Bisoprolol-teva tab n / 5mg film about 30 pc

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Bisoprolol-teva tab n / 5mg film about 30 pc

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Description

Composition
Active substance:
bisoprolol fumarate 5.00 mg
Excipients:
microcrystalline cellulose (21.10 mg), mannitol (148.50 mg), croscarmellose sodium (1.80 mg), magnesium stearate (3.60 mg);
film coating: Hypromellose 2.19 mg titanium dioxide 0.88 mg macrogol 6000 0.53 mg;
allowed in the finished casing «OPADRY® 03F280038 white» (Hypromellose 60.83%, 24.45% titanium dioxide, macrogol-6000 14.72%).
Description:
Round biconvex tablets, film-coated white or almost white, engraved on one side: «BISOPROLOL 5″ (dosage 5 mg).
Product form:
Tablets, film-coated, 5 mg.
10 tablets in a blister from a film of PVC / PVDC and aluminum foil.
3 blisters with instruction for use in a cardboard package.
Contraindications
– Hypersensitivity to the drug and other beta-blockers;
– acute heart failure and chronic heart failure decompensation requiring of inotropic therapy;
– cardiogenic shock;
– collapse;
– atrioventricular (AV) block II-III extent without the pacemaker;
– sinoatrial block;
– sick sinus syndrome;
– bradycardia (heart rate before treatment less than 60 beats / min.);
– marked hypotension (systolic blood pressure less than 100 mm Hg);
– cardiomegaly (without heart failure);
– severe bronchial asthma and chronic obstructive pulmonary disease (COPD) in history;
– The expressed disturbances of peripheral circulation;
– Raynaud’s syndrome;
– metabolic acidosis;
– pheochromocytoma (without simultaneous application of alpha-blockers);
– simultaneous reception of monoamine oxidase inhibitors (MAO) (except MAO-B inhibitors);
– concomitant use floctafenine and sultopride;
– the age of 18 years (effectiveness and safety have been established).
CAREFULLY
Psoriasis, depression (including history), diabetes (may mask symptoms of hypoglycemia), allergic reaction (history), bronchoconstriction (history) holding desensitizing therapy, Prinzmetal angina, AV block I degree expressed by renal dysfunction (creatinine clearance (CC) of less than 20 ml / min); expressed human liver; thyrotoxicosis, advanced age.
Dosage
5 mg
Indications
– Arterial hypertension;
– Ischemic heart disease: prevention of attacks of stable angina.
Interaction with other drugs
The effectiveness and tolerability of drugs may affect the simultaneous use of other drugs. Such interaction may also occur in those cases when the two drugs are taken over a short period of time. The doctor should be informed about the use of other drugs, even if the application is carried out without a prescription.
Class I antiarrhythmics (e.g., quinidine, disopyramide, lidocaine, phenytoin;
flecainide, propafenone), while the use of bisoprolol can reduce AV
conduction and contractility of the myocardium.
Class III antiarrhythmics (e.g., amiodarone) may enhance violation AV
conductivity.
The action of beta-blockers for topical (e.g., eye drops for treating glaucoma) may enhance the systemic effects of bisoprolol (reduction of blood pressure, slowing
HR).
Parasympathomimetics while the use of bisoprolol can exacerbate violation of AV conduction and increase the risk of bradycardia.
Simultaneous use of the drug bisoprolol-Teva with beta-agonists (e.g.,
isoprenaline, dobutamine) may reduce the effect of both drugs.
Bisoprolol combination with agonists affecting the beta- and alpha-adrenergic receptors (such as norepinephrine, epinephrine), may enhance the vasoconstrictor effects of these agents arising with alpha-adrenoceptors, leading to increased blood pressure. Such interactions are more likely to occur when using non-selective beta-blockers.
Mefloquine while the use of bisoprolol may increase the risk of bradycardia.
The 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 radiopaque diagnostic agents for intravenous administration increases the risk of anaphylactic reactions.
Phenytoin intravenous administration, agents for inhalation anesthesia (hydrocarbon derivatives) increase the severity cardiodepressive action and reduce the likelihood of
HELL.
The effectiveness of insulin and hypoglycemic agents for receiving may change inside the treatment with bisoprolol (masking the symptoms of developing hypoglycemia: tachycardia,
increased blood pressure).
The clearance of lidocaine and xanthine (except theophylline) may be reduced due to the possible increase of their plasma concentrations, especially in patients with initially increased clearance of theophylline under the influence of smoking.
The hypotensive effect of weakening the non-steroidal anti-inflammatory drugs (NSAIDs)
(Delay sodium and kidney blockade of prostaglandin synthesis) and glucocorticoids, estrogens (delay sodium ions).
