Concor AM tablets 10 + 10mg, No. 30

Oral tablets. The tablets should be taken in the morning, regardless of food intake, without chewing. The risk is only intended to facilitate breaking for ease of swallowing. Not to be divided into equal doses!

The recommended daily dose is 1 tablet of a certain dosage per day.

The selection and titration of the dose individually for each patient is carried out by the doctor in the course of prescribing monocomponent preparations containing the active substances that are part of the ConcorЃ AM preparation.

Duration of treatment. Treatment with ConcorЃ AM is usually a long-term therapy. Treatment should not be stopped abruptly because this can lead to a temporary deterioration of the clinical condition. Especially, treatment should not be abruptly stopped in patients with coronary artery disease. A gradual dose reduction is recommended.

active substances: amlodipine and bisoprolol fumarate

• severe arterial hypotension;

• shock (including cardiogenic);

• unstable angina (with the exception of Prinzmetal's angina);

• hemodynamically unstable heart failure after acute myocardial infarction;

• obstruction of the left ventricular outlet (eg, clinically significant aortic stenosis).

• acute heart failure or chronic heart failure (CHF) in the stage of decompensation, requiring inotropic therapy;

• cardiogenic shock;

• AV block II and III degree, without pacemaker;

• SSSU;

• sinoatrial blockade;

• severe bradycardia (heart rate less than 60 beats / min);

• symptomatic arterial hypotension;

• severe forms of bronchial asthma;

• severe peripheral arterial circulation disorders or Raynaud's syndrome;

• pheochromocytoma (without the simultaneous use of alpha-blockers);

• metabolic acidosis.

pharmachologic effect

This drug has pronounced antihypertensive and antianginal effects due to the complementary action of two active ingredients: BMCC - amlodipine and selective beta1-blocker - bisoprolol.

Indications of the drug ConcorЃ AM

arterial hypertension: replacement of therapy with monocomponent drugs amlodipine and bisoprolol in the same doses.

Dosage regimen

Oral tablets. The tablets should be taken in the morning, regardless of food intake, without chewing. The risk is only intended to facilitate breaking for ease of swallowing. Not to be divided into equal doses!

The recommended daily dose is 1 tablet of a certain dosage per day.

The selection and titration of the dose individually for each patient is carried out by the doctor in the course of prescribing monocomponent preparations containing the active substances that are part of the ConcorЃ AM preparation.

Duration of treatment. Treatment with ConcorЃ AM is usually a long-term therapy. Treatment should not be stopped abruptly because this can lead to a temporary deterioration of the clinical condition. Especially, treatment should not be abruptly stopped in patients with coronary artery disease. A gradual dose reduction is recommended.

Side effect

On the part of the blood and lymphatic system: very rarely - leukopenia, thrombocytopenia.

From the immune system: very rarely - allergic reactions.

From the side of metabolism and nutrition: very rarely - hyperglycemia.

Mental disorders: infrequently - insomnia, mood changes (including anxiety), depression; rarely - confusion.

From the nervous system: often - headache, dizziness, drowsiness (especially at the beginning of treatment); infrequently - fainting, hypesthesia, paresthesia, dysgeusia, tremor; very rarely - muscle hypertension, peripheral neuropathy. There have been isolated cases of extrapyramidal syndrome.

From the side of the organ of vision: often - visual impairment (including diplopia).

On the part of the organ of hearing and labyrinth disorders: infrequently - tinnitus.

From the gastrointestinal tract: often - nausea, abdominal pain, dyspepsia, changes in bowel movements (including constipation or diarrhea); infrequently - vomiting, dryness of the oral mucosa; very rarely - gastritis, gingival hyperplasia, pancreatitis.

From the liver and biliary tract: very rarely - hepatitis, jaundice, increased liver enzymes *.

From the side of the heart: often - a feeling of palpitations; infrequently - arrhythmia (bradycardia, ventricular tachycardia, atrial fibrillation); very rarely - myocardial infarction.

From the side of the vessels: often - 'hot flashes'; infrequently - a pronounced decrease in blood pressure; very rarely - vasculitis.

From the respiratory system, chest and mediastinal organs: often - shortness of breath; infrequently - cough, rhinitis.

From the side of the kidneys and urinary tract: infrequently - pollakiuria, urinary disorder, nocturia.

From the genitals and mammary gland: infrequently - impotence, gynecomastia.

From the musculoskeletal system and connective tissue: often - ankle swelling, muscle cramps; infrequently - arthralgia, myalgia, back pain.

Contraindications for use

• severe arterial hypotension;

• shock (including cardiogenic);

• unstable angina (with the exception of Prinzmetal's angina);

• hemodynamically unstable heart failure after acute myocardial infarction;

• obstruction of the left ventricular outlet (eg, clinically significant aortic stenosis).

• acute heart failure or chronic heart failure (CHF) in the stage of decompensation, requiring inotropic therapy;

• cardiogenic shock;

• AV block II and III degree, without pacemaker;

• SSSU;

• sinoatrial blockade;

• severe bradycardia (heart rate less than 60 beats / min);

• symptomatic arterial hypotension;

• severe forms of bronchial asthma;

• severe peripheral arterial circulation disorders or Raynaud's syndrome;

• pheochromocytoma (without the simultaneous use of alpha-blockers);

• metabolic acidosis.

Application during pregnancy and lactation

Pregnancy

ConcorЃ AM is not recommended during pregnancy unless the intended benefit to the mother outweighs the potential risk to the fetus. If treatment with ConcorЃ AM is necessary, blood flow in the placenta and uterus should be monitored, as well as the growth and development of the unborn child should be monitored, and, in the event of adverse events in relation to pregnancy and / or the fetus, alternative therapies should be taken.

