Medicinal reference book geotar. Diltiazem lannacher - instructions for use Marketing authorization holder

P N013738 / 01

Trade name of the drug:

Diltiazem Lannacher

International Non-Proprietary Name (INN):

diltiazem

Dosage form:

prolonged-release film-coated tablets.

Compound:

one tablet contains: active substance: diltiazem hydrochloride 90 mg, 180 mg; Excipients: lactose monohydrate 60.0 / 120.0 mg, methyl methacrylate and ethyl acrylate copolymer 4.5 / 9.0 mg, methacrylic acid and ethyl acrylate copolymer (1: 1) 57.75 / 79.5 mg, methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer 7.5 / 15.0 mg, hypromellose 5 mPa * s 9.5 / 15.0 mg, magnesium stearate 0.75 / 1.5 mg; shell: macrogol 6000 2.247 / 2.996 mg, hypromellose 5 mPa * s 1.875 / 2.500 mg, titanium dioxide 1.017 / 1.356 mg, talc 9.303 / 12.404 mg, methyl methacrylate and ethyl acrylate copolymer 0.558 / 0.744 mg.

Description

Round biconvex film-coated tablets of white color, on a cross-section the core of the tablet is white.

Pharmacotherapeutic group:

blocker of "slow" calcium channels.

ATX code C08DB01

Pharmacological properties

Pharmacodynamics
Diltiazem is a benzothiazepine derivative; possesses antiarrhythmic, antianginal and hypotensive activity. A blocker of "slow" calcium channels (BMCC), reduces the intracellular content of calcium ions in cardiomyocytes and smooth muscle cells, expands coronary and peripheral arteries and arterioles, reduces total peripheral vascular resistance (OPSR), smooth muscle tone, increases coronary, cerebral and renal blood flow , reduces the heart rate (HR).
Antiarrhythmic action due to the suppression of the transport of ionized calcium in the tissues of the heart, which leads to an increase in the effective refractory period and a lengthening of the conduction time in the atrioventricular (AV) node (it is of clinical importance in patients with sick sinus syndrome, elderly patients in whom the blockade of calcium channels can interfere with the generation of pulse in the sinus node and cause sinoatrial (SA) block). Normal atrial action potential or intraventricular conduction does not change (normal sinus rhythm is usually not affected), but when the amplitude of atrial contraction decreases, the rate of depolarization and conduction rate decrease. The anterograde effective refractory period in additional bypass conduction bundles can be shortened. The antianginal effect is due to the expansion of peripheral vessels and a decrease in systemic arterial pressure (afterload), which leads to a decrease in the stress of the myocardial wall and its oxygen demand. At concentrations that do not lead to the appearance of a negative inotropic effect, it causes relaxation of the smooth muscles of the coronary vessels and dilatation of both large and small arteries.
Antihypertensive action due to dilatation of resistive vessels and a decrease in OPSS. The degree of decrease in blood pressure (BP) correlates with its initial level (in "normotonics" there is a minimal effect on blood pressure). Reduces blood pressure both in the "lying" and "standing" position. Rarely causes postural arterial hypotension and reflex tachycardia. Does not change or slightly reduces the maximum heart rate during exercise. Long-term therapy does not lead to hypercatecholaminemia, an increase in the activity of the renin-angiotensin-aldosterone system. Reduces the renal and peripheral effects of angiotensin II. Improves diastolic relaxation of the myocardium in arterial hypertension, coronary heart disease, hypertrophic obstructive cardiomyopathy, reduces platelet aggregation.
Has a minimal effect on the smooth muscles of the gastrointestinal tract (GIT). During long-term (8 months) therapy, tolerance does not develop. Does not affect blood lipid profile.
Able to cause regression of left ventricular hypertrophy in patients with arterial hypertension. The onset of action when taken orally is 2-3 hours. The duration of action is 12-14 hours.
The maximum severity of the hypotensive effect is achieved within 2 weeks.

Firmakokinetics
After oral administration, it is rapidly and almost completely absorbed in the gastrointestinal tract. The time to reach the maximum concentration in the blood plasma is 6-14 hours. The connection with blood plasma proteins is 70-80% (with albumin - 35-40%). It is extensively metabolized in the liver by deacetylation and demethylation (with the participation of isoenzymes CYP3A4, CYP3A5 and CYP3A7) with the formation of an active metabolite of deacetyldyltiazem, which is determined in plasma in 5-10 times lower concentration than diltiazem, and has 2-4 times less activity.
Penetrates into breast milk.
The half-life of diltiazem when taken orally is biphasic: early - 20-30 minutes, final - 3.5 hours (5-8 hours - with high and repeated doses). The half-life of the drug Diltiazem Lannacher in the dosage form of a prolonged-release tablet of 90 mg and 180 mg is up to 10 hours. It is excreted through the intestines with bile (65%) and kidneys (35%, including 2-4% unchanged).
The pharmacokinetics of diltiazem does not change with prolonged use.
The drug does not cumulate or induce its own metabolism. In patients with angina pectoris and impaired renal function, the pharmacokinetics of diltiazem does not change. In patients with hepatic insufficiency, bioavailability increases and the half-life is lengthened. In old age, the clearance of diltiazem may also be reduced. Not excreted during hemodialysis and peritoneal dialysis.

Indications for use

Arterial hypertension
Prevention of angina attacks (including Prinzmetal's angina)
Prevention of attacks of supraventricular arrhythmias (paroxysmal tachycardia, atrial fibrillation or flutter, extrasystole)

Contraindications

Hypersensitivity to the drug and to other benzothiazepine derivatives, sinoatrial and atrioventricular block II and III degree (except for patients with a pacemaker), severe bradycardia, sick sinus syndrome without the use of an artificial pacemaker, cardiogenic shock, Wolff-Parkinson-White syndrome, syndrome Launa-Ganonga-Levin in combination with atrial flutter or fibrillation (except for patients with a pacemaker), severe arterial hypotension (systolic blood pressure less than 90 mm Hg), acute heart failure, chronic heart failure (in the stage of decompensation), myocardial infarction with signs of left ventricular failure, ventricular tachycardia with a wide QRS complex, pregnancy, lactation, age up to 18 years (efficacy and safety have not been established), lactose intolerance, lactase deficiency and glucose-galactose malabsorption.

