دواعي استعمال بروكورلان 7.5مجم 28 قرص
معلومات من نشرات دوائية ومراجع موثقة، مع مصدر كل معلومة. السعر الحالي: 352ج.م.
دواعي الاستعمال
- Symptomatic treatment of chronic stable angina pectoris in adults with sinus rhythm and HR >= 70 bpm (beta-blocker intolerant/contraindicated or with a beta-blocker)European Medicines Agency (EPAR product information)
- Chronic heart failure NYHA II-IV with systolic dysfunction, sinus rhythm, HR >= 75 bpm, with standard therapyEuropean Medicines Agency (EPAR product information)
الآثار الجانبية
- Most common: luminous phenomena (phosphenes, 14.5%) and bradycardia (3.3%), dose-dependent.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
موانع الاستعمال
- Resting HR < 70 bpm before treatment; cardiogenic shock; acute MI; severe hypotension (< 90/50 mmHg); severe hepatic insufficiency; sick sinus syndrome; SA block; unstable/acute heart failure; pacemaker dependence; unstable angina; 3rd-degree AV block; strong CYP3A4 inhibitors; verapamil or diltiazem; pregnancy, lactation and women not using contraception.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
تحذيرات واحتياطات
- No benefit on cardiovascular outcomes in stable angina (symptomatic use only). Increased risk of atrial fibrillation - monitor; not recommended with AF or 2nd-degree AV block. Reduce dose or stop if resting HR persistently < 50 bpm or bradycardia symptoms.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
- Transient luminous phenomena (phosphenes) may affect driving, especially at night with sudden light changes.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
التداخلات الدوائية
- Strong CYP3A4 inhibitors (azole antifungals, macrolides, HIV protease inhibitors, nefazodone)Contraindicated combination (raised ivabradine exposure).European Medicines Agency (EPAR product information)
- Verapamil, diltiazemContraindicated: moderate CYP3A4 inhibitors with heart-rate-lowering properties.European Medicines Agency (EPAR product information)
الحمل والرضاعة
- Contraindicated in pregnancy: animal studies showed embryotoxic and teratogenic effects; women of childbearing potential must use appropriate contraception.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
- US label: may cause fetal harm based on animal data (cardiac teratogenicity in rats); advise effective contraception.نشرة دولية لنفس التركيبة · DailyMed (U.S. National Library of Medicine)
- Contraindicated during breast-feeding (excreted in animal milk); women needing treatment should stop breast-feeding.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
المتابعة أثناء العلاج
- Serial heart-rate measurement/ECG before starting and when titrating; regular clinical monitoring for atrial fibrillation.نشرة دولية لنفس المنتج · European Medicines Agency (EPAR product information)
كيف يعمل الدواء
- Selectively inhibits the cardiac pacemaker If current in the sinoatrial node, lowering heart rate (EU SmPC).
المصادر
- السعر: قوائم أسعار الأدوية المنشورة في مصر.
- European Medicines Agency (EPAR product information)
- DailyMed (U.S. National Library of Medicine)
- WHO Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index)