Catad_pgroup Calcium channel blockers

Isoptin for injection - instructions for use

Currently the drug is not listed in the State Register medicines or specified registration number excluded from the register.

Registration number:

P N015547/01

Active substance:

Verapamil

Dosage form:

solution for intravenous administration

Compound:

For 2 ml of solution:

active substance: verapamil hydrochloride 5.0 mg;

Excipients: sodium chloride 17.0 mg, 36% hydrochloric acid - to adjust the pH, water for injection - up to 2 ml.

Description:

Transparent colorless solution.

Pharmacotherapeutic group:

Blocker of "slow" calcium channels

ATX:

C.08.D.A.01

Pharmacodynamics:

Verapamil blocks the transmembrane entry of calcium ions (and possibly sodium ions) through “slow” channels into the cells of the myocardial conduction system and the smooth muscle cells of the myocardium and blood vessels. Antiarrhythmic effect verapamil is probably due to its effect on the “slow” channels in the cells of the cardiac conduction system.

Electrical activity The sinoatrial (SA) and atrioventricular (AV) nodes largely depend on the entry of calcium into the cells through the “slow” channels. By inhibiting this calcium supply,
verapamil slows atrioventricular (AV) conduction and increases the effective refractory period in the AV node in proportion to heart rate (HR). This effect leads to a decrease in the frequency of ventricular contractions in patients with atrial fibrillation and/or atrial flutter. By stopping the re-entry of excitation in the AV node,
verapamil can restore proper sinus rhythm in patients with paroxysmal supraventricular tachycardia, including Wolff-Parkinson-White (WPW) syndrome.

Verapamil has no effect on conduction along accessory pathways, does not affect the normal atrial action potential or intraventricular conduction time, but reduces the amplitude, rate of depolarization and conduction in altered atrial fibers.

Verapamil does not cause spasm of peripheral arteries and does not change general content serum calcium. Reduces afterload and myocardial contractility. In most patients, including patients with organic heart disease, the negative inotropic effect of verapamil is offset by a decrease in afterload, cardiac index usually does not decrease, but in patients with moderate to severe heart failure (wedge pressure pulmonary artery more than 20 mm Hg. Art., left ventricular ejection fraction less than 35%) may experience acute decompensation of chronic heart failure.

Maximum therapeutic action observed 3-5 minutes after bolus intravenous administration of verapamil.

Standard therapeutic doses of verapamil 5-10 mg when administered intravenously cause a transient, usually asymptomatic, decrease in normal blood pressure(BP), systemic vascular resistance and contractility; Left ventricular filling pressure increases slightly.

Pharmacokinetics:

Verapamil hydrochloride is a racemic mixture consisting of equal amounts of the R-enantiomer and the S-enantiomer.

Norverapamil is one of 12 metabolites found in urine. The pharmacological activity of norverapamil is 10-20% of the pharmacological activity of verapamil, and the proportion of norverapamil is 6% of the excreted drug. The equilibrium concentrations of norverapamil and verapamil in blood plasma are similar. Equilibrium concentration with long-term use once a day is achieved after 3-4 days.

Distribution

Verapamil is well distributed in body tissues, the volume of distribution (Vd) in healthy volunteers is 1.8-6.8 l/kg. Communication with blood plasma proteins is about 90%.

Metabolism

Verapamil undergoes extensive metabolism. Metabolic studies in vitro showed that
verapamil is metabolized by cytochrome P450 isoenzymes CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18.

In healthy volunteers after oral administration
verapamil undergoes intensive metabolism in the liver, with 12 metabolites detected, most of which are in trace amounts. The main metabolites were identified as the N and O-dealkylated forms of verapamil. Among the metabolites, only norverapamil has pharmacological action(about 20% compared to the parent compound), which was revealed in a study on dogs.

Removal

When administered intravenously, the curve of changes in the concentration of verapamil in the blood is biexponential in nature with a fast early distribution phase (half-life (T 1/2) - about 4 minutes) and a slower terminal elimination phase (T 1/2 - 2-5 hours).

Within 24 hours, about 50% of the verapamil dose is excreted by the kidneys, within five days - 70%. Up to 16% of the verapamil dose is excreted through the intestines. Approximately 3-4% of verapamil is excreted unchanged by the kidneys. The total clearance of verapamil approximately coincides with the hepatic blood flow, i.e. about 1 l/h/kg (range: 0.7-1.3 l/h/kg).

Special patient groups

Elderly patients

Age may affect the pharmacokinetic parameters of verapamil when administered to patients with arterial hypertension. T1/2 may be increased in elderly patients. There was no relationship between the antihypertensive effect of verapamil and age.

Renal dysfunction

Impaired renal function does not affect the pharmacokinetic parameters of verapamil, which was revealed in comparative studies involving patients with terminal stage renal failure and patients with normal function kidney
Verapamil and norverapamil are practically not excreted during hemodialysis.

Indications for use

For the treatment of supraventricular tachyarrhythmias, including:

Recovery sinus rhythm for paroxysmal supraventricular tachycardia, including conditions associated with the presence of additional pathways in Wolff-Parkinson-White (WPW) and Lown-Ganong-Levine (LGL) syndrome.

If there are clinical indications, it is advisable to try to influence the nervus vagus(eg Valsalva maneuver);

Temporary control of the ventricular rate during atrial flutter and fibrillation (tachyarrhythmic variant), except in cases where atrial flutter or fibrillation is associated with the presence of additional pathways (WPW and LGL syndromes).

Contraindications

Increased sensitivity to active substance or auxiliary components of the drug;

Cardiogenic shock;

Atrioventricular block II or III degree, with the exception of patients with artificial driver rhythm;

Sick sinus syndrome, except in patients with an artificial pacemaker;

Heart failure with reduced left ventricular ejection fraction of less than 35% and/or pulmonary artery wedge pressure of more than 20 mmHg. Art., with the exception of heart failure caused by supraventricular tachycardia, subject to treatment with verapamil;

Severe arterial hypotension (systolic blood pressure less than 90 mm Hg);

Atrial fibrillation/flutter in the presence of additional pathways (Wolf-Parkinson-White, Lown-Ganong-Levine syndromes). These patients are at risk of developing ventricular tachyarrhythmia, incl. ventricular fibrillation when taking verapamil;

Ventricular tachycardia with wide QRS complexes (> 0.12 sec.) (see section " special instructions");

Simultaneous use with beta-blockers, intravenously.
Verapamil and beta-blockers should not be administered simultaneously (within several hours), since both drugs can reduce myocardial contractility and AV conduction (see section "Interaction with other drugs"). medicines");

Use of disopyramide 48 hours before and 24 hours after taking verapamil;

Pregnancy, period breastfeeding(efficacy and safety have not been established);

Age up to 18 years (efficacy and safety have not been established).