Carefully should be used in patients with severe hepatic and renal dysfunction, acute porphyria, severe aortic stenosis, in the acute phase of myocardial infarction (without signs of left ventricular failure), hypertrophic obstructive cardiomyopathy, mild and moderate arterial hypotension, grade I atrioventricular block or lengthening the PQ interval, with simultaneous use with beta-blockers or digoxin, compensated for chronic heart failure, with a tendency to bradycardia, in old age.

Pregnancy and breastfeeding

Diltiazem Lannacher is contraindicated during pregnancy and lactation.
Women of childbearing age should exclude pregnancy before the appointment of diltiazem.

Method of administration and dosage

The tablets should be taken orally, before meals, without chewing and with a small amount of liquid. The dosage regimen is set individually.
The initial dose of Diltiazem Lannacher is 1 tablet, 90 mg 2 times a day. The average daily dose is 180-270 mg. The dosage regimen can be adjusted only after 2 weeks. The maximum daily dose is 360 mg. With long-term treatment with a good therapeutic effect, a dose reduction is possible.

Side effect

On the part of the cardiovascular system: bradycardia, ventricular premature beats, chronic heart failure, sinoauricular block, atrioventricular block up to asystole, marked decrease in blood pressure, fainting, skin redness, angina pectoris, arrhythmia (including flutter and fibrillation of the ventricles), dyspnea, periphery. When used in high doses - angina pectoris, bradycardia, atrioventricular block.
From the digestive system: dry mouth, increased appetite, vomiting, nausea, heartburn, diarrhea, hypertrophic gingivitis, constipation, hypercreatininemia, abdominal pain, abnormal liver function, intestinal obstruction.
From the side of the central nervous system: headache, general weakness, asthenia, increased fatigue, anxiety, dizziness, drowsiness, insomnia, depression, a state of pathological fear, extrapyrapid disorders, parkinsonism (ataxia, "mask-like" face, "shuffling" gait, stiffness of the arms or legs, trembling of the hands and fingers, difficulty swallowing). When used in high doses - paresthesia.
From the senses: visual impairment (transient blindness).
Allergic reactions: increased photosensitivity, itching, skin rash, facial flushing, Stevens-Johnson syndrome, erythema polymorphism, exfoliative dermatitis.
Others: taking the drug can lead to an increase in the concentration of "liver" enzymes in the blood serum, peripheral edema. When used in high doses - pulmonary edema (difficulty breathing, cough, stridor breathing), thrombocytopenia, agranulocytosis, galactorrhea, weight gain. With a sharp withdrawal of the drug, a "withdrawal" syndrome may develop with concomitant tachycardia, arterial hypertension and worsening of the course of angina pectoris.

Overdose

Symptoms: bradycardia, marked decrease in blood pressure, turning into collapse, violation of atrioventricular and sinoatrial conduction, heart failure, cardiogenic shock, asystole, nausea, vomiting, metabolic acidosis, hyperkalemia.
Treatment: depending on the severity of the overdose. It is necessary to flush the stomach, prescribe activated charcoal, further treatment is symptomatic. If necessary, it is recommended to prescribe atropine, isoprenaline, dopamine or dobutamine, and also, in case of severe conduction disturbances, the use of electrocardiostimulation is possible.
Hemodialysis and peritoneal dialysis are not effective.

Interaction with other medicinal products

Interaction with other medicinal products

Pharmacodynamic
With the simultaneous administration of diltiazem with antihypertensive drugs, an increase in the antihypertensive effect is noted.
With the simultaneous administration of diltiazem and digoxin, an increase in the concentration of digoxin in the blood is possible.
With the simultaneous administration of diltiazem with antiarrhythmic drugs, beta-blockers, cardiac glycosides, it is possible to develop bradycardia, violation of atrioventricular conduction, and the appearance of symptoms of heart failure.
With simultaneous use with adenosine, the risk of developing prolonged bradycardia is increased.
Salicylates additionally inhibit the ability to aggregate platelets.
Ethanol: increased antihypertensive effect.
Procainamide, quinidine, and other drugs that cause QT prolongation increase the risk of QT prolongation.
Means for inhalation anesthesia (hydrocarbon derivatives), thiazide diuretics and other drugs that lower blood pressure, increase the hypotensive effect of diltiazem.
Phenytoin reduces the effect of diltiazem.
Antipsychotic drugs (neuroleptics) enhance the antihypertensive effect of diltiazem.
Simultaneous administration of nitrates (including prolonged forms) is possible.
Lithium preparations may increase the neurotoxic effects of diltiazem (nausea, vomiting, diarrhea, ataxia, trembling and / or tinnitus).
Indomethacin and other non-steroidal anti-inflammatory drugs, glucocorticosteroids and estrogens, as well as sympathetic drugs reduce the hypotensive effect.
Enhances the cardiodepressant effect of general anesthetics.

Pharmacokinetic
Cimetidine weakens the process of biotransformation of diltiazem in the liver, slows down its excretion, increasing the duration of action of diltiazem.
Diltiazem increases the concentration of theophylline and carmazepine in blood plasma (40-70%) and increases the risk of adverse reactions, incl. ataxia, nystagmus, diplopia, headache, vomiting, confusion, and also increases the concentration of cyclosporine, digoxin (up to 50%), imipramine, lithium and midazolam.
Strengthens the effect of hypoglycemic agents for oral administration (for example, chlorpropamide and glipizide).
With the simultaneous use of diltiazem and cyclosporin in patients with a transplanted kidney, the development of intoxication by the latter, paresthesia, is possible. Therefore, it is necessary to closely monitor the level of plasma concentrations of cyclosporine in this group of patients. Food intake increases the absorption and bioavailability of diltiazem by 20-30%.
May increase the bioavailability of propranolol. Increases the concentration of moracizin in blood plasma.
Phenobarbital, diazepam, rifampicin reduce the concentration of diltiazem in the blood plasma.
Increases the concentration in the blood of quinidine, valproic acid (dose reduction may be required).
Antivirals: ritonavir can increase plasma concentrations of BMCA.
Anxiolytics and hypnotics: diltiazem inhibits the metabolism of midazolam (plasma concentration increases with increased sedative effect.
BMCC: excretion of nifedipine is reduced by diltiazem (plasma concentration increases).
Diltiazem significantly increases the plasma concentration of lovastatin. It also enhances the effect of simvastatin, therefore, with their simultaneous use, the dose of simvastatin must be reduced. With the simultaneous use of diltiazem with lovastatin and simvastatin, monitoring of patients is necessary, due to the possibility of developing myositis or rhabdomyolysis.

