CONCOR AM PILLS 10 MG + 5 MG

Indications and usage

- arterial hypertension: replacement of therapy with monocomponent drugs Amlodipine and Bisoprolol in the same doses.

Tablets for oral administration. pills should be taken in the morning, regardless of the meal, without chewing.

The recommended daily dose is 1 pill / day of a certain dosage.

The selection and titration of the dose individually for each patient is carried out by the doctor during the prescription of monocomponent preparations containing the active substances that make up the Concor preparation.® AM

Concor treatment® AM is usually a long-term therapy.

Have patients with impaired liver function Amlodipine excretion may be slowed. A special dosing regimen for this group of patients is not defined, however, the drug in this case should be administered with caution.

For patients with severely impaired liver function The maximum daily dose of bisoprolol is 10 mg.

Patients with impaired renal function mild or moderate correction dosing regimen is usually not required. Amlodipine is not excreted through dialysis. Patients undergoing dialysis should be given amlodipine with extreme caution.

For patients with severe impaired renal function (CC less than 20 ml / min) The maximum daily dose of bisoprolol is 10 mg.

Elderly patients the drug can be prescribed in usual doses. Caution is required only when increasing the dose.

The drug is not recommended for use in children and adolescents under the age of 18 in the absence of data on efficacy and safety.

Treatment should not be stopped abruptly, because this may lead to a temporary deterioration in the clinical condition. Especially, treatment should not be abruptly stopped in patients with coronary artery disease. A gradual reduction in dose is recommended.

Determination of the frequency of adverse reactions observed with separate use of amlodipine and bisoprolol: very often (≥1 / 10), often (≥1 / 100 - <1/10), infrequently (≥1 / 1 000 - <1/100), rarely (≥1 / 10 000 - <1/1 000), very rarely (<1/10 000), is unknown (assessment cannot be carried out on the basis of available data).

Amlodipine

Hemic and lymphatic: very rarely - leukopenia, thrombocytopenia.

Immune system: very rarely - allergic reactions.

Metabolism: very rarely - hyperglycemia.

From the psyche: infrequently - insomnia, change of mood (including anxiety), depression; rarely - confusion.

Nervous system: often - headache, dizziness, drowsiness (especially at the beginning of treatment); infrequently - fainting, hypesthesia, paresthesia, dysgeusia, tremor; very rarely - muscle hypertension, peripheral neuropathy.

Special senses: Infrequently - visual impairment (including diplopia).

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

Gastrointestinal: often - nausea, abdominal pain; infrequently - a change in the mode of defecation (including constipation or diarrhea), dyspepsia, dryness of the oral mucosa; very rarely - gastritis, gingival hyperplasia, pancreatitis.

Liver and biliary tract: very rarely - hepatitis (in most cases with cholestasis), jaundice (in most cases with cholestasis).

Cardiovascular: often - palpitations, flushing of the face; infrequently - pronounced decrease in blood pressure; very rarely - myocardial infarction, arrhythmia (bradycardia, ventricular tachycardia, atrial fibrillation), vasculitis.

Respiratory: infrequently - shortness of breath, rhinitis; very rarely - cough.

Urogenital: infrequently - pollakiuria, painful urge to urinate, nocturia.

From the genital and breast organs: infrequently - impotence, gynecomastia.

Musculoskeletal system: often - ankle swelling; infrequently - arthralgia, myalgia, muscle cramps, back pain.

Allergic reactions: very rarely - angioedema, urticaria, angioedema.

Dermatological: infrequently - alopecia, purpura, change in skin color, increased sweating, itching, rash, rash; very rarely - exudative erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, photosensitization.

General violations: often - peripheral edema, fatigue; infrequently - chest pain, asthenia, pain, general malaise.

Laboratory and instrumental data: infrequently - weight gain, weight loss; very rarely - an increase in liver enzymes in most cases with cholestasis.

Bisoprolol

Metabolism: rarely, an increase in triglyceride concentration.

From the psyche: infrequently - depression; rarely - hallucinations, nightmares.