Carefully:

Marked decrease in blood pressure, acute heart attack myocardium, left ventricular dysfunction, first degree AV block, bradycardia, asystole, hypertrophic obstructive cardiomyopathy, heart failure.

Renal dysfunction and/or severe violations liver functions.

Diseases affecting neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy).

Simultaneous use with cardiac glycosides, quinidine, flecainide, simvastatin, lovastatin, atorvastatin; ritonavir and others antiviral drugs for the treatment of HIV infection; beta-blockers for oral administration; agents that bind to blood plasma proteins (see section "Interactions with other drugs").

Elderly age.

Pregnancy and lactation:

There is insufficient data on the use of Isoptin® in pregnant women. Animal studies do not reveal direct or indirect toxic effects on reproductive system. Due to the fact that the results of drug studies in animals do not always predict response to treatment in humans, Isoptin® can be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus/child.

Verapamil penetrates the placental barrier and is found in the blood of the umbilical vein during childbirth.
Verapamil and its metabolites are excreted in breast milk. The limited available data regarding oral administration of Isoptin® indicate that the dose of verapamil that infants receive through mother's milk is quite small (0.1-1% of the dose of verapamil taken by the mother) and the use of verapamil may be compatible with feeding chest. However, a risk to newborns and infants cannot be excluded.

Considering the possibility of serious side effects in infants, Isoptin® should be used during breastfeeding only if the benefit to the mother outweighs the potential risk to the child.

Directions for use and doses

Only intravenously.

Intravenous administration should be performed slowly over at least 2 minutes while continuously monitoring the ECG (electrocardiogram) and blood pressure.

In elderly patients and administration is carried out over at least 3 minutes to reduce the risk unwanted effects.

Initial dose is 5-10 mg (0.075-0.15 mg/kg body weight).

Repeat dose is 10 mg (0.15 mg/kg body weight), administered 30 minutes after the first injection if the response to the first injection is inadequate.

Stability

Isoptin® is compatible with the most widely used large-volume parenteral solutions and is chemically stable in them for at least 24 hours at 25 ° C, protected from light.

Before use dosage form for parenteral administration should be assessed visually for the presence of sediment and color change. Do not use if the solution is cloudy or the bottle seal is damaged.

The remaining unused solution must be destroyed immediately after taking a portion of the contents of any volume.

Incompatibility

To avoid instability, it is not recommended to dilute Isoptin® with sodium lactate solutions for injection in polyvinyl chloride bags. Avoid mixing with solutions of albumin, amphotericin B, hydralazine hydrochloride or trimethoprine and sulfamethoxazole.

Verapamil precipitates in any solution with a pH greater than 6.0.

Side effect

Side effects identified during clinical trials and with post-marketing use of the drug Isoptin®, are presented below by organ systems and the frequency of their occurrence in accordance with the WHO classification: very often (>1/10); often (from?1/100 to<1/10); нечасто (от?1/1000 до <1/100); редко (от?1/10000 до <1/1000); очень редко (<1/10000); частота неизвестна (невозможно определить на основании доступных данных).

The most frequently observed side effects were: headache, dizziness, nausea, constipation, abdominal pain, bradycardia, tachycardia, palpitations, marked decrease in blood pressure, flushing of the facial skin, peripheral edema and increased fatigue.

Immune system disorders:

frequency unknown: hypersensitivity.

Metabolic and nutritional disorders:

frequency unknown: hyperkalemia.

Mental disorders:

rarely: drowsiness.

Nervous system disorders:

often: dizziness, headache;

rarely: paresthesia, tremor;

frequency unknown: extrapyramidal disorders, paralysis (tetraparesis) 1, seizures.

Hearing and labyrinthine disorders:

rarely: tinnitus;

frequency unknown: twirls.

Cardiac disorders:

often: bradycardia;

uncommon: palpitations, tachycardia;

frequency unknown: AV block I, II, III degrees; heart failure, arrest of the sinus node ("sinus arrest"), sinus bradycardia, asystole.

Vascular disorders:

often: “flushes” of blood to the skin, marked decrease in blood pressure.

Disorders of the respiratory system, chest and mediastinal organs:

frequency unknown: bronchospasm, shortness of breath.

Gastrointestinal disorders:

often: constipation, nausea;

uncommon: abdominal pain;

rarely: vomiting;

frequency unknown: abdominal discomfort, gingival hyperplasia, intestinal obstruction.

Disorders of the skin and subcutaneous tissues:

rarely: hyperhidrosis;

frequency unknown: angioedema, Stevens-Johnson syndrome, erythema multiforme, alopecia, pruritus, pruritus, purpura. maculopapular rash, urticaria.

Musculoskeletal and connective tissue disorders:

frequency unknown: arthralgia, muscle weakness, myalgia.

Renal and urinary tract disorders:

frequency unknown: renal failure.

Disorders of the genital organs and breast:

frequency unknown: erectile dysfunction, galactorrhea, gynecomastia.

Common disorders:

often: peripheral edema;

infrequently: increased fatigue.

Laboratory and instrumental data:

frequency unknown: increased concentration of prolactin, increased activity of liver enzymes.

1 - during the post-registration period of use of the drug Isoptin®, a single case of paralysis (tetraparesis) associated with the combined use of verapamil and colchicine was reported. This could be due to the penetration of colchicine through the blood-brain barrier due to the suppression of the activity of the CYP3A4 isoenzyme and P-glycoprotein under the influence of verapamil (see section "Interaction with other drugs").

Overdose:

Symptoms: pronounced decrease in blood pressure; bradycardia, turning into AV block and stopping the activity of the sinus node (“sinus arrest”); hyperglycemia, stupor and metabolic acidosis. There have been reports of deaths due to overdose.

Treatment: supportive symptomatic therapy should be carried out. For clinically significant hypotensive reactions or AV block, vasopressor drugs or pacing should be prescribed, respectively. For asystole, beta-adrenergic stimulation (isoprenaline), other vasopressor drugs, or resuscitation should be used. Hemodialysis is ineffective.

Interaction

In patients with severe cardiomyopathy, chronic heart failure, or after myocardial infarction, concomitant administration of verapamil and beta-blockers or intravenous disopyramide has rarely resulted in serious adverse events.

Concomitant use of intravenous verapamil with drugs that suppress adrenergic function may lead to increased antihypertensive effects.

