Bisoprolol-Teva 5 mg 50 tablets — Made in Germany — Free Delivery

(Bisoprolol-Teva)
Bisoprolol-Teva 5 mg 50 tablets — Made in Germany — Free Delivery
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TEVA Brand: TEVA

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Description Bisoprolol-Teva 5 mg 50 tablets — Made in Germany — Free Delivery

Pharmacological properties

Pharmacodynamics.
The maximum effect of bisoprolol occurs 3-4 hours after administration. The plasma half-life is 10-12 hours, which leads to 24-hour efficacy after a single dose of the preparation. The maximum antihypertensive effect is achieved after 2 weeks of administration.

Pharmacokinetics.

After oral administration, the preparation is well absorbed from the gastrointestinal tract. The effect of the first passage through the liver is not very pronounced, which contributes to high bioavailability - about 90%. Plasma protein binding is approximately 30%. The volume of distribution is 3.5 l / kg. The total clearance of bisoprolol is 15 l / h.
Bisoprolol is excreted from the body in two ways. Approximately 50% is metabolized in the liver with the formation of inactive metabolites, which are excreted by the kidneys. The remaining 50% is excreted unchanged by the kidneys. After approximately the same participation of the kidneys and liver in the elimination of this preparation , patients with renal or hepatic insufficiency do not need to adjust the dose. The kinetics of bisoprolol is linear and does not depend on age.

Indications

Arterial hypertension
  • ischemic heart disease (angina pectoris)
  • chronic heart failure with left ventricular systolic dysfunction in combination with ACE inhibitors, diuretics, and, if necessary, cardiac glycosides.

Contraindications

Hypersensitivity to bisoprolol or other components of the preparation:
  • acute heart failure or heart failure in a state of decompensation requiring inotropic therapy
  • cardiogenic shock
  • blockade II and III degree
  • sick sinus syndrome
  • pronounced sinoatrial blockade
  • bradycardia with a heart rate of less than 60 beats per minute before starting therapy
  • arterial hypotension (systolic blood pressure below 100 mm Hg)
  • severe bronchial asthma or severe chronic obstructive pulmonary disease,
  • late stages of peripheral circulatory disorders and Raynaud's syndrome
  • metabolic acidosis
  • pheochromocytoma, not treated
  • a combination of floktaphenin and sultopride.

Interaction

Combinations are contraindicated.

Floktaphenin: β-blockers can exacerbate compensatory cardiovascular reactions due to arterial hypotension and shock, which may result from the use of floktaphenin.

Sultopride: bisoprolol should not be used concomitantly with sultopride due to the increased risk of ventricular arrhythmia.

Combinations not recommended.

Treatment of chronic heart failure.

Class I antiarrhythmics (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone): negative effect on AV conduction and inotropic myocardial function.

All indications.

Centrally acting antihypertensive preparations (clonidine, methyldopa, guanfacine, moxinidine, rilmenidine): increased risk of reflex hypertension, as well as a significant slowdown in heart rate, possibly inhibition of AV conduction, worsening heart failure. With combination therapy, abrupt withdrawal of these agents may increase the risk of reflex hypertension.

Combinations should be used with caution.

Treatment of arterial hypertension or coronary heart disease (angina pectoris).

Class I antiarrhythmic preparations (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone): negative effects on AV conduction and inotropic myocardial function.

All indications.

Class III antiarrhythmic preparations (eg amiodarone): negative effect on AV conduction.

Calcium antagonists (dihydropyridine derivatives, such as nifedipine, felodipine, amlodipine): may increase the risk of arterial hypotension and the risk of heart failure. The possibility of an increase in the negative effect on the inotropic function of the myocardium in patients with heart failure is not excluded.

Anticholinesterase agents (including tacrine): increased AV conduction and increased risk of bradycardia.

Cardiac glycosides (digitalis preparations): reduce heart rate, increase AV conduction time.

Anesthetic agents: increase the risk of suppression of myocardial function and the development of arterial hypotension.

Non-steroidal anti-inflammatory preparations (NSAIDs): reduce the hypotensive effect of bisoprolol.

Ergotamine derivatives: exacerbation of peripheral circulatory disorders.

Tricyclic antidepressants, barbiturates, phenothiazines and other antihypertensive preparations: increase the risk of hypotension.