special instructions

Diltiazem reduces the conductivity of the myocardium, therefore it is prescribed with extreme caution in patients with AV block of the 1st degree and with bradycardia. Caution is also required when used in patients with impaired left ventricular function of the heart.
Diltiazem is prescribed with caution to patients already taking other drugs, in particular beta-blockers. In this group of patients, the treatment process should be carried out under the close supervision of a cardiologist.
Diltiazem is used with caution in patients with renal or hepatic impairment; in this group of patients, if necessary, the prescribed doses of the drug should be reduced and the content of urea in urine and creatinine should be monitored. In patients with impaired liver function, the daily dose should not exceed 90 mg and it is recommended to regularly monitor liver function.
For elderly patients, the dose is selected individually, because the half-life of diltiazem may increase.
Since diltiazem reduces the systemic vascular resistance and can cause secondary arterial hypotension, it is necessary to control blood pressure, in particular, at the beginning of the course of treatment, while the therapeutic doses have not yet been clarified.
In case of persistent skin rashes developing into polymorphic erythema and exfoliative dermatitis, Diltiazem Lannacher should be discontinued.
If during therapy the patient needs to undergo surgery under general anesthesia, it is necessary to inform the anesthesiologist about the nature of the therapy (the patient is taking Diltiazem Lannacher).

Influence on the ability to drive vehicles and mechanisms

The use of the drug Diltiazem Lannacher can adversely affect the performance of work that requires a high speed of mental and physical reactions (for example, driving vehicles, mechanisms, working at height, etc.). While taking the drug Diltiazem Lannacher, the use of alcoholic beverages is not recommended.

Release form

Sustained-release tablets, film-coated 90 and 180 mg.
10 tablets in PVC / Al blister.
2 blisters (for 90 mg tablets) or 3 blisters (for 180 mg tablets) together with instructions for use in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription.

Marketing Authorization Holder:

LLC "VALEANT", 115162, Moscow, st. Shabolovka, 31, building 5, Russia

Manufacturer, packer, packer:
"G.L. Pharma GmbH, Industristrasse 1, A-8502 Lannach, Austria

Issuing quality control:
Lannacher Heilmittel GmbH, Schlossplatz 1, A-8502 Lannach, Austria

Consumer claims should be sent to VALEANT LLC:
115162, Moscow, st. Shabolovka, 31, building 5, Russia

Selective calcium antagonists are a promising group of drugs included in the list of first-line drugs for hypertensive patients. One of the most popular drugs in this group is Diltiazem, which is used to effectively lower blood pressure and prevent the development of complications of hypertension.

The main active ingredient of the drug is diltiazem hydrochloride. The drug is available in pill form. Auxiliary and shaping agents differ depending on the manufacturer.

Diltiazem Lannacher is a drug from an Austrian pharmaceutical company. It is available in two dosages - 90 or 180 mg of active ingredient in one tablet. Diltiazem Lannacher also contains lactose, talc, titanium dioxide and other excipients. The drug has a prolonged action and is a small light-colored film-coated tablets.

The long-acting drug Diltiazem Lannacher is available in two dosages

Diltiazem Retard - extended-release tablets, which are produced in the Donetsk region and Romania. Available in three dosages: 60, 90 and 120 mg of active ingredient in one tablet. The mechanism of slow release of the active substance is carried out due to the following auxiliary components:

microcrystalline cellulose;
glycolic wax;
lactose monohydrate;
mineral oil;
magnesium stearate.

Diltiazem Retard tablets are packaged in 12 pieces in a blister. The medicine is sold in 1-10 blisters per pack. Diltiazem Lannacher is available in 10 tablets in a blister, two blisters in a package.

Diltiazem is a prescription drug that can be purchased in pharmacies, but you must first take a prescription from your doctor.

What is the difference between different forms of the drug?

Diltiazem Lannacher and Diltiazem Retard are long-acting drugs. They differ in a two-stage scheme for the release of the active substance. The drug begins to act several hours after taking the pill, the peak of its work is noted 7-8 hours after taking, and then the effect slowly decreases. This feature allows you to take the medicine only twice a day.

Unlike other prolonged-release drugs, the effect of Diltiazem lasts not 24, but 12 hours, so the tablets are drunk in the morning and in the evening.

On the shelves of pharmacies, you can find the drug Diltiazem without any prefixes and explanatory words in the name. This medication works like a regular tablet. After taking it, a rapid release of the active substance begins, the peak of action occurs two hours later, and then the process of removing the agent from the body begins. Such tablets must be taken several times a day, but in smaller doses than Diltiazem Retard.

As a rule, slow-release tablets are more expensive, but due to the peculiarities of their metabolism, Diltiazem Retard and Diltiazem Lannacher are less likely to cause side effects.

Long-acting drugs are more easily tolerated by the body

Indications for use

Diltiazem is a selective calcium antagonist with a predominant effect on the heart. Taking the drug Diltiazem is indicated for lowering blood pressure while monitoring cardiac performance.

The main indications for the use of Diltiazem are arterial hypertension of any type with the risk of developing complications in the heart. According to the doctor's prescription, the drug can be taken for angina pectoris, coronary heart disease, during the recovery period after a heart attack.

The drug reduces the risks of developing heart failure and other disorders of the myocardium against the background of hypertension.

