Procoralan Tablets / Film-coated
Ivabradine
7.5mg
Les Laboratoires Servier Industrie
| Pack size | 56's (14's Blister x 4) |
|---|---|
| Dispensing mode | POM |
| Source | FRANCE |
| Agent | Modern Pharmaceutical Co. |
| Retail Price | 334.50 AED |
Available as:
Indications
Procoralan Tablets / Film-coated is used for:
Chronic stable angina, Heart Failure
Adult Dose
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
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment:
CrCl (ml/min) Dosage Recommendation
<15 Use w/ caution.
Administration
Should be taken with food. Avoid excessive consumption of grapefruit juice.
Contra Indications
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.
Precautions
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.
Pregnancy-Lactation
Pregnancy
May cause fetal toxicity when administered to a pregnant woman, based on findings in animal studies
There are no adequate and well-controlled studies in pregnant women to inform any drug-associated risks
Advise females of childbearing potential to use effective contraception
Animal data
In animal reproduction studies, embryo-fetal toxicity and teratogenic effects (eg, abnormal shape of the heart, interventricular septal defect, complex anomalies of primary arteries) were observed
Increased postnatal mortality was associated with these teratogenic effects in rats
In pregnant rabbits, increased postimplantation loss was noted at an exposure 5 times the human exposure at the MRHD; lower doses were not tested in rabbits
Clinical considerations
Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester
Pregnant patients with LVEF <35% on maximally tolerated doses of beta-blockers may be particularly heart rate dependent for augmenting cardiac output
Therefore, closely follow pregnant patients starting treatment, especially during the first trimester, for destabilization of their congestive heart failure; monitor pregnant women with chronic heart failure in 3rd trimester of pregnancy for preterm birth
Lactation
Unknown if distributed in human breast milk
Animal studies have shown, however, that ivabradine is present in rat milk
Because of potential risk to breastfed infants, breastfeeding is not recommended
Interactions
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.
Adverse Effects
Side effects of Ivabradine :
1-10%
Bradycardia (10%)
Hypertension or increased blood pressure (8.9%)
Atrial fibrillation (8.3%)
Luminous phenomena (phosphenes) or visual brightness (2.8%)
Mechanism of Action
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.
Note
Procoralan 7.5mg Tablets / Film-coated manufactured by Les Laboratoires Servier Industrie. Its generic name is Ivabradine. Procoralan is availble in United Arab Emirates.
Farmaco UAE drug index information on Procoralan Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.