Xamic 500 mg

Description

Indications

• In Medicine: Prophylaxis and therapy of hemoptysis, digestive hemorrhages, hemorrhagic syndromes in leukemia, cirrhosis, hemophilia, thrombocytopenic purpura, accidents during thrombolytic therapy, and transfusion.
• In Surgery: Prophylaxis and antihemorrhagic therapy during operations of any type, especially in pulmonary, cardiovascular, and abdominal surgeries, as well as post-operative and traumatic shock.
• In Urology: Prophylaxis and antihemorrhagic therapy for prostatic, vesical, and renal surgery, and hematuria.
• In Obstetrics: Prophylaxis and therapy for post-partum and puerperium hemorrhages, hemorrhagic metropathies, functional menometrorrhagias, idiopathic or IUD-induced menorrhagias, primitive hyperfibrinolysis (such as abruptio placentae, premature placenta detachment), and cervical conization.
• In Otorhinolaryngology: Prophylaxis and antihemorrhagic therapy during tonsillectomies, specialist surgeries, and epistaxis.
• In Stomatology: Prophylaxis and antihemorrhagic 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, and to reduce bleeding during surgical interventions.

• Please take the medication as per the advice of a registered doctor.*

Pharmacology
This is a preparation of tranexamic acid (trans-4 aminomethyl-cyclohexanecarboxylic acid). Tranexamic acid is a potent antifibrinolytic agent, 10 times more active than conventional hemostatics in both in vivo and in vitro tests. Its antihemorrhagic action works by inhibiting the activation of plasminogen by both exogenous activators (like streptokinase) and endogenous ones (like urokinase and tissue plasminogen activator). This mechanism ensures antihemorrhagic activity under various conditions.
Tranexamic acid has extremely low acute toxicity, and chronic toxicity is almost non-existent. It is well absorbed orally, with effects observed 15-30 minutes after administration. The drug is excreted mainly through the kidneys but more slowly than conventional hemostatics. This results in a longer-lasting effect compared to traditional agents. Tranexamic acid does not interfere with normal clotting processes and does not induce thrombophilia, even with prolonged use.

Dosage & Administration
Adults:

• The usual dose is 500-1000 mg 3 times daily.
• For prophylaxis: 0.5-1 gm orally or 500 mg parenterally (intravenous or intramuscular).
• For therapy of hemorrhagic manifestations: Increase oral dose to 1-3 gm in divided doses. For serious cases, start with an intravenous dose of 500 mg slowly, followed by necessary oral doses.
  Children:
• For prophylaxis: 5-10 mg/kg body weight orally, in divided doses.
• For therapy: Oral doses are doubled to 10-20 mg/kg. Start intravenous or intramuscular treatment with 10 mg/kg (0.5 ml per 5 kg body weight) via slow intravenous route, continuing oral administration up to the required dose.
  Elderly patients: No dose reduction is needed unless renal failure is present.

• Please take the medication as per the advice of a registered doctor.*

Interaction
Xamic is a synthetic amino acid that is incompatible with solutions containing penicillins (e.g., benzylpenicillin). Thrombolytic drugs like streptokinase and urokinase antagonize the antifibrinolytic effect of Xamic. The potential for thrombus formation may be increased with concomitant use of estrogen-containing drugs, such as oral contraceptives. Direct admixture with whole blood during transfusions should be avoided.

Contraindications

• Known hypersensitivity to the product.
• Thromboembolic disease, arterial and venous thrombosis, endocavitary hemorrhages, and serious kidney failure.

Side Effects
Xamic is generally well tolerated, though rare side effects include fatigue, conjunctival irritation, nasal blockage, itching, skin reddening, and exanthems.

• After oral administration: Nausea, diarrhea, and gastric pyrosis may occur.
• Rare cases of postural hypotension have been reported.
• In cases of hypersensitivity, discontinue treatment and begin appropriate therapy.

Pregnancy & Lactation

• Pregnancy: Tranexamic acid should not be used during pregnancy unless the potential benefits outweigh the risks to the fetus.
• Lactation: Tranexamic acid passes into breast milk at about 1/100th the concentration found in maternal blood. Its antifibrinolytic effect on the infant is unlikely.

Precautions & Warnings

• Use with caution in cases of hyperfibrinolysis. Prophylactic treatment should begin 24 hours before surgery and continue for 3-4 days post-operation.
• Hemorrhage therapy should last at least 24 hours after symptoms resolve.
• For hematuria without other hemorrhagic manifestations, reduce doses to prevent clot formation in the urinary tract.
• Do not use in severe renal insufficiency or anuric conditions. Use cautiously in less severe renal dysfunction.
• Special care should be taken when administering the drug to patients with heart or liver conditions.

Therapeutic Class
Anti-fibrinolytic drugs, Hemostatic drugs.

Storage Conditions
Store in a dry place at 15-30°C, away from light. Keep out of reach of children.