Karvedilol Zentiva of the tab. of 12.5 mg No. 30

Karvedilol Zentiva is shown to use:

• Essential arterial hypertension as monotherapy or in a combination with other antihypertensive medicaments (especially a hydrochlorothiazide).
• Chronic stable stenocardia (not to use medicament for treatment of a bad attack of stenocardia).
• Treatment of chronic heart failure of moderate and heavy degree as addition to standard therapy with diuretics, digoxin or APF inhibitors.

Structure

• active ingredient: karvedilol;
• 1 tablet supports a karvedilol of 12.5 mg;
• other components: microcrystalline cellulose; sodium of a kroskarmeloz; the vegetable oil hydrogenated; silicon dioxide colloidal anhydrous, magnesium stearate.

Contraindication

• Hypersensitivity to a karvedilol or other components of drug.
• Dekompensirovannaya heart failure – the heart failure of the IV class on classification of NYHA demanding intravenous administration of inotropic means.
• Atrioventricular block ІІ-ІІІ degrees (if the constant pacemaker is not established).
• Accompanying administration of verapamil, diltiazem or other antiarrhytmic means (especially antiarrhytmic means of class I).
• Heavy bradycardia (heart rate (HR) <50 beats per minute).
• Sick sinus syndrome (including sinuatrial blockade).
• Cardiogenic shock.
• Heart failure demanding introduction of positive isotropic means and/or diuretics.
• Heavy hypotension (systolic pressure <85 mm Hg.).
• Pulmonary hypertensia.
• Pulmonary heart.
• Period of pregnancy or feeding by a breast.
• Children's age.

Side reactions

Frequency of side effects does not depend on a medicament dose, except for dizziness, disorders of vision and bradycardia. Dizziness, a loss of consciousness, a headache and an asthenia usually easy and probably develop in an initiation of treatment.

About heart failure it was often reported as about by-effects as at the patients accepting placebo and at the patients accepting karvedilol (14.5% and 15.4% respectively, at patients with dysfunction of a left ventricle after an acute myocardial infarction).

at therapy karvediloly at patients with chronic heart failure with the low ABP, coronary heart disease and a diffusion disease of vessels and/or the main renal failure.

Route of administration

Pill should be taken, washing down with enough water. To take the medicament irrespective of food, however administration of medicament at meal time reduces risk of developing postural hypotension.

Essential hypertensia.

Recommended initial dose makes 12.5 mg/days (1 tablet in the morning) during the first 2 days of treatment. At good tolerance this dosage can be increased.

Recommended maintenance dose – 25 mg/days (1 tablet on 25 mg in the morning or 1 tablet on 12.5 mg 2 times a day, in the morning and in the evening). In case of unsatisfactory effect, but not earlier than in 14 days of treatment the dose can be increased to the maximum 50 mg/days (1 tablet on 25 mg twice a day, in the morning and in the evening). The maximum single dose makes 25 mg, the maximum daily dosage should not exceed 50 mg.

Chronic stable stenocardia.

Recommended initial dose makes 12.5 mg 2 times a day (1 tablet on 12.5 mg in the morning and in the evening) in the first 2 days of treatment. The recommended maintenance dose – 25 mg 2 times a day (1 tablet on 25 mg in the morning and in the evening). At unsatisfactory effect in 14 days of treatment a dose it is possible to increase to the maximum dose 50 mg 2 times a day (2 tablets on 25 mg in the morning and in the evening).

Use during pregnancy or feeding by a breast

Clinical experience of use of a karvedilol during pregnancy is limited to

Feature of use

whether gets karvedilol into breast milk of the person. As karvedilol can have an adverse effect on the baby, for feeding by a breast treatment karvediloly should be stopped.

Safety and efficiency of a karvedilol are not established to children (up to 18 years) by

therefore this category of patients should not appoint drug.

Ability to influence speed of response at control of motor transport or other mechanisms

Should avoid control of motor transport and work with other mechanisms, especially in an initiation of treatment.

Overdose

At overdose can develop heavy arterial hypotension, bradycardia, heart failure, cardiogenic shock, cardiac arrest. Also breath difficulty, a bronchospasm, vomiting, disturbance of consciousness and generalized spasms were observed.

Treatment: during the first hours – to cause vomiting and to wash out a stomach, further – control and correction of the vital indicators in intensive care unit.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.