Yvabradyn | Bravadin tablets is covered.pl.ob. 5 mg 28 pcs. pack

Release form

Film-coated tablets.

Packing

28 pcs.

Indications

1. Stable angina pectoris.

Therapy of stable angina pectoris in adult patients with normal sinus rhythm: - in case of intolerance or contraindications for the use of

beta-blockers - in combination with beta-blockers with inadequate control of stable angina pectoris against the background of an optimal dose of beta-blocker.

2. Chronic heart failure.

To reduce the incidence of cardiovascular complications (mortality from cardiovascular disease and hospitalization due to increased symptoms of chronic heart failure (CHF)) in patients with heart failure, with sinus rhythm and heart rate of at least 70 beats / min.

Contraindications

- hypersensitivity to ivabradine or any of the auxiliary components of the drug Bravadin

- bradycardia (resting heart rate less than 60 beats / min (before treatment))

- cardiogenic shock

- acute myocardial hypertension blood pressure (BP) less than 90 mm Hg and diastolic blood pressure less than 50 mm Hg)

- severe liver failure (more than 9 points on the Child-Pugh scale)

- syndrome of sinus node weakness

- sinoatrial blockade

unstable or acute congestive heart failure

- the presence of an artificial pacemaker, operating in continuous stimulation mode

- unstable angina pectoris

- atrioventricular block (AV) of the third degree

- simultaneous use with strong inhibitors of isoenzymes of the cytochrome P450 ZA4 system, such as antifungal agents of the azole group (ketoconazole, itraconazole, antibiotic, macrolitrol, antibiotic erythromycin for oral administration, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone

- pregnancy and lactation

- age under 18 years (eff the effectiveness and safety of the drug in this age group has not been studied)

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Precautions: moderate hepatic impairment (less than 9 Child-Pugh scores), severe renal failure (CC less than 15 ml / min), congenital lengthening of the QT interval, simultaneous use of drugs that prolong the QT interval, simultaneous use of moderate inhibitors and inducers of the isoenzyme CYP3A4 and grapefruit juice, asymptomatic left ventricular dysfunction, AV block II degree , recent stroke, retinitis pigmentosa (retinitis pigmentosa), arterial hypotension, heart failure IV functional class according to NYHA classification, simultaneous use with slow calcium blockers channels (BCCI) slows heart rate (verapamil or diltiazem), the simultaneous application of nekaliysberegayuschimi diuretics.

Use during pregnancy and lactation

Pregnancy.

Animal studies have demonstrated the presence of reproductive toxicity, embryotoxicity, and teratogenicity.

The drug Bravadin is contraindicated for use during pregnancy due to insufficient safety data.

Breastfeeding period.

The use of the drug Bravadin during breastfeeding is contraindicated. It is not known whether ivabradine passes into breast milk.

If you need to use the drug Bravadin during lactation, breastfeeding should be discontinued.

Composition

1 tab.: - ivabradine hydrobromide, respectively. the content of ivabradine 5 mg.

Dosage and administration

Inside, twice a day (morning and evening) during meals.

1. Stable angina pectoris: The recommended starting dose is 10 mg per day (1 tablet 5 mg twice a day).

After 3-4 weeks of therapy, the dose can be increased to 15 mg per day (1 tablet 7.5 mg twice a day) depending on the therapeutic effect.

If during the use of the drug Bravadin heart rate at rest is less than 50 beats / min, or the patient has symptoms associated with bradycardia (dizziness, increased fatigue, or a marked decrease in blood pressure), the dose of the drug Bravadin should be reduced to 2.5 mg (1 / 2 tablets 5 mg) twice a day.

Bravadin therapy should be discontinued if, with a decrease in the dose of Bravadin, heart rate remains less than 50 beats / min or symptoms of severe bradycardia persist.

2. Chronic heart failure: The recommended starting dose is 10 mg per day (1 tablet 5 mg twice a day).

After 2 weeks of therapy, the dose can be increased to 15 mg per day (1 tablet 7.5 mg twice a day), if heart rate alone is stable over 60 beats / min, or reduced to 2.5 mg (1 / 2 tablets 5 mg) twice a day, if the heart rate is stable less than 50 beats / min or the patient develops symptoms associated with bradycardia (dizziness, increased fatigue, or a marked decrease in blood pressure). If the heart rate is in the range of 50-60 beats / min, it is recommended to use the drug Bravadin in a dose of 5 mg twice a day.