Diltiazem can be taken with a steady increase in blood pressure, both as an independent agent (mono-therapy), and in combination with other antihypertensive drugs.

As the only drug for blood pressure control, Diltiazem Retard is prescribed when the pressure rises within 150 mm Hg. If the tonometer readings are significantly higher, it is necessary to additionally take diuretics or other medications.

At the initial stage of hypertension, Diltiazem can be prescribed to patients at risk of developing complications and disruption of the heart.

How to take Diltiazem?

Diltiazem is taken in the morning and evening, at the same time. The instruction for Diltiazem contains a detailed description of all possible reception regimens. It is recommended to take the drug immediately after a meal. In this case, the tablet must be swallowed, violation of its integrity leads to a deterioration in the therapeutic effect.

The dosage of the drug is selected individually for each patient. Typically, therapy is started with Diltiazem 60 mg twice daily. After a week of therapy, the effectiveness of the drug for the patient's body is evaluated, and the dosage can be increased to taking Diltiazem 90 mg.

Diltiazem, the indication of which is hypertension, is intended for long-term use. Moreover, if therapy is carried out with high doses, after a few weeks or months they must be reduced in order to minimize the risk of side effects.

Patients with angina pectoris or coronary artery disease should stop taking the drug by gradually reducing the dosage.

Treatment with the drug begins with a minimum dosage.

Use in pregnancy, children and the elderly

The drug is not intended for use during the period of gestation, since no studies of its effect on the fetus have been carried out. You can start therapy with this medicine only after pregnancy has been ruled out.

The main active ingredient penetrates into breast milk, and therefore the drug is not allowed to be used during lactation.

The drug is well tolerated, therefore, elderly patients can take the drug in standard dosages.

Diltiazem is not used in pediatric practice and is intended for the treatment of adult patients only.

Side effects

Side effects while taking Diltiazem are rare. The listed symptoms were observed in one out of 10 thousand patients:

nervousness;
sleep disturbance;
confusion of consciousness;
headache;
dizziness;
tremor;
hot flashes;
light sensitivity of the eyes;
pain and pain in the eyes;
noise in ears;
dyspnea;
bleeding from the nose;
gynecomastia and impotence in men.

In the first days of taking the drug, hypotension may develop due to high dosages of the drug. Usually, the symptoms of low blood pressure go away as the body gets used to it. If after 3-4 days there is dizziness, loss of strength, pallor of the skin, you should consult your doctor about reducing the amount of the drug taken.

Contraindications

The instructions for use prohibit taking Diltiazem in the following cases:

hypersensitivity to the active substance;
hypotension;
cardiogenic shock;
bradycardia;
period of gestation and lactation;
childhood;
acute heart failure.

The drug does not affect the functioning of the liver and kidneys, therefore it can be used for renal and hepatic insufficiency. The action of the medicinal pill does not affect drugs to lower blood sugar, so Diltiazem can be prescribed to patients with type 2 diabetes.

special instructions

Patients with renal insufficiency do not need to adjust the dosage of the drug, except in cases of severe renal impairment. It is recommended that you consult with your doctor about reducing the number of pills.

In hepatic insufficiency, dosage reduction is not required, except for severe forms of impairment, while treatment is advisable to carry out the drug in a dosage of 60 mg.

In case of heart failure, the drug should be taken under the supervision of a specialist. It is recommended to regularly monitor changes in the work of the myocardium. The drug is prescribed with caution for bradycardia, left ventricular failure, aortic stenosis.

In case of heart disease, regular monitoring is required during the period of taking the drug.

Overdose

Taking large doses of the drug (over 1.5 g) leads to the development of severe intoxication. This is manifested by a number of symptoms: irritability, nervousness, loss of strength, respiratory failure, nausea, decreased pressure. There are known cases of cardiac arrest due to an overdose of this drug, which can be fatal.

There is no specific antidote, symptomatic treatment and, if necessary, resuscitation measures are used. If you suspect an overdose, it is recommended not to wait, but to immediately call an ambulance to your home.

Drug interactions

Any medication must be taken correctly. Despite its seeming safety, Diltiazem can cause negative reactions when taken with other drugs.

Despite the fact that Diltiazem can be taken with other antihypertensive drugs, only a doctor should make the decision to prescribe ancillary drugs. Self-therapy with several different drugs for hypertension entails a strong decrease in blood pressure, the development of hypotension and bradycardia.
Drugs that reduce heart rate are not recommended to be taken together with Diltiazem. Due to the potentiation of their action, the use of Diltiazem tablets with such drugs can lead to cardiac arrhythmias and bradycardia.
Diltiazem increases the toxicity of cyclosporine and carbamazepine. If it is necessary to take them together, the dosage of these drugs should be halved.
Diltiazem increases the concentration of buspirone in the blood, which leads to severe side effects from taking the latter.
Cases of a decrease in the action of the injected insulin when taking Diltiazem have been recorded, which must be taken into account in patients with type 1 diabetes mellitus.
Diltiazem should not be taken with lithium preparations, since such a combination of drugs can lead to the development of mental disorders and parkinsonism.

It is important to remember that while taking Diltiazem, you should refrain from drinking alcoholic beverages, in order to avoid increasing the load on the liver.

Cost and analogues

With the constant use of the drug Diltiazem, price plays an important role. The medicine is affordable for everyone - Diltiazem Lannacher will cost 150 rubles for a pack of 90 mg tablets, or 310 rubles at a dosage of 180 mg.

Ukrainian Diltiazem Retard in a dosage of 60 mg costs about 90 rubles per pack, a Romanian drug with the same name will cost 230 rubles, but already in a dosage of 180 mg.

There are no complete analogues of the drug. To date, pharmacies have only two prolonged-release drugs based on diltiazem. If necessary, a cardiologist will help you to choose analogs to replace Diltiazem, but you will have to look for substitutes among drugs based on other active ingredients.

