12 August

Coraxan - instructions for use , indications, dosage

Coraxan - antianginal drug, a selective inhibitor of the sinus node If-channels.

release form and composition

dosage form - tablets, film-coated: the orange-pink color, are engraved on one side - the company logo on the other - in pills oval biconvex shape with notches on both sides - a figure 5,in triangular tablets - number 7.5 (14 pcs in blister packs in a cardboard unit 1, 2 or 4 blisters.).

active substance - ivabradine hydrochloride:

  • 1 oval tablet - 5.39 mg, equivalent to 5 mg ivabradine;
  • 1 triangular-shaped tablet - 8.085 mg, equivalent to 7.5 mg ivabradine.

Auxiliary ingredients: magnesium stearate, lactose monohydrate, corn starch, colloidal anhydrous silica, maltodextrin.

composition of film-coating: hypromellose, glycerol, dye iron oxide yellow (E172), macrogol 6000, titanium dioxide (E171), iron oxide red dye (E172), magnesium stearate.

Indications

Application Coraxan indicated for the treatment of stable angina pectoris in patients with normal sinus rhythm:

  • presence of contraindications to beta-blockers or their intolerance;
  • Inadequate control of stable angina under optimal doses of beta-blockers for the combination with beta-blockers.

In addition, the drug is prescribed for chronic heart failure patients with a heart rate (HR) of 70 or more beats per minute and sinus rhythm in order to reduce the incidence of possible cardiovascular complications.

Contraindications

  • sinoatrial block;
  • bradycardia, with resting heart rate less than 60 beats per minute;
  • Acute myocardial infarction;
  • Unstable angina;
  • Cardiogenic shock;
  • Severe hypotension (systolic blood pressure (BP) is lower than 90 mm of mercury (Hg) and diastolic blood pressure below 50 mm Hg);
  • sick sinus syndrome (SSS);
  • Acute or unstable heart failure;
  • atrioventricular block (AV-block) III degree;
  • constant stimulation of artificial cardiac pacemaker;
  • Simultaneous reception potent inhibitors isozymes of cytochrome P450 3A4, such as nefazodone, antibiotic macrolides (telithromycin, clarithromycin, josamycin, oral erythromycin), antifungals group azoles (itraconazole, ketoconazole), HIV protease inhibitors (ritonavir, nelfinavir);
  • Severe hepatic insufficiency (according to Child-Pugh score more than 9);
  • syndrome of malabsorption of glucose-galactose, lactose intolerance, lactase deficiency;
  • Pregnancy and breast-feeding;
  • the age of 18;
  • hypersensitivity to the drug.

The drug is contraindicated in women of childbearing age, do not use reliable contraception.

Precautions recommended to appoint Coraxan patients with hypotension, AV-blockade II degree, chronic heart failure class IV (NYHA classification), moderate form of liver failure, renal insufficiency (with creatinine clearance (CC) of less than 15 ml / min)congenital prolongation of the interval QT, recent stroke, retinitis pigmentosa.

under careful medical supervision is necessary to take the drug when combined with moderate inhibitors and inducers of CYP3A4 isoenzymes, drug, prolongs the QT interval, grapefruit juice, calcium channel blockers slow that reduce heart rate (diltiazem, verapamil), nekaliysberegayuschimi diuretics.

Dosage and Administration

tablets taken orally with meals, 2 times a day (morning and evening).

With stable angina initial daily dose is 10 mg (1 tablet of 5 mg in the morning and evening).Based on the clinical indications, 3-4 weeks of daily dose may be increased to 15 mg.In case of reduction of resting heart rate below 50 beats per minute, or the appearance of bradycardia symptoms (dizziness, severe decrease in blood pressure, fatigue), the daily dose should be reduced to 5 mg.In the absence of therapeutic effect after reducing the dose use of the drug should be discontinued.

In chronic heart failure, the recommended initial daily dose - 10 mg.After 2 weeks of application, if the resting heart rate is stable at more than 60 beats per minute, the dose may be increased to 15 mg.

Correction Coraxan daily dose depends on the stability at the heart rate of the patient at rest:

  • 50 beats per minute or less - 5 mg (amid the symptoms of bradycardia);
  • 50 to 60 beats per minute - 10 mg;
  • above 60 bpm - 15 mg.

If the heart rate of 50 beats per minute and less than or bradycardia symptoms persist the patient should consider the abolition of the drug.

Patients aged 75 years and older the recommended initial daily dose is 5 mg, may further increase it.

Patients with impaired renal function (creatinine clearance greater than 15 mL / min) the initial recommended daily dose is administered in the amount of 10 mg, in the case of the therapeutic effect of increasing it to 15 mg may after 3-4 weeks of treatment.

patients with mild hepatic insufficiency (up to 7 points on a scale Child-Pugh) correction usual recommended dosage is not required.

When severe impaired renal function to moderate hepatic insufficiency recommended drug be used with caution.

