bisoprolol | Coronal tablets 5 mg, 30 pcs.

Release form

Tablets.

Packing

30 pcs

Indications

- arterial hypertension

- CHD: prevention of angina attacks.

Contraindications

- shock (including especially with myocardial infarction)

- bronchial asthma and chronic obstructive pulmonary disease with a history of

- concomitant use of MAO inhibitors (except for type B MAO inhibitors)

- late stages of peripheral circulation disturbance

- Raynaud's disease

- pheochromocytoma blockers)

- metabolic acidosis

- under the age of 18 years (efficacy and safety have not been established)

- hypersensitivity to the drug and other beta-blockers oram.

Special instructions

When prescribing Coronal, heart rate and blood pressure should be regularly monitored (at the beginning of treatment daily, then 1 time every 3-4 months), an ECG should be performed, blood glucose levels should be determined in patients with diabetes mellitus (1 time every 4- 5 months). In elderly patients, it is recommended to monitor renal function (1 time in 4-5 months).

The patient should be trained in the method of calculating heart rate and instructed on the need for medical advice for heart rate less than 50 bpm.

Before starting treatment, it is recommended to study the function of external respiration in patients with a history of bronchopulmonary burden.

Please note that in approximately 20% of patients with angina pectoris, beta-blockers are ineffective due to severe coronary atherosclerosis with a low threshold of ischemia (heart rate less than 100 beats / min) and an increased final diastolic volume of the left ventricle that violates subendocardial blood flow.

Beta-blockers are less effective in smokers.

Patients using contact lenses should consider that tear fluid production may be reduced during treatment.

When using Coronal in patients with pheochromocytoma, there is a risk of developing paradoxical hypertension (unless effective alpha-adrenoblockade is previously achieved).

Bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt abolition of Coronal in patients with thyrotoxicosis is contraindicated, because it can enhance the symptoms of the disease.

In diabetes mellitus, bisoprolol may mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose concentrations to normal levels.

With the simultaneous administration of clonidine, its administration can be stopped only a few days after the cancellation of the drug Coronal.

It is possible to increase the severity of the hypersensitivity reaction and the lack of effect of the usual doses of epinephrine against the background of a burdened allergic history.

If it is necessary to carry out planned surgical treatment, drug withdrawal is carried out 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should choose a drug for general anesthesia with minimal negative inotropic effect.

Reciprocal vagus nerve activation can be eliminated iv by administration of atropine (1-2 mg).

Medicines that reduce the reserves of catecholamines (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia.

Patients with concomitant bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. An overdose is dangerous for the development of bronchospasm.

In the case of elderly patients with increasing bradycardia (less than 50 beats / min), a pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), AV block, it is necessary to reduce the dose or stop treatment.

It is recommended that therapy be discontinued if depression develops.

The drug should be discontinued before conducting a study of blood and urine levels of catecholamines, normetanephrine, vanillinindic acid, and antinuclear antibody titers.

Do not abruptly interrupt treatment because of the danger of developing severe arrhythmias and myocardial infarction. Cancellation is carried out gradually, reducing the dose for 2 weeks or more (the dose is reduced by 25% in 3-4 days).

Use in pediatrics

The use of the drug Coronal in children under 18 years of age is contraindicated, since efficacy and safety have not been established.

Effect on the ability to drive vehicles and control mechanisms

During treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Composition

1 tablet contains 5 mg of bisoprolol fumarate

Excipients: microcrystalline cellulose, corn starch, sodiumI lauryl sulfate, colloidal silicon dioxide anhydrous, magnesium stearate.

Dosage and administration

The drug is prescribed orally 2.5-5 mg 1 time / day. If necessary, increase the dose to 10 mg 1 time / day. The maximum daily dose is 20 mg.

In patients with impaired renal function with CC <20 ml / min or with severe impaired liver function, the maximum daily dose is 10 mg.

Tablets should be taken in the morning on an empty stomach, without chewing.

Side effects

The frequency of occurrence of side effects is defined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely ( ? 1/10 000 and <1/1000), very rarely (<1/10 000, including individual messages).

From the side of the central nervous system and peripheral nervous system: infrequently - increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression rarely - hallucinations, nightmares, convulsions.

From the sensory organs: rarely - impaired vision, decreased secretion of lacrimal fluid, dry and sore eyes, hearing impairment is very rare - conjunctivitis.