"Diltiazem" is a drug for the treatment of heart diseases, which belongs to the group of calcium channel blockers. Medicines of this group are calcium antagonists, since they slow down the release of calcium ions and their penetration into the cellular structure through calcium channels. The drug is produced at pharmaceutical factories in France and Macedonia, has a low cost and is often prescribed as part of combination therapy for patients with cardiac and vascular pathologies.

"Diltiazem" has antianginal activity, reduces myocardial oxygen demand and improves blood supply to the heart muscle, so this drug is often prescribed after a myocardial infarction. The antihypertensive effect allows the drug to be used to treat primary and secondary hypertension.

Properties of the preparation:

reduces the amount of calcium in the smooth muscle fibers of blood vessels and capillaries, as well as cardiomyocytes - muscle cells that make up the bulk of the myocardium;
reduction of heart rate and prevention of angina pectoris;
improvement of renal, cerebral and coronary blood flow by relaxing the smooth muscle tissue of the coronary arteries and blood vessels;
an increase in the relaxation time of left ventricular diastole;
reduction of platelet aggregation (fusion) and prevention of blood clots.

"Diltiazem" can be used prophylactically in surgical treatment to prevent spasm of the coronary vessels. This is necessary for coronary artery bypass grafting, coronary angiography (a method for diagnosing coronary artery disease using contrast agents) and other surgical interventions with a high risk of developing coronary spasm.

Antiarrhythmic and antianginal effects allow the drug to be used to treat exertional angina and a rare type of angina caused by vasospasm through which blood enters the heart muscle (spontaneous angina or Prinzmetal's angina).

If necessary, "Diltiazem" can be prescribed to people with diabetes mellitus for the treatment of diabetic retinopathy - severe damage to the retina of the eye caused by systemic vascular disease.

Forms of issue

Diltiazem is available in the form of tablets and capsules for oral administration. In total, there are four dosage forms of the drug on the pharmaceutical market:

prolonged-release tablets;
tablets with prolonged action, film-coated gastrointestinal;
tablets;
extended release capsules.

Depending on the form of release, the drug may contain 30 mg, 60 mg, 90 mg or 180 mg of the active ingredient - diltiazem hydrochloride. It is necessary to store the medicine at room temperature for no more than 2 years from the production date indicated on the carton.

Instructions for use

Tablets and capsules must be taken before meals (about 10-15 minutes) - this will improve the absorption of the active substance and increase the effectiveness of therapy. You do not need to chew the tablets or open the capsules - they should be swallowed whole with a little water.

Price

The cost of Diltiazem in online pharmacies is:

60 mg tablets - 70-105 rubles;
90 mg tablets - 80-110 rubles;
sustained-release capsules 180 mg - 270 rubles;
prolonged-release tablets 90 mg - 115 rubles.

All prices are for a pack of 30 tablets or capsules.

Analogs

The selection of drugs with a similar composition or pharmacological properties may be necessary in case of an allergic reaction or intolerance to any component that is part of the drug. Replacement of the drug may also be required in the absence of pronounced positive dynamics during treatment. The most effective and popular analogs of Diltiazem are listed below.

"Diltiazem retard"(110-220 rubles). The drug is from the group of calcium channel blockers, which contains the same active ingredient. It is available in the form of capsules with a dosage of 90 mg and 180 mg.
"Cardil"(320 rubles). The drug is in pill form, used to treat hypertension, angina pectoris and cardiac arrhythmias.
"Diakordin"(290 rubles). A drug based on diltiazem, available in three dosages: 60 mg, 90 mg and 120 mg. It has a fairly small list of side effects and, according to patients, is better tolerated than other drugs in this pharmacological group.

Self-replacement of drugs and termination of treatment without consulting a doctor are not allowed.

The list of contraindications and side effects even for structural analogs may be different due to the auxiliary components that are added to drugs to create a base, to give a certain color or odor, therefore, only a doctor should select an analogue of Diltiazem, if necessary.

Contraindications

"Diltiazem" has a fairly large list of contraindications, which must be familiarized with before starting treatment. The absolute contraindications for prescribing the drug include:

arterial hypertension 4 degrees;
violation of the conduction of electrical impulses from the atria to the ventricles;
atrial fibrillation and flutter with atrial fibrillation;
violations in the structure of the heart muscle, accompanied by a syndrome of premature excitation of the ventricles;
weakness of the sinus node;
chronic heart failure;
aortic valve stenosis;
cardiogenic shock.

The appointment of preparations containing diltiazem is contraindicated for pregnant and lactating women. In case of severe violations of the sinus rhythm (bradycardia), the drug should be prescribed with increased caution. The same applies to the elderly, as well as patients with complete or partial dysfunctions of the renal and hepatic systems.

Dosage

For the treatment of arterial hypertension, the drug is prescribed in a dosage of 30 mg. For patients with delayed creatinine clearance, as well as for the elderly, the drug is prescribed 2 times a day. Patients in other groups should take tablets 3-4 times a day.

For the treatment of atrial fibrillation, as well as for the prevention of supraventricular tachycardia, "Diltiazem" is prescribed in the form of tablets or capsules with prolonged release according to the following scheme:

within 14 days - 60-120 mg 2 times a day or 180-240 mg once;
in the next two weeks - 120 mg 3 times a day or 180 mg 2 times a day.

If the drug is used for a long period of time, every three months it is necessary to adjust the prescribed dosage regimen downward.

In case of hypertension in a small circle of circulation, "Diltiazem" can be taken in the maximum daily dosage, which is 720 mg (4 tablets of 180 mg).

Side effects

During treatment with Diltiazem, it is important to follow the prescribed dosage regimen, as the drug can cause a large number of side effects. Most of them are associated with the functioning of the cardiovascular system. The patient may experience an uncontrolled drop in blood pressure, as well as a change in heart rate. With self-correction of the dosage, atrial fibrillation, angina pectoris, tachycardia and bradycardia may occur.

Often, side effects are manifested on the part of the nervous system and digestive organs. It can be:

nausea and vomiting, independent of food intake;
a decrease in the activity of the salivary glands and the resulting dryness of the mucous membranes of the oral cavity;
soreness during bowel movements and a change in the nature of the stool;
headache;
depressive disorders;
asthenic syndrome (chronic fatigue);
sleep disturbances;
tremors and seizures;
violation of motor coordination;
incoherent speech.

