Procoralan is a popular medication for heart disease patients, contains the active substance ivabradine.Procoralan is available as tablets. It works by lowering the heart rate, reducing stress on the heart. Procoralan is used when treatment with beta-blockers is not tolerated or recommended. Procoralan is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with beta-blockers.
The brand Procoralan is manufactured by Servier laboratories. The Generic brands include; Corlanor, Coralan, Corlentor, Coraxan, Ivabid and Bradia.
Table of Contents
- Symptomatic treatment of chronic stable angina pectoris with a normal sinus rhythm , if beta-blockers are not tolerated or are contraindicated, or in combination with a beta-blocker if an optimal dosage of the beta-blocker is insufficiently effective and the heart rate ≥ 70 beats / min.
- Treatment of stable chronic heart failure (NYHA class II-IV) in patients with systolic dysfunction with a normal sinus rhythm and a heart rate ≥ 75 beats / min, in combination with standard therapy (including a β-blocker) or if β-blockers are contraindicated -indicated or not tolerated.
How does Procoralan work?
Procoralan acts by reducing heart rate (heart rate) at a few beats per minute. This decreases the need for oxygen from the heart, especially in situations where an angina attack is more likely to occur. In this way, Procoralan helps to control and reduce the number of angina attacks.
In addition, since elevated heart rate (heart rhythm) adversely affects heart function and the vital prognosis of patients with chronic heart failure, the specific action of ivabradine in reducing heart rate (heart rhythm) contributes to improved heart rate. functioning of the heart and the vital prognosis in these patients.
The 5 mg tablets have a break slot.
Stable angina pectoris
Initial dose: 5 mg 2 × / day (morning and evening). If the starting dose is well tolerated and the heart rate at rest is> 60 beats per minute, increase after three to four weeks to the next higher dose. Maximum maintenance dose: 7.5 mg 2 × / day. At a resting heart rate of <50 beats per minute or with symptoms of bradycardia (dizziness, fatigue, hypotension), reduce the dose, if necessary to 2.5 mg 2 × / day; Reduce heart rate after dose reduction.
Stop treatment altogether if the heart rate remains below 50 beats per minute, or the symptoms of bradycardia persist.
Stable heart failure
initial dose: 5 mg 2 × / day (morning and evening). After two weeks, possibly increase to 7.5 mg 2 × / day at a resting heart rate> 60 beats per minute; at a resting heart rate <50 beats per minute or with persistent symptoms of bradycardia (dizziness, fatigue, hypotension), reduce the dose to at least 2.5 mg 2 × / day, or stop the application. At a resting heart rate of 50-60 strokes / minute maintain the dosage of 5 mg 2 × / day.
In the elderly (≥ 75 years) and in co-medication with moderately strong CYP3A4 inhibitors (verapamil or diltiazem are contraindicated) consider starting with 2.5 mg 2 × / day.
How to Take ?
Take Procoralan exactly as it was prescribed by your doctor or pharmacist. Talk to your doctor or pharmacist if you are not sure.
Procoralan should be taken at mealtime
If you are on stable angina pectoris treatment
The starting dose should not exceed one 5mg Procoralan tablet twice daily. If you still have symptoms of angina and if you tolerate well the dose of 5mg twice a day, the dose can be increased. The maintenance dose should not exceed 7.5mg twice daily. Your doctor will prescribe the correct dose for you. The usual dose is one tablet in the morning and another in the evening. In some cases (eg if you are elderly), your doctor may prescribe half a dose, ie half a tablet of Procoralan 5mg (corresponding to 2.5mg ivabradine) in the morning and a half tablet of 5mg in the evening,
If you are in the treatment of chronic heart failure
The usual recommended starting dose is one 5 mg Procoralan tablet twice daily, increasing, if necessary, one tablet of Procoralan 7.5 mg twice daily. Your doctor will decide the right dose for you. The usual dose is one tablet in the morning and another in the evening. In some cases (eg, elderly patients), your doctor may prescribe half the dose, ie half a tablet of Procoralan 5mg (corresponding to 2.5mg ivabradine) in the morning and half a tablet of Procoralan 5mg at night.
If You Stop Taking Procoralan
As treatment for angina or chronic heart failure is usually a long-term treatment, you should talk to your doctor before stopping treatment with this drug.
If you notice that the effect of Procoralan is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about this medicine, consult your doctor or pharmacist.
Follow the advice of your doctor, always respecting the times, doses and duration of treatment. Do not discontinue treatment without your doctor’s knowledge.
Very common (> 10%): especially during the first two months of treatment: sensing of light phenomena with sudden variations in light intensity (phosphenes). In the majority of patients (77.5%) all phosphenes disappear during treatment.
Common (1-10%): bradycardia, atrial fibrillation, first degree AV block, ventricular extrasystoles. Uncontrolled blood pressure. Headache (often during the first treatment month), dizziness. Blurred vision.
Uncommon (0.1-1%): hypotension. Palpitations, supraventricular extrasystoles, extended QT interval, syncope. Dyspnea. Double vision, disturbed eyesight, turning ambiguity. Asthenia, fatigue. Nausea, constipation, diarrhea, abdominal pain. Angioedema, skin rash. Muscle cramps. Eosinophilia. Increased creatinine in the blood, hyperuricemia.
Rare (0.01-0.1%): erythema, itching, urticaria, malaise.