The newborn should be carefully examined after delivery. In the first three days of life, symptoms of bradycardia and hypoglycemia may occur.

Lactation

There are no data on the excretion of bisoprolol and amlodipine in breast milk. Therefore, taking ConcorЃ AM is not recommended for women during breastfeeding. If taking bisoprolol during lactation is necessary, breastfeeding should be discontinued.

Overdose

Amlodipine

Symptoms: a pronounced decrease in blood pressure with the possible development of reflex tachycardia and excessive peripheral vasodilation (the risk of developing severe and persistent arterial hypotension, including with the development of shock and death).

Treatment: gastric lavage, the appointment of activated charcoal, maintaining the function of the cardiovascular system, monitoring the indicators of the function of the heart and lungs, giving an elevated position to the lower extremities, monitoring the BCC and diuresis. Intensive symptomatic therapy. To restore vascular tone - the use of vasoconstrictor drugs (in the absence of contraindications to their use); to eliminate the consequences of calcium channel blockade - intravenous administration of calcium gluconate. Hemodialysis is not effective.

Bisoprolol

The most common symptoms of overdose: AV block, severe bradycardia, marked decrease in blood pressure, bronchospasm, acute heart failure and hypoglycemia. The sensitivity to a single dose of a high dose of bisoprolol varies greatly among individual patients and, probably, patients with chronic heart failure are highly sensitive.

Treatment: if an overdose occurs, first of all, it is necessary to stop taking the drug and start supportive symptomatic therapy.

With severe bradycardia, intravenous administration of atropine. If the effect is insufficient, a remedy with a positive chronotropic effect can be introduced with caution. Sometimes it may be necessary to temporarily insert a pacemaker.

With a pronounced decrease in blood pressure - in / in the introduction of plasma-substituting solutions and vasopressor drugs. IV glucagon may also be indicated.

With AV blockade (II or III degree) - patients should be under constant supervision and receive treatment with beta-adrenergic agonists, such as epinephrine. If necessary, install a pacemaker.

With an exacerbation of CHF, intravenous administration of diuretics, drugs with a positive inotropic effect, as well as vasodilators.

With bronchospasm - the appointment of bronchodilators, incl. beta2-adrenergic agonists and / or aminophylline.

With hypoglycemia, intravenous administration of dextrose (glucose).

Bisoprolol is practically not amenable to dialysis.

Drug interactions

Amlodipine

CYP3A4 inhibitors: Amlodipine should be used with caution in conjunction with CYP3A4 inhibitors.

Strong and moderate CYP3A4 inhibitors (protease inhibitors, for example, indinavir, saquinavir and ritonavir, antifungals of the azole group, such as fluconazole and itraconazole, macrolides such as erythromycin or clarithromycin, verapamil or diltiazem) can increase the concentration of amlodipine in the blood plasma levels of amlodipine significantly. These changes may be more pronounced in elderly patients, which requires clinical monitoring of the concentration of amlodipine and dose adjustment if necessary.

CYP3A4 inducers: simultaneous use with CYP3A4 inducers (including rifampicin, St. John's wort) can lead to a decrease in the concentration of amlodipine in the blood plasma. Amlodipine should be used with caution in conjunction with CYP3A4 inducers.

Dantrolene (infusion): Animals have experienced lethal ventricular fibrillation and cardiovascular failure due to hyperkalemia following intravenous verapamil and dantrolene. Due to the risk of hyperkalemia, co-administration of calcium channel blockers such as amlodipine is not recommended during the treatment of malignant hyperthermia and in patients prone to malignant hyperthermia.

Tacrolimus: There is a risk of increased blood levels of tacrolimus when taken together with amlodipine, but the pharmacokinetic mechanism of this interaction is not fully understood. To avoid tacrolimus toxicity, blood levels should be monitored in patients undergoing treatment and the tacrolimus dose adjusted as needed.

Cyclosporine: Consideration should be given to monitoring the level of cyclosporine in patients undergoing kidney transplantation while taking amlodipine, the dose of cyclosporine should be reduced if necessary.

Simvastatin: simultaneous use with amlodipine can lead to an increase in the concentration of simvastatin in blood plasma. Co-administration of amlodipine at a dose of 10 mg with 80 mg of simvastatin resulted in a 77% increase in the effect of simvastatin compared with simvastatin alone. The dose of simvastatin in patients receiving amlodipine should be limited to 20 mg 1 time / day.

Taking amlodipine with grapefruit or grapefruit juice is not recommended due to the possible increase in the bioavailability of amlodipine, which leads to the effect of lowering high blood pressure.

Cimetidine, aluminum / magnesium (as part of antacids) and sildenafil do not affect the pharmacokinetics of amlodipine.

Amlodipine can enhance the antihypertensive effect of other antihypertensive drugs.

Amlodipine does not affect the pharmacokinetics of atorvastatin, digoxin, ethanol (alcohol-containing drinks), warfarin.

Bisoprolol

Combinations not recommended

Blockers of 'slow' calcium channels (BMCC) such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility, a pronounced decrease in blood pressure and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV blockade.

Central antihypertensive drugs (such as clonidine, methyldopa, moxonidine, rilmenidine), when used simultaneously with bisoprolol, can lead to a decrease in heart rate and a decrease in cardiac output, as well as to vasodilation due to a decrease in central sympathetic tone. Abrupt withdrawal, especially before the withdrawal of beta-blockers, may increase the risk of developing 'rebound' arterial hypertension.