Active Substance: Rivaroxaban (micronized).
Overview
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This medicine contains an important and useful components, as it consists of
Rivaroxaban (micronized)is available in the market in concentration
Rivaroxaban
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
Atrial fibrillation, Strokes, Deep venous thrombosis
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).
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
3
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 .
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.
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