased risk of clot formation when used with tranexamic acid due to combined effects on clotting factors.

• Antifibrinolytic drugs: Caution should be exercised when using tranexamic acid in combination with other antifibrinolytic agents to avoid excessive inhibition of clot breakdown.

• Anticoagulants (e.g., warfarin, heparin): Tranexamic acid may alter the effectiveness of anticoagulants, increasing the risk of clotting or bleeding.

Summary:

Tranexamic Acid (Aneptil) 500mg/5ml Solution for Injection is an effective treatment for managing excessive bleeding in various clinical scenarios, including postoperative bleeding, trauma, and menorrhagia (heavy menstrual bleeding). The typical dosage is 10-15mg/kg administered via intravenous (IV) or intramuscular (IM) injection. Side effects may include gastrointestinal discomfort, dizziness, and muscle pain. Serious side effects, though rare, include blood clots, allergic reactions, and visual disturbances. Tranexamic Acid should be avoided in patients with active thromboembolic disorders, severe renal impairment, or those who are pregnant or breastfeeding. Regular monitoring is recommended to ensure safety during treatment.

Always consult a healthcare professional before starting or adjusting the dosage of this medication.