Baclofen: increased antihypertensive activity.

Amifostine: increased hypotensive activity.

Parasympathomimetics: AV conduction time may increase and the risk of bradycardia increases.

Antihypertensive preparations (eg tricyclic antidepressants, barbiturates, phenothiazine): increase the risk of arterial hypotension.

Combinations are allowed.

Mefloquine: increased risk of bradycardia.

Corticosteroids: the antihypertensive effect may decrease due to water and sodium retention in the body.

Application features

The preparation should be used with caution in patients with the following conditions:

  • bronchospasm (bronchial asthma, chronic obstructive pulmonary disease) requires concomitant therapy with bronchodilators. In patients with bronchial asthma, an increase in the tone of the airways is possible, which may require an increase in the dose of b 2 -sympathomimetics. Before starting treatment, it is recommended to conduct a study of the function of external respiration in patients with a history of bronchial asthma.
  • diabetes mellitus with sharp fluctuations in blood glucose levels due to the possibility of masking symptoms of hypoglycemia
  • thyrotoxicosis due to the possibility of masking adrenergic symptoms (tachycardia, palpitations, excessive sweating)
  • strict diet
  • during desensitization. Like other b-blockers, bisoprolol can increase sensitivity to allergens and increase anaphylactic reactions. Treatment with adrenaline does not always provide the expected therapeutic effect
  • blockade I degree
  • peripheral circulatory disorders, including with Raynaud's disease or intermittent claudication: complaints may increase, especially at the beginning of therapy,
  • patients with pheochromocytoma can be prescribed bisoprolol only after therapy with a-blockers
  • patients with psoriasis (including a family history) should be prescribed bisoprolol only after a thorough assessment of the benefit / risk ratio
  • simultaneous treatment with anticholinesterase preparations (including tacrine): this can increase the time of atrioventricular conduction and / or increase bradycardia
  • current desensitizing therapy.

At the beginning of treatment, it is necessary to monitor patients, especially elderly patients. Treatment should not be stopped abruptly if there is no clear indication for this. If patients with coronary artery disease are suddenly stopped from treatment, there is a risk of myocardial infarction and sudden death. If necessary, preparation therapy should be completed slowly, gradually reducing the dose.

Currently, there is not enough therapeutic experience in the treatment of chronic heart failure in patients with such diseases and pathological conditions: type I diabetes mellitus, severe renal dysfunction, severe liver dysfunction, restrictive cardiomyopathy, congenital heart defects, hemodynamically significant acquired valvular heart disease, heart attack myocardium in the last 3 months.

The combination with amiodarone is not recommended, given the risk of contractility automatism and cardiac conduction disorders (suppression of compensatory sympathetic responses).

When using bisoprolol, a positive result may be observed during doping control.

If necessary, preparation therapy should be completed slowly, gradually reducing the dose.

The preparation contains lactose, so it should not be prescribed to patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

Use during pregnancy or lactation

The ability to influence the reaction rate when driving or driving other mechanisms

In some cases, at the beginning of treatment, when changing the preparation, as well as when interacting with alcohol, the ability to drive a car and other mechanisms may be reduced.

Method of administration and dosage

The tablets are intended for oral administration.

Arterial hypertension ischemic heart disease (angina pectoris).

The recommended dose is 5 mg per day. In the case of moderate hypertension (diastolic pressure up to 105 mm Hg), a dose of 2.5 mg is suitable.

If necessary, the dose can be increased to 10 mg per day. The maximum recommended dose is 20 mg per day.

The dose change and adjustment are set individually depending on the patient's condition.

Bisoprolol must be used with caution in patients with arterial hypertension or ischemic heart disease, accompanied by heart failure.

Chronic heart failure with left ventricular systolic dysfunction in combination with ACE inhibitors, diuretics, and, if necessary, cardiac glycosides.

Bisoprolol is prescribed for the treatment of patients with chronic heart failure without signs of exacerbation.

Treatment of chronic heart failure with bisoprolol begins in accordance with the titration scheme presented below and can be adjusted depending on the individual reactions of the body.

1.25 mg * bisoprolol fumarate 1 time per day for 1 week, increasing to

2.5 mg * bisoprolol fumarate 1 time per day for the next 1 week, increasing to

3.75 mg * bisoprolol fumarate 1 time per day for the next 1 week, increasing to

5 mg bisoprolol fumarate once a day for the next 4 weeks, increasing to

7.5 mg bisoprolol fumarate once a day for the next 4 weeks, increasing to

10 mg bisoprolol fumarate 1 time per day as maintenance therapy.