Metabolic studies in vitro indicate that
verapamil is metabolized by the isoenzymes CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18 of cytochrome P450.

Verapamil is an inhibitor of the CYP3A4 isoenzyme and P-glycoprotein. Clinically significant interactions were observed with simultaneous use with inhibitors of the CYP3A4 isoenzyme, and an increase in the concentration of verapamil in the blood plasma was observed, while inducers of the CYP3A4 isoenzyme decreased the concentration of verapamil in the blood plasma. When using such drugs simultaneously, the possibility of this interaction should be taken into account.

The table below provides data on possible drug interactions based on pharmacokinetic parameters.

Possible interactions associated with the CYP-450 isoenzyme system
A drug	Possible drug interactions	A comment
Alpha blockers
Prazosin	An increase in C m ah of prazosin (~40%) does not affect T 1/2 of prazosin.	Additional antihypertensive effect.
Terazosin	Increase in AUC of terazosin (-24%) and Cmax (~25%).
Antiarrhythmic drugs
Flecainide	Minimal effect on plasma clearance of flecainide (<~10 %); не влияет на клиренс верапамила в плазме крови.
	Reduced oral clearance of quinidine (~35%).	Marked decrease in blood pressure. Pulmonary edema may occur in patients with hypertrophic obstructive cardiomyopathy.
Drugs for the treatment of bronchial asthma
Theophylline	Reduced oral and systemic clearance (~20%).	Reduced clearance in smoking patients (~11%).
Anticonvulsants/antiepileptic drugs
Carbamazepine	Increased carbamazepine AUC (~46%) in patients with resistant partial epilepsy.	An increase in the concentration of carbamazepine, which may lead to the development of side effects of carbamazepine such as diplopia, headache, ataxia or dizziness.
Phenytoin	Decreased plasma concentrations of verapamil.
Antidepressants
Imipramine	Increase in AUC of imipramine (~15%).	Does not affect the concentration of the active metabolite, desipramine.
Hypoglycemic agents
Glibenclamide	Increase in Cmax of glibenclamide (-28%), AUC (~26%).
Antigout drugs
Colchicine	Increase in AUC of colchicine (~ 2.0 times) and Cmax (~ 1.3 times).	Reduce the dose of colchicine (see instructions for use of colchicine).
Antimicrobials
Clarithromycin
Erythromycin	The concentration of verapamil may increase.
Rifampicin	Decreased AUC (~97%), Cmax (~94%), bioavailability (~92%) of verapamil.
Telithromycin	The concentration of verapamil may increase.
Antitumor agents
Doxorubicin	Increase in AUC (104%) and Cmax (61%) of doxorubicin.	In patients with small cell lung cancer.
Barbiturates
Phenobarbital	Increased oral clearance of verapamil ~5 times.
Benzodiazepines and other tranquilizers
Buspirone	Increase in AUC and Cmax of buspirone ~ 3.4 times.
Midazolam	Increase in AUC (~ 3 times) and Cmax (~ 2 times) of midazolam.
Beta blockers
Metoprolol	Increased AUC (-32.5%) and Cmax (-41%) of metoprolol in patients with angina pectoris.	See the "Special Instructions" section.
Propranolol	Increased AUC (-65%) and Cmax (-94%) of propranolol in patients with angina pectoris.
Cardiac glycosides
Digitoxin	Decreased total clearance (-27%) and extrarenal clearance (-29%) of digitoxin.
Digoxin	Increase in C m ax (by -44%), C 12 h (by -53%), C ss (by -44 %) and AUC (by -50 %) of digoxin in healthy volunteers.	Reduce the dose of digoxin. See the "Special Instructions" section.
H2 receptor antagonists
Cimetidine	An increase in the AUC of R- (-25%) and S- (-40%) verapamil with a corresponding decrease in the clearance of R- and S-verapamil.
Immunological/immunosuppressive agents
Cyclosporine	Increase in AUC, C ss, C max (by - 45%) of cyclosporine.
Everolimus	Everolimus: increase in AUC (~ 3.5 times) and Cmax (~ 2.3 times) Verapamil: increase in Chough (concentration of the drug in the blood plasma immediately before taking its next dose) (~ 2.3 times).	Concentration determination and dose titration of everolimus may be necessary.
Sirolimus	Increased AUC of sirolimus (~2.2 times); increase in AUC of S-verapamil (~ 1.5 times).	Concentration determination and dose titration of sirolimus may be necessary.
Tacrolimus	Increased concentrations of tacrolimus are possible.
Lipid-lowering drugs (HMG-CoA reductase inhibitors)
Atorvastatin	It is possible to increase the concentration of atorvastatin in the blood plasma, and an increase in the AUC of verapamil - 43%.	Additional information is provided below.
Lovastatin	Possible increase in the concentration of lovastatin and AUC of verapamil (~ 63%) and C m ax (~ 32%) in blood plasma
Simvastatin	Increase in AUC (~2.6 times) and Cmax (~4.6 times) of simvastatin.
Serotonin receptor agonists
Almotriptan	Increase in AUC (~20%) and Cmax (~24%) of almotriptan.
Uricosuric drugs
Sulfinpyrazone	Increase in oral clearance of verapamil (~ 3 times), decrease in its bioavailability (~ 60%).	The antihypertensive effect may be reduced.
Other
Grapefruit juice	Increase in AUC R- (~49%) and S- (~37%) verapamil and C m ax R- (~75%) and S-C-51%) verapamil.	T1/2 and renal clearance did not change. Grapefruit juice should not be taken with verapamil.
St. John's wort	A decrease in the AUC of R- (~78%) and S- (~80%) verapamil with a corresponding decrease in Cmax.

Other drug interactions

Antiviral drugs for the treatment of HIV infection

Ritonavir and other antiviral drugs used to treat HIV infection may inhibit the metabolism of verapamil, resulting in increased plasma concentrations. Therefore, when using such drugs and verapamil simultaneously, caution should be exercised or the dose of verapamil should be reduced.

Lithium

Increased lithium neurotoxicity was observed during concomitant administration of verapamil and lithium, with no change or increase in serum lithium concentrations. However, additional administration of verapamil also led to a decrease in serum lithium concentrations in patients taking lithium orally for a long time. If these drugs are used concomitantly, patients should be closely monitored.

Neuromuscular blockers

Clinical data and preclinical studies suggest that
verapamil may potentiate the effect of drugs that block neuromuscular conduction (such as curare-like and depolarizing muscle relaxants). Therefore, it may be necessary to reduce the dose of verapamil and/or the dose of drugs that block neuromuscular conduction when used simultaneously.