Cardiac glycosides, methyldopa, reserpine and guanfacine blockers “slow” calcium channel blockers (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs increase the risk of developing or worsening of bradycardia, AV block, cardiac arrest and heart failure.
Nifedipine can lead to a significant reduction in blood pressure.
Diuretics, clonidine, sympatholytic, hydralazine, and other antihypertensive agents can lead to excessive reduction in blood pressure.
The action of non-depolarizing muscle relaxants and anticoagulant effect of coumarin during treatment with bisoprolol may lengthen.
Tricyclic and tetracyclic antidepressants, antipsychotics (neuroleptics), ethanol, sedatives and hypnotics enhance central nervous system depression.
Not recommended simultaneous application with MAO inhibitors due to a significant increase in hypotensive action. Break in treatment between reception and bisoprolol MAO inhibitor should not be less than 14 days.
Non-hydrogenated ergot alkaloids increase the risk of peripheral circulatory disorders.
Ergotamine increases the risk of peripheral circulatory disorders.
Sulfasalazine increases the concentration of bisoprolol in blood plasma.
Rifampin shortens the half-life of bisoprolol.
Overdose
Symptoms: arrhythmia, ventricular premature beats, bradycardia, AV block,
marked reduction of blood pressure, congestive heart failure, hypoglycemia, akrozianoz,
shortness of breath, bronchospasm, dizziness, fainting, seizures.
Treatment: in the event of an overdose, it is necessary first of all to stop taking the drug,
to gastric lavage, assign adsorbing agent, a symptomatic therapy.
In severe bradycardia – intravenous administration of atropine. If the effect is insufficient, you can enter with caution agent with positive chronotropic effect.
Sometimes it may require temporary staging an artificial pacemaker.
In marked decrease in blood pressure – intravenous plasma-substituting solutions and vasopressors.
When hypoglycemia can be shown intravenous glucagon or intravenous administration of dextrose (glucose).
When AV blockade: patients should be under constant supervision and be treated with beta-agonists such as epinephrine. If necessary – setting an artificial pacemaker.
During exacerbation flow CHF – intravenous diuretics, drugs with a positive inotropic effect, and vasodilators.
When bronchospasm – appointment of bronchodilators including beta2-agonists and / or aminophylline.
pharmachologic effect
Pharmacological group:
Beta1-selective blocker
Pharmacodynamics:
Bisoprolol – selective beta1-adrenergic blocker, without own sympathomimetic activity, has no membrane stabilizing effect. As with other beta1- blockers mechanism of action in hypertension is unclear. However, it is known that bisoprolol reduces renin activity in blood plasma, reduces myocardial oxygen demand, slows the heart rate (HR). It has a hypotensive, antiarrhythmic and antianginal effects.
Blocking in low doses beta1-adrenergic receptors of the heart, stimulated by catecholamines reduces the formation of cyclic adenosine monophosphate (cAMP) from adenosine triphosphate (ATP), the current lowers intracellular calcium ions, inhibits all heart functions reduces atrioventricular (AV) conduction and excitability. When exceeding the therapeutic dose has beta2-adrenoceptor blocking effect. Total peripheral vascular resistance at the beginning of the drug in the first 24 hours, is increased (as a result of reciprocal increase in the activity of alpha-adrenoceptor stimulation and removal of beta2-adrenoceptor), after 1-3 days returned to the initial value, and long-term use – is reduced.
The antihypertensive effect is associated with a decrease in cardiac output, sympathetic stimulation of peripheral blood vessels, reduction in the activity of the sympathoadrenal system (SAS) (important for patients with initial hypersecretion renin) sensitivity reduction in response to the lowering of blood pressure (BP) and the influence on the central nervous system (CNS). When hypertension effect develops after 2-5 days, stable operation is noted after 1-2 months.
Antianginal effect due to a decrease in myocardial oxygen demand by reducing contractility and other functions of the myocardium, lengthening of diastole, improving myocardial perfusion. By increasing the end-diastolic pressure in the left ventricle and increased tensile ventricular muscle fibers may be increased oxygen demand, especially in patients with chronic heart failure (CHF).
When applied in high therapeutic doses, unlike nonselective betaadrenoblokatorov, it has a less pronounced effect on organs containing beta2- adrenoceptor (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchial and uterine) and carbohydrate metabolism; It does not cause a delay of sodium ions in the body; atherogenic action expression is not different from that of propranolol.
Pharmacokinetics:
Bisoprolol almost completely absorbed in the gastrointestinal tract, food intake does not affect absorption. The effect of “first pass” through the liver is insignificant, resulting in a high bioavailability (90%).