If during use of the drug Bravadin heart rate at rest is less than 50 beats / min or the patient has symptoms associated with bradycardia, for patients receiving the drug Bravadin in a dose of 5 mg twice a day or 7.5 mg twice a day , the dose of the drug should be reduced.

If in patients receiving the drug Bravadin at a dose of 2.5 mg (1/2 tablet of 5 mg) twice a day or 5 mg twice a day, heart rate at rest is stable over 60 beats / min, the dose of the drug Bravadin can be increased.

If heart rate remains below 50 beats / min or the patient has symptoms associated with bradycardia, Bravadin therapy should be discontinued.

Patients older than 75 years: For patients 75 years of age and older, treatment should be started with a lower dose. The recommended starting dose is 2.5 mg (1/2 tablet of 5 mg) twice a day. In the future, the dose may be increased.

Impaired renal function: Patients with impaired renal function (CC more than 15 ml / min) do not require dose adjustment.

Recommended starting dose is 10 mg per day (1 tablet 5 mg twice a day). After 3-4 weeks of therapy, the dose can be increased to 15 mg per day (1 tablet 7.5 mg twice a day).

Due to insufficient clinical data, Bravadin should be used with caution in patients with CC less than 15 ml / min.

Impaired liver function: Dose adjustment is not required in patients with mild liver failure (up to 7 Child-Pugh scores). Caution should be exercised when using the drug Bravadin in patients with moderate hepatic insufficiency (7-9 points on the Child-Pugh scale).

In patients with severe hepatic insufficiency (more than 9 points on the Child-Pugh scale), the use of the drug Bravadin is contraindicated.

Children and adolescents: The safety and effectiveness of ivabradine in children and adolescents under the age of 18 have not been established.

Drug Interaction

Pharmacodynamic Interaction: Concomitant use is not recommended: QT prolonging drugs: - antiarrhythmic agents that prolong QT intervals (e.g., quinidine, disopyramide, bepridil, sotalol, lumbar, sotolol, sotolol, ll) related to antiarrhythmic agents (eg, pimozide, ziprasidone, sertindol, mefloquine, halofantrine, pentamidine, cisapride, erythromycin for intravenous administration). Co-administration of ivabradine and drugs, QT lengthening is not recommended as a heart rate break may cause additional QT lengthening. When concomitant administration is required, careful monitoring of the ECG is required.

Concomitant use with caution: - Non-potassium diuretics (thiazide and "loop")

Hypokalemia may increase the risk of arrhythmia. Because ivabradine can cause bradycardia, the combination of hypokalemia and bradycardia is a predisposing factor for the development of severe arrhythmia, especially in patients with long QT syndrome, both congenital and induced by LS.

Pharmacokinetic interaction: Cytochrome P450 ZA4 (CYP3A4 isoenzyme)

Ivabradine undergoes hepatic metabolism involving only CYP3A4 isoenzyme and is a very weak inhibitor of this cytochrome. Does not affect the metabolism and concentration in the blood plasma of other substrates (strong, moderate and weak inhibitors) of the CYP3A4 isoenzyme. CYP3A4 isoenzyme inhibitors and inducers may interact with ivabradine and have clinically relevant effects on its metabolism and pharmacokinetic properties. CYP3A4 isoenzyme inhibitors increase, and CYP3A4 isoenzyme inducers reduce the plasma concentration of ivabradine. Increasing the concentration of ivabradine in the blood plasma may cause the risk of severe bradycardia (see section “Special instructions”).

Concurrent use is contraindicated: Concomitant use with potent CYP3A4 isoenzyme inhibitors, such as antifungal agents of the azole group (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin for ingestion, jazzamycin, telithromycin), protease inhibitors see Contraindications section). Strong CYP3A4 isoenzyme inhibitors - ketoconazole (200 mg once daily) or mozamycin (1 g twice daily) increase the average plasma concentration of ivabradine 7-8 times.

overdose

Symptoms: An overdose of Bravadine can lead to severe and prolonged bradycardia.

Treatment: Treatment of severe bradycardia is symptomatic and should be performed in a specialist hospital setting. In case of combination of bradycardia with violation of hemodynamic parameters, the use of beta-adrenomimetics (isoprenaline) is required. If necessary, install an artificial rhythm driver.

drugstore conditions

drugstore

lekarstvennaja form

tablets

Prescribing

For adults as prescribed by a doctor

Indications

Indications

Angina pectoris, Arrhythmia, Heart failure, Chronic circulatory failure

KRKA d.d. Novo mesto AO, Slovenia