Bisoprolol AML-cs tab 5mg 5mg + 30 pcs

Description

Composition
Active substance:
bisoprolol fumarate 5 mg and 10 mg
Excipients:
core – sodium croscarmellose (primel- vine) – 2.2 mg, 4.4 mg; povidone (polyvinylpyrrolidone of middle) – 6.0 mg, 12.0 mg; pregelatinized starch (starch 1500) – 4.0 mg, 8.0 mg; colloidal silicon dioxide (Aerosil) – 1.54 mg, 3.08 mg; Talc – 2.0 mg, 4.0 mg; Microcrystalline cellulose – 30.4 mg, 60.8 mg; lactose (milk sugar) – 47.86 mg, 95.72 mg; Magnesium stearate – 1.0 mg
shell – Opadry II (polyvinyl alcohol, partially hydrolyzed – 1.2 mg 2.4 mg Titanium dioxide – 0.67998 mg 1.35996 mg talc – 0.444 mg, 0.888 mg macrogol (polyethylene glycol 3350) – 0.606 mg , 1.212 mg of iron oxide colorant (II) yellow – 0.07002 mg 0.14004 mg).
Description:
Tablets, film-coated, from beige yellow to beige, round, biconvex shape. Tablets on a break white or nearly white.
Product form:
Tablets, film-coated, 5 mg and 10 mg.
10 or 30 tablets in blisters.
30 tablets in plastic cans or bottles of plastic.
Each jar or vial, 3, 5 or 10 contour cell packs of 10 tablets, or 2, 3 or 4 blisters with 30 tablets with instructions for use placed in a cardboard box.
Contraindications
Increased sensitivity to the drug and other beta blockers, shock (including cardiogenic) collapse, pulmonary edema, congestive heart failure, chronic heart failure decompensation, atrioventricular (AV) block II-III art. Sinoatrialnaya blockade syndrome sick sinus bradycardia, Prinzmetal angina, cardiomegaly (without heart failure), hypotension (systolic blood pressure less than 100 mm Hg, particularly in myocardial infarction); severe bronchial asthma and chronic obstructive pulmonary disease in history; concomitant use of monoamine oxidase inhibitors (MAOIs) (except MAO-B), the later stages of peripheral circulatory disorders, Raynaud’s disease), pheochromocytoma (without the simultaneous use of alpha-blockers), metabolic acidosis, age 18 years (effectiveness and safety have been established).
Precautions: hepatic insufficiency, chronic renal failure, myasthenia gravis, thyrotoxicosis, diabetes, atrioventricular block I degree, depression (including history), psoriasis, old age.
Dosage
30 pc
Indications
– arterial hypertension;
– Ischemic heart disease: prevention of angina attacks.
Interaction with other drugs
The allergens used for immunotherapy, or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving biso- prolol.
Iodine-containing radiopaque medicines for intravenous administration increases the risk of anaphylactic reaction. Phenytoin intravenous administration, drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity cardiodepressive action and likely to reduce blood pressure. Changes effectiveness of insulin and of oral hypoglycemic drugs, masking the symptoms of developing hypoglycemia (tachycardia, increased blood pressure). Reduces the clearance of lidocaine and xanthine (except dyphylline) and increases their concentration in plasma, 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 (delay Na + and blockage of prostaglandin synthesis by the kidneys), glucocorticoids and estrogens (delay ions Na +).
Cardiac glycosides, methyldopa, reserpine and guanfacine blockers “slow” calcium channel blockers (verapamil, diltiazem), amiodoron and other antiarrhythmic drugs increase the risk of developing or worsening of bradycardia, AV-blockade, cardiac arrest and heart failure. Nifedipine can lead to a significant reduction in blood pressure.
Diuretics, clonidine, sympatholytic, hydralazine, and other antihypertensive drugs may cause an excessive decrease of blood pressure. Prolongs the action of non-depolarizing muscle relaxants and anticoagulant effect of coumarin.
Tri- and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives and hypnotics drugs increase CNS depression.
Not recommended simultaneous application with MAO inhibitors due to a significant increase in hypotensive action, a break in treatment between the reception of MAO inhibitors and bisoprolol should be at least 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 the plasma; rifampin shortens the half-life.
