Trenaxa Inj

TRENAXA INJ by MACLEODS PHARMACEUTICALS LTD.

Name

• Common Name: Tranexamic Acid
• Brand Name: TRENAXA INJ (by MACLEODS PHARMACEUTICALS LTD.)

Composition

TRENAXA INJ contains Tranexamic Acid at a concentration of 500 mg/5 ml.

Uses

TRENAXA INJ is an antifibrinolytic medication primarily used to prevent or control excessive bleeding. It is prescribed for various conditions, including:

• Heavy menstrual bleeding (menorrhagia) and abnormal uterine bleeding.
• Dental procedures in patients with hemophilia to reduce blood loss and the need for replacement therapy.
• Reduction of blood loss during and after surgical procedures, such as cardiac surgery, orthopedic surgery (e.g., total knee or hip arthroplasty), gynecological, obstetric, prostate, bladder, ear, nose, and throat (ENT) surgeries.
• Gastrointestinal bleeding and nosebleeds (epistaxis).
• Trauma-associated hemorrhage.
• Hemorrhagic urinary disorders.

Dosage and Administration

TRENAXA INJ is administered via slow intravenous (IV) injection or infusion. It is generally given by a healthcare professional in a hospital or clinic setting.

• Adults: Dosage varies based on the condition being treated, typically ranging from 500 mg to 1000 mg (5-10 ml) per dose, administered slowly over 10-15 minutes. For local fibrinolysis, 500-1000 mg three times a day. For general fibrinolysis, 1000 mg every 6 to 8 hours (equivalent to 15 mg/kg body weight).
• Pediatrics: For children over one year, the dosage is around 20 mg/kg/day for approved indications.
• Renal Impairment: The dose should be reduced in patients with kidney impairment due to the risk of accumulation.
• Administration Rate: The recommended rate of IV administration is usually 0.5-1 mL/minute (50-100 mg/minute) to avoid hypotension.
• Important Note: This medicine should not be administered via intramuscular (IM), intrathecal, or epidural routes.

Side Effects

Common Side Effects:

• Nausea, vomiting, diarrhea.
• Dizziness or giddiness.
• Injection site reactions (pain, swelling, redness).
• Mild itching or rash.

Serious Side Effects (Report to your doctor immediately):

• Blood clots (e.g., pain, swelling, warmth in the leg, chest pain, shortness of breath).
• Changes in vision, including color vision disturbances.
• Seizures.
• Allergic reactions (e.g., skin rash, itching, hives, swelling of the face, lips, tongue, or throat, trouble breathing).
• Hypotension (low blood pressure) if injected rapidly.

Precautions

• Contraindications: Do not use if you have active intravascular clotting (blood clots), severe kidney impairment, a history of seizures, subarachnoid hemorrhage (bleeding in the brain), or hypersensitivity to tranexamic acid.
• Thromboembolic Risk: Exercise caution in patients with a history of thromboembolic disease. Concomitant use with hormonal contraceptives or other prothrombotic medications may increase the risk of blood clots.
• Kidney Disease: Dose adjustment is necessary for mild to moderate renal impairment due to the risk of drug accumulation.
• Vision: Regular eye examinations are recommended during long-term treatment, and the medication should be discontinued if color vision disturbances occur.
• Irregular Menstrual Bleeding: The cause of irregularity should be established before using Tranexamic Acid Injection.
• Seizures: Tranexamic acid can cause seizures, especially with high doses or in specific surgical settings. Monitoring is advised.
• Pregnancy and Breastfeeding: Consult your doctor if pregnant or breastfeeding.

Storage

Store TRENAXA INJ at room temperature, typically below 25°C or 30°C. Keep it in the original packaging, protected from light, and do not refrigerate or freeze. The product is for single use only, and any unused portion should be discarded immediately after opening.

TRENAXA INJ, containing tranexamic acid, is an anti-fibrinolytic medication used to manage and prevent excessive bleeding. It is administered as an injection by a healthcare professional.

What is Trenaxa Inj used for?

