Rivarox 15 - Tablet Rivaroxaban - 15mg 10 Tablet(s) / Strip Eskayef Pharmaceuticals Ltd. Introduction: Rivarox 15 is a medicine known as an anticoagulant or blood thinner. It helps prevent and treat blood clots. It is used to reduce the risk of stroke and heart attack. It prevents and treats clot formation in the veins of your legs, lungs, brain and heart. Rivarox 15 is commonly used in patients with irregular heart rhythm (atrial fibrillation) to prevent clot formation. It also reduces the risk of getting clots in people who have undergone knee or hip replacement surgeries. It should be taken with food and it is best to take them at the same time each... Uses of Rivarox 15: Deep vein thrombosisPulmonary embolismStroke prevention Side effects of Rivarox 15: Anemia (low number of red blood cells)Nausea How to use Rivarox 15: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Rivarox 15 is to be taken with food. How Rivarox 15 works: Rivarox 15 is a novel oral anticoagulant (NOAC). It works by preventing the formation of blood clots in the body. What if you forget to take Rivarox 15?: If you miss a dose of Rivarox 15, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose. Indication: Atrial fibrillation, Strokes, Deep venous thrombosis Administration: 10-Mg Tab: May be taken with or without food. 15- & 20-Mg Tab: Should be taken with food. Adult Dose: 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... Child Dose: Safety and efficacy not established Renal Dose: 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 Contraindication: 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). Mode of Action: 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 . Precaution: 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 Side Effect: 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 Interaction: 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.