Overdose
Symptoms: arrhythmia, ventricular arrythmia, bradycardia, AV block, marked decrease in blood pressure, chronic heart failure, cyanosis nails of fingers or hands, shortness of breath, bronchoconstriction, dizziness, fainting, convulsions.
Treatment: gastric lavage purpose absorbent and drugs; Symptomatic therapy: which developed at AV blockade –
1-2 mg intravenous atropine epines ^ rina formulation or temporary pacemaker; with ventricular arrhythmia – lidoka- Institute (IA class of drugs does not apply); while lowering blood pressure – the patient must be in the Trendelenburg position; if no signs of edema legkih- plasma-substituting solutions intravenously at inefficiency – administration of epinephrine, dopamine, dobutamine (to maintain chronotropic and inotropic action and removal of significant decrease in blood pressure); in heart failure – cardiac glycosides, diuretics, glucagon; in convulsions – diazepam intravenously; with bronchospasm – beta2-adrenostimulyatorov inhalation.
pharmachologic effect
Pharmacological group:
Beta1-selective blocker
Pharmacological properties:
Selective betagadrenoblokator without own sympathomimetic activity, has no membrane stabilizing effect. Reduces plasma renin activity, reduces myocardial oxygen demand, slows the heart rate (HR) (at rest and during exercise). It has anti-hypertensive, anti-arrhythmic and anti-anginal action. Blocking in low doses betagadrenoretsep- tori heart stimulated by catecholamines reduces the formation of cAMP from ATP, reduces intracellular calcium ion current has a negative chronotropic, dromo-, BATM inotropic effect and inhibits the conduction and excitability and reduces atrioventricular conduction. With increasing doses of the above therapeutic exerts beta2 adrenoblo- kiruyuschee action.
Total peripheral vascular resistance at the beginning of use 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), which is 1-3 days returns to the original, and prolonged decreases appointment. The hypotensive effect was associated with reduced cardiac output, peripheral vascular sympathetic stimulation, decreased activity of the renin-howling system angiotenzino- (important for patients with initial hypersecretion renin) sensitivity reduction in response to lowering blood pressure (BP) and the influence on the central nervous system (CNS). When hypertension effect occurs within 2-5 days, stable operation – in 1-2 months. Antianginal effect due to a decrease in myocardial oxygen demand as a result of deceleration in heart rate and decrease contractility, lengthening of diastole, improving myocardial perfusion. By increasing the end-diastolic pressure in the left ventricle and increased tensile ventricular muscle fibers may increase the oxygen demand, especially in patients with chronic heart failure. Antiarrhythmic effect is due to the elimination of arrhythmogenic factors (tachycardia, increased sympathetic nervous system activity, increased cAMP levels, hypertension), decrease the rate of spontaneous excitation of the sinus and ectopic pacemakers and slowing atrioventricular (AV) of the (preferably antegrade and to a lesser extent, in retrograde direction through the AV node) and additional routes.
When applied in high therapeutic doses, unlike nonselective beta-blockers, has a less pronounced effect on organs containing beta 2-adrenoreceptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchial and uterine) and carbohydrate metabolism, does not cause delays sodium ions (Na +) in the body; atherogenic action expression is not different from that of propranolol.
Pharmacokinetics:
Absorption – 80 – 90%, food intake does not affect absorption. The maximum plasma concentration observed after 1-3 hours, the connection to plasma proteins for about 30%. The permeability of the blood-brain barrier and the placental barrier – low secretion breast milk – low.
50% of the dose is metabolized in the liver to inactive metabolites, elimination half-life of 10-12 hours. About 98% of kidney – 50% intact, less than 2% in the bile.
Pregnancy and breast-feeding
Perhaps in that case, if the benefit to the mother outweighs the risk of side effects in the fetus and child.
Conditions of supply of pharmacies
On prescription.
side effects
Central nervous system: fatigue, weakness, dizziness, headache, sleep disorders, depression, anxiety, confusion, or short-term memory loss, hallucinations, asthenia, myasthenia gravis, paresthesia in the extremities (in patients with “intermittent” claudication and Raynaud’s syndrome ), tremor.
From the senses: visual disturbances, reduced secretion of tear fluid, dryness and soreness of the eyes, conjunctivitis.
