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Thread: Procoralan 7.5 mg tablets

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    Default Procoralan 7.5 mg tablets

    IVABRADINE (AS HYDROCHLORIDE) 7.5 MG


    * Procoralan (Ivabradine 7.5 mg) 4 blisters × 7 film-coated tablets. Oral route.
    * Composition: Each coated tablet contains:
    8.085 mg ivabradine hydrochloride, corresponding to 7.5 mg ivabradine base.
    * Indications:
    Procoralan is a heart medicine used to treat stable angina pectoris which causes chest pain, when beta-blockers (like atenolol,
    propranolol, metoprolol, etc, for high blood pressure, heart rhythm disorders, or angina pectoris) are not suitable.
    * Dosage & Administration:
    The usual recommended starting dose is 1 tablet or Procoralan 5 mg twice daily increasing if necessary to 1 tablet Procoralan
    7.5 mg twice daily. The usual dose is one tablet in the morning & one tablet in the evening. In some cases (e.g. if you are elderly),
    your doctor may prescribe half the dose i.e., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine)
    in the morning & one half 5 mg tablet in the evening. Procoralan should be taken during meals. Procoralan is not intended for use
    in children & adolescents younger than 18 years.
    * Do not use without prescription.
    * Store at room temperature.
    * Manufactured by: Les Laboratoires Servier Industrie - France. Packed by: SERVIER EGYPT INDUSTRIES LIMITED - A.R.E.

    Procoralan tablets attachment.php?attachmentid=124&stc=1&d=1429546491

    Therapeutic indications
    Symptomatic treatment of chronic stable angina pectoris.
    Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:
    - in adults unable to tolerate or with a contra-indication to the use of beta-blockers
    - or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
    Treatment of chronic heart failure
    Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated


    Posology and method of administration
    Posology
    For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available.
    Symptomatic treatment of chronic stable angina pectoris
    It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring.
    The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. After three to four weeks of treatment, if the patient is still symptomatic, if the initial dose is well tolerated and if resting heart rate remains above 60 bpm, the dose may be increased to the next higher dose in patients receiving 2.5 mg twice daily or 5 mg twice daily. The maintenance dose should not exceed 7.5 mg twice daily.
    If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
    In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.
    If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily (one half 5 mg tablet twice daily). After dose reduction, heart rate should be monitored . Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
    Treatment of chronic heart failure
    The treatment has to be initiated only in patient with stable heart failure. It is recommended that the treating physician should be experienced in the management of chronic heart failure.
    The usual recommended starting dose of ivabradine is 5 mg twice daily. After two weeks of treatment, the dose can be increased to 7.5 mg twice daily if resting heart rate is persistently above 60 bpm or decreased to 2.5 mg twice daily (one half 5 mg tablet twice daily) if resting heart rate is persistently below 50 bpm or in case of symptoms related to bradycardia such as dizziness, fatigue or hypotension. If heart rate is between 50 and 60 bpm, the dose of 5 mg twice daily should be maintained.
    If during treatment, heart rate decreases persistently below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia, the dose must be titrated downward to the next lower dose in patients receiving 7.5 mg twice daily or 5 mg twice daily. If heart rate increases persistently above 60 beats per minute at rest, the dose can be up titrated to the next upper dose in patients receiving 2.5 mg twice daily or 5 mg twice daily.
    Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist .

    Special population
    Older people
    In patients aged 75 years or more, a lower starting dose should be considered for these patients (2.5 mg twice daily i.e. one half 5 mg tablet twice daily) before up-titration if necessary.

    Patients with renal impairment
    No dose adjustment is required in patients with renal insufficiency and creatinine clearance above 15 ml/min .
    No data are available in patients with creatinine clearance below 15 ml/min. Ivabradine should therefore be used with precaution in this population.

    Patient with hepatic impairment
    No dose adjustment is required in patients with mild hepatic impairment. Caution should be exercised when using ivabradine in patients with moderate hepatic impairment. Ivabradine is contra-indicated for use in patients with severe hepatic insufficiency, since it has not been studied in this population and a large increase in systemic exposure is anticipated.

    Paediatric population
    The safety and efficacy of ivabradine in the treatment of chronic heart failure in children aged below 18 years have not been established.
    .
    Method of administration
    Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals.