From the cardiovascular system: very often - sinus bradycardia often - decrease in blood pressure, manifestation of angiospasm (increased disturbance of peripheral circulation, cooling of the lower extremities, paresthesia) infrequently - impaired AV conduction, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema.

From the digestive system: often - dry mucous membranes of the oral cavity, nausea, vomiting, diarrhea, constipation rarely - hepatitis, increased activity of hepatic transaminases.

From the respiratory system: infrequently - difficulty breathing when prescribed in high doses (loss of selectivity) and / or in predisposed patients - laryngo- and bronchospasm rarely - nasal congestion, allergic rhinitis.

From the endocrine system: rarely - hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients, receiving insulin).

Allergic reactions: rarely - skin itching, rash, urticaria.

Dermatological reactions: rarely - increased sweating, skin hyperemia very rarely - psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

From the musculoskeletal system: infrequently - muscle weakness, cramps in the calf muscles, arthralgia.

From the hemopoietic system: in some cases - thrombocytopenia, agranulocytosis.

Other: rarely - hypertriglyceridemia very rarely - impaired potency, rarely - withdrawal syndrome (increased angina attacks, increased blood pressure).

Drug Interactions

Allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.

When used simultaneously with Coronal, iodine-containing radiopaque drugs for intravenous administration increase the risk of anaphylactic reactions.

With the simultaneous use of phenytoin for iv administration with Coronal, drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of a decrease in blood pressure.

With the simultaneous use of Coronal changes the effectiveness of insulin and oral hypoglycemic drugs, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure).

With simultaneous use, Coronal reduces the clearance of lidocaine and xanthines (except diphillin) and increases their concentration in plasma, especially in patients with initially increased clearance of theophylline under the influence of smoking.

NSAIDs (due to the delay of sodium ions and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to the delay of sodium ions) weaken the hypotensive effect of Coronal.

When used concomitantly with Coronal, cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone, and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV blockade, heart failure, and heart failure.

When used concomitantly with Coronal, nifedipine can lead to a significant decrease in blood pressure.

When used concomitantly with Coronal, diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure.

Coronal prolongs the action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

When used simultaneously with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (antipsychotics), ethanol, sedative and hypnotic drugs increase central nervous system depression.

The simultaneous use of Coronal with MAO inhibitors is not recommended due to a significant increase in the hypotensive effect, the break in treatment between taking MAO inhibitors and Coronal should be at least 14 days.

When used simultaneously with Coronal, non-hydrogenated ergot alkaloids, ergotamine increase the risk of peripheral circulation disorders.

When used concomitantly with Coronal, sulfasalazine increases the plasma concentration of bisoprolol.

When used simultaneously with Coronal, rifampicin shortens the elimination half-life of bisoprolol.

Overdose

Symptoms: arrhythmia, ventricular extrasystole, marked bradycardia, AV blockade, decreased blood pressure, heart failure, cyanosis of finger nails or palms, shortness of breath, bronchospasm, dizziness fainting conditions, convulsions.

Treatment: It is necessary to wash the stomach and appoint adsorbing drugs. Conduct symptomatic therapy: with advanced AV blockade - in / in the introduction of 1-2 mg of atropine, epinephrine (epinephrine (adrenaline) or staging of a temporary pacemaker with ventricular extrasystole - in / in lidocaine (drugs of class I A are not used) in reducing blood pressure patient should be in the position of Trendelenburg in the absence of symptoms of pulmonary edema - in / in plasma replacement solutions, with inefficiency - the introduction of epinephrine (adrenaline), dopamine, dobutamine (to maintain chrono- and inotropic action and eliminate pronounced reduction of A ) With cardiac insufficiency - serdechn e glycosides, diuretics, glucagon with convulsions - in / diazepam with bronchospasm - beta2-adrenomymetyky inhalation.

Storage Conditions

At 15 РC to 25 РC.

Shelf life

2 years.

Deystvuyushtee substance

Bisoprolol

Terms and conditions

prescription

Dosage form

tablets

Possible product names

CORONAL 0.005 N30 TABLE P / O

Coronal 5mg tab. p / o X30 (R)

Coronal 5mg tab. p / o X30 (R) /! until 04.09./

Coronal 5mg tab. n / a X30 (R) /! until 09.12g /

Coronal 5mg Tab. p / pl / rev X30 (R)