Bisoprolol-Teva, 5 mg 50 pcs

Pharmacotherapeutic group: Beta1-adrenoblocker selective

ATX code: C07AB07

Pharmacological Properties

Pharmacodynamics

Indications

– Arterial hypertension;

Active ingredient

Composition

1 tablet contains: the active ingredient: bisoprolol fumarate 5.00 or 10.00 mg; excipients: microcrystalline cellulose (21.10/20.00 mg), mannitol (148.50/144.60 mg), croscarmellose sodium (1.80/1.80 mg), magnesium stearate (3.60/3.60 mg); film coating: hypromellose 2.19 mg, titanium dioxide 0.88 mg, macrogol-6000 0.53 mg;

Prepackaged shell “OPADRY® 03F280038 white (60.83% hypromellose, 24.45% titanium dioxide, 14.72% macrogoal-6000).

How to take, the dosage

Interaction

The effectiveness and tolerability of drugs can be affected by the simultaneous use of other drugs. This interaction can also occur when two drugs are taken at short intervals. The physician should be informed about the use of other drugs, even if the use is made without a prescription.

The class I antiarrhythmic drugs (e.g., quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone) when used concomitantly with bisoprolol may decrease AV conduction and myocardial contractility.

The class III antiarrhythmic agents (e.g., amiodarone) may increase AV conduction impairment.

The effects of beta-adrenoblockers for topical use (e.g. eye drops to treat glaucoma) may increase the systemic effects of bisoprolol (BP reduction, heart rate slowing).

Parasympathomimetics when used concomitantly with bisoprololol may increase AV conduction abnormalities and increase the risk of bradycardia.

The concomitant use of Bisoprolol-Teva with beta-adrenomimetics (e.g., isoprenaline, dobutamine) may decrease the effect of both drugs.

The combination of bisoprolol with adrenomimetics affecting beta- and alpha-adrenoreceptors (e.g. norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these agents arising from alpha-adrenoreceptors, leading to increased BP. Such interactions are more likely when using non-selective beta-adrenoblockers.

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

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

Iodine-containing x-ray contrast diagnostic agents for intravenous administration increase the risk of anaphylactic reactions.

Phenytoin when administered intravenously, agents for inhalation anesthesia (hydrocarbon derivatives) increase the severity of cardiodepressant effects and the likelihood of BP reduction.

The effectiveness of insulin and oral hypoglycemic agents may change with bisoprolol treatment (it masks the symptoms of developing hypoglycemia: tachycardia and increased BP).

The clearance of lidocaine and xanthines (except theophylline) may be decreased due to possible increase of their plasma concentrations, especially in patients with initially increased clearance of theophylline due to smoking.

The hypotensive effect is weakened by nonsteroidal anti-inflammatory drugs (NSAIDs) (retention of sodium ions and blockade of prostaglandin synthesis by kidneys), glucocorticosteroids and estrogens (retention of sodium ions).

The cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone and other antiarrhythmic agents increase the risk of developing or worsening bradycardia, AV block, heart failure and heart failure.

Nifedipine can lead to a significant decrease in BP.

Diuretics, clonidine, sympatholytics, hydralazine, and other hypotensive agents can lead to excessive BP reduction.

The effects of nondepolarizing myorelaxants and the anticoagulant effect of coumarins may be prolonged during treatment with bisoprolol.

Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics increase central nervous system depression.

The concomitant use with MAO inhibitors is not recommended due to a significant increase in hypotensive effect. A treatment interval of at least 14 days between MAO inhibitors and bisoprolol should be observed.

Unhydrogenated ergot alkaloids increase the risk of peripheral circulatory disorders.

Ergotamine increases the risk of peripheral circulatory disorders.

Sulfasalazine increases the plasma concentration of bisoprolol.

Rifampicin shortens the half-life of bisoprolol.

Special Instructions

Control of patients taking Bisoprolol-Teva should include measurement of HR and BP, ECG, determination of blood glucose concentration in patients with diabetes mellitus (once every 4-5 months). In elderly patients it is recommended to monitor kidney function (once every 4-5 months).

