دواعي استعمال ريفاروسبير 15مجم 42 قرص
معلومات من نشرات دوائية ومراجع موثقة، مع مصدر كل معلومة. السعر الحالي: 534ج.م.
دواعي الاستعمال
- Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation (15 mg dose for CrCl 50 mL/min or less)الفئة: AdultsDailyMed (U.S. National Library of Medicine)
- Treatment of deep vein thrombosis and pulmonary embolism (initial 21 days)الفئة: AdultsDailyMed (U.S. National Library of Medicine)
الآثار الجانبية
- The most common adverse reactions are bleeding complications.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
موانع الاستعمال
- Active pathological bleeding.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Severe hypersensitivity reaction to rivaroxaban (e.g. anaphylaxis).نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Lesion or condition at significant risk of major bleeding; concomitant treatment with any other anticoagulant except when switching; hepatic disease associated with coagulopathy (incl. Child-Pugh B and C cirrhosis); pregnancy and breast-feeding.نشرة دولية لنفس التركيبة · European Medicines Agency
تحذيرات واحتياطات
- Boxed warning: premature discontinuation increases the risk of thrombotic events; consider coverage with another anticoagulant.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Boxed warning: epidural or spinal haematomas, which may cause long-term or permanent paralysis, can occur with neuraxial anaesthesia or spinal puncture.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Increased risk of bleeding, including serious or fatal bleeding; risk increased with aspirin, P2Y12 inhibitors, other antithrombotics, fibrinolytics, NSAIDs, SSRIs and SNRIs.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Not recommended in patients with prosthetic heart valves (higher death and bleeding rates after TAVR in GALILEO).نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
التداخلات الدوائية
- Combined P-gp and strong CYP3A inhibitors (e.g. ketoconazole, ritonavir)Increase rivaroxaban exposure and bleeding risk; avoid concomitant use.DailyMed (U.S. National Library of Medicine)
- Combined P-gp and strong CYP3A inducers (e.g. carbamazepine, phenytoin, rifampin, St John's wort)Decrease rivaroxaban exposure and may increase thromboembolic risk; avoid concomitant use.DailyMed (U.S. National Library of Medicine)
- Anticoagulants, aspirin, clopidogrel and NSAIDsCoadministration may increase bleeding risk; avoid other anticoagulants unless benefit outweighs risk and evaluate promptly any signs of blood loss.DailyMed (U.S. National Library of Medicine)
الحمل والرضاعة
- Limited data are insufficient to inform drug-associated developmental risk; use with caution in pregnancy because of potential pregnancy-related haemorrhage and/or emergent delivery.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Contraindicated during pregnancy because of potential reproductive toxicity, intrinsic bleeding risk and placental passage; women of child-bearing potential should avoid becoming pregnant during treatment.نشرة دولية لنفس التركيبة · European Medicines Agency
- Rivaroxaban has been detected in human milk; insufficient data on effects on the breastfed child; weigh benefits of breastfeeding against maternal need.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Contraindicated during breast-feeding; decide whether to discontinue breast-feeding or therapy.نشرة دولية لنفس التركيبة · European Medicines Agency
المتابعة أثناء العلاج
- Promptly evaluate any signs or symptoms of blood loss; assess renal function (CrCl) for dosing; anticoagulant effect cannot be reliably monitored with standard laboratory testing.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
المصادر
- السعر: قوائم أسعار الأدوية المنشورة في مصر.
- DailyMed (U.S. National Library of Medicine)
- European Medicines Agency