KRKA #Circulatory_system #Preparations_supporting_the_work_of_the_heart #HEALTH_CARE
Product description
- Symptomatic treatment of chronic stable angina.
- Treatment of chronic heart failure.
Compound
Active ingredient: ivabradine;
1 film-coated tablet contains 7.5 mg of ivabradine, equivalent to 8.085 mg of ivabradine hydrochloride;
Excipients: lactose, magnesium stearate, corn starch, maltodextrin, colloidal silicon dioxide, hypromellose;
Film shell: hypromellose, titanium dioxide (E 171), talc, propylene glycol, iron oxide yellow (E172), iron oxide red (E 172).
Contraindications
Hypersensitivity to the active substance or any excipients.
Resting heart rate <70 bpm prior to treatment.
Cardiogenic shock.
Acute myocardial infarction.
Severe arterial hypotension (BP <90/50 mm Hg).
Severe liver failure.
Sick sinus syndrome.
Sinoatrial blockade.
Unstable or acute heart failure.
The presence of an artificial pacemaker in the patient (heart rate is controlled exclusively with the help of an artificial pacemaker).
Unstable angina.
3rd degree AV block.
Mode of application
The preparation Bravadin is prescribed for adults.
Tablets are taken orally twice a day: in the morning and in the evening with meals.
The tablet of the preparation Bravadin 7.5 mg can be divided into equal parts.
Application features
pregnant
Contraindicated.
Children
Contraindicated.
Drivers
Carefully.
Overdose
An overdose of ivabradine can lead to severe and prolonged bradycardia (see section "Adverse reactions"). Severe forms of bradycardia require symptomatic treatment in specialized institutions. In the event of bradycardia with impaired hemodynamic parameters, the use of intravenous beta-stimulating agents, such as isoprenaline, is recommended. In extremely severe cases, temporary use of a pacemaker may be considered.
Side effects
neurological disorders. Often: headache, usually during the first month of treatment; dizziness, probably due to bradycardia.
From the organs of vision. Very often visual phenomena (phosphene). Often blurred vision.
Cardiac disorders. Often bradycardia AV blockade of the first degree (on the ECG - prolongation of the PQ interval) ventricular extrasystole atrial fibrillation.
From the side of the vessels. Often uncontrolled blood pressure.
From the respiratory system, chest organs and mediastinum. Infrequently shortness of breath.
From the gastrointestinal tract. Infrequently nausea, constipation, diarrhea, abdominal pain.
From the skin and subcutaneous tissue. Uncommon: angioedema; rashes.
From the musculoskeletal system and connective tissue. Uncommon muscle spasms.
Interaction
The concomitant use of ivabradine and cardiovascular and non-cardiovascular preparations that prolong the QT interval should be avoided, since a decrease in heart rate may increase the prolongation of the QT interval. If such a combination is necessary, careful monitoring of cardiac activity should be ensured.
Concomitant use of ivabradine and strong CYP3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone is contraindicated ( see section "Contraindications"). Such strong CYP3A4 inhibitors as ketoconazole (200 mg/day) and josamycin (1 g 2 times a day) increase the average plasma concentration of ivabradine by 7-8 times.
Storage conditions
Keep out of the reach of children.
Shelf life - 2 years.
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