Composition: RAKSABAN 20 tablets: each film-coated tablet contains the active ingredient rivaroxaban 20 mg. RAKSABAN 15 tablets: each film-coated tablet contains the active ingredient rivaroxaban 15 mg.
Form: Film-coated tablets
Indications: – Stroke and systemic embolism prevention in adults with non-valvular atrial fibrillation and risk factors; – Treatment and prevention of recurrent DVT and PE: 15 mg twice daily for 21 days, then 20 mg once daily; – Prevention of venous thromboembolism in patients after major orthopedic surgery on the lower limbs.
Contraindications: • Hypersensitivity to rivaroxaban or the excipients. • Clinically significant active bleeding. • Conditions with significant risk factors for major bleeding, such as current or recent gastrointestinal ulceration, malignant tumours with a high risk of bleeding, recent brain or spinal injury, recent brain, spinal or eye surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. • Concomitant treatment with any other anticoagulant, such as unfractionated heparin (UFH), low-molecular-weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban, etc.), except in specific circumstances of switching anticoagulants or when UFH is given at doses necessary to maintain a central venous or arterial catheter’s patency. • Liver disease associated with coagulopathy and a risk of clinically significant bleeding, including Child–Pugh B and C cirrhosis. • Pregnancy and breastfeeding.
Dosage: – AF: 20 mg once daily with food. – DVT/PE: 15 mg twice daily for 21 days, then 20 mg once daily with food. – Long-term DVT/PE prevention: 10 or 20 mg once daily with food. – VTE prevention post-orthopedic surgery: 10 mg once daily starting 6–10 hours post-op, duration as per physician's decision.
Side effects: Bleeding (nasal, gastrointestinal), anemia; less commonly — epistaxis, hematuria, ecchymosis.
Interactions: Do not use with strong CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, ritonavir) or strong CYP3A4 inducers (rifampicin, phenobarbital, carbamazepine, St. John's wort); caution with NSAIDs, antiplatelets, other anticoagulants.
Warnings: Risk of bleeding; routine coagulation monitoring not required but assess if bleeding occurs and stop drug if needed; contraindicated with artificial heart valves or antiphospholipid syndrome; caution during neuraxial anesthesia or surgery — stop at least 24h prior.
Age restrictions: 18+
Pregnancy: Contraindicated during pregnancy and lactation.
Country of origin: India
Manufacturer: Synokem Pharmaceuticals
Storage conditions: Store in a dry, light-protected place below 30°C. Keep out of reach of children. Do not freeze.
