Type:10 Tablets
Generic Name:Ivabradine
Manufacturer:Incepta Pharmaceuticals Ltd.
Price:৳250.00
Chronic stable angina, Heart Failure
Should be taken with food. Avoid excessive consumption of grapefruit juice.
Oral Heart Failure Initial: 5 mg PO BID with meals (all see Dosage Modifications) After 2 weeks, assess patient and adjust dose to achieve a resting heart rate of 50-60 bpm (see dose adjustment section below) Thereafter, adjust dose prn based on resting heart rate and tolerability; not to exceed 7.5 mg BID Dose adjustment HR >60 bpm: Increase dose by 2.5 mg (given twice daily) up to a maximum dose of 7.5 mg BID HR 50-60 bpm: Maintain dose HR <50 bpm or signs and symptoms of bradycardia: Decrease dose by 2.5 mg (given twice daily); if current dose is 2.5 mg BID, discontinue therapy Chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm Adult: Initially, should not exceed 5 mg bid. Increase if necessary to 7.5 mg bid after 3-4 wk. Titrate downward to as low as 2.5 mg bid, if patient develops bradycardia symptoms (e.g. dizziness, fatigue) or resting heart rate is persistently <50 beats/min. Elderly: >75 yr Initiate treatment at 2.5 mg bid. Titrate up if necessary. Hepatic impairment Mild or moderate (Child-Pugh A or B): No dose adjustment required Severe (Child-Pugh C): Contraindicated
Safety and efficacy not established
Renal impairment: CrCl (ml/min) Dosage Recommendation <15 Use w/ caution.
Pregnancy, lactation, resting heart rate <60 beats/min prior to treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure patients with NYHA class III-IV, pacemaker dependent, unstable angina, 3rd degree AV-block, concurrent use with potent CYP3A4 inhibitors.
Ivabradine is a heart rate lowering agent that works through selective and specific inhibition of the cardiac pacemaker If current. If current controls the spontaneous diastolic depolarisation in the sinus node and regulate heart rate.
Reduce dose if resting heart rate is persistently <50 beats/min or patient develops bradycardia symptoms during treatment; discontinue if heart rate <50 beats/min and symptoms persist. Not recommended in patient with AF or other cardiac arrhythmias that interfere with sinus node rhythm; monitor regularly for AF occurrence. Not recommended for concomitant use with heart rate reducing calcium channel blockers (e.g. diltiazem or verapamil), immediate use after a stroke or in patients with 2nd degree AV-block. Severe renal insufficiency, Moderate hepatic insufficiency. Stop treatment if visual field deteriorates unexpectedly. Patients with retinitis pigmentosa.
1-10% Bradycardia (10%) Hypertension or increased blood pressure (8.9%) Atrial fibrillation (8.3%) Luminous phenomena (phosphenes) or visual brightness (2.8%)
Concomitant use with QT-prolonging drugs (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone, pimozide, ziprasidone, sertinole, mefloquine, halofantrine, pentamide, cisapride, erythromycin IV) is not recommended as QT prolongation may be enhanced by heart rate reduction. Concentrations may increase when used with CYP3A4 inhibitors. Use with verapamil or diltiazem (moderate CYP3A4 inhibitors) is not recommended. If used with other moderate CYP3A4 inhibitors (e.g. fluconazole), may consider starting at lower dose and with heart rate monitoring if resting heart rate >60 beats/min. Concentration may be reduced with CYP3A4 inducers (e.g. rifampicin, barbiturates, phenytoin, St John's Wort) and may require Ivabradine dose adjustment. Potentially Fatal: Concurrent use with potent CYP3A4 inhibitors is contraindicated; e.g. azole antifungals (ketoconazole, itraconazole), macrolides (clarithromycin, erythromycin PO, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone.