Very rare (<0.01%): second or third degree AV block, sick sinus syndrome.
Procoralan (Ivabradine) is a substrate for CYP3A4 and a very weak inhibitor of CYP3A4. Combination with strong CYP3A4 inhibitors such as macrolide antibiotics (clarithromycin, oral erythromycin), HIV protease inhibitors (ritonavir, nelfinavir), itraconazole and oral ketoconazole is contraindicated. Combination with the moderately potent CYP3A4 inhibitors diltiazem and verapamil is also contraindicated, because these drugs themselves also reduce the heart rate.
In case of co-medication with other moderately strong CYP3A4 inhibitors such as fluconazole (avoid grapefruit juice), a lower starting dose of Procoralan (Ivabradine) and monitoring of the heart rate is recommended.
Co-administration with QT-prolonging agents (such as amiodarone, sotalol, disopyramide, quinidine, ibutilide, intravenous erythromycin, pimozide, sertindole, pentamidine and mefloquine) is not recommended because QT prolongation is exacerbated by reduction in heart rate. If combination is necessary, careful cardiac monitoring is required.
Combination with agents that can cause hypokalaemia (including lis and thiazide diuretics) increases the likelihood of QT prolongation.
Co-administration with CYP3A4 inducers (eg phenobarbital, carbamazepine, phenytoin, rifampicin, efavirenz, nevirapine and St. John’s Wort) may require a higher dose of ivabradine. Limit the intake of St. John’s wort during treatment.
Exposure to ivabradine hydrochloride (active substance) increased 2 – fold following the co – administration with grapefruit juice or grapefruit ( grapefruit ). Therefore, ingestion of this juice should be avoided during treatment with Ivabradine Hydrochloride (active substance).
- Teratogenesis : In humans, insufficient data. In animals at therapeutic doses indications of harmfulness (ectrodactyly, heart defects).
- Advice : Use is contraindicated.
- Others : A fertile woman should take adequate contraceptive measures during therapy.
- Transition in human milk : unknown (in humans), yes (in animals).
- Advice : Use is contraindicated.
- resting heart rate <70 beats / min before the start of treatment;
- severe hypotension (<90/50 mmHg), cardiogenic shock;
- unstable angina pectoris, acute myocardial infarction;
- unstable or acute heart failure;
- sicksinus syndrome, sinoatrial block, third degree AV block, pacemaker dependence (heart rate determined exclusively by pacemaker present);
- severe hepatic insufficiency.
Warnings and Precautions
Before the start of treatment or when titration is considered, determine heart rate (using consecutive heart rate measurements, ECG or ambulatory 24-hour monitoring). Treatment only start with a heart rate at rest ≥ 70 beats per minute.
Monitor the condition of the patient, including blood pressure, during treatment and with each dose adjustment. At a resting heart rate of <50 beats per minute or when symptoms of bradycardia (dizziness, fatigue, hypotension) reduce the dose and if no improvement occurs discontinue treatment.
Use of Procoralan (Ivabradine) is not recommended in atrial fibrillation and other arrhythmias that interfere with the function of the sinus node, in second-degree AV block, acute CVA and congenital QT syndrome.
It is recommended that no electrical cardioversion be performed within 24 hours of the last dose of Procoralan (Ivabradine) due to insufficient data.
Caution in mild to moderate hypotension, heart failure NYHA class IV, creatinine clearance <15 ml / min, moderate hepatic impairment and retinitis pigmentosa.
Procoralan (Ivabradine) can cause bradycardia, which can exacerbate QT prolongation, leading to severe cardiac arrhythmias, including ‘Torsade de pointes’.
Treatment with Procoralan (Ivabradine) also increases the risk of atrial fibrillation and regularly checks for this during treatment. Inform the patient about the signs and symptoms of atrial fibrillation and contact the prescriber if they occur.
ECG monitoring for atrial fibrillation is necessary in case of worsening of the angina, palpitations and an irregular pulse. There is a greater risk of developing atrial fibrillation in patients with chronic heart failure or in combination with certain medicines (amiodarone, strong class I antiarrhythmics). Monitoring patients with chronic heart failure with intraventricular conduction disturbances (left / right bundle branch block) and ventricular dyssynchrony.
In the event of unexpected deterioration in vision, consider discontinuing treatment. Ivabradine affects the function of the retina, but there is no evidence of a toxic effect on the retina during long-term treatment (3 years).
There are insufficient data concerning safety and efficacy in children <18 years.
Symptoms such as severe and long-term bradycardia.
Procoralan 5mg is presented in the form of salmon-colored, oblong-coated tablets with a dividing bar and engraved with “5” on one side and on the other.
Procoralan 7.5mg is in the form of salmon-colored coated triangular tablets engraved with ‘7,5’ on one side and on the other.
Mechanism of Action
Procoralan (Ivabradine) decreases the heart rate by inhibiting the spontaneous diastolic depolarization in the sinus node via a specific inhibition of the cardiac pacemaker I f current. Ivabradine also affects the retinal I h flow in response to the retina for bright light stimuli.
Procoralan (Ivabradine) has no effect on intracardiac conduction, contractility (no negative inotropic effect), ventricular repolarization or peripheral resistance. Operation: after approx. 1 hour (reduction in heart rate), within approx. 3-4 weeks (antianginal effect), after 2 weeks (in case of heart failure). Operating time: approx. 12 hours.