Type:Tablet
Generic Name:Rivaroxaban
Manufacturer:Opsonin Pharma Limited
Price:৳45.00
Atrial fibrillation, Strokes, Deep venous thrombosis
10-Mg Tab: May be taken with or without food. 15- & 20-Mg Tab: Should be taken with food.
DVT Prophylaxis (Orthopedic Surgery) Indicated for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing knee or hip replacement surgery Knee replacement: 10 mg PO qDay for 12 days; may take with or without food Hip replacement: 10 mg PO qDay for 35 days; may take with or without food Administer initial dose at least 6-10 hr after surgery once hemostasis has been established Nonvalvular Atrial Fibrillation Indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 20 mg/day PO with the evening meal DVT or PE Treatment Indicated for treatment of DVT and PE 15 mg PO q12hr for 21 days with food, THEN 20 mg PO qDay for 6 months Reduce risk for recurrent DVT or PE Indicated to reduce the risk of recurrence of DVT and PE following initial 6 months treatment for DVT and/or PE 20 mg PO qDay following initial 6 months of treatment for DVT and/or PE Hepatic impairment Moderate impairment: Not studied Avoid use in patients with moderate-to-severe impairment (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment or with any hepatic disease associated with coagulopathy
Safety and efficacy not established
Renal impairment (nonvalvular AF) CrCl 30-50 mL/min: 20 mg/day CrCl 15-50 mL/min: 15 mg/day ESRD on intermittent renal dialysis: 15 mg/day Renal impairment (postoperative thromboprophylaxis) CrCl >50 mL/min: Dose adjustment not necessary CrCl 30-50 mL/min: Use with caution; dose adjustment not necessary CrCl <30 mL/min: Avoid use
Patient w/ active pathologic bleeding, significant risk of major bleeding (e.g. recent GI ulcer, oesophageal varices, recent brain, spine, or ophth surgery, recent intracranial haemorrhage, malignant neoplasms, vascular aneurysm).
Factor Xa inhibitor that inhibits platelet activation by selectively blocking the active site of factor Xa without requiring a cofactor (eg, antithrombin III) for activity. Blood coagulation cascade is dependent on the activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the blood coagulation cascade. Dose-dependent inhibition of factor Xa activity observed; antifactor Xa activity is also influenced by rivaroxaban; prolongs PT and aPTT and HepTest .
Patient w/ hepatic disease associated w/ coagulopathy, severe HTN, prosthetic heart valve, vascular retinopathy, bronchiectasis. Anaesth w/ post-op indwelling epidural catheter. Hepatic and renal impairment. Pregnancy and lactation. Lactation: Unknown whether distributed in human breast milk; not recommended; a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
1-10% Abdominal pain (<2%),Back pain (<4%),Blister (1%),Bruising (3%),Constipation (<3%),Diarrhea (<5%),Dizziness (<6%),Dyspepsia (<2%),Epistaxis (4-10%),Fatigue (<3%),Headache (3-5%),Nausea (1-3%),Hematuria (<4%),Muscle spasm (1%),Oropharyngeal pain (<1%),Osteoarthritis (<2%),Peripheral edema (<6%),Pruritus (<2%),Pyrexia (1-3%),Rash (2%),Syncope (<2%),Toothache (<1%),Urinary tract infection (<1%),Vomiting (<2%),Wound secretion (<3%) Bleeding Atrial fibrillation (21%; major bleeding 6%) DVT prophylaxis (5-6%; major bleeding <1%) DVT treatment (6-10%; major bleeding 1%) Hematoma (<3%) <1% Agranulocytosis,Hepatitis,Dysuria,Fatal bleeding,Hematoma,Hemiparesis,Hemorrhage,Hypotension,Increased amylase,Increased BUN,Jaundice,Menorrhagia,Retroperitoneal bleeding,Stevens-Johnson syndrome,Thrombocytopenia,Urticaria,Xerostomia
Reduced hepatic & renal clearance w/ strong CYP3A4 inhibitors (clarithromycin, erythromycin, fluconazole). Increased bleeding risk w/ azole antimycotics (eg ketoconazole, itraconazole, voriconazole, posaconazole) or HIV-PIs (eg ritonavir); other anticoagulants; NSAIDs (including acetylsalicylic acid) & platelet aggregation inhibitors. Reduced plasma conc w/ CYP3A4 inducers (eg rifampicin, phenytoin, carbamazepine, phenobarb, St. John's wort). 20-mg FC tab: Increased prothrombin time/INR of warfarin.