Acetylsalicylic acid (as an antiplatelet agent)

Increased risk of bleeding.

Ethanol (alcohol)

Increasing the concentration of ethanol in the blood plasma and slowing down its elimination. Therefore, the effects of ethanol may be increased.

HMG-CoA reductase inhibitors (statins)

Patients receiving
verapamil, treatment with HMG-CoA reductase inhibitors (i.e. simvastatin, atorvastatin or lovastatin) should be started with the lowest possible dose, which is then increased. If it is necessary to assign
verapamil in patients already receiving HMG-CoA reductase inhibitors, it is necessary to review and reduce their doses according to the concentration of cholesterol in the blood serum.

Fluvastatin,
pravastatin and
rosuvastatin is not metabolized by CYP3A4 isoenzymes, so their interaction with verapamil is less likely.

Drugs that bind to plasma proteins

Verapamil, as a drug that is highly bound to plasma proteins, should be used with caution when taken simultaneously with other drugs that have a similar ability.

Means for inhalation general anesthesia

When using drugs for inhalation anesthesia and blockers of “slow” calcium channels, which include
verapamil, the dose of each agent should be carefully titrated to achieve the desired effect to avoid excessive cardiovascular depression.

Antihypertensives, diuretics, vasodilators

Strengthening the antihypertensive effect.

Cardiac glycosides

Verapamil for intravenous administration was used in conjunction with cardiac glycosides. Because these drugs slow AV conduction, patients should be monitored for early detection of AV block or significant bradycardia.

Quinidine

Intravenous verapamil was administered to a small group of patients receiving
quinidine orally. There are several reports of cases of a pronounced decrease in blood pressure when taking quinidine orally and verapamil intravenously, so this combination of drugs must be used with caution.

Flecainide

A study in healthy volunteers showed that the combined use of verapamil and flecainide may have an additive effect with a decrease in myocardial contractility, a slowdown in AV conduction and myocardial repolarization.

Disopyramide

Pending data on a possible interaction between verapamil and disopyramide, disopyramide should not be administered 48 hours before or 24 hours after verapamil (see section "Contraindications").

Beta blockers

Verapamil for intravenous administration was prescribed to patients receiving beta-blockers by mouth. The possibility of adverse interactions must be taken into account, since both drugs may reduce myocardial contractility or AV conduction. The simultaneous administration of verapamil and beta-blockers intravenously led to the development of serious adverse reactions, especially in patients with severe cardiomyopathy, chronic heart failure or after myocardial infarction (see section "Contraindications").

Special instructions:

Rarely, life-threatening side effects may develop (atrial fibrillation/flutter with a high frequency of ventricular contraction, with the presence of accessory pathways, severe hypotension or severe bradycardia/asystole).

Acute myocardial infarction

The drug Isoptin® should be used with caution in patients with acute myocardial infarction complicated by bradycardia, a marked decrease in blood pressure or left ventricular dysfunction.

Heart block/Atrioventricular block I degree/Bradycardia/A systole

Verapamil affects the AV and SA nodes and slows AV conduction. The drug Isoptin® should be used with caution, since the development of II or III degree AV block (see section "Contraindications") or single-bundle, double-bundle or triple-bundle block requires discontinuation of verapamil and appropriate therapy if necessary.

Verapamil affects the AV and SA nodes and in rare cases can cause the development of second or third degree AV block, bradycardia and, in extreme cases, asystole. These events are most likely to occur in patients with sick sinus syndrome, which is more common in older patients.

Asystole in patients without sinus node weakness is usually short-lived (a few seconds) with spontaneous restoration of atrioventricular or normal sinus rhythm. If sinus rhythm is not restored in a timely manner, appropriate treatment should be prescribed immediately.

Beta blockers and antiarrhythmic drugs

Mutual enhancement of the effect on the cardiovascular system (high-degree AV blockade, significant decrease in heart rate, exacerbation of heart failure and marked decrease in blood pressure). Asymptomatic bradycardia (36 beats/min) with migration of the rhythm along the atrium was observed in a patient simultaneously taking
timolol (beta blocker) in the form of eye drops and
verapamil orally.

Digoxin

If verapamil is taken concomitantly with digoxin, the dose of digoxin should be reduced. See section "Interaction with other drugs".

Heart failure

Patients with heart failure and a left ventricular ejection fraction greater than 35% should achieve a stable condition before starting Isoptin® and receive appropriate therapy thereafter.

Marked decrease in blood pressure

Intravenous administration of the drug Isoptin® often causes a decrease in blood pressure below initial values, usually short-term and asymptomatic, but may be accompanied by dizziness.

HMG-CoA reductase inhibitors (statins)

See section "Interaction with other drugs".

Neuromuscular transmission disorders

The drug Isoptin® should be used with caution in patients with diseases affecting neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy).

Renal dysfunction

Comparative studies have demonstrated that the pharmacokinetics of verapamil remains unchanged in patients with end-stage renal failure. However, some available reports suggest that Isoptin® should be used with caution and under close monitoring in patients with impaired renal function.
Verapamil is not excreted during hemodialysis.

Liver dysfunction

Isoptin® should be used with caution in patients with severe liver dysfunction.

Ventricular tachycardia

Intravenous administration of the drug Isoptin® to patients with ventricular tachycardia with wide QRS complexes (> 0.12 sec.) can lead to a significant deterioration in hemodynamics and ventricular fibrillation. Before starting treatment, it is imperative to carry out proper diagnosis and exclude ventricular tachycardia with wide QRS complexes.

Effect on ability to drive:

The drug Isoptin® may affect the speed of psychomotor reactions due to its antihypertensive effect and as a result of individual sensitivity. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. This is especially important at the beginning of treatment, when increasing the dose or when switching from therapy with another drug.

Release form:

Solution for intravenous administration, 5 mg/2 ml.

Package:

2 ml in ampoules made of colorless hydrolytic glass type I with a blue break point.

5, 10 or 50 ampoules in a cardboard tray or PVC or polystyrene blister, covered with paper foil, along with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Best before date:

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies:

On prescription

Registration Certificate Holder:

Registration Certificate Holder: Abbott GmbH and Co.KG

Manufacturer

EBEWE PHARMA, Ges.m.b.H.Nfg.KG Austria
EBEWE PHARMA, GmbH Nfg KG. Austria Representative office: ABBOTT LABORATORIES LLC

In this medical article you can familiarize yourself with the drug Isoptin. The instructions for use will explain in what cases you can take tablets and dragees 40 mg and 80 mg, 240 mg (Forte), injections in injection ampoules, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the forms of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Isoptin, from which one can find out whether the medicine has helped in the treatment of heart rhythm disorders in adults and children, for which it is also prescribed. The instructions list analogues of Isoptin, prices of the drug in pharmacies, as well as its use during pregnancy.