* Apply bisoprolol in an appropriate dosage.

The maximum recommended dose of bisoprolol fumarate is 10 mg once a day.

At the beginning of treatment for persistent chronic failure, regular monitoring is necessary. During the titration phase, it is necessary to monitor the following vital signs (blood pressure, heart rate) and symptoms of progression of heart failure.

Treatment modification.

If during the titration phase or after it worsens heart failure, arterial hypotension or bradycardia develops, a dose adjustment of the preparation is recommended, which may require a temporary reduction in the dose of bisoprolol or, possibly, suspension of treatment. After stabilization of the patient's condition, treatment should be continued.

The course of treatment is long.

You should not stop treatment suddenly and change the recommended dose without consulting your doctor, as this may worsen the patient's condition. If necessary, treatment should be completed slowly, gradually reducing the dose.

Patients with impaired renal and liver function

Arterial hypertension ischemic heart disease.

Chronic heart failure.

There are no data on the pharmacokinetics of bisoprolol in patients with chronic heart failure simultaneously with impaired liver and / or kidney function, therefore, the dose should be increased with caution.

For elderly patients, dose adjustment of bisoprolol is not needed. However, it is recommended to start taking the preparation with the lowest possible dose.

Children

There is no experience with the preparation in children, so its use is not recommended.

Overdose

Symptoms: bradycardia, arterial hypotension, acute heart failure, bronchospasm, hypoglycemia. There is wide variability in individual sensitivity to a single high dose of bisoprolol; patients with heart failure may be more sensitive to the preparation.

In case of overdose, consult a doctor immediately.

In case of an overdose, cases of the development of AV block of the III degree and dizziness were also recorded.

Treatment: stop taking the preparation and carry out supportive and symptomatic treatment. There is limited evidence that bisoprolol is difficult to dialysis.

Artificial respiration may be indicated if necessary to monitor respiratory function.

With atrioventricular block II and III degree: infusion of isoprenaline, if necessary - pacemaker.

Deterioration in heart failure: the introduction of diuretics, vasodilators.

With bradycardia: administration of atropine. If there is no reaction, isoprenaline or another preparation with a positive chronotropic effect should be administered with caution. In exceptional cases, introduce an artificial pacemaker.

With arterial hypotension: taking vasoconstrictor preparations and plasma substitutes, the introduction of glucagon.

With hypoglycemia: intravenous glucose.

Adverse Reactions

On the part of the immune system: the appearance of antinuclear antibodies with specific clinical symptoms such as lupus-like syndrome disappeared after discontinuation of treatment.

From the side of the psyche: sleep disturbances, depression, nightmares, hallucinations.

Metabolic disorders: increased triglyceride levels in the blood, hypoglycemia.

From the nervous system: increased fatigue, exhaustion, dizziness * headache *, loss of consciousness.

From the side of the organs of vision: decreased tear production (should be considered when wearing contact lenses), conjunctivitis.

From the side of the hearing organs: hearing impairment.

From the side of the heart: bradycardia, violation of AV conduction, the appearance / strengthening of signs of heart failure.

From the side of the vessels: a feeling of coldness or numbness of the extremities, arterial hypotension (especially in patients with heart failure), worsening of the course of Raynaud's disease, increased existing intermittent claudication, orthostatic hypotension.

From the respiratory system: bronchospasm in patients with bronchial asthma or chronic obstructive pulmonary disease in history, allergic rhinitis.

From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain, constipation.

From the liver: increased liver enzymes (ALT, AST) in the blood plasma, hepatitis.

From the musculoskeletal system: muscle weakness, convulsions, arthropathy.

On the part of the reproductive system: violation of potency.

General disorders: increased fatigue *, asthenia.

Laboratory tests: increased levels of triglycerides, liver enzymes (ALT, AST) *.

* Applies only to patients with hypertension or coronary artery disease. These symptoms usually appear at the beginning of therapy, are mild and disappear within the first 1-2 weeks.

In case of side effects or adverse reactions, you must immediately inform your doctor.

Shelf life

3 years.

Tags: Bisoprolol

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