Xanoxiban 10 mg 10 tablets

Xanoxiban 10 mg 10 tablets

Composition:

Each tablet contains:
Rivaroxaban 10 mg.
Excipients:
Microcrystalline cellulose, croscarmellose sodium, hypromellose 5 cP, lactose monohydrate, magnesium stearate, sodium lauryl sulfate.

Product Description:

Xanoxiban is a highly selective direct inhibitor of Factor Xa with high oral bioavailability.
Inhibition of Factor Xa prevents thrombin formation and fibrin clot development, reducing the risk of thrombosis.

Properties:

• Highly selective inhibition of Factor Xa.
• Prevention of the “thrombin burst.”
• Influence on laboratory coagulation parameters.

Indications for Use:

• Prevention of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Prevention of recurrent DVT and PE.

Method of Administration and Dosage:

• The preparation should be taken with food.
• Stroke and thromboembolism prevention: 20 mg once daily.
• Patients with renal impairment (CrCl 30–49 ml/min): 15 mg once daily.
• Treatment of acute DVT/PE: 15 mg twice daily for 3 weeks, then 20 mg once daily.
• After ≥6 months of therapy: 10 mg or 20 mg once daily depending on risk balance.

Contraindications:

• Hypersensitivity to rivaroxaban or excipients.
• Active bleeding.
• Conditions with high bleeding risk (ulcers, tumors, CNS trauma).
• Concomitant use of other anticoagulants (except transition schemes).
• Liver disease with coagulopathy.
• Severe renal impairment (CrCl <15 ml/min).
• Pregnancy and breastfeeding.
• Age under 18 years.
• Hereditary lactose intolerance.

Precautions:

• Not recommended with strong CYP3A4 and P-glycoprotein inhibitors (ketoconazole, ritonavir).
• Use with caution in moderate renal impairment.
• Possible interaction with azole antifungals (fluconazole has less pronounced effect).

Adverse Reactions:

• Anemia, bleeding (eye, GI, urogenital tract, nosebleeds).
• Dyspepsia, nausea, diarrhea, constipation, vomiting.
• Fever, peripheral edema, weakness.
• Elevated transaminases.
• Headache, dizziness.
• Skin reactions: itching, rash, ecchymosis.
• Arterial hypotension, hematoma.

Pregnancy and Lactation:

Contraindicated during pregnancy and breastfeeding.

Storage Conditions:

Store at temperatures not exceeding 30°C in a dry place.

Packaging:

Cardboard box containing 1 blister of 10 tablets.