The instructions for use classify the drug Isoptin as a drug that has hypotensive, antiarrhythmic and antianginal effects.

Release form and composition

The medicine Isoptin is sold in the form of ampoules with a solution for injections and in the form of tablets. These forms differ not only in their use, but also in the amount of active ingredient in one serving and the list of additional ingredients.

Isoptin tablets are available in dosages of 40, 80, 120 and 240 mg. They are white or green in color, and have a round shape, convex on both sides. On one side of each tablet there is an engraving with the dosage of the active substance in the composition, and on the other - the emblem of the manufacturer or the name of the drug. There is a separation mark on each portion of the drug.

Isoptin SR (retard). A more powerful product, which is produced in the form of green pills with an active substance mass of 240 mg.

5, 10 or 50 ampoules are placed in plastic trays. One package includes one pallet with the drug. Tablets are sold in plastic blisters of 10 pcs. One cardboard package can contain from 1 to 10 plates of tablets.

Isoptin in 2 ml ampoules contains 5 mg of the working ingredient. It is colorless and odorless. The following additional components are used: hydrochloric acid, saline solution, sodium chloride.

pharmachologic effect

Isoptin is a selective class I calcium channel blocker, a diphenylalkylamine derivative that has antianginal, antihypertensive and antiarrhythmic effects.

The antianginal effect is associated with a direct effect on the myocardium and with an effect on peripheral hemodynamics. Blockade of calcium entry into the cell leads to a decrease in the transformation of energy contained in high-energy bonds of ATP into mechanical work, a decrease in myocardial contractility and myocardial oxygen demand. The drug has a vasodilating, negative ino- and chronotropic effect. Increases the period of diastolic relaxation of the left ventricle, reduces the tone of the myocardial wall.

A decrease in OPSS may be due to the antihypertensive effect of Isoptin.

The drug reduces AV conduction, prolongs the refractory period and suppresses the automaticity of the sinus node. Has an antiarrhythmic effect in supraventricular arrhythmias.

Indications for use

What does Isoptin help with? The instructions indicate that the drug is prescribed for the treatment of:

• Atrial fibrillation and flutter, which are accompanied by tachyarrhythmia (with the exception of WPW syndrome).
• Arterial hypertension: as monotherapy in mild or moderate cases, as part of combination treatment in severe cases.
• Angiospastic angina (Prinzmetal's angina).
• Paroxysmal supraventricular tachycardia.
• Stable angina.

Instructions for use

Isoptin is prescribed by the attending physician based on clinical indications, severity of the disease and a detailed study of the patient’s medical history.

The tablets are taken orally, without chewing during meals, with water.

Dosage and treatment period are determined individually; usually treatment begins with a dose of 40-80 mg 3-4 times a day. The maximum daily dose of 480 mg per day according to the instructions should be taken only under the supervision of a doctor in a hospital.

Isoptin solution is intended only for intravenous administration; the procedure is carried out very slowly, while monitoring electrocardiography and the patient’s blood pressure. According to the instructions, the initial dose is 5-10 mg; if necessary, after half an hour, the drug can be repeated at a dose of 10 mg. The treatment period is determined by the doctor.

Contraindications

Absolute:

• complicated myocardial infarction (hypotension, bradycardia, left ventricular failure);
• sinoatrial block;
• AV block of the second or third degree;
• cardiogenic shock;
• bradycardia-tachycardia syndrome.

Relative contraindications:

• heart failure;
• arterial hypotension;
• atrial fibrillation due to WPW syndrome;
• AV block of the first degree;
• bradycardia.

Side effects

When taking Isoptin, various side effects may occur: muscle and joint pain, bradycardia, constipation, depression, nausea, peripheral edema, fainting, headache, allergic skin reactions, collapse, increased heart rate, angina.

Children, pregnancy and breastfeeding

Isoptin should not be used during pregnancy and lactation.

In childhood

Should be used with caution in patients under 18 years of age.

special instructions

When taking Isoptin, it is better to temporarily avoid work that requires attention and precision. Driving should be temporarily stopped.

The peculiarity of taking the drug is that the drug must be discontinued abruptly; the dosage should be reduced gradually.

Drug interactions

With the simultaneous use of Isoptin with inhibitors of the CYP3A4 isoenzyme, an increase in the concentration of verapamil in the blood plasma is observed, with inducers of the CYP3A4 isoenzyme - a decrease in its concentration (the interaction should be taken into account when using such drugs simultaneously).

When Isoptin is used simultaneously with certain drugs, undesirable effects may occur (Css is the average equilibrium concentration of the substance in the blood plasma, Cmax is the maximum concentration of the substance in the blood plasma, AUC is the area under the pharmacokinetic concentration-time curve, T1/2 is the half-life ):