In rare cases, patients were diagnosed with disturbances in the functioning of the organs of vision, as well as signs of gingival hyperplasia. Changes can also be observed on the part of the hematopoietic system. Thrombocytopenia and agranulocytosis were recorded in 4% of patients during treatment.

Compatibility

The appointment of "Diltiazem" with the simultaneous administration of lithium preparations is contraindicated due to the increased neurotoxic effect on the body. This combination can cause auditory-vestibular disorders, manifested by headache and tinnitus, as well as signs of body intoxication: nausea, vomiting, chills.

Some drugs can reduce the effectiveness of antihypertensive treatment, so they also cannot be combined with Diltiazem. These drugs include:

glucocorticosteroid hormones;
oral contraceptives that contain estrogens;
"Indomethacin".

Thiazide diuretics, drugs used for anesthesia using inhalation spray, and antihypertensive drugs, on the contrary, enhance the hypotensive properties of Diltiazem, therefore their simultaneous use requires mandatory correction of the regimen.

Combinations of "Diltiazem" with certain medicinal substances can be fatal to the patient. These drugs include: cardiac glycosides, beta-blockers, quinidine, and antiarrhythmic drugs.

Overdose

An overdose of "Diltiazem" can have serious consequences for the health and life of the patient, so it is important to follow the prescribed dosage and intake regimen. In case of accidental intake of an increased amount of the drug, the patient may have a violation of antrioventricular conduction, the development of cardiogenic shock, heart failure and asystole.

For treatment, it is necessary to rinse the patient's stomach and give any sorbing drug (Polysorb, Activated Carbon, Smecta). Further treatment depends on the complications manifested.

Diltiazem is a benzodiazepine calcium channel blocker with a number of application features.

So, when using forms of the drug with prolonged action, their combination with beta-blockers is undesirable. Also, you should not use the drug in order to stabilize the heart rate in case of impaired hemodynamic parameters.

On this page you will find all the information about Diltiazem: full instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews of people who have already used Diltiazem. Want to leave your opinion? Please write in the comments.

Clinical and pharmacological group

Selective class III calcium channel blocker, benzothiazepine derivative.

Conditions of dispensing from pharmacies

Dispensed by prescription.

Prices

How much does Diltiazem cost? The average price in pharmacies is at the level of 100 rubles.

Release form and composition

Diltiazem is produced in the form of round white tablets, on one of the sides of which there is a risk, in blisters of 10 pcs.

One tablet contains 60 or 90 mg of diltiazem chloride and excipients such as:

Corn starch;
Povidone;
Microcrystalline cellulose;
Talc;
Gelatin;
Colloidal silicon dioxide;
Lactose;
Calcium phosphate dibasic;
Magnesium stearate;
Hydroxypropyl methylcellulose;
Sodium benzoate.

Also, dry substance Diltiazem is produced, intended for the preparation of a solution for injection, in transparent vials. One bottle contains 10 or 25 mg of diltiazem chloride.

Pharmacological effect

Diltiazem belongs to a group of medicines that can block L-type calcium channels. These specific channels are located in a fairly large number in the heart and in blood vessels (arteries and arterioles).

Calcium ions are involved in the formation of an action potential at the level of the cardiac conduction system (a special complex of cells that regulates the contractile function of the heart). As a result, this leads to a decrease in the heart rate, but practically does not affect the strength of the contractions of the heart muscle (pumping function). Also, diltiazem reduces the oxygen and energy demand of the myocardium (heart muscle).

At the level of the vessels of the heart (coronary arteries) and in the arteries of large, medium and small caliber, blockage of calcium channels leads to their reflex expansion (dilatation). Diltiazem relieves spasm of the coronary vessels (contraction of the smooth muscle of the heart vessels, which is accompanied by pain) and other arteries, and also reduces the total peripheral pressure in the vessels (antihypertensive effect). Along with the above effects, diltiazem improves renal and cerebral blood flow to some extent.

Indications for use

According to the instructions for Diltiazem, the use of the drug is indicated for:

Prevention of attacks, including Prinzmetal's angina;
Treatment of various forms and coronary heart disease;
Prevention of supraventricular arrhythmias: paroxysmal supraventricular, atrial flutter, extrasystole, atrial fibrillation.

Contraindications

Diltiazem has a number of contraindications, so only a doctor can prescribe it. The doctor recommends that the patient undergo an examination, on the basis of which the best treatment is selected.

It is forbidden to take pills to a certain group of patients:

Laun-Ganogh-Levin syndrome;
low blood pressure;
dysfunction of the liver and kidneys;
bradycardia in a neglected form;
cardiogenic shock;
weak sinus node;
heart attack, which was accompanied by congestion in the lungs;
heart failure (2 and 3 degrees);
aortic stenosis;
the period of pregnancy and breastfeeding;
individual intolerance to one of the components;
Wolff-Parkinsom-White syndrome.

It is used with caution in case of AV blockade of I degree, intraventricular conduction disorders, in patients prone to arterial hypotension, chronic heart failure, myocardial infarction with left ventricular failure, ventricular tachycardia with expansion of the QRS complex, liver failure, renal failure, in elderly patients, in children (efficacy and safety of use have not been studied).

Application during pregnancy and lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). In experimental studies, the teratogenic effect of diltiazem has been established.

Instructions for use

The instructions for use indicate that Diltiazem should be taken orally by swallowing the tablets whole and drinking some liquid.

The drug is taken 3 times a day at 60 mg or 2 times a day at 90 mg. The optimal dosage of Diltiazem is 180-360 mg per day.

Under the supervision of a physician in a hospital setting, it is possible to increase the daily dose to 480 mg.

