Vedicardol, pills 12.5mg, 30pcs

Composition

Active ingredient:

carvedilol 12.5 mg.

Auxiliary substances:

microcrystalline cellulose-66 mg,

calcium stearate-1.5 mg,

crospovidone-3 mg,

talc-4.5 mg,

lactose monohydrate-up to 150 mg

Pharmacological action

of Alpha-and beta-adrenoblocker. Carvedilol has a combined non-selective effect due to the blockade of 1 -,2 – and 1-adrenergic receptors. The drug does not have its own sympathomimetic activity, it has membrane-stabilizing properties. Due to the blockade of-adrenoreceptors of the heart, blood pressure decreases, cardiac output decreases and heart rate decreases.

Carvedilol suppresses the renin-angiotensin-aldosterone system by blocking the adrenergic receptors of the kidneys, causing a decrease in plasma renin activity. By blocking beta-adrenergic receptors, the drug can cause dilation of peripheral blood vessels, thereby reducing OPSS.

The combination of adrenoreceptor blockade and vasodilation has the following effects: in arterial hypertension – a decrease in blood pressure; in CHD-an antianginal effect; in patients with left ventricular dysfunction and circulatory insufficiency, it favorably affects hemodynamic parameters, increases the ejection fraction of the left ventricle and helps to reduce its size.

Indications

-arterial hypertension (as monotherapy and in combination with diuretics);

— coronary heart disease: stable angina pectoris;

– chronic heart failure (as part of combination therapy).

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of Vedicardol during pregnancy have not been conducted, so the drug can only be prescribed during pregnancy if the intended benefit to the mother outweighs the potential risk to the fetus.

Breast-feeding is not recommended during carvedilol treatment.

Contraindications

— acute heart failure;

chronic heart failure (decompensation);

— severe liver failure;

— AV-block II-III degree;

— severe bradycardia (less than 50 beats/min);

— SSSU;

— arterial hypotension (systolic blood pressure less than 85 mm Hg. calendar);

— cardiogenic shock;

— chronic obstructive pulmonary disease;

— age under 18 years (effectiveness and safety not established);

— hypersensitivity to the components of the drug.

It should be used with caution in Prinzmetal angina, thyrotoxicosis, occlusive diseases of peripheral vessels, pheochromocytoma, psoriasis, renal failure, AV block of the first degree, with extensive surgical interventions and general anesthesia, with diabetes mellitus, hypoglycemia, depression, myasthenia gravis.

Side effects

From the central nervous system and peripheral nervous system: dizziness, headache (usually mild and at the beginning of treatment), loss of consciousness, myasthenia gravis (more often at the beginning of treatment), increased fatigue, depression, sleep disorders, paresthesia.

From the cardiovascular system: bradycardia, orthostatic hypotension, grade II-III AV block; rarely-peripheral circulatory disorders, progressive heart failure (during the period of increasing the dose), edema of the lower extremities, angina pectoris, a pronounced decrease in blood pressure, intermittent claudication.

From the digestive tract: dry mouth, nausea, diarrhea or constipation, vomiting, abdominal pain, loss of appetite, increased activity of hepatic transaminases.

From the hematopoietic system: rarely-thrombocytopenia, leukopenia.

From the side of metabolism: weight gain, violation of carbohydrate metabolism.

From the respiratory system: shortness of breath and bronchospasm (in predisposed patients).

From the side of the organ of vision: visual impairment, reduced lacrimation.

Musculoskeletal disorders: myalgia, arthralgia, pain in the extremities.

From the urinary system: rarely-impaired urination, impaired renal function.

Allergic reactions: skin manifestations, nasal congestion.

Dermatological reactions: exacerbation of psoriasis.

Other: flu-like syndrome, sneezing.

Interaction

Carvedilol may potentiate the effect of other concomitant antihypertensive agents or drugs that have a hypotensive effect (nitrates).

When carvedilol and diltiazem are used together, cardiac conduction disorders and hemodynamic disorders may develop.

With simultaneous use of carvedilol and digoxin, the concentration of the latter increases and the AV time may increase.

Carvedilol can potentiate the effects of insulin and oral hypoglycemic agents, while the symptoms of hypoglycemia (especially tachycardia) can be masked, so regular monitoring of blood sugar levels is recommended in diabetic patients.