• Theophylline: decrease in its systemic clearance;
• : increase in its AUC in patients with resistant partial epilepsy;
• Metoprolol, propranolol: increase in their AUC and Cmax in patients with angina pectoris;
• Buspirone, midazolam: increase in their AUC and Cmax;
• Quinidine: possible increased hypotensive effect; in patients with hypertrophic obstructive cardiomyopathy, pulmonary edema may develop;
• Acetylsalicylic acid: increased bleeding;
• Grapefruit juice: increase in AUC and Cmax of the R-enantiomer and S-enantiomer of verapamil (renal clearance and T1/2 do not change);
• Quinidine: decreased clearance;
• Cyclosporine: increase in its AUC, Css, Cmax;
• Beta-blockers, antiarrhythmic drugs: mutual enhancement of cardiovascular effects (more significant decrease in heart rate, more pronounced AV blockade, increased arterial hypotension and development of symptoms of heart failure);
• Sulfinpyrazone: increased clearance of verapamil and decreased bioavailability;
• Diuretics, antihypertensives, vasodilators: increased hypotensive effect;
• Cimetidine: increased AUC of the R-enantiomer and S-enantiomer of verapamil with a corresponding decrease in the clearance of R- and S-verapamil;
• Carbamazepine: increasing its concentration in blood plasma; it is possible to develop adverse reactions characteristic of carbamazepine (headache, diplopia, dizziness or ataxia);
• Prazosin: increase in its Cmax, T1/2 of prazosin does not change;
• Terazosin: increase in its AUC and Cmax;
• Phenobarbital: increased clearance of verapamil;
• Digoxin: increase in its Cmax, AUC and Css;
• Glibenclamide: increase in its Cmax and AUC;
• Clarithromycin, erythromycin, telithromycin: possible increased concentrations of verapamil;
• Imipramine: increase in its AUC; Isoptin has no effect on the concentration of the active metabolite of imipramine - desipramine;
• Doxorubicin: an increase in its AUC and Cmax in patients with small cell lung cancer;
• Ritonavir and other antiviral drugs for the treatment of HIV infection: inhibition of the metabolism of verapamil is possible, which can lead to an increase in its concentration in the blood plasma (with simultaneous use of the dose of Isoptin should be reduced);
• : possible increase in its concentration and AUC;
• St. John's wort: decrease in AUC of the R-enantiomer and S-enantiomer of verapamil with a corresponding decrease in Cmax;
• Sirolimus, tacrolimus, lovastatin: their concentrations may increase;
• Ethanol (alcohol): an increase in its concentration in the blood plasma;
• Rifampicin: decreased AUC, Cmax and bioavailability of verapamil when taken orally;
• Terazosin, prazosin: additive hypotensive effect;
• Simvastatin, almotriptan: increase in their AUC and Cmax;
• Rifampicin, sulfinpyrazone: the hypotensive effect of verapamil may be reduced;
• Digitoxin: reduction of its general and extrarenal clearance;
• Muscle relaxants: their effect may be enhanced;
• Colchicine: a significant increase in its concentration in the blood is possible;
• Lithium: increased neurotoxicity.

Analogues of the drug Isoptin

Analogues are determined by structure:

1. Verogalide EP 240 mg;
2. Verapamil hydrochloride solution for injection 0.25%;
3. Isoptin CP 240;
4. Kaveril;
5. Lekoptin;
6. Vero Verapamil;
7. Finoptin;
8. Veracard.

Vacation conditions and price

The average cost of Isoptin 30 tablets of 40 mg varies in the range of 310 - 355 rubles. For Isoptin SR you need to pay 605 - 656 rubles, and the injection solution costs about 612 - 705 rubles. To purchase medicines, you need a prescription from a doctor.

The instructions indicate that the drug must be stored in a dry, cool place and out of reach of children. Shelf life – 3 years.

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Isoptin is a calcium channel blocker that has antihypertensive and antiarrhythmic effects, reducing myocardial oxygen demand.

Release form and composition

Dosage forms of Isoptin:

• Film-coated tablets;
• Solution for intravenous administration.

Composition of tablets:

• 40 or 80 mg verapamil hydrochloride;
• Excipients: croscarmellose sodium, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate, colloidal silicon dioxide;
• Shell composition: sodium lauryl sulfate, hypromellose 3 mPa, titanium dioxide, macrogol 6000.

Isoptin tablets are sold in blisters:

• 10 pcs., 2 or 10 blisters per package;
• 20 pcs., 1 or 5 blisters per package.

One ampoule with solution contains:

• 5 mg verapamil hydrochloride;
• Additional components: 36% hydrochloric acid, sodium chloride and injection water.

The solution is sold in ampoules of 2 ml, 5 or 50 ampoules in a cardboard box.

Indications for use

Isoptin tablets are used for:

• Arterial hypertension;
• Paroxysmal supraventricular tachycardia;
• Coronary heart disease, incl. for angina caused by vasospasm, unstable angina, chronic stable angina;
• Atrial fibrillation or flutter accompanied by tachyarrhythmia (with the exception of Lown-Ganong-Levine and Wolff-Parkinson-White syndrome).

In the form of a solution, the drug is used for:

• Restoration of sinus rhythm in paroxysmal supraventricular tachycardia, including Lown-Ganong-Levine (LGL) and Wolff-Parkinson-White (WPW) syndromes;
• Controlling the frequency of ventricular contractions during atrial fibrillation and flutter, with the exception of LGL and WPW syndromes.

Contraindications

The use of Isoptin is contraindicated in:

• Cardiogenic shock;
• Sick sinus syndrome, with the exception of patients with an artificial pacemaker;
• Acute myocardial infarction, complicated by bradycardia, left ventricular failure and severe arterial hypotension;
• Chronic heart failure;
• AV block II or III degree, with the exception of patients with an artificial pacemaker;
• Atrial fibrillation/flutter in the presence of additional conduction pathways (with LGL and WPW syndromes).

In addition, the drug is not prescribed:

• In case of hypersensitivity to any component of Isoptin;
• Simultaneously with colchicine;
• Children and teenagers under 18 years of age;
• During pregnancy;
• When breastfeeding;
• Simultaneously with beta-blockers (in the case of intravenous use of Isoptin).

The drug is used with caution when:

• Bradycardia;
• Severe liver/kidney dysfunction;
• AV blockade of the first degree;
• Arterial hypotension;
• Diseases associated with neuromuscular transmission, including Duchenne muscular dystrophy, myasthenia gravis, Lambert-Eaton syndrome.

Directions for use and dosage

Isoptin solution is intended for slow intravenous injections with continuous monitoring of ECG and blood pressure. Enter it:

• slowly intravenously (over at least 2 minutes, for elderly people - 3 minutes) at an initial dose of 5 mg, if ineffective - at the same dosage again after 5-10 minutes;
• IV drip (to maintain the effect) at a dose of 5-10 mg/h in a glucose solution, physiological or other solution with a pH less than 6.5. The general dosage is 100 mg per day.

In the form of tablets, Isoptin should be taken with meals or immediately after meals, without breaking or chewing, with water.

At the beginning of treatment, 40-80 mg is prescribed three or four times a day. Subsequently, the dosage is determined individually, taking into account the type of disease and clinical picture.

The average daily dose is 240-480 mg, but the maximum dose can only be taken in a hospital.

Isoptin should not be discontinued abruptly; the dosage should be gradually reduced.

Side effects

When using Isoptin, the following side effects may occur:

• Hypersensitivity reactions;
• Dizziness, headache, paresthesia, increased fatigue, tremor, extrapyramidal disorders (stiffness of the arms and/or legs, mask-like face, ataxia, difficulty swallowing, tremors of the hands and fingers, shuffling gait);
• Arrest of the sinus node, marked decrease in blood pressure, tachycardia, peripheral edema, sinus bradycardia, AV block (grades I, II, III), heart failure, palpitations, flushing of the face;
• Nausea, vomiting, gum hyperplasia, intestinal obstruction, constipation, abdominal pain or discomfort;
• Pruritus, maculopapular rash, Stevens-Johnson syndrome, urticaria, angioedema, purpura, alopecia, erythema multiforme;
• Muscle weakness, arthralgia, myalgia;
• Tinnitus;
• Galactorrhea, erectile dysfunction, gynecomastia;
• Hyperprolactinemia, increased activity of liver enzymes.

