Frabex (Tranexamic Acid): An Anti-Fibrinolytic and Haemostatic Drug

Frabex contains Tranexamic Acid, a synthetic amino acid with a strong anti-fibrinolytic action. It is classified as an anti-fibrinolytic and haemostatic drug, meaning it helps to prevent the breakdown of blood clots and stop bleeding.

How Frabex Works (Pharmacology)

Tranexamic acid's anti-hemorrhagic action is primarily due to its inhibition of plasminogen activation. Plasminogen is a precursor to plasmin, an enzyme that breaks down fibrin (a key component of blood clots). By inhibiting both exogenous activators (like streptokinase) and endogenous activators (like urokinase and tissue plasminogen activator), Tranexamic Acid ensures its anti-hemorrhagic activity through an anti-fibrinolytic mechanism under various conditions.

Key Pharmacokinetic Features:

• Absorption: Well absorbed orally, with effects seen 15-30 minutes after administration.
• Elimination: Primarily excreted via the renal route, but more slowly than conventional hemostatics, leading to a more lasting effect. This allows for lower single doses at greater intervals without plasma levels dropping to ineffective levels.
• Clotting Process: At therapeutic doses, Tranexamic Acid does not interfere with normal clotting processes.
• Thrombophilia: Even prolonged administration has not been associated with a tendency to thrombophilia (increased risk of blood clot formation).
• Toxicity: Acute toxicity is extremely low, and chronic toxicity is almost non-existent.

Key Indications & Benefits

Frabex is indicated for the prophylaxis (prevention) and therapy (treatment) of various hemorrhagic conditions across different medical and surgical specialties:

• In Medicine: Prophylaxis and therapy of hemoptysis (coughing up blood), digestive hemorrhages, hemorrhagic syndromes in leukemia, cirrhosis, and hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy, and transfusion.
• In Surgery: Prophylaxis and anti-hemorrhagic therapy during operations of any type, particularly in pulmonary, cardiovascular, and abdominal surgery, and in post-operative and traumatic shock.
• In Urology: Prophylaxis and anti-hemorrhagic therapy for prostatic, vesical (bladder), and renal surgery; hematurias (blood in urine).
• In Obstetrics: Prophylaxis and therapy of post-partum and puerperium hemorrhages, hemorrhagic metropathies, functional menometrorrhagias (abnormal uterine bleeding), idiopathic or IUD-induced menorrhagias (heavy menstrual bleeding), primitive hyperfibrinolysis (e.g., abruptio placentae, premature placenta detachment), and in cervical conization.
• In Otorhinolaryngology (ENT): Prophylaxis and anti-hemorrhagic therapy during tonsillectomy, general specialist surgery, and epistaxis (nosebleeds).
• In Stomatology (Dentistry): Prophylaxis and anti-hemorrhagic therapy during maxillofacial operations and tooth extractions.
• In Oncology (as supportive therapy): To promote the formation of a fibrin capsule to wall off and inhibit the growth of ovarian tumors; to cause regression of ascites secondary to carcinoma; to reduce bleeding during surgical interventions.

Dosage & Administration

Always consult a registered physician for medication use.

• Adults:
  • Usual dose: 500-1000 mg three times daily.
  • For prophylaxis: Mean recommended daily doses are 0.5-1 gm orally, or 500 mg by parenteral (intravenous or intramuscular) route.
  • For therapy of hemorrhagic manifestations: Oral dose increases to 1-3 gm in divided doses. In serious/urgent cases, begin with a slow intravenous injection of one ampoule (500 mg), followed by necessary subsequent oral doses.
• Children:
  • For prophylaxis: 5-10 mg per kg of body weight orally daily in divided doses.
  • For therapeutic purposes: Oral doses are doubled (10-20 mg/kg). Intravenous and intramuscular treatment begins with 10 mg/kg (=0.5 ml every 5 kg) by slow intravenous route, continuing oral administration up to the required dose.
  • For small babies, ampoules diluted in sweetened water may be administered orally instead of capsules.
• Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking Frabex.

Contraindications:

• Known individual hypersensitivity to the product.
• Thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism).
• Arterial and venous thrombosis.
• Endocavitary hemorrhages.
• Serious kidney failure.

Side Effects:

• Frabex is generally well tolerated.
• Infrequent cases: Sense of fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, exanthems (rashes).
• After oral administration: Nausea, diarrhea, gastric pyrosis (heartburn).
• Rare cases: Postural hypotension (dizziness upon standing).
• In case of hypersensitivity, avoid or suspend treatment and start suitable therapy.

Pregnancy & Lactation:

• Pregnancy: The transplacental passage and possible effects on the fetus are unknown. Tranexamic Acid should not be administered during known or presumed pregnancy.
• Lactation: Tranexamic Acid passes into breast milk at a concentration of approximately one-hundredth of the maternal blood concentration. An anti-fibrinolytic effect in the infant is unlikely.

Precautions & Warnings:

• Frabex should be used in cases where there is hyperfibrinolysis (excessive breakdown of clots).
• Prophylactic treatment: Must begin 24 hours before the operation and continue for 3-4 days after.
• Therapy of hemorrhages: Must be prolonged for at least 24 hours after manifestations have disappeared.
• Hematuria: Especially when not accompanied by other hemorrhagic manifestations, reduce doses to prevent the formation of clots in the urinary tract.
• Renal Insufficiency: Must not be used in serious renal insufficiency or anuric syndromes. Use with caution in less serious renal dysfunctions.
• Cardiopathic and Hepatopathic Subjects: Administration requires particular care in patients with heart or liver disease.

Drug Interactions:

• Penicillins (e.g., Benzyl penicillin): Frabex is a synthetic amino acid that is incompatible with solutions containing penicillins.
• Thrombolytic drugs (e.g., Streptokinase & Urokinase): These drugs antagonize the anti-fibrinolytic action of Frabex.
• Estrogen-containing drugs (e.g., oral contraceptives): Concomitant administration may increase the potential for thrombus formation.
• Whole blood: Direct admixture of Frabex with whole blood should be avoided during transfusion.

Storage Conditions

Store in a dry place at 15-30°C, away from light, and keep out of children's reach.