Inhibitors of microsomal oxidation (cimetidine) enhance, and inducers (phenobarbital, rifampicin) weaken the hypotensive effect of carvedilol.

Drugs that reduce the content of catecholamines (reserpine, MAO inhibitors)increase the risk of hypotension and severe bradycardia.

Concomitant use of cyclosporine increases the concentration of the latter (correction of the daily dose of cyclosporine is recommended).

Concomitant use of clonidine may potentiate the antihypertensive and heart rate-reducing effects of carvedilol.

General anesthetics enhance the negative inotropic and hypotensive effects of carvedilol.

How to take, course of use and dosage

The drug is taken orally, regardless of food intake.

Arterial hypertension:

The initial dose is 6.25-12.5 mg 1 time / day in the first 2 days of treatment. Then 25 mg 1 time/day. If the antihypertensive effect is insufficient, the dose can be increased 2-fold after 2 weeks of therapy. The maximum recommended daily dose of the drug is 50 mg 1 time/day, it can be divided into 2 doses.

Coronary heart disease:

The initial dose is 12.5 mg 2 times / day in the first 2 days of treatment. Then 25 mg 2 times/day. If the antianginal effect is insufficient, the dose can be increased 2-fold after 2 weeks of therapy. The maximum recommended daily dose of the drug is 100 mg / day, divided into 2 doses.

Chronic heart failure

The dose is selected individually, under the careful supervision of a doctor. The recommended starting dose is 3.125 mg twice daily for 2 weeks. With good tolerability, the dose is increased at intervals of at least 2 weeks to 6.25 mg 2 times/day, then to 12.5 mg 2 times/day and then to 25 mg 2 times/day. The dose should be increased to the maximum, which is well tolerated by patients. In patients with a body weight of less than 85 kg, the target dose is 50 mg / day; in patients with a body weight of more than 85 kg, the target dose is 75-100 mg/day.

Overdose

Symptoms: decreased blood pressure (accompanied by dizziness or fainting), bradycardia. Shortness of breath may occur due to bronchospasm and vomiting. In severe cases, cardiogenic shock, respiratory disorders, confusion, and conduction disorders are possible.

Treatment: it is necessary to monitor and correct vital signs, if necessary – in the ICU. Symptomatic therapy is performed. Intravenous use of m-holinoblokatorov (atropine), adrenomimetics (epinephrine, norepinephrine) is advisable.

Special instructions

Therapy should be carried out for a long time and not abruptly stopped, especially in patients with CHD, as this can lead to a worsening of the course of the underlying disease. If necessary, the dose reduction should be gradual, within 1-2 weeks.

At the beginning of therapy with Vedicardol or with an increase in the dose of the drug, patients, especially the elderly, may experience an excessive decrease in blood pressure, mainly when standing up. It is necessary to adjust the dose of the drug. In patients with chronic heart failure, when selecting the dose, it is possible to increase the symptoms of heart failure, the appearance of edema. At the same time, the dose of Vedicardol should not be increased, it is recommended to prescribe large doses of diuretics until the patient’s condition stabilizes.

Continuous monitoring of ECG and blood pressure is recommended with simultaneous use of Vedicardol and slow calcium channel blockers, phenylalkylamine derivatives (verapamil), benzodiazepine derivatives (diltiazem), as well as with Class I antiarrhythmics.

It is recommended to monitor renal function in patients with chronic renal failure, arterial hypotension and chronic heart failure.

In the case of surgical intervention using general anesthesia, the anesthesiologist should be warned about previous therapy with Vedicardol.

Vedicardol does not affect the concentration of glucose in the blood and does not cause changes in the glucose tolerance test in patients with non-insulin-dependent diabetes mellitus.

Patients with pheochromocytoma should be prescribed alpha-blockers before starting therapy.

When prescribing to patients using contact lenses, it should be taken into account that the drug can cause a decrease in lacrimation.

Avoid using ethanol during treatment.

Influence on the ability to drive motor vehicles and manage mechanisms

It is not recommended to drive a car at the beginning of therapy and when increasing the dose of Vedicardol. You should refrain from other activities related to the need for high concentration of attention and rapid psychomotor reactions.

Form of production

Pills.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Carvedilol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Angina, Hypertension, Heart Failure