The patient should be instructed on how to calculate heart rate and instructed to consult a physician if the heart rate is less than 50 bpm.

Patients with a history of bronchopulmonary problems should have an external respiratory function study before starting treatment.

Patients who wear contact lenses should note that there may be a decrease in tear fluid production during treatment with the drug.

In patients with pheochromocytoma, there is a risk of paradoxical arterial hypertension when using Bisoprolol-Teva (unless effective alpha-adrenoreceptor blockade has first been achieved).

In thyrotoxicosis, bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt withdrawal of the drug in patients with thyrotoxicosis is contraindicated because it may exacerbate the symptoms.

In diabetic patients may mask tachycardia caused by hypoglycemia. Unlike non-selective beta-adrenoblockers, it practically does not increase insulin-induced hypoglycemia and does not delay the recovery of blood glucose concentration to normal values.

If clonidine is used concomitantly, its administration may be discontinued only after several days of discontinuation of Bisoprolol-Teva.

The severity of hypersensitivity reactions and lack of effect of usual doses of epinephrine with a history of allergy may increase.

If planned surgical treatment is necessary, the drug should be discontinued 48 hours before general anesthesia. If the patient has taken the drug prior to surgical intervention, the patient should choose a general anesthesia drug with minimal negative inotropic effect.

The reciprocal activation of the vagus nerve may be relieved by intravenous administration of atropine (1-2 mg).

Drugs that deplete catecholamine depots (including reserpine) can potentiate the effects of beta-adrenoblockers, so patients taking these combinations of drugs should be kept under constant medical supervision for signs of marked BP reduction or bradycardia.

Patients with bronchospastic disorders may be prescribed cardioselective beta-adrenoblockers with caution if other hypotensive agents are intolerant and/or ineffective. Against the background of taking beta-adrenoblockers in patients with concomitant bronchial asthma, airway resistance may increase. If the dose of Bisoprolol-Teva is exceeded in such patients, there is a risk of bronchospasm.

If patients show increasing bradycardia (HR less than 50 beats/min), marked BP decrease (systolic BP less than 100 mm Hg), AV blockade, the dose should be reduced or treatment should be stopped.

It is recommended to discontinue therapy with Bisoprolol-Teva if depression develops.

Bisoprolol-Teva should not be stopped abruptly because of the risk of severe arrhythmias and myocardial infarction. The drug should be withdrawn gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% every 3 to 4 days).

The drug should be discontinued before blood and urine concentrations of catecholamines, normetanephrine, vanillin acid, and antinuclear antibody titers are tested.

In smokers, the effectiveness of beta-adrenoblockers is lower.

Impact on ability to drive vehicles and operate machinery requiring increased concentration

The use of Bisoprolol-Teva does not affect the ability to drive according to the results of studies in patients with CHD. However, due to individual reactions the ability to drive vehicles or operate technically complex mechanisms may be impaired. Special attention should be paid to this in the beginning of treatment, after changing the dose, as well as in case of concomitant use of alcohol.

Synopsis

Contraindications

– Hypersensitivity to the components of the drug and other beta-adrenoblockers;

– Acute heart failure and CHF in the decompensation stage, requiring inotropic therapy;

– Cardiogenic shock;

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– collapse;

– atrioventricular (AV) block of degree II-III, without a pacemaker;

– sinoatrial block;

– sinus node weakness syndrome;

– bradycardia (HR less than 60 bpm before treatment.

– significant arterial hypotension (systolic blood pressure less than 100 mm Hg).);

– cardiomegaly (without signs of heart failure);

– a history of severe bronchial asthma and chronic obstructive pulmonary disease (COPD);

– significant peripheral circulatory disorders;

– Raynaud’s syndrome;

– metabolic acidosis;

– pheochromocytoma (without concomitant use of alpha-adrenoblockers);

– concomitant use of monoamine oxidase (MAO) inhibitors (except for MAO type B inhibitors);

– concomitant use of floktafenine and sultopride;

– age less than 18 years (efficacy and safety not established).