Side effects

Application Coraxan may cause side effects:

  • Since the cardiovascular system: often - bradycardia;infrequently - supraventricular arrhythmias, palpitations;very rarely - SSS, atrial fibrillation, AV-block II and III level;the frequency is unknown - marked reduction of blood pressure (may be associated with bradycardia);
  • From the senses: very often - changes svetovospriyatiya (photopsia);often - blurred vision;rare - vertigo;the frequency is unknown - blurred vision, double vision;
  • From the digestive system: rarely - nausea, diarrhea or constipation;
  • part of the respiratory system: rarely - shortness of breath;
  • From the nervous system: often - headache (especially the first 4 weeks of treatment), dizziness;the frequency is unknown - fainting;
  • From the musculoskeletal system: rarely - muscle spasms;
  • part of the skin and subcutaneous fat: the frequency is unknown - itching, skin rash, erythema, urticaria, angioedema,
  • From the laboratory and instrumental parameters: Infrequent - eosinophilia, hyperuricemia, lengthening of the QT interval on the electrocardiogram (ECG), increased creatinine concentration in the blood;
  • General disorders: frequency not known - fatigue, asthenia, malaise.

most common adverse effects from taking ivabradine are dose dependent and related to the mechanism of the clinical effect of the drug.

Cautions

Coraxan has no clinical effect in the treatment or prevention of arrhythmia, against supraventricular or ventricular tachycardia its effect falls.

not recommended the appointment of ivabradine in patients with atrial fibrillation (atrial fibrillation) and other types of arrhythmias caused by violation of the sinus node function.

risk of developing atrial fibrillation are more prone to patients with chronic heart failure who take the drug, and patients with other diseases - against the backdrop of the simultaneous application of amiodarone or antiarrhythmic drugs of class I.Use of the drug in patients with disorders of intraventricular conduction (blockade of the left or right bundle branch), chronic heart failure and ventricular dyssynchrony should take place under the close supervision of a physician.

If bradycardia with resting heart rate less than 60 beats per minute, unstable heart failure, and stroke immediately after the appointment of the drug is contraindicated.

When disturbances of visual functions, it is necessary to consult a doctor.

The appointment of the drug in patients with congenital long QT syndrome, treatment should take place under the strict supervision of the ECG.

In patients with atrial fibrillation has not confirmed the risk of bradycardia when pharmacological cardioversion to sinus rhythm.Within 24 hours prior to the scheduled electrical cardioversion should stop taking Coraxan.

Change antihypertensive therapy in patients with chronic heart failure in patients receiving Coraxan should be held under the monitoring of blood pressure.

The drug does not affect the patient's ability to drive vehicles and mechanisms, however, should take into account a possible violation of a temporary change svetovospriyatiya and caution during abrupt changes in light intensity, especially at night.

Drug Interactions

Not recommended for combination with inducers and inhibitors of CYP3A4 isoenzyme, as they cause the decrease and increase (respectively) the level of ivabradine plasma concentrations.

Coraxan Contraindicated combination with potent inhibitors of CYP3A4 isoenzyme, as they may cause a rise in average ivabradine plasma concentrations 7-8 times.

concomitant administration of fluconazole and other moderate inhibitors of CYP3A4 may if resting heart rate greater than 60 beats per minute.The initial dose is recommended at a rate of 5 mg per day, the treatment should be accompanied by heart rate control.

additional QT prolongation is the combination of ivabradine with disopyramide, quinidine, bepridilom, ibutilide, sotalol, amiodarone and other antiarrhythmic drugs;ziprasidone, pimozide, sertindole, cisapride, halofantrine, pentamidine, mefloquine, erythromycin (when administered intravenously).Treatment in this combination should be carried out under the close and regular supervision of the ECG.

increased risk of arrhythmia development can contribute to hypokalaemia, so caution should be prescribed at the same time taking nekaliysberegayuschih diuretics (loop and thiazide diuretics).

combined use of rifampicin, barbiturates, phenytoin, herbal remedies, including St. John's wort or other inducers of CYP3A4 may reduce the concentration and the effect of ivabradine.

No clinically meaningful effect on the pharmacokinetics and pharmacodynamics of the drug from the combination with warfarin, digoxin, proton pump inhibitors (lansoprazole, omeprazole), inhibitors of HMG-CoA reductase inhibitors (simvastatin), PDE5 inhibitors (sildenafil), blockers of slow calcium channels derivatives dihydropyridine(lacidipine, amlodipine).

Coraxan does not affect the pharmacokinetics of amlodipine, warfarin, digoxin, simvastatin, lacidipine and the pharmacodynamics of warfarin, digoxin, acetylsalicylic acid.

Grapefruit juice increases the concentration of ivabradine plasma 2 times, so in the period of treatment is recommended to avoid its use.

shown to use the drug in combination with an angiotensin II receptor antagonists, ACE inhibitors, beta-blockers, aldosterone antagonists, diuretics, nitrates, prolonged and short action, fibrates, HMG-CoA reductase inhibitors, proton pump inhibitors, hypoglycemic agents for oral administration,antiplatelet drugs.

Terms and conditions of storage

Store at room temperature.Keep away from children.

Shelf life - 3 years.

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