An overdose of verapamil hydrochloride is manifested by a pronounced decrease in blood pressure, hyperglycemia, sinus bradycardia, turning into high-degree AV block, stupor, sinus node arrest and metabolic acidosis. There are data on cases of deaths. If the patient has taken too large a dose of Isoptin, gastric and intestinal lavage should be done, and activated charcoal should be taken. In the future, symptomatic and supportive therapy, parenteral administration of beta-agonists and calcium preparations are indicated. Hemodialysis is ineffective.

special instructions

The concentration of verapamil in the blood can be increased by clarithromycin, erythromycin, telithromycin and antiviral drugs intended to treat HIV infection. Isoptin helps increase the concentration of sirolimus, tacrolimus, atorvastatin, lovastatin, carbamazepine.

With the simultaneous use of antiarrhythmic drugs and beta-blockers, a mutual increase in cardiovascular effects is observed, which is manifested by more pronounced AV blockade, a significant decrease in heart rate, the development of symptoms of heart failure and increased arterial hypotension.

In the case of combined use of Isoptin with quinidine, the hypotensive effect may be enhanced; in patients with hypertrophic obstructive cardiomyopathy there is a risk of developing pulmonary edema.

A decrease in antihypertensive effect is observed when the drug is combined with sulfinpyrazone and rifampicin.

Verapamil increases the neurotoxicity of lithium and enhances the effect of muscle relaxants.

During treatment with Isoptin:

• It is not recommended to drink alcoholic beverages;
• Care should be taken when driving a car and performing potentially dangerous types of work;
• Acetylsalicylic acid should be avoided.

Analogs

Verapamil, Verapamil-LekT, Verapamil Sopharma, Verapamil-ratiopharm, Verapamil-Ferein, Verapamil-Eskom, Verogalid ER 240, Isoptin SR 240, Finoptin.

Terms and conditions of storage

Isoptin should be stored in a dark place at a temperature of 15-25 ºС. Shelf life – 5 years.

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One tablet of the drug Isoptin CP 240 includes 240 mg verapamil hydrochloride .

Additional substances: povidone K30, microcrystalline cellulose, sodium alginate, magnesium stearate, water.

Coating composition: aluminum varnish, hypromellose, macrogol 6000, macrogol 400, talc, titanium dioxide, glycol wax.

Release form

Long-acting, light green tablets, oblong in shape, cross-scorched on both sides, with two triangle symbols engraved on one edge.

pharmachologic effect

Antiarrhythmic, antianginal And antihypertensive action.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Belongs to group calcium channel blockers . Suppresses transmembrane ion transport calcium into vascular cells and smooth myocardial myocytes. It has antiarrhythmic, antianginal and antihypertensive effects.

Antihypertensive the effect of the drug is due to a weakening of peripheral vascular resistance without a reflex increase in heart rate. The pressure begins to decrease already on the first day of therapy and this effect persists during long-term therapy. Isoptin CP 240 is used to treat all types: in combination with other antihypertensive drugs (diuretics And ACE inhibitors ) renders vasodilator, negative inotropic And chronotropic action; in the form of compensated monotherapy arterial hypertension .

Antianginal the effect is associated with an effect on hemodynamics and myocardium (reduces the tone of peripheral arteries, the resistance of the vascular walls). Inhibition of ion transport calcium inside the cell causes a decrease in energy transformation ATP into mechanical work and weakening of myocardial contractility.

The drug also has a strong antiarrhythmic action, mainly supraventricular . Inhibits the conduction of nerve impulses AV node , restoring normal sinus rhythm. The normal frequency of myocardial contractions does not change or decreases slightly.

Pharmacokinetics

Absorbed quickly and completely (90-92%) in the small intestine. The average bioavailability is 22% in healthy individuals; in patients with cardiac pathology it can reach 35%.

Binding to blood proteins by 90%. The drug is able to penetrate the placenta and be excreted in breast milk. Metabolized almost completely in the liver. Main – norverapamil is active, the remaining metabolites are inactive.

The half-life is 4-6 hours after a single dose. Excreted primarily in urine. Up to 16% is evacuated with feces.

Indications for use

Indications for use of Isoptin SR 240:

• tension;
• arterial hypertension;
• angina pectoris caused by vasospasm;
• atrial fibrillation on the background tachyarrhythmias (except );
• supraventricular paroxysmal.

Contraindications

Absolute contraindications:

• complicated ( hypotension, bradycardia, left ventricular failure );
• sinoatrial block;
• bradycardia-tachycardia syndrome;
• cardiogenic shock;
• AV block second or third degree.

Relative contraindications:

• arterial hypotension;
• AV block first degree;
• bradycardia;
• atrial fibrillation on the background WPW syndrome;
• heart failure.

Side effects

• Circulatory reactions: , AV block, tachycardia , feeling of heartbeat, Ahypotension , increased symptoms heart failure.
• Reactions of nervous activity: fatigue, nervousness, .
• Digestive reactions: vomiting, nausea, intestinal obstruction, abdominal pain, increased liver levels , reversible gingival hyperplasia.
• Reactions from the musculoskeletal system: pain in muscles and joints.
• Allergic reactions: exanthema, Stevens-Johnson syndrome.
• Hormonal reactions: increased levels prolactin, galactorrhea , reversible gynecomastia, .
• Other reactions: erythromelalgia , , tides .

Instructions for use Isoptin SR 240 (Method and dosage)

Instructions for use of Isoptin CP 240 indicate that the average dose of the drug is 240-360 mg per day. For long-term treatment, it is not recommended to exceed a dose of 480 mg per day. The tablets should be taken during or immediately after a whole meal with water.

At arterial hypertension Prescribe 240 mg of the drug once a day in the morning. If a slow decrease in pressure is necessary, it is recommended to start treatment with 120 mg once a day in the morning.

At coronary heart disease (angina pectoris, Prinzmetal angina ) the drug is prescribed 120-240 mg twice a day (morning and evening).

At supraventricular paroxysmal tachycardia or atrial fibrillation on the background tachyarrhythmias the drug is prescribed 120-240 mg twice a day.

If the liver function is impaired, treatment with the drug should be started with low doses of 40 mg twice a day.