WARNING

. Psoriasis, depression (including history), diabetes mellitus (may mask symptoms of hypoglycemia), allergic reactions (history), bronchospasm (history), desensitization therapy, Prinzmetal angina, grade I AV block, severe renal impairment (creatinine clearance (CK) less than 20 ml/min) Severe liver function abnormalities; thyrotoxicosis, advanced age.

Side effects

The incidence of adverse reactions below was determined according to the following (World Health Organization classification): very common – at least 10%; common – at least 1%, but less than 10%; infrequent – at least 0.1%, but less than 1%; rare – at least 0.01%, but less than 0.1%; very rare – less than 0.01%, including individual reports.

Heart and vascular side: very often – reduced HR (bradycardia, especially in patients with CHF); sensation of palpitation, often – marked decrease in BP (especially in patients with CHF), manifestation of angiospasm (increased peripheral circulatory disorders, feeling of cold in the extremities (paresthesias); infrequent – AV conduction disorders (up to complete transverse blockade and cardiac arrest), arrhythmias, orthostatic hypotension, worsening of CHF with development of peripheral edema (edema of ankles, feet, dyspnea), chest pain.

Nervous system disorders:often – dizziness headache, asthenia, fatigue, sleep disorders, depression, anxiety; rarely – confusion or short-term memory loss, “nightmare” dreams, hallucinations, myasthenia, tremor, muscle cramps. Usually these phenomena are mild and usually go away within 1-2 weeks after the start of treatment.

Sensory organs: frequently – visual impairment, decreased tear production (should be considered when wearing contact lenses), tinnitus, decreased hearing, ear pain; very rarely – dry and painful eyes, conjunctivitis, taste disorders.

The respiratory system: infrequent – bronchospasm in patients with bronchial asthma or obstructive airway disease; rare – allergic rhinitis; nasal congestion.

Digestive system disorders: frequently – nausea, vomiting, diarrhea, constipation, dry oral mucosa, abdominal pain; rarely – hepatitis, increased activity of liver enzymes (alanine aminotransferase, aspartate aminotransferase), increased concentration of bilirubin, change in taste.

Musculoskeletal system disorders: infrequent – arthralgia, back pain.

System of the genitourinary system: very rarely – impaired potency, weakened libido.

Laboratory findings: frequently – increased concentration of triglycerides in the blood; in isolated cases – thrombocytopenia, agranulocytosis, leukopenia.

Allergic reactions: frequently – skin itching, rash, urticaria

Skin reactions:seldom – increased sweating, skin hyperemia, exanthema, psoriasis-like skin reactions; very rarely – alopecia, beta-adrenoblockers may aggravate the course of psoriasis.

Others:withdrawal syndrome (increased frequency of angina attacks, increased BP).

Overdose

Pregnancy use

Pregnancy

Bisoprolol has no direct cytotoxic, mutagenic and teratogenic effects, but has pharmacological effects that may have harmful effects on pregnancy and/or the fetus, or the newborn. Typically, beta-adrenoblockers decrease placental perfusion, which leads to fetal growth retardation, intrauterine fetal death, miscarriage, or preterm birth. The fetus and the newborn baby may have pathological reactions such as intrauterine developmental delay, hypoglycemia, and bradycardia.

Bisoprolol-Teva should not be used during pregnancy, use is possible if the benefit to the mother exceeds the risk of side effects in the fetus and/or child. If treatment with Bisoprolol-Teva is considered necessary, the blood flow in the placenta and uterus should be monitored and the growth and development of the unborn child should be monitored, and if adverse effects on pregnancy and/or fetus occur, alternative therapies should be adopted. The newborn should be carefully examined after delivery. Symptoms of hypoglycemia and bradycardia usually occur within the first 3 days of life.

Breastfeeding period

There is no evidence of bisoprolol penetration into breast milk. Therefore, taking the drug Bisoprolol-Teva is not recommended for women while breastfeeding.

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Similarities