Bisoprolol is metabolized by oxidative pathway without subsequent conjugation. All metabolites have a strong polarity and excreted by the kidneys. The main metabolites found in blood plasma and urine, does not exhibit pharmacological activity. Data obtained from experiments with liver microsomes in vitro human show that bisoprolol is metabolized primarily via isoenzyme CYP3A4 (about 95%) and CYP2D6 isozyme plays only a small role.
Communication with the plasma proteins for about 30%. Volume of distribution – 3.5 l / kg. Total clearance – about 15 l / h. The maximum plasma concentration is determined after 2-3 hours.
The permeability of the blood-brain barrier and the placental barrier – is low.
The half-life of plasma (10-12 hours) have provided efficiency within 24 hours after receiving a single daily dose.
Bisoprolol excreted two paths, 50% of the dose is metabolized in the liver to inactive metabolites. About 98% of kidney, of which 50% is excreted in unaltered; less than 2% – through the intestine (in bile).
Since excretion takes place in the kidneys and liver alike, patients with impaired liver function or renal insufficiency dose adjustment is required.
The pharmacokinetics of bisoprolol is linear and independent of age.
In patients with chronic heart failure bisoprolol plasma concentrations above and half-life is longer compared with healthy volunteers.
Pregnancy and breast-feeding
Pregnancy
Bisoprolol has no direct cytotoxic, mutagenic and teratogenic effects, but it has pharmacological effects that may cause harmful effects on pregnancy and / or the fetus or newborn. Typically, beta-blockers reduce placental perfusion, leading to slower growth of the fetus, fetal death, premature delivery or miscarriage. In the fetus and newborn child may have abnormal reactions such as intrauterine growth retardation, hypoglycemia, bradycardia.
Bisoprolol-Teva should not be used during pregnancy, the use is possible in the event that the benefit to the mother outweighs the risk of side effects in the fetus and / or the child. In the case when treatment with bisoprolol-Teva seen as necessary, should monitor blood flow in the placenta and uterus, as well as to observe the growth and development of the unborn child and in case of occurrence of adverse events in relation to pregnancy and / or fetus, take alternative methods therapy. It is necessary to carefully examine the newborn after delivery. Symptoms of hypoglycaemia and bradycardia are generally
occur within the first 3 days of life.
Breastfeeding
Information about the penetration of bisoprolol into breast milk is not. Therefore, the drug bisoprolol-Teva is not recommended for women during lactation.
If necessary, use during lactation, breast-feeding should be discontinued.
Conditions of supply of pharmacies
Prescription.
side effects
The frequency of adverse reactions listed below, was determined according to the following (World Health Organization): very often – at least 10%; often – at least 1% but less than 10%; infrequently – at least 0.1% but less than 1%; rarely – at least 0.01% but less than 0.1%; very rarely – less than 0.01%, including isolated reports.
Of the heart and blood vessels:
very often – slowing of heart rate (bradycardia, particularly in patients with chronic heart failure); palpitations,
frequently – marked reduction of blood pressure (especially in patients with CHF), a manifestation of vasoconstriction (increased peripheral circulatory disorders, cold sensation in the extremities (paraesthesia);
infrequently – a violation of AV conduction (up to the full development of cross-blockade and heart failure), arrhythmia, orthostatic hypotension, worsening of heart failure with the current development of peripheral edema (swelling of ankles, feet, shortness of breath), chest pain.
From the nervous system:
often – dizziness, headache, asthenia, fatigue, sleep disturbances, depression, anxiety;
rare – confusion, or short-term memory loss, “nightmarish” dream, hallucination, myasthenia gravis, tremor, muscle cramps. Usually, these effects are mild and are usually within 1 to 2 weeks after initiation of treatment.
From the senses:
rarely – visual disturbances, reduced lacrimation (to consider when wearing contact lenses), tinnitus, hearing loss, ear pain;
very rare – dryness and soreness of the eyes, conjunctivitis, taste disturbances.
The respiratory system:
infrequently – bronchospasm in patients with asthma or obstructive airways disease;
rarely – allergic rhinitis; nasal congestion.
From the digestive system:
common – nausea, vomiting, diarrhea, constipation, dryness of the oral mucosa, stomach pain; rarely – hepatitis, elevated liver enzymes (ALT, AST), bilirubin increased concentration, change in taste.
On the part of the musculoskeletal system:
Infrequent – arthralgia, back pain.
With the genitourinary system:
very rarely – a violation of potency, libido weakening.
Laboratory findings:
rarely – increased concentration of triglycerides in the blood; in some cases -trombotsitopeniya, agranulocytosis, leukopenia.