Nervous system: often - headache *, dizziness *; infrequently - insomnia; rarely - fainting.

Special senses: rarely, reduced tearing (should be considered when wearing contact lenses); very rarely - conjunctivitis.

On the part of the organ of hearing and labyrinth disorders: rarely - hearing impairment.

Cardiovascular: often - a feeling of cooling or numbness in the limbs, a pronounced decrease in blood pressure; infrequently - a violation of AV-conduction, bradycardia, aggravation of symptoms of chronic heart failure, orthostatic hypotension.

Respiratory: infrequently - bronchospasm in patients with bronchial asthma or a history of airway obstruction; rarely - allergic rhinitis.

Gastrointestinal: often - nausea, vomiting, diarrhea, constipation.

Liver and biliary tract: rarely - hepatitis.

From the skin and subcutaneous tissues: rarely, hypersensitivity reactions such as itchy skin, rash, skin hyperemia; very rarely - alopecia. Beta-blockers may exacerbate the symptoms of psoriasis or cause a psoriasis-like rash.

Musculoskeletal system: infrequently - muscle weakness, muscle cramps.

From the genital and breast organs: rarely - impotence.

Common disorders: often - increased fatigue *; infrequently - exhaustion *.

Laboratory and instrumental data: rarely, increased activity of hepatic transaminases in the blood (ACT and ALT).

* Especially often these symptoms appear at the beginning of the course of treatment. Usually these phenomena are mild and usually take place within 1-2 weeks after the start of treatment.

Contraindications

Amlodipine

- unstable angina (with the exception of Prinzmetal stenocardia);

- acute myocardial infarction (during the first 28 days);

- clinically significant aortic stenosis.

Bisoprolol

- acute heart failure or chronic heart failure in the decompensation stage, requiring inotropic therapy;

- AV blockade II and III degree, without pacemaker;

- SSSU;

- sinoatrial block;

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

- severe forms of bronchial asthma or COPD;

- pronounced disorders of the peripheral arterial circulation or Raynaud's syndrome;

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

- metabolic acidosis.

Amlodipine / bisoprolol combination:

- severe arterial hypotension (systolic blood pressure less than 100 mm Hg);

- shock (including cardiogenic);

- age up to 18 years (efficacy and safety have not been established);

- Hypersensitivity to amlodipine, other derivatives of dihydropyridine, bisoprolol and / or any of the excipients.

WITH caution: chronic heart failure (includingnon-ischemic etiology of functional class III-IV according to NYHA classification), liver failure, renal failure, hyperthyroidism, diabetes mellitus with significant fluctuations in glucose concentration in the blood, AV block I degree, Prinzmetal angina, occlusive peripheral artery disease, psoriasis (including in history), starvation (strict diet), pheochromocytoma (with simultaneous use of alpha-blockers), bronchial asthma and COPD, while undergoing desensitization therapy, general anesthesia ii, advanced age, hypotension, type 1 diabetes, aortic stenosis, mitral stenosis, acute myocardial infarction (after 28 days).

Amlodipine

AT experimental studies the fetotoxic and embryotoxic effects of the drug have not been established, but use during pregnancy is possible only when the benefit to the mother outweighs the potential risk to the fetus.

There is no evidence of excretion of amlodipine in breast milk. However, it is known that other BCCA-derivatives of dihydropyridine are excreted in breast milk. In this connection, if it is necessary to prescribe amlodipine during lactation, it is necessary to decide on the termination of breastfeeding.

Bisoprolol

The use of bisoprolol during pregnancy is possible only in the case when the intended benefits to the mother outweigh the potential risk to the fetus. Beta-blockers reduce blood flow in the placenta and can affect the development of the fetus.

The blood flow in the placenta and uterus should be monitored, and the growth and development of the unborn child should be monitored, and in the event of adverse events with regard to pregnancy and / or the fetus, alternative methods of therapy should be taken.

You should carefully examine the newborn after childbirth. In the first three days of life, symptoms of bradycardia and hypoglycemia may occur.

There is no data on the allocation of bisoprolol with breast milk. Therefore, the drug is not recommended for women during breastfeeding. If taking bisoprolol during lactation is necessary, breastfeeding should be discontinued.

