Verapamil-SZ - instructions for use, doses, side effects, contraindications

Each coated tablet contains the active substance - verapamil hydrochloride 0.08 g (80 mg) and excipients: sugar milk, potato starch, talc, calcium stearic acid, hydroxypropylcellulose or methylcellulose water soluble, titanium dioxide, tween 80, tropeoline O or yellow water-soluble dye KF-6001.

Description:

The tablets covered with a cover of yellow color, round biconcave forms. Two layers are visible on the cross-section.

Pharmacotherapeutic group:The blocker of "slow" calcium channels

ATX: & nbsp

C.08.D.A.01 Verapamil

C.08.D.A Phenylalkylamine derivatives

Pharmacodynamics:

Verapamil is one of the main drugs group of blockers of "slow" calcium channels. It has antiarrhythmic, anti-anginal and antihypertensive activity.

The drug reduces the need for myocardium in oxygen by decreasing myocardial contractility and reducing the heart rate. Causes coronary dilatation of the heart and increases coronaryblood flow; reduces the tone of the smooth muscles of peripheral arteries and the general peripheral vascular resistance.

Verapamil significantly slows the atrioventricular conduction, depresses the automatism of the sinus node, which allows the use of the drug for the treatment of supraventricular arrhythmias.

Verapamil is the drug of choice for the treatment of angina of vasospastic genesis (Prinzmetal angina). Has an effect in angina pectoris, as well as in the treatment of angina with supraventricular rhythm disorders.

Pharmacokinetics:

When ingested absorbed more than 90% of the dose. Bioavailability - 10-20%. The maximum concentration of the drug in the blood plasma is achieved 1-2 hours after ingestion (80-400 ng / ml). Verapamil penetrates through blood-brain and placental barriers. It is metabolized at the first pass through the liver. The main metabolites are norveralamil, N-dialkylverapamil and N-dealkylnorverapamil. Accumulation of the drug and its metabolites in the body explains the increased effect of course treatment. Binding to blood plasma proteins - 90%.The half-life with a single dose is 2.8-7.4 hours; when taking repeated doses - 4,5 - 12 hours. It is excreted in a small amount in unchanged form (3-4%), the rest - in the form of metabolites (70%) kidneys, about 25% - with bile. The secretion of breast milk is low.

Indications:

1. Treatment and prevention of cardiac arrhythmias: paroxysmal supraventricular tachycardia; flutter and atrial fibrillation (tachyarrhythmic variant); supraventricular extrasystole;

2. Treatment and prevention chronic stable angina (stress angina); unstable angina; vasospastic angina (Prinzmetal angina, variant angina);

3. Treatment of arterial hypertension.

Contraindications:

Hypersensitivity to the components of the drug, pronounced bradycardia, chronic heart failure of II B - III stage, arterial hypotension, cardiogenic shock (except for caused by arrhythmia), sinoauric blockade, atrioventricular blockade of II and III degree (excluding patients with an artificial pacemaker); acute myocardial infarction, sinus node weakness syndrome, stenosis of the aortic aorta,Wolff-Parkinson-White syndrome, Morgagni-Adams-Stokes syndrome, acute heart failure, simultaneous use of beta-blockers (intravenously), pregnancy, lactation, age 18 years.

Carefully:

With caution, it is necessary to prescribe the drug to patients with atrioventricular blockade of the 1st degree, chronic heart failure, expressed violations of the liver function.

Dosing and Administration:

Verapamil is taken orally during or after a meal, with a small amount of water.

The dosage regimen and duration of treatment are set individually, depending on the patient's condition, severity, the features of the course of the disease and the effectiveness of therapy.

To prevent attacks of angina pectoris, arrhythmia and in the treatment of hypertension, the drug is prescribed to adults at an initial dose of 40-80 mg 3-4 times a day. If necessary, increase the single dose to 120-160 mg.

The maximum daily dose of the drug is 480 mg.

In patients with severe hepatic impairment, excretion of verapamil from the body is slowed, so it is advisable to start treatment with minimal doses.The daily dose of the drug should not exceed 120 mg.

Side effects:

When using Verapamil, the following are possible:

from the cardiovascular system: possible reddening of the face, pronounced bradycardia, atrioventricular blockade, marked decrease in blood pressure, the appearance of symptoms of heart failure when using the drug in high doses, especially in predisposed patients;

from the gastrointestinal tract: nausea, vomiting, constipation: t; in some cases - a transient increase in the activity of "liver" transaminases and alkaline phosphatase in the blood plasma;

from the side of the central nervous system: dizziness, headache, in rare cases - increased nervous excitability, inhibition, fatigue, allergic reactions: skin rash, itching.

Other: development of peripheral edema, gynecomastia, hyperprolactinemia, gingival hyperplasia.

Overdose:

Symptoms: sinus bradycardia, passing into atrioventricular blockade, sometimes asystole, marked decrease in arterial pressure, heart failure, shock, sinoatrial blockade.

Treatment: with early detection - gastric lavage, Activated carbon; with rhythm and conduction disturbances - intravenous injection of isoprenaline, norepinephrine, atropine, 10-20 ml of 10% calcium gluconate solution, artificial pacemaker; IV infusion of plasma-substituting solutions. Hemodialysis is not effective.

Interaction:

With the simultaneous use of verapamil with: - antiarrhythmic drugs, beta adrenoblockers and inhalation anesthetics, there is an increase in cardiotoxic effect (increased risk of atrioventricular blockade, a sharp decrease in heart rate, development of heart failure, a sharp drop in blood pressure);

- antihypertensive agents and diuretics - it is possible to strengthen the hypotensive effect of verapamil;

- digoxin may increase the level of digoxin concentration in the blood plasma due to the deterioration of its excretion by the kidneys (so it is necessary to monitor the level of digoxin in the blood plasma in order to determine its optimal dosage and prevent intoxication);

- with cimetidine and ranitidine, the level of concentration of verapamil in the blood plasma increases;

- rifampicin, phenobarbital may decrease the concentration in the blood plasma and weaken the action of verapamil;

- Theophylline, prazosin, cyclosporine may increase the concentration of these substances in the blood plasma;

- muscle relaxants may enhance the muscle relaxant effect; Acetylsalicylic acid increases the possibility of bleeding;

- Quinidine increases the concentration of quinidine in the blood plasma, increases the threat of lowering blood pressure, and in patients with hypertrophic cardiomyopathy, the emergence of severe arterial hypotension;

- carbamazepine and lithium, the risk of neurotoxic effects increases.

Special instructions:

To increase blood pressure in patients with hypertrophic cardiomyopathy, alpha-adrenergic stimulants (phenylephrine); Do not use isoprenaline.

Before starting therapy for heart failure, it is necessary to achieve a compensated state.

In the treatment it is necessary to monitor the function of the cardiovascular and respiratory systems, the content of glucose and blood electrolytes, bcc and the amount of urine released.

It is not recommended to stop treatment suddenly.

Form release / dosage:

Tablets, film-coated, 80 mg.

Packaging:

10 tablets in a planar cell packaging.

For 50 tablets in a polymer jar or vial polymer.

Each jar or bottle, 5 contour cell packs together with the instructions for use are placed in a cardboard box.

Storage conditions:

List B. Store in a dry, dark place at a temperature of no higher than 25 ° C.

The drug should be stored in places inaccessible to children.

Shelf life:

3 years. Do not use the medicinal product after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002317 / 01

Date of registration:04.04.2008 / 15.04.2015

Expiration Date:Unlimited

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Information update date: & nbsp28.01.2017

Illustrated instructions

Instructions

Verapamil-SZ (Verapamil-CZ)