Side effects

In the reviews for Diltiazem, the following side effects of this drug are indicated:

From the gastrointestinal tract: vomiting, dry mouth, nausea, improved appetite, diarrhea or constipation, bleeding, swelling of the gums.
Quite rarely, there may be problems with the formation of blood cells, which is accompanied by agranulocytosis or thrombocytopenia.
Severe headaches, fainting and dizziness, disturbed sleep patterns, constant fatigue and drowsiness, poor mobility of the arms and legs, slow or shuffling gait, poor facial expressions, trembling hands, problems swallowing. Taking the drug in large quantities can cause tremors and vision problems.
Depending on the specific organism (as shown by the reviews for Diltiazem), itching, arthritis, rashes, redness of the facial skin, as well as Steven-Johnson syndrome may occur.
As for the cardiovascular system, there is often a decrease in blood pressure, arrhythmia, bradycardia, angina pectoris, asystole, heart failure, tachycardia.

If you take Diltiazem in very large doses, then this can cause difficulty breathing, severe cough, swelling of the legs. Sometimes there is galactorrhea and an increase in total body weight.

Overdose

When using the drug in large doses, peripheral edema, pulmonary edema, increased serum creatinine, weight gain, galactorrhea, hyperglycemia, and impaired potency may occur.

special instructions

Abrupt withdrawal of diltiazem can lead to the development of an anginal attack.
The simultaneous use of beta-blockers and diltiazem for parenteral administration is not recommended.
Patients with impaired liver and / or kidney function and the elderly require dosage adjustment.
IV is used only for emergency therapy, but if necessary, it can be administered for several days. With the introduction of diltiazem, careful monitoring of the function of the cardiovascular system is necessary. Against the background of regular intake of beta-blockers, the indications for intravenous administration of diltiazem should be strictly clarified and used only after ECG monitoring in the intensive care unit, while taking into account the possible need to use a pacemaker.

Drug interactions

Diltiazem cannot be used alone with other medicines without first consulting a doctor. Taking it with concomitant medications can lead to the consequences shown in the table.

Diltiazem and	Reception result
Cimetidine	Reduces the effect of the medication in question, slows down recovery
Disopyramide	Induces a decrease in the concentration of potassium ions in the blood
Carbamazepine Cyclosporine Quinidine	In this case, Diltiazem increases the toxicity of medications. If their joint reception is vital, then the dosage of medications is reduced
Buspirone	Increases its concentration in the blood, and this leads to side effects
Insulin	Diltiazem reduces the effect of the drug
MidazolamTriazolam	Increases drug concentration
Theophylline	Reduces the metabolism of this medication in liver cells

This is only a small part of the drugs that interact negatively with the drug.

In this article, you can read the instructions for the use of the medicinal product. Diltiazem... Reviews of website visitors - consumers of this medication, as well as opinions of doctors of specialists on the use of Diltiazem in their practice are presented. A big request to more actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, which may not have been declared by the manufacturer in the annotation. Diltiazem analogs in the presence of available structural analogs. Use for the treatment of hypertension or pressure reduction and prevention of angina attacks in adults, children, as well as during pregnancy and lactation.

Diltiazem- a class 3 selective calcium channel blocker, a benzothiazepine derivative. It has antianginal, hypotensive and antiarrhythmic effects. Reduces myocardial contractility, slows down AV conduction, decreases heart rate, reduces myocardial oxygen demand, dilates coronary arteries, increases coronary blood flow. Reduces the tone of smooth muscles of peripheral arteries and OPSS.

Reduces the intracellular content of calcium ions in cardiomyocytes and cells of smooth muscles of blood vessels, reduces heart rate, may have a slight negative inotropic effect, increases coronary, cerebral and renal blood flow. At concentrations at which there is no negative inotropic effect, it causes relaxation of the smooth muscles of the coronary vessels and dilatation of both large and small arteries.

The antianginal effect is due to an improvement in the blood supply to the myocardium and a decrease in its oxygen demand as a result of a decrease in systemic vascular resistance, systemic blood pressure (afterload), a decrease in myocardial tone and an increase in the time of diastolic relaxation of the left ventricle.

The antiarrhythmic effect is due to the suppression of the transport of calcium ions in the heart tissues, which leads to a lengthening of the effective refractory period and a slowdown in conduction in the AV node (in patients with sick sinus syndrome (SSS), elderly people, in whom calcium channel blockade can interfere with pulse generation in the sinus node and cause sinoatrial block). Normal atrial action potential or intraventricular conduction does not change (normal sinus rhythm is usually not affected), but when the amplitude of atrial contraction decreases, the rate of depolarization and conduction rate decrease. The anterograde effective refractory period in additional bypass conduction bundles can be shortened. When administered parenterally, it causes a rapid transition of paroxysmal supraventricular tachycardia (including those associated with additional bypass conduction bundles) into sinus rhythm, as well as a temporary cessation of ventricular tachycardia with atrial flutter or atrial fibrillation.

The antihypertensive effect is due to the dilatation of resistive vessels and a decrease in the systemic vascular resistance. The degree of decrease in blood pressure correlates with its initial level (with fluctuations in blood pressure within the normal range, there is a minimal effect on blood pressure). Reduces blood pressure both in a horizontal and vertical position. Rarely causes postural arterial hypotension and reflex tachycardia. Does not change or slightly reduces the maximum heart rate during exercise. Long-term therapy does not lead to hypercatecholaminemia, an increase in the activity of the RAAS. Reduces the renal and peripheral effects of angiotensin 2. Promotes diastolic relaxation of the myocardium in arterial hypertension, coronary artery disease, hypertrophic obstructive cardiomyopathy, reduces platelet aggregation. Able to cause regression of left ventricular hypertrophy in patients with arterial hypertension.

Slightly affects the smooth muscles of the gastrointestinal tract. During long-term (8 months) therapy, tolerance does not develop. Does not affect blood lipid profile.

The onset and duration of action depends on the dosage form used.

Compound

Diltiazem hydrochloride + excipients.