Have patients with impaired liver function Amlodipine excretion may be slowed. A special dosing regimen for this group of patients is not defined, however, the drug in this case should be administered with caution.

For patients with severely impaired liver function The maximum daily dose of bisoprolol is 10 mg.

Patients with impaired renal function mild or moderate correction dosing regimen is usually not required. Amlodipine is not excreted through dialysis. Patients undergoing dialysis should be given amlodipine with extreme caution.

For patients with severe impaired renal function (creatinine clearance (CC) less than 20 ml / min) The maximum daily dose of bisoprolol is 10 mg.

The drug is not recommended for use in children under the age of 18 in the absence of data on efficacy and safety.

Elderly patients may be given the usual dose of the drug. Caution is required only when increasing the dose.

Amlodipine

Patients with heart failure should take amlodipine with caution. In patients with heart failure stage III-IV, according to the NYHA classification, amlodipine increases the risk of pulmonary edema, which is not associated with the worsening of symptoms of chronic heart failure.

Bisoprolol

Cessation of treatment with bisoprolol should not be abrupt, especially in patients with coronary artery disease, unless there are clear indications for discontinuation of the drug. The sudden cancellation of bisoprolol can lead to a temporary worsening of the cardiac pathology.

Bisoprolol should be prescribed with extreme caution in patients with arterial hypertension or angina, in combination with heart failure.

As in the case of other beta-blockers, bisoprolol may cause an increase in sensitivity to allergens and an increase in Anaphylactic reactions, so care must be taken when desensitizing therapy is simultaneously performed. The use of adrenaline may not always give the expected therapeutic effect.

When using bisoprolol, symptoms of hyperthyroidism may be masked.

In patients with pheochromocytoma, bisoprolol should be administered only after blockade of α-adrenoreceptors.

Before performing general anesthesia, the anesthesiologist must be informed about the patient's admission of beta-blockers. If it is necessary to cancel the beta-blocker before surgery, this should be done gradually and completed approximately 48 hours before anesthesia.

In case of bronchial asthma or COPD, simultaneous application of bronchodilating agents is indicated. In patients with asthma, an increase in airway resistance is possible, which requires a higher dose of beta.2- adrenomimetics.

Influence on ability to drive motor transport and control mechanisms

During the period of drug treatment, care must be taken in driving and working with technically complex mechanisms.

Amlodipine

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

Treatment: gastric lavage, the appointment of Activated carbon, maintaining the function of the cardiovascular system, monitoring indicators of the function of the heart and lungs, the elevated position of the limbs, control of the BCC and diuresis. Intensive symptomatic therapy. To restore vascular tone, the use of vasoconstrictor drugs (in the absence ofcontraindications to their use); to eliminate the effects of Calcium channel blockade - on / in the introduction of Calcium gluconate. Hemodialysis is not effective.

Bisoprolol

Symptoms: AV blockade, severe bradycardia, marked reduction 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: in the event of an overdose, first of all, you must stop taking the drug and begin supportive symptomatic therapy. With severe bradycardia - in / in the introduction of atropine. If the effect is insufficient, with caution, you can enter a tool with a positive chronotropic effect. Sometimes you may need a temporary setting of an artificial pacemaker.

With a pronounced decrease in blood pressure - in / in the introduction of plasma-substituting solutions and vasopressor drugs. It can also be shown in / in the introduction of glucagon.

In AV blockade, patients should be monitored continuously and receive treatment with beta-adrenomimetics, such as epinephrine. If necessary - staging an artificial pacemaker. With the exacerbation of the course of chronic heart failure in / in the introduction of diuretics, drugs with a positive inotropic effect, as well as vasodilators.

In case of bronchospasm - the appointment of bronchodilators, incl. beta2β-adrenomimetics and / or aminophylline.

When hypoglycemia - in / in the introduction of dextrose (glucose).

Bisoprolol is practically not excreted during dialysis.