Trenaxa Inj is primarily used to treat abnormal heavy bleeding in various conditions. This includes heavy menstrual bleeding (menorrhagia), nosebleeds (epistaxis), and bleeding associated with surgical procedures such as cervical surgery, prostate surgery (post-prostatectomy), and bladder surgery (post-cystectomy). It is also used to control bleeding before tooth removal in individuals with hemophilia, for traumatic hyphaema (bleeding inside the eye), postpartum hemorrhage, and trauma-associated hemorrhage.

How does Trenaxa Inj work?

Trenaxa Inj works as an anti-fibrinolytic. It contains tranexamic acid, which helps the body's natural blood clotting system. It does this by reducing the breakdown of fibrin, which is a protein essential for blood clot formation, and by inhibiting fibrinolysis, a process that limits the development of blood clots. By competitively inhibiting the activation of plasminogen to plasmin, Trenaxa Inj stabilizes existing fibrin clots and prevents their premature dissolution, thereby preventing excessive bleeding.

What is the usual dosage of Trenaxa Inj?

The dosage of Trenaxa Inj is determined by your doctor based on your specific medical condition and response to treatment. Trenaxa Inj is a parenteral formulation and must be administered intravenously by a healthcare professional; it should not be self-administered. A common intravenous dosage for general fibrinolysis is 1 gram every 6 to 8 hours, given as a slow injection (no faster than 1 ml/minute).

What are the possible side effects of Trenaxa Inj?

Common side effects may include nausea, diarrhea, vomiting, itchy skin, and pain at the injection site. Other reported common side effects are headache, back pain, tiredness, muscle or joint pain, and nasal congestion. More serious, but less common, side effects can include vision problems (such as blurred vision or changes in color vision), hypotension (low blood pressure) if injected too rapidly, convulsions or seizures, and allergic reactions (like hives, swelling, or difficulty breathing). Rarely, it can increase the risk of blood clot formation, such as deep vein thrombosis (DVT).

Is Trenaxa Inj safe during pregnancy or breastfeeding?

Pregnancy: The use of Trenaxa Inj during pregnancy requires caution. Some sources indicate it is generally safe or probably safe, while others advise limited information and that it should only be used if clearly necessary and prescribed by a doctor after assessing the benefits and risks. It is often not recommended in the first trimester of pregnancy. Breastfeeding: Information on breastfeeding is mixed. Some sources suggest it is safe for breastfeeding mothers, while others recommend caution as the drug may pass into breast milk. It is not considered a reason to discontinue breastfeeding if a mother requires the medication, but close monitoring of the infant is recommended. However, some sources suggest it is contraindicated or potentially unsafe due to possible harm to the baby. Always consult your doctor before using Trenaxa Inj while pregnant or breastfeeding.

Can Trenaxa Inj be taken with other medications?

Trenaxa Inj can interact with several medications. Combining it with oral contraceptives (like ethinylestradiol or levonorgestrel) or other medications that increase blood clot formation (such as aprotinin, tretinoin, or anti-inhibitor coagulant complex/factor IX complex concentrates) may increase the risk of blood clots. Conversely, its effect may be reduced if taken with blood thinners (anticoagulants like warfarin or heparin) or fibrinolytic agents (medicines that dissolve blood clots, like streptokinase). Your doctor should be informed of all medications you are taking to avoid potential interactions.

What precautions should be taken while using Trenaxa Inj?

Before receiving Trenaxa Inj, inform your doctor if you have kidney disease (as dose adjustments may be needed), liver problems, a history of blood clots (thrombosis), disseminated intravascular coagulation (DIC), irregular periods, blood in your urine (except during menstruation), or a history of seizures or fits. Regular eye tests may be advised during long-term treatment to monitor for visual disturbances. Avoid rapid intravenous injection, as this can lead to hypotension. Trenaxa Inj is not for self-administration.

What happens if a dose of Trenaxa Inj is missed?

Since Trenaxa Inj is administered by a healthcare professional in a clinical setting, it is unlikely that a dose will be missed. However, if you believe a dose has been missed, inform your doctor or nurse immediately. Do not attempt to self-administer an extra dose to compensate for the missed one.

How should Trenaxa Inj be stored?

Trenaxa Inj should be stored in a cool and dry place, protected from direct sunlight, moisture, and heat. The typical storage temperature is below 25°C or 30°C. Keep this medicine out of sight and reach of children. Any unused medicine should be discarded properly by a healthcare professional.