    Contraindications
    - Hypersensitivity to the active substance
    - Resting heart rate below 70 beats per minute prior to treatment
    - Cardiogenic shock
    - Acute myocardial infarction
    - Severe hypotension (< 90/50 mmHg)
    - Severe hepatic insufficiency
    - Sick sinus syndrome
    - Sino-atrial block
    - Unstable or acute heart failure
    - Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
    - Unstable angina
    - AV-block of 3rd degree
    - Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
    - Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties
    - Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures


    Special warnings and precautions for use
    Special warnings
    Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris
    Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris because ivabradine has no benefits on cardiovascular outcomes (e.g. myocardial infarction or cardiovascular death) .

    Measurement of heart rate
    Given that the heart rate may fluctuate considerably over time, serial heart rate measurements, ECG or ambulatory 24-hour monitoring should be considered when determining resting heart rate before initiation of ivabradine treatment and in patients on treatment with ivabradine when titration is considered. This also applies to patients with a low heart rate, in particular when heart rate decreases below 50 bpm, or after dose reduction .

    Cardiac arrhythmias
    Ivabradine is not effective in the treatment or prevention of cardiac arrhythmias and likely loses its efficacy when a tachyarrhythmia occurs (eg. ventricular or supraventricular tachycardia). Ivabradine is therefore not recommended in patients with atrial fibrillation or other cardiac arrhythmias that interfere with sinus node function.
    In patients treated with ivabradine the risk of developing atrial fibrillation is increased . Atrial fibrillation has been more common in patients using concomitantly amiodarone or potent class I anti-arrhythmics. It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g. in case of exacerbated angina, palpitations, irregular pulse). Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur. If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
    Chronic heart failure patients with intraventricular conduction defects (bundle branch block left, bundle branch block right) and ventricular dyssynchrony should be monitored closely.

    Use in patients with AV-block of 2nd degree
    Ivabradine is not recommended in patients with AV-block of 2nd degree.

    Use in patients with a low heart rate
    Ivabradine must not be initiated in patients with a pre-treatment resting heart rate below 70 beats per minute .
    If, during treatment, resting heart rate decreases persistently below 50 bpm or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward or treatment discontinued if heart rate below 50 bpm or symptoms of bradycardia persist

    Combination with calcium channel blockers
    Concomitant use of ivabradine with heart rate reducing calcium channel blockers such as verapamil or diltiazem is contraindicated . No safety issue has been raised on the combination of ivabradine with nitrates and dihydropyridine calcium channel blockers such as amlodipine. Additional efficacy of ivabradine in combination with dihydropyridine calcium channel blockers has not been established

    Chronic heart failure
    Heart failure must be stable before considering ivabradine treatment. Ivabradine should be used with caution in heart failure patients with NYHA functional classification IV due to limited amount of data in this population.

    Stroke
    The use of ivabradine is not recommended immediately after a stroke since no data is available in these situations.

    Visual function
    Ivabradine influences on retinal function. To date, there is no evidence of a toxic effect of ivabradine on the retina, but the effects of long-term ivabradine treatment beyond one year on retinal function are currently not known. Cessation of treatment should be considered if any unexpected deterioration in visual function occurs. Caution should be exercised in patients with retinitis pigmentosa.

    Precautions for use
    Patients with hypotension
    Limited data are available in patients with mild to moderate hypotension, and ivabradine should therefore be used with caution in these patients. Ivabradine is contra-indicated in patients with severe hypotension (blood pressure < 90/50 mmHg)

    Atrial fibrillation - Cardiac arrhythmias
    There is no evidence of risk of (excessive) bradycardia on return to sinus rhythm when pharmacological cardioversion is initiated in patients treated with ivabradine. However, in the absence of extensive data, non urgent DC-cardioversion should be considered 24 hours after the last dose of ivabradine.

    Use in patients with congenital QT syndrome or treated with QT prolonging medicinal products
    The use of ivabradine in patients with congenital QT syndrome or treated with QT prolonging medicinal products should be avoided . If the combination appears necessary, close cardiac monitoring is needed.

    Heart rate reduction, as caused by ivabradine, may exacerbate QT prolongation, which may give rise to severe arrhythmias, in particular Torsade de pointes.
    Hypertensive patients requiring blood pressure treatment modifications.
    In the SHIFT trial more patients experienced episodes of increased blood pressure while treated with ivabradine (7.1%) compared to patients treated with placebo (6.1%). These episodes occurred most frequently shortly after blood pressure treatment was modified, were transient, and did not affect the treatment effect of ivabradine. When treatment modifications are made in chronic heart failure patients treated with ivabradine blood pressure should be monitored at an appropriate interval .
    Excipients
    Since tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.











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