The duration of treatment with the drug is not limited.

Overdose

Symptoms of a drug overdose depend on the dose of the drug taken, the time of detoxification measures and the ability of the myocardium to contract. There are reports of fatal overdoses.

Signs: pressure drop , shock, AV block , loss of consciousness, slipping rhythm, sinus bradycardia , cardiac arrest.

Treatment: gastric lavage, taking emetics And laxatives . If necessary, perform artificial respiration, closed cardiac massage and electrical stimulation of the heart.

Terms of sale

Purchase is possible only with a prescription.

Storage conditions

Store in original packaging at temperatures up to 24 degrees. Keep away from children

Best before date

Three years.

special instructions

Individual reactions to the drug are possible which lead to a decrease in the ability to control mobile mechanisms.

Analogs

Level 4 ATX code matches:

Analogues of Isoptin SR 240: Hydrochloride, Verapamil Darnitsa, Verogalid ER 240, Isoprtin SR, .

For children

There are no studies that confirm the safety of the drug in children, so it is recommended to avoid prescribing verapamil for this category of persons.

During pregnancy and lactation

When this drug is prescribed only for strict indications, when it is not prescribed at all.

Isoptin is a medication from a group of drugs that block the flow of calcium ions into the heart and blood vessels. Its main functions: normalization of heart rhythm and high blood pressure.

The main active substance is verapamil, the effect of which is to reduce myocardial contractions, significantly dilate the coronary arteries, reduce the overall vascular resistance and tone of the smooth muscles of the arteries of the upper and lower extremities.

Absorption of the drug occurs in the small intestine (90-91%). The absorption of the drug is 22% with a single dose and doubles with regular use.

Features of distribution: the therapeutic agent combines with blood plasma proteins and is metabolized in the kidneys.

Peculiarities of elimination from the body: half of the taken dose of the drug is eliminated 24 hours after taking it, 70% - over the next 5 days.

Indications for use

1. All forms of IHD (coronary heart disease).
2. High blood pressure.
3. A sharp increase in the frequency of contractions of the heart muscle (supraventricular paroxysmal tachycardia).
4. Atrial fibrillation.

Method and doses

The injection solution is administered intravenously. In this case, regular diagnostics of blood pressure and electrocardiography (ECG) of the patient are necessary. The starting dose is usually 5 mg of the drug.

If the effect of intravenous administration of the drug does not occur after 10 minutes, then repeated administration of Isoptin in the same dose is allowed.

The tablets are taken orally, after meals. Starting dose of the drug: from 40 to 80 mg 3 or 4 times a day (depending on the type of disease and the patient’s condition).

If necessary and with the doctor's permission, the initial dose can be increased to 160 mg. Average dose: 240 to 480 mg per day. The maximum permissible dose is 480 mg.

Release form and composition

The drug is prepared in the form:

• tablets in blister packs. Number of blisters in a pack: 1, 2, 5 or 10. One blister contains 10 tablets. Each tablet contains 40 or 80 mg of the main active ingredient. Tablet shape: round, color: white;
• solution for intravenous injection in transparent glass ampoules. The tray contains 5, 10 or 50 ampoules. 1 ampoule contains 2 ml of the main substance.

Composition of tablets:

1. Active ingredient: verapamil (verapamil hydrochloride).
2. Additional substances: acid salt of calcium and orthophosphoric acid, MCC, pyrogenic silicon dioxide, sodium salt of croscarmellose, magnesium salt of stearic acid (E 572).
3. Shell: hypromellose 3 mPa, talc, sodium lauryl sulfuric acid, PEG 6000, E 171 (titanium dioxide).

Solution composition:

1. Main component: verapamil hydrochloride.
2. Additional components: water, sodium salt of hydrochloric acid, hydrochloric acid 36%.

Features of interaction with other medications

The effect of the drug is enhanced by: medications that normalize heart rhythm, beta-blockers, inhaled anesthetics, diuretics and drugs to lower high blood pressure.

The effect of the drug is significantly reduced by: non-steroidal anti-inflammatory drugs, sympathomimetic drugs, Rifampicin, Phenobarbital, drugs containing high doses of calcium or hormones (estrogen).

When taken together with aspirin, there is a risk of bleeding.

When taken simultaneously with drugs containing carbamazepine and lithium, there is a risk of developing depression, drowsiness, dizziness, memory and attention problems.

Side effects

When taking this medication (depending on the individual characteristics of the body and the age of the patient), side effects may occur, such as: dizziness, body swelling, migraine, frequent fatigue, ringing in the ears, difficulty swallowing, a sharp increase in appetite, weight gain, nausea , abnormal stool, itching of the skin, trembling of the upper extremities, anxiety, fainting.

All of the above side effects are temporary and disappear after discontinuation of Isoptin.

Contraindications

1. A sharp decrease in the contractility of the heart muscle.
2. Acute stage of myocardial infarction.
3. AVB II, III degrees.
4. SSSU.
5. Atrial fibrillation.
6. Age under 18 years.
7. Individual intolerance to the components of the drug.

Overdose

When taking a dose of a medicinal product that significantly exceeds the recommended one, the following main symptoms occur: an excessive decrease in blood pressure, an increase in blood sugar levels, and a sharp short-term cessation of cardiac activity.

In case of overdose, you should immediately call an ambulance or go to the nearest sanitary inspection station.

Treatment: gastric lavage procedure, hospital treatment.

During pregnancy

Isoptin is not prescribed during pregnancy and breastfeeding due to insufficient data on taking the drug in pregnant and lactating women.

It is known that the main substance of the drug is able to penetrate the placental barrier.

Storage: conditions and terms

The medication must be kept in a dry place, out of reach of children.

The maximum permissible temperature is 25 °C. Shelf life - 5 years.

Price

Average cost of a medicinal product (100 tablets, 80 mg) in Russia- 350 rub.

Average price of Isoptin (100 tablets, 80 mg) in Ukraine- 200 UAH.

Analogs

Medications with similar effects containing verapamil include:

• Verapamil (Macedonia).
• Verapamil (Russia).
• Verapamil-OBL (Yugoslavia).
• Verapamil-LekT (Yugoslavia).
• Verapamil hydrochloride (Yugoslavia).
• Verohalid (Yugoslavia).
• Verohalid ER (Croatia).
• Verogalid EP (USA).
• Veracard (Yugoslavia).
• Finoptin (Finland).

Drugs included in the same group and having an effect similar to Isoptin:

• Kaveril (Yugoslavia).
• Lekoptin (Yugoslavia).
• Amlodak (India).