Pharmacokinetics

After oral administration, diltiazem is almost completely absorbed from the gastrointestinal tract. Undergoes intensive metabolism during the "first pass" through the liver. Bioavailability is about 40%. Plasma concentration is variable. Plasma protein binding is about 80%. Diltiazem is excreted in breast milk. It is extensively metabolized in the liver with the participation of the cytochrome P450 enzyme system. One of the metabolites - desacetyldylthiazem - has 25-50% activity of the unchanged substance. It is excreted mainly in the form of metabolites in the bile and urine, approximately 2-4% is excreted in the urine unchanged. Diltiazem is poorly cleared by dialysis.

Indications

prevention of angina attacks (including Prinzmetal's angina)
arterial hypertension (decrease in pressure)
prevention of supraventricular arrhythmias (paroxysmal supraventricular tachycardia, atrial fibrillation, atrial flutter, extrasystole)
relief of acute attacks of angina pectoris, prevention of spasm of the coronary arteries during coronary angiography or coronary artery bypass grafting, paroxysmal ventricular tachycardia, for arresting rapid ventricular rhythm during atrial fibrillation or atrial flutter (except for WPW syndrome) - for intravenous administration.

Forms of issue

Tablets 30 mg, 60 mg and 90 mg.

Extended-release coated tablets 90 mg and 180 mg (Diltiazem Lannacher).

Sustained-release capsules 90 mg, 120 mg and 180 mg (Diltiazem Retard).

Extended-release film-coated tablets 120 mg and 240 mg (Diltiazem Teva).

Instructions for use and dosage

Tablets

For oral administration, the initial dose is 60 mg 3 times a day or 90 mg 2 times a day. In case of insufficient effectiveness, the dose is increased to 180 mg 2 times a day. Prolonged forms are used 1-2 times a day, depending on the dose.

The maximum daily oral dose is 360 mg.

Ampoules

When administered intravenously, a single dose is 300 mcg / kg.

For intravenous drip, the dose is 2.8-14 μg / kg / min. The maximum daily dose is 300 mg.

Retard tablets

The tablets should be taken orally, before meals, whole, without chewing or crushing, with a small amount of liquid.

The initial dose of the drug Diltiazem retard is 1 tablet, 90 mg 2 times a day. The average daily dose is 180-240 mg. The dosage regimen can be adjusted only after 2 weeks.

The maximum dose is 360 mg per day (used only in a hospital).

Lannacher tablets

The drug is prescribed in a daily dose of 180-360 mg, divided into 2 doses. When switching to long-term maintenance therapy, the dose of the drug can be reduced to 180 mg once a day (in the morning).

The tablets should be taken whole without chewing and with a small amount of liquid.

Side effect

dry mouth;
nausea, vomiting;
constipation;
flatulence;
heartburn;
increased activity of hepatic transaminases;
arterial hypotension;
violation of AV conduction;
symptoms of heart failure;
bradycardia;
headache;
dizziness;
increased fatigue;
sleep disorders;
nervousness;
skin rash;
exanthema;
swelling of the lower extremities;
hyperplasia of the gingival mucosa.

Contraindications

severe bradycardia;
sick sinus syndrome (SSS);
cardiogenic shock;
AV block 2 and 3 degrees (except for patients with a pacemaker);
WPW syndrome;
arterial hypotension;
chronic heart failure stage 2B-3;
acute heart failure;
severe liver dysfunction;
severe renal dysfunction;
pregnancy;
lactation;
children under the age of 18;
hypersensitivity to benzothiazepine derivatives.

Application during pregnancy and lactation

Diltiazem is contraindicated during pregnancy and lactation (breastfeeding).

Application in children

The drug is not indicated for use in children and adolescents under the age of 18 years.

special instructions

With caution, the drug should be prescribed to patients prone to arterial hypotension, bradycardia, with violations of intraventricular conduction, elderly patients, patients with impaired liver and kidney function.

During the period of taking the drug, alcohol should be avoided.

Influence on the ability to drive vehicles and use mechanisms

The drug can affect the performance of work that requires the speed of psychomotor reactions (control of mechanisms, vehicles).

Drug interactions

With the simultaneous administration of the drug Diltiazem with antihypertensive drugs, an increase in the hypotensive effect is noted.

With the simultaneous administration of Diltiazem and digoxin, an increase in the concentration of digoxin in the blood is possible.

With the simultaneous administration of the drug Diltiazem with antiarrhythmic drugs, beta-blockers, cardiac glycosides, bradycardia, impaired AV conduction, and symptoms of heart failure may develop.

Cimetidine weakens the process of biotransformation of diltiazem in the liver, slows down its excretion, increasing the duration of action of the drug Diltiazem.

With the simultaneous administration of the drug with carbamazepine, quinidine, cyclosporine and theophylline, the toxic effect of the latter may increase due to the inhibitory effect of diltiazem on cytochrome P450.

Analogs of the drug Diltiazem

Structural analogues for the active substance:

Altiazem RR;
Blockalcin;
Diakordin 120 Retard;
Diakordin 60;
Diakordin 90 Retard;
Dilcardia;
Diltazem SR;
Diltiazem hydrochloride;
Diltiazem Lannacher;
Diltiazem retard;
Diltiazem Teva;
Dilren;
Dilts;
Silden;
Cardil;
Cortiazem;
Tiakem.

Pharmacological group analogs (calcium channel blockers):

Adalat;
Amlodipine;
Amlokard Sanovel;
Amlonorm;
Amlorus;
Ancardine;
Vamloset;
Verapamil;
Vertizin;
Dilceren;
Isoptin;
Kulchek;
Ko Dalneva;
Co Exforge;
Corvadil;
Cordaflex;
Cordipin;
Corinfar;
Lerkamen;
Lercanidipine;
Lomir;
Nebilong;
Nicardia;
Nimotope;
Nifedex;
Nifedipine;
Nifecard;
Norvask;
Normodipine;
Octidipine;
Plendil;
Posikor;
Prestans;
Procorum;
Stamlo;
Stugeron;
Tenox;
Felodipine;
Felotenz retard;
Finoptin;
Foridon;
Cinnarizine;
Qinnasan;
Equacard;
Equator;
Exforge;
Enanorm.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and see the available analogues for the therapeutic effect.