Aritel

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 78 rubles.

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Aritel is a drug with β-adrenergic blocking, hypotensive, antianginal action.

Release form and composition

Dosage form Aritel - film-coated tablets: biconvex, round, light orange; the inner layer in the cross section is almost white (7 pcs. in blister packs, in a cardboard bundle of 2 or 4 packs; 10 pcs. in blister packs, in a cardboard bundle of 3, 5 or 10 packs; 28 pcs. in blisters, in a cardboard box, 1 or 2 packs; 30 pcs. in a blister, in a cardboard box, 1-3 packs).

Composition of 1 tablet:

active substance: bisoprolol - 5 or 10 mg (in the form of fumarate);
auxiliary components (5/10 mg): potato starch - 24/36 mg; colloidal silicon dioxide (aerosil) - 1.8 / 2.7 mg; magnesium stearate - 0.6 / 0.9 mg; milk sugar (lactose monohydrate) - 63.1 / 91.7 mg; povidone - 4.5 / 6.7 mg; microcrystalline cellulose - 21/32 mg;
film shell: selecoat AQ-02140 - 6/9 mg (hydroxypropyl methylcellulose (hypromellose) - 3.3 / 4.95 mg; polyethylene glycol 400 (macrogol 400) - 0.54 / 0.81 mg; polyethylene glycol 6000 (macrogol 6000) - 0.84 / 1.26 mg; titanium dioxide - 1.278 / 1.917 mg; sunset yellow dye - 0.042 / 0.063 mg).

Indications for use

arterial hypertension;
chronic heart failure (CHF);
attacks of stable angina pectoris with ischemic heart disease (prevention).

Contraindications

Absolute:

cardiogenic shock;
collapse;
acute heart failure;
atrioventricular block II-III degree (without electrostimulator);
chronic heart failure in the stage of decompensation, requiring inotropic therapy;
sick sinus syndrome;
sinoatrial blockade;
arterial hypotension (systolic blood pressure (BP) <90 mm Hg);
severe bradycardia (with a heart rate (HR) up to 50 beats / min);
metabolic acidosis;
severe bronchial asthma;
pheochromocytoma (without the combined use of α-blockers);
Raynaud's syndrome / severe peripheral circulatory disorders;
chronic obstructive pulmonary disease in severe course;
combined use with monoamine oxidase (MAO) inhibitors (except MAO type B);
combined use with floktaphenin and sultopride;
lactose intolerance, lactase deficiency, galactose / glucose malabsorption syndrome;
age up to 18 years (the safety profile for this category of patients has not been studied);
lactation period (the safety profile for this category of patients has not been studied);
hypersensitivity to the components of the drug, as well as to other β-blockers.

Relative (Aritel is prescribed with caution in such diseases / conditions):

Prinzmetal's angina;
pheochromocytoma (when combined with α-blockers);
hyperthyroidism;
type 1 diabetes mellitus and diabetes mellitus, occurring with significant fluctuations in the concentration of glucose in the blood;
congenital heart defects / heart valve disease with severe hemodynamic disturbances;
atrioventricular block I degree;
severe functional disorders of the liver;
severe renal failure (creatinine clearance less than 20 ml / min);
psoriasis;
restrictive cardiomyopathy;
chronic heart failure with myocardial infarction over the past 3 months;
adherence to a strict diet;
conducting desensitizing treatment.

For pregnant women, Aritel is prescribed only after evaluating the benefit-risk ratio (the effect of therapy on fetal development is possible).

Method of administration and dosage

Aritel is taken orally in the morning. Food intake does not affect the effectiveness of the drug. The tablets should be taken with sufficient liquid. They should not be ground into powder or chewed.

Frequency rate of taking Aritel - 1 time per day.

Chronic heart failure

A prerequisite for the appointment of Aritel is stable chronic heart failure, proceeding without signs of exacerbation.

At the beginning of therapy, a special titration phase and regular monitoring by a specialist are indicated. Individual adaptation may be required depending on tolerance: increasing the dose is possible only if the previously prescribed dose is well tolerated.

In order to ensure an appropriate titration process, the use of Aritel in lower doses is recommended at the initial stages of therapy.

The recommended dosage regimen is the initial dose with a gradual (break - at least 14 days) increase, in case of good tolerance: 1.25 / 2.5 / 3.75 / 5 / 7.5 / 10 mg. With poor tolerance of increasing the dose, it may be reduced.

The maximum dose per day is 10 mg.

During the titration period, it is recommended to carry out regular monitoring of heart rate, blood pressure and symptoms indicating an increase in the severity of CHF (it can be observed from the first day of using Aritel).

The titration phase and the period after its end may be accompanied by a worsening of CHF, arterial hypotension or bradycardia. In such cases, it is recommended, first of all, to adjust the dose of concomitant therapy drugs, sometimes in combination with reducing the dose of Aritel or discontinuing treatment.

After stabilization of the condition, it is necessary to re-titrate the dose or continue therapy.

Ischemic heart disease (prevention of attacks of stable angina pectoris) and arterial hypertension

The initial daily dose is 5 mg. If necessary, it can be increased to 10 or 20 (maximum) mg.