Allergic reactions:
rarely – itching, rash, urticaria
For the skin:
rarely – increased sweating, flushing of the skin, rash, psoriasiform skin reactions; very rare – alopecia, beta-blockers may exacerbate psoriasis.
Other: syndrome “cancel” (increased frequency of angina attacks, increased blood pressure).
special instructions
Monitoring the state of patients taking the drug bisoprolol-Teva should include heart rate and blood pressure measurement, ECG conduct, determining the concentration of blood glucose in patients with diabetes mellitus (1 every 4-5 months.). In elderly patients it is recommended to monitor renal function (1 every 4-5 months.).
It should teach the patient’s heart rate counting procedure and to instruct the need of medical advice in heart rate less than 50 beats / min.
Before treatment is recommended to study the external breathing function in patients with a history of bronchopulmonary history.
Patients who use contact lenses, you should consider that in the context of drug treatment may decrease the production of tear fluid.
In applying bisoprolol-Teva drug in patients with pheochromocytoma are at risk of paradoxical hypertension (if not previously achieved effective blockade of alpha-adrenoceptors).
Thyrotoxicosis bisoprolol may mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Abrupt withdrawal of the drug in patients with hyperthyroidism contraindicated because the symptoms can increase.
In diabetes may mask tachycardia caused by hypoglycemia. In contrast, nonselective beta-blockers practically no increase insulin-induced hypoglycemia and delay recovery of the concentration of glucose in the blood to normal.
With simultaneous application of clonidine its reception can be stopped only several days after the drug bisoprolol-Teva.
May increase the severity of hypersensitivity reactions and the lack of effect of conventional doses of epinephrine with aggravated allergic history.
If necessary, the planning of surgical treatment medication should be discontinued 48 hours prior to general anesthesia. If a patient has taken the drug before surgery, he should pick up the drug for general anesthesia with minimal negative inotropic effects.
Reciprocal activation of the vagus nerve can be eliminated intravenous atropine (2.1 mg).
Drugs that deplete depot catecholamines (in t. H. Reserpine), may enhance the action of beta-blockers, however, patients taking such drug combinations should be under constant medical supervision for identifying expressed BP reduction or bradycardia.
Patients with bronhospasticheskimi diseases can be prescribed with care cardioselective beta-blockers in the case of intolerance and / or ineffectiveness of other antihypertensive agents. While taking beta-blockers in patients with concomitant asthma may be exacerbated airway resistance. In excess doses of bisoprolol-Teva in such patients at risk of developing bronchoconstriction occurs.
In case of patients increasing bradycardia (heart rate less than 50 bpm. / Min.), Pronounced decrease in blood pressure (systolic blood pressure less than 100 mm Hg), AV blockade is necessary to reduce the dosage or discontinue treatment.
It is recommended to discontinue therapy with bisoprolol-Teva in the development of depression.
Do not abruptly discontinue treatment because of the risk of severe arrhythmias and myocardial infarction.
Abolition of the drug are gradually reducing the dose for 2 weeks or more (at lower dose
25% 3-4 days).
Следует отменять препарат перед исследованием концентрации в крови и моче катехоламинов, норметанефрина, ванилинминдальной кислоты, титров антинуклеарных антител.
Smokers efficacy of beta-blockers lower.
Effects on ability to drive and operate machinery which requires high concentration of attention
Применение препарата Бисопролол-Тева не влияет на способность управлять транспортными средствами согласно результатам исследования у пациентов с ИБС. Однако вследствие индивидуальных реакций способность управлять транспортными средствами или работать с технически сложными механизмами может быть нарушена. На это следует обратить особое внимание в начале лечения, после изменения дозы, а также при одновременном употреблении алкоголя.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Препарат Бисопролол-Тева принимают внутрь, утром натощак, 1 раз в сутки с небольшим количеством жидкости, утром до завтрака, во время или после него. Tablets should not be chewed or triturate.
Во всех случаях режим приема и дозу подбирает врач каждому пациенту индивидуально, в частности, учитывая ЧСС и состояние пациента.
При артериальной гипертензии и ишемической болезни сердца препарат назначают по 5 мг 1 раз в сутки. If necessary to increase the dose of 10 mg 1 time per day.
При лечении артериальной гипертензии и стенокардии максимальная суточная доза составляет 20
мг 1 раз/сут.
Для пациентов с выраженными нарушениями функции почек (КК менее 20 мл/мин.) или с выраженными нарушениями функции печени максимальная суточная доза составляет – 10 мг 1 раз в сутки. Увеличение дозы у таких пациентов необходимо проводить с особой осторожностью.
No dose adjustment in elderly patients is not required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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