Drug interaction

Amlodipine

The simultaneous use of amlodipine with thiazide diuretics, beta-blockers, long-acting nitrates, Nitroglycerin sublingual preparations, NSAIDs, antibiotics and hypoglycemic oral administration is considered safe.

CYP3A4 inhibitors: Amlodipine should be used with caution at the same time as CYP3A4 inhibitors.

Strong and moderate inhibitors of CYP3A4 (for example, protease inhibitors, azoles antifungals, macrolides such as Erythromycin or Clarithromycin, Verapamil or diltiazem) can increase the concentration of amlodipine in the blood plasma to clinically significant values.

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

Simvastatin: simultaneous use with amlodipine can lead to an increase in the concentration of Simvastatin in the blood plasma. Patients taking amlodipine are not recommended to use simvastatin at a dose of more than 20 mg / day.

Grapefruit juice, cimetidine, aluminum / Magnesium (as part of antacids) and Sildenafil do not affect the pharmacokinetics of amlodipine.

Amlodipine may enhance the antihypertensive effect of other antihypertensive drugs.

Amlodipine does not affect the pharmacokinetics of Atorvastatin, Digoxin, ethanol (alcohol-containing beverages), Warfarin, or cyclosporine.

Amlodipine has no effect on laboratory performance.

Bisoprolol

Combinations not recommended

BMCC type verapamil and, to a lesser extent, diltiazem, while used with bisoprolol can lead to a decrease in myocardial contractility, marked reduction in blood pressure and impaired AV conduction. In particular, in / in the introduction of verapamil to patients taking beta-blockers, can lead to severe arterial hypotension and AV-blockade.

Antihypertensive agents of central action (such as clonidine, methyldopa, Moxonidine, rilmenidine), while used 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 cancellation, especially before the abolition of beta-blockers, may increase the risk of ricochet hypertension.

Combinations that require caution

BCCA dihydropyridine derivatives (for example, nifedipine) when used concomitantly with bisoprolol may increase the risk of arterial hypotension. In patients with chronic heart failure, the risk of a subsequent deterioration of the contractile function of the heart cannot be excluded.

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, Lidocaine, phenytoin, flecainide, propafenone), while used with bisoprolol, can reduce AV conductivity and myocardial contractility.

Class III antiarrhythmic drugs (eg, amiodarone) may exacerbate the disturbance of AV conduction.

Parasympathomimetics with simultaneous use with bisoprolol may increase the violation of AV-conductivity and increase the risk of developing bradycardia.

The action of beta-blockers for local use (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lower blood pressure, decrease in heart rate).

The hypoglycemic effect of insulin or hypoglycemic agents for oral administration may increase. Signs of hypoglycemia - in particular, tachycardia - may be masked. Such interactions are more likely when using non-selective beta-blockers.

Funds for general anesthesia may weaken reflex tachycardia and increase the risk of arterial hypotension.

Cardiac glycosides when used simultaneously with bisoprolol can lead to an increase in the duration of the impulse and to the development of bradycardia.

NSAIDs can reduce the antihypertensive effect of bisoprolol.

The simultaneous use of bisoprolol with beta-adrenomimetics (for example, isoprenaline, dobutamine) can reduce the effect of both drugs.

The combination of bisoprolol with adrenomimetics that affect the α- and β-adrenergic receptors (for example, norepinephrine, epinephrine) can enhance the vasoconstrictor effects of these agents that occur with the participation of α-adrenergic receptors, leading to an increase in blood pressure.Such interactions are more likely when using non-selective beta-blockers.

Antihypertensive drugs, as well as other agents with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines) can enhance the antihypertensive effect of bisoprolol.

Combinations to Consider

Mefloquine when used concomitantly with bisoprolol may increase the risk of developing bradycardia.

MAO inhibitors (with the exception of MAO B inhibitors) can enhance the antihypertensive effect of beta-blockers. Simultaneous use can also lead to the development of hypertensive crisis.

Rifampicin slightly shortens T1/2 bisoprolol. As a rule, dose adjustment is not required.

Derivatives of ergotamine, while used with bisoprolol, increase the risk of developing impaired peripheral circulation.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.