bisoprolol | Bidop tablets 5 mg, 28 pcs.

Release form

Tablets.

Packing

28 pcs

Pharmacological action

Bidop is a selective beta1-blocker without internal sympathomimetic activity, does not have a membrane-stabilizing effect. Bidop reduces plasma renin activity, reduces myocardial oxygen demand, and reduces heart rate (at rest and during exercise).

It has hypotensive, antiarrhythmic and antianginal effects.

Blocking in low doses the 1-adrenergic receptors of the heart, reduces the formation of cAMP stimulated by catecholamines from ATP, reduces the intracellular current of calcium ions, has a negative chrono-, dromo-, batmo- and inotropic effect, inhibits conduction and excitability, reduces myocardial contractility.

With increasing doses has a beta2-blocking effect.

Indications

Arterial hypertension prophylaxis of angina attacks.

Contraindications

hypersensitivity to bisoprolol and other beta-blockers

shock (including cardiogenic), collapse

acute heart failure, pulmonary edema

chronic heart failure in the decompensation stage (i.e. cardiogenic shock)

AV block II – III stage, sinoatrial block, sine sinus weakness syndrome

severe bradycardia

angina pectorismetal

cardiomegaly (without signs of heart failure)

arterial hypertension and cardiac arrhythmias (except for MAO-B inhibitors)

late stages of peripheral circulatory disorders

Raynaud's disease

pheochromocytoma (without the simultaneous use of alpha-blockers)

metabolic a idose

age of 18 years (effectiveness and safety have not been established) ..

Use during pregnancy and lactation

Use of Bidop during pregnancy and during breastfeeding is possible if if the benefit to the mother outweighs the risk of side effects in the fetus and the baby.

Composition

1 tablet contains 5 mg bisoprolol hemifumarate.

Excipients:

lactose monohydrate,

microcrystalline cellulose,

magnesium stearate,

crospovidone,

pigment grade PB 27215 beige (lactose monohydrate 87%, iron oxide red and yellow 13%).

Dosage and administration

Inside, in the morning, on an empty stomach, without chewing, 2.5–5 mg bidop once.

If necessary, increase the dose to 10 mg once a day.

The maximum daily dose is 20 mg per day.

Side effects

Side effects observed with the use of the drug Bidop are classified into categories depending on the frequency of their occurrence: very often ( 1/10) often ( 1/100, <1/10) infrequently ( 1/1000 , <1/100) rarely ( 1/10 000, <1/1000) very rarely (<1/10 000), including single messages.

From the side of the central nervous system and peripheral nervous system: infrequently - increased fatigue, weakness, asthenia, dizziness, headache, sleep disorders, depression, anxiety, confusion or short-term memory loss rarely - hallucinations, myasthenia gravis, nightmares, cramps (including in the calf muscles), paresthesia in the limbs (in patients with intermittent claudication and Raynaud's syndrome), tremor.

On the part of the sensory organs: rarely - impaired vision, decreased secretion of lacrimal fluid, dryness and soreness of the eyes very rarely - conjunctivitis.

From the side of the cardiovascular system: very often - sinus bradycardia, palpitations often - marked decrease in blood pressure, manifestation of angiospasm (increased disturbance of peripheral circulation, cooling of the lower extremities, Raynaud's syndrome) infrequently - orthostatic hypotension, impaired myocardial conduction, AV block (up to to the development of complete transverse blockade and cardiac arrest), arrhythmias, weakening of myocardial contractility, the development of chronic heart failure (swelling of the ankles, feet shortness of breath), chest pain.

From the digestive system: often - dry oral mucosa, nausea, vomiting, abdominal pain, constipation or diarrhea rarely - impaired liver function (dark urine, yellowness of the sclera or skin, cholestasis), taste changes, hepatitis, increased enzyme activity liver (ACT, ALT), hyperbilirubinemia, hypertriglyceridemia.

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.

From the endocrine system: hyperglycemia (in patients with non-insulin-dependent diabetes mellitus), hypoglycemia (in patients receiving insulin), hypothyroid state.

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

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

From the hemopoietic system: in some cases - thrombocytopenia (unusual bleeding and hemorrhage), agranulocytosis, leukopenia.

Other: infrequently - arthralgia rarely - back pain, weakening libido, decreased potency, withdrawal syndrome (increased angina attacks, increased blood pressure).

Drug Interaction

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 drugs for I / O administration increase the risk of anaphylactic reactions.

Phenytoin with / in administration, medications for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of cardio-depressive action and the likelihood of reducing blood pressure.

Changes the effectiveness of insulin and oral hypoglycemic drugs, masks the symptoms of developing hypoglycemia (tachycardia, increased blood pressure).

Reduces the clearance of lidocaine and xanthines (except theophylline) and increases their plasma concentration, especially in patients with initially elevated theophylline clearance under the influence of smoking.

Hypotensive effect is weakened by NSAIDs (delay of sodium ions and blockade of synthesis of prostaglandin by kidneys), GKS and estrogens (delay of sodium ions).

Cardiac glycosides, methyldopa, reserpine and guanfacin, slow calcium channel blockers (verapamil, diltiazem), amiodarone and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV blockade, cardiac arrest, and cardiac arrest.

overdose

Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV blockade, severe BP, chronic heart failure, finger or palm cyanosis, difficulty breathing, bronchospasm, dizziness, syncope, convulsions, hypoglycemia.

Treatment: gastric lavage and the appointment of adsorbing drugs symptomatic therapy: with developed AV blockade - 1-2 mg of atropine, epinephrine or staging of a temporary pacemaker with ventricular extrasystole - lidocaine (class IA medications) should be in Trendelenburg position if there is no evidence of pulmonary edema, - in / in plasma replacement solutions, with inefficiency - administration of epinephrine, dopamine, dobutamine (to maintain chronotropic and inotropic actions and the elimination of marked decrease in blood pressure) in heart failure - cardiac glycosides, diuretics, glucagon in convulsions - in / in diazepam with bronchospasm - beta2-adreno-stimulators inhalation.

Storage conditions

Store in a dry, dark place, out of the reach of children, at a temperature not exceeding 20 РC.

The Expiration of

is 3 years.

Deystvuyuschee substances

bisoprolol

Pharmacy terms

Prescription

dosage form

dosage form

tablets

Gedeon Richter-Rus, Hungary