The dosage regimen in all cases is selected individually based on the individual characteristics and condition of the patient.

Correction of the regimen of taking the drug in case of impaired liver / kidney function of moderate or mild degree is usually not required.

It is possible to use another dosage form of bisoprolol (2.5 mg tablets).

The maximum daily dose for severe functional impairment of the kidneys (with creatinine clearance less than 20 ml / min) and severe liver disease is 10 mg. For such patients, the dose is increased, taking special care.

There are insufficient data on the use of Aritel in CHF, occurring with type 1 diabetes mellitus, restrictive cardiomyopathy, severe functional disorders of the liver / kidneys, hemodynamically caused heart disease, congenital heart defects, as well as myocardial infarction over the past 3 months.

Side effects

Possible adverse reactions (very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1 / 1000); very rare (<1/10 000, taking into account individual cases):

cardiovascular system: very often - bradycardia (treatment of CHF); often - aggravation of symptoms of the course of CHF (treatment of CHF), a feeling of numbness / coldness in the extremities, a marked decrease in blood pressure (especially in the treatment of CHF); infrequently - orthostatic hypotension, violation of atrioventricular conduction, bradycardia (treatment of arterial hypertension / angina pectoris), aggravation of symptoms of CHF (treatment of arterial hypertension / angina pectoris);
respiratory system: infrequently - bronchospasm in patients with airway obstruction or bronchial asthma (anamnestic data); rarely - allergic rhinitis;
nervous system: infrequently - headache, dizziness; rarely - loss of consciousness;
hematopoietic system: in some cases - agranulocytosis, thrombocytopenia;
urinary system: rarely - renal colic, cystitis, polyuria;
digestive system: often - diarrhea, nausea, vomiting, constipation; rarely - hepatitis;
psyche: infrequently - insomnia, depression; rarely - hallucinations, nightmares;
reproductive system: rarely - weakening of libido, impaired potency, Peyronie's disease;
musculoskeletal system: infrequently - muscle cramps, muscle weakness;
skin: rarely - hypersensitivity reactions (in the form of itching, rash, hyperemia of the skin); very rarely - alopecia; possible exacerbation of symptoms of the course of psoriasis or the appearance of a psoriasis-like rash;
organ of sight and hearing: rarely - hearing impairment, decreased lacrimation; very rarely - conjunctivitis;
laboratory parameters: rarely - an increase in the concentration of triglycerides and the activity of hepatic transaminases in the blood (alanine aminotransferase, aspartate aminotransferase);
effect on the fetus: hypoglycemia, intrauterine growth retardation, bradycardia;
others: often - asthenia (treatment of CHF), increased fatigue; infrequently - asthenia (treatment of arterial hypertension / angina pectoris).

special instructions

Abruptly interrupt therapy and independently, without medical advice, do not change the prescribed dose, as this can lead to a short-term deterioration in the activity of the heart. Abrupt discontinuation of Aritel, especially in patients with coronary heart disease, is not recommended. If it is necessary to stop treatment, the dose should be reduced gradually.

During the period of therapy, monitoring of the condition of patients is shown, including observation of heart rate and blood pressure (first - every day, then - once every 3-4 months), ECG, blood glucose concentration against the background of diabetes mellitus (once every 4-5 months), as well as renal function (for elderly patients; 1 time in 4-5 months). With a heart rate of less than 50 beats / min, you need to consult a specialist.

With a burdened bronchopulmonary anamnesis, a study of the function of external respiration is recommended before starting therapy.

The effectiveness of Aritel in smoking patients is lower.

In about 20% of cases, treatment with angina pectoris is ineffective. Possible causes: severe coronary atherosclerosis with a low ischemic threshold (heart rate up to 100 beats / min) and an increased end-diastolic volume of the left ventricle, which disrupts subendocardial blood flow.

During the period of therapy, the production of tear fluid may decrease, which must be taken into account when using contact lenses.

With pheochromocytoma, there is a likelihood of paradoxical arterial hypertension (in cases where effective α-blockade has not been achieved in advance).

In patients with hyperthyroidism, Aritel therapy can mask certain clinical symptoms of the disease, for example, tachycardia. Abrupt withdrawal of treatment in such patients is contraindicated, since the likelihood of increased symptoms is high.

The use of the drug in diabetes mellitus is capable of masking tachycardia associated with hypoglycemia. Aritel practically does not increase the hypoglycemia caused by insulin, and does not delay the restoration of blood glucose to normal values.

In the case of combined use with clonidine, its reception can be stopped only a few days after the withdrawal of Aritel.

With a burdened allergic history, there may be no effect from the use of usual doses of adrenaline (epinephrine) and there may be an increase in the manifestations of hypersensitivity reactions.

When elective surgery is required, Aritel should be canceled 48 hours before general anesthesia. If the patient took the drug before the operation, for general anesthesia it is necessary to select the drug with the least negative inotropic effect. The anesthesiologist must be informed about the drug taken.

The reciprocal activation of the vagus nerve can be eliminated by the administration of atropine (intravenously at a dose of 1-2 mg).

