AstraZeneca #Circulatory_system #Hypertension #HEALTH_CARE
Product description
Tablets "Betaloc Zok" are used for the following indications:
- arterial hypertension;
- angina;
- stable symptomatic chronic heart failure with impaired systolic function of the left ventricle;
- prevention of cardiac death and re-infarction after the acute phase of myocardial infarction;
- cardiac arrhythmias, including supraventricular tachycardia, a decrease in the frequency of ventricular contraction in atrial fibrillation and ventricular extrasystoles;
- functional disorders of cardiac activity, accompanied by palpitations;
- migraine prevention.
Compound
The active substance is metoprolol (one tablet contains 95 mg of metoprolol succinate, which corresponds to 100 mg of metoprolol tartrate).
Excipients: ethylcellulose, hydroxypropylcellulose, hypromellose, microcrystalline cellulose, paraffin, macrogol, anhydrous colloidal silicon dioxide, sodium stearyl fumarate, titanium dioxide (E 171).
Contraindications
- cardiogenic shock;
- sick sinus syndrome (in the absence of a permanent pacemaker);
- blockade II and III degree;
- heart failure in the stage of decompensation (pulmonary edema, hypoperfusion or arterial hypotension);
- long-term or intermittent inotropic therapy aimed at stimulating beta receptors;
- symptomatic bradycardia or arterial hypotension;
- metoprolol should not be given to patients with suspected acute myocardial infarction with heart rate < 45 beats/minute, P-Q interval > 0.24 seconds, systolic blood pressure < 100 mmHg; in the presence of symptoms of heart failure, the condition of patients with recurring blood pressure readings below 100 mmHg in the supine position should be re-evaluated before starting treatment;
- serious peripheral vascular disease with the threat of gangrene;
- hypersensitivity to the components of the preparation or other beta-blockers.
Mode of application
"Betaloc Zok" should be used once a day, preferably in the morning. The sustained release tablets can be divided but should not be chewed or crushed. Tablets should be taken with at least 0.5 glass of liquid. Simultaneous ingestion of food does not affect the bioavailability of the preparation.
The dose should be selected individually, in order to avoid the development of bradycardia. Dosing is recommended as indicated below.
Arterial hypertension
50-100 mg 1 time per day. If a dose of 100 mg is insufficient to achieve a therapeutic effect, the preparation can be combined with other antihypertensive preparations, preferably diuretics and calcium antagonists of the dihydropyridine type, or the dose of the preparation can be increased.
angina pectoris
100-200 mg 1 time per day. If necessary, "Betaloc Zok" can be combined with nitrates or increase the dose.
Adjunctive therapy in treatment with angiotensin-converting enzyme inhibitors, diuretics, and possibly digitalis preparations for stable symptomatic heart failure
Patients must have stable chronic heart failure without episodes of decompensation for at least 6 weeks and without significant changes in basic therapy during the last 2 weeks. Treatment of heart failure with beta-blockers may lead to a temporary worsening of symptoms. In some cases, further continuation of therapy or a decrease in the dose of the preparation is possible; in some cases, preparation withdrawal may be required. In patients with severe heart failure (NYHA functional class IV), only an experienced specialist should start therapy with Betaloc Zok.
Stable heart failure, functional class II
The recommended initial dose of Betaloc Zok for the first two weeks is 25 mg once a day. After 2 weeks, the dose can be increased to 50 mg once a day, and then the dose can be doubled every two weeks. The target dose of Betaloc Zok for long-term treatment is 200 mg once a day.
Stable heart failure, III-IV functional class
The recommended starting dose is 12.5 mg (half a 25 mg tablet) once daily. The dose of the preparation is adjusted individually. During the period of increasing the dose, the patient should be under the supervision of a physician, since in some patients the symptoms of heart failure may worsen. After 1-2 weeks of taking Betaloc Zok, the dose of the preparation can be increased to 25 mg 1 time per day. After two weeks, the dose of the preparation can be increased to 50 mg 1 time per day. For patients who tolerate high doses well, the dose can be doubled every two weeks up to a maximum dose of 200 mg per day.
In the event of arterial hypotension and / or bradycardia, it may be necessary to reduce the dose of the concomitant preparation or reduce the dose of Betaloc Zok. Arterial hypotension at the beginning of therapy does not necessarily indicate that the dose of Betaloc Zok should be reduced. However, the dose should be increased until the patient's condition stabilizes. Careful monitoring of kidney function may also be required.
cardiac arrhythmia
100-200 mg 1 time per day. If necessary, the dose can be increased.
Prophylactic treatment after myocardial infarction
The recommended maintenance dose is 200 mg once daily.
Functional disorders of cardiac activity, which are accompanied by palpitations
100 mg 1 time per day. If necessary, the dose can be increased.
Migraine Prevention
100-200 mg 1 time per day.
Application features
pregnant
The preparation "Betaloc Zok" should not be used during pregnancy and lactation, unless the doctor considers that the benefit outweighs the possible harm to the fetus / child.
Children
The safety and efficacy of Betaloc Zok in children for these indications has not yet been determined.
Drivers
During treatment with Betaloc Zok, dizziness and fatigue may occur. Patients whose activities are associated with attention strain, for example, driving a car and working with other mechanisms, should be warned about the possibility of such effects.
Overdose
Toxicity
In an adult, a dose of 7.5 g was the cause of lethal intoxication. Taking 100 mg of the preparation by a 5-year-old child was not accompanied by symptoms of intoxication after gastric lavage. A moderate intoxication was caused by a dose of 450 mg in a 12-year-old child and a dose of 1.4 g in an adult, a serious intoxication in an adult was caused by a dose of 2.5 g, and a dose of 7.5 g - a very serious intoxication.
Symptoms
The most important are cardiovascular symptoms, but in some cases, especially in children and young people, central nervous system symptoms and respiratory depression may predominate. Bradycardia, I-III degree blockade, prolongation of the QT interval (exceptional cases), asystole, drop in blood pressure, insufficient peripheral perfusion, heart failure, cardiogenic shock. Respiratory depression, respiratory arrest. The first signs of an overdose can be observed 20 minutes - 2 hours after taking the preparation.
Treatment
Treatment is provided in a facility that is able to offer supportive measures, monitoring and supervision.
Side effects
Adverse reactions are observed in approximately 10% of patients, usually they are dose-dependent. Adverse reactions are associated with the use of metoprolol.
From the side of the central and peripheral nervous system: very often (≥ 1/10) - fatigue; often (from ≥ 1/100 to < 1/10) - dizziness, headache.
Cardiac disorders: often (from ≥ 1/100 to < 1/10) - cold extremities, bradycardia, palpitations.
From the respiratory system: often (from ≥ 1/100 to < 1/10) - shortness of breath during physical activity.
From the gastrointestinal tract: often (from ≥ 1/100 to < 1/10) - abdominal pain, nausea, vomiting, diarrhea, constipation.
Storage conditions
Store at a temperature not exceeding 30 ° C, out of the reach of children.
Shelf life - 3 years.
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