With the cardiovascular system: sinus bradycardia, palpitations, impaired myocardial conduction, AV-block (up to the full development of cross-blockade and heart failure), arrhythmia, weakening of the myocardial contractility, the development of (worsening) of chronic heart failure (swelling of ankles, feet; dyspnea), reduced blood pressure, orthostatic hypotension, a manifestation of vasospasm (strengthening of peripheral blood circulation, cooling of the lower extremities, Raynaud’s syndrome), pain in the chest.
From the digestive system: dryness of the oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea, liver dysfunction (dark urine, yellow skin or sclera, cholestasis) changes the taste.
The respiratory system: nasal congestion, difficulty breathing when administered at high doses (loss of selectivity) and / or in predisposed patients – laryngo and bronchospasm.
From endocrine system: hyperglycemia (in patients insulinne- dependent diabetes), hypoglycemia (in patients receiving insulin), hypothyroid state.
Allergic reactions: itching, rash, urticaria.
For the skin: sweating, skin redness, rash, psoriasiform skin reactions, exacerbation of psoriasis symptoms.
Laboratory findings: trombouitopeniya (unusual bleeding and hemorrhage), agranulocytosis, leukopenia, changes in the activity of liver enzymes (ALT increase, the ACT), bilirubin, triglycerides. Effect on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.
Other: back pain, arthralgia, weakening of libido, reduced potency, syndrome “cancel” (increasing angina attacks, increased blood pressure).
special instructions
Control of the patients taking bisoprolol-NW, should include measurement of heart rate and blood pressure (at the beginning of treatment – daily, then 1 every 3-4 months) holding LIM, determine the level of blood glucose in diabetic patients (1 in 4 times -5 mo.). 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 bpm. / Min.
Before treatment is recommended to study the external breathing function in patients with a history of bronchopulmonary history. Approximately 20% of patients with angina Beta-blockers are ineffective. The main reasons – severe coronary atherosclerosis low threshold ischemia (heart rate less than 100 beats / min..) And increased end-diastolic volume of the left ventricle, which violates subendokar- dially bloodstream.
The “smoking” the effectiveness of beta-blockers lower. Patients who use contact lenses should bear in mind that during treatment may decrease the production of tear fluid.
When used in patients with pheochromocytoma has a risk of paradoxical hypertension (if not previously reached effective alpha adrenoblockade).
Thyrotoxicosis bisoprolol-NW can mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Abrupt withdrawal 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 blood glucose to normal levels. At the same time taking clonidine his appointment may be terminated only a few days after discontinuation of bisoprolol-NW. May increase the severity of hypersensitivity reactions and the lack of effect of conventional doses of epinephrine with aggravated allergic history.
In case of need for surgical planning preparation carried cancellation for 48 hours prior to general anesthesia. If the patient took the drug before surgery, he must pick a medicament for general anesthesia with minimal negative inotropic effect.
Reciprocal activation of the vagus nerve can be eliminated intravenous atropine (2.1 mg).
Medicines that reduce the supply of catecholamines (including reserpine), may enhance the effect of beta-blockers, so patients taking such drug combinations should be under the constant supervision of a physician to identify pronounced reduction in blood pressure or bradycardia.
Patients with the disease can be administered bronhospasticheskimi carboxy dioselektivnye blockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. Overdose risk of developing bronchoconstriction.
In case of elderly patients increasing bradycardia (less than 50 u. / Min.), Expressed lowering blood pressure (systolic blood pressure below 100 mm Hg), AV-blockade, it is necessary to reduce the dosage or discontinue treatment.
It is recommended to discontinue therapy in the development of depression.
Do not abruptly discontinue treatment because of the risk of severe arrhythmias and myocardial infarction. Cancellation are gradually reducing the dose for 2 weeks or more (dose reduced by 25% in 3-4 days). Should be lifted before testing of blood and urine catecholamines, normetanephrine and vanilinmindalnoy acid antinuclear antibody titers.
You need to use the drug bisoprolol-NW with caution in severe forms of chronic obstructive pulmonary disease, mild form of asthma, conducting desensitizing therapy, as well as in compliance with a strict diet.
Effects on ability to drive vehicles and management mechanisms.
During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In the dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Inside, in the morning on an empty stomach is not liquid, 5 mg once daily. If necessary to increase the dose of 10 mg 1 time per day. The maximum daily dose – 20 mg / day.
Patients with impaired renal function when creatine clearance less than 20 mL / min or with severe hepatic impairment maximum daily dose of -10 mg. 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