Strengthening the action of Aritel is possible when combined with drugs that lower the reserves of catecholamines (including reserpine). In this regard, the condition of patients taking such a combination must be monitored in order to detect bradycardia or arterial hypotension. With bronchospastic diseases, it is possible to prescribe cardioselective adrenergic blockers in cases of ineffectiveness / intolerance to other antihypertensive drugs, however, the prescribed dosage regimen must be strictly observed. In case of an overdose, there is a possibility of bronchospasm.

Elderly patients in cases of developing bradycardia (less than 50 beats / min), arterial hypotension (systolic pressure below 100 mm Hg), AV blockade, ventricular arrhythmias, bronchospasm, severe renal / liver dysfunction is shown to reduce the dose or cancel therapy … Also, the abolition of Aritel is necessary in the event of depression associated with the ongoing therapy.

Due to the likelihood of severe arrhythmias and myocardial infarction, Aritel cannot be abruptly canceled. The treatment should be completed gradually, decreasing the dose every 3-4 days by 25%.

Before conducting a study of the content in urine and blood of normetanephrine, catecholamines and vanillyl mandelic acid, the drug must be canceled.

While taking Aritel, patients are advised to be careful when driving vehicles and work, the performance of which requires an increased concentration of attention and rapid psychomotor reactions.

Drug interactions

With the combined use of Aritel with certain drugs / substances, various effects may develop.

Contraindicated combinations:

sultopride: the likelihood of ventricular arrhythmia;
floctafenin: interfering with compensatory cardiovascular reactions in hypotension associated with its intake.

Combinations that require special care:

class I antiarrhythmic drugs (flecainide, disopyramide, quinidine, lidocaine, phenytoin, propafenone): decrease in AV conduction and myocardial contractility in the treatment of stable angina pectoris, arterial hypertension;
class III antiarrhythmic drugs (amiodarone): increased AV conduction disorders;
blockers of slow calcium channels, dihydropyridine derivatives (felodipine, nifedipine, amlodipine): increasing the likelihood of arterial hypotension in the treatment of chronic heart failure, stable angina pectoris, arterial hypertension; with CHF, the likelihood of a subsequent deterioration in the contractile function of the heart cannot be ruled out;
local β-adrenergic blockers (eye drops for the treatment of glaucoma): increased systemic action of bisoprolol (in the form of lowering blood pressure, slowing heart rate);
parasympathomimetics: an increase in AV conduction disorders and an increase in the likelihood of bradycardia;
insulin, oral hypoglycemic agents: enhancement of their action, while suppression or masking of signs of hypoglycemia (in particular, tachycardia) is noted;
drugs for general anesthesia: an increase in the likelihood of a cardiodepressant effect and, as a consequence, the development of arterial hypotension;
cardiac glycosides: an increase in the duration of the impulse and, as a result, the occurrence of bradycardia;
non-steroidal anti-inflammatory drugs: reducing the hypotensive effect of bisoprolol;
β-adrenergic agonists (isoprenaline, dobutamine): decrease in the effectiveness of both drugs;
adrenergic agonists that affect α- and β-adrenergic receptors (norepinephrine, epinephrine): increased vasoconstrictor action of these drugs, which occurs with the participation of α-adrenergic receptors, increased blood pressure;
antihypertensive drugs, other drugs with a possible hypotensive effect (barbiturates, tricyclic antidepressants, phenothiazines): increasing the hypotensive effect of bisoprolol;
mefloquine: increased likelihood of bradycardia;
MAO inhibitors (except type B): increased hypotensive action of Aritel, the occurrence of a hypertensive crisis.

Combinations not recommended:

class I antiarrhythmic drugs (lidocaine, quinidine, disopyramide, flecainide, phenytoin, propafenone): decrease in AV conduction and cardiac contractility in the treatment of chronic heart failure;
centrally acting antihypertensive drugs (methyldopa, clonidine, rilmenidine, moxonidine): a decrease in heart rate, a decrease in cardiac output, the development of vasodilation due to a decrease in central sympathetic tone; abrupt withdrawal, especially before the withdrawal of β-blockers, may increase the risk of rebound arterial hypertension;
blockers of slow calcium channels such as verapamil and, to a lesser extent, diltiazem: a decrease in myocardial contractility and the occurrence of AV conduction disorders in the treatment of arterial hypertension, chronic heart failure, stable angina pectoris (in particular, verapamil, when administered intravenously, to patients taking β-blockers to the development of AV blockade and severe arterial hypotension).

Analogs

Aritel's analogues are: Coronal, Aritel Cor, Bisogamma, Bidop, Condinorm, Biprol, Bisokard, Bisomor, Bisoprolol, Concor, Biol, Concor, Corbis, Concor Cor, Cordinorm Cor, Tirez, Niperten.

Terms and conditions of storage

Store in a dark, dry place, out of reach of children, at temperatures up to 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Aritel: prices in online pharmacies

Drug name

Price

Pharmacy

Aritel 5 mg film-coated tablets 30 pcs.

RUB 78

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Aritel Cor 2.5 mg film-coated tablets 30 pcs.

RUB 80

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Aritel 10 mg film-coated tablets 30 pcs.

RUB 90

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!