Description
Latin name
Bisoprolol-Teva
Release form
Coated tablets.
Packing
30 pcs packaged.
Pharmacological action
Bisoprolol-Teva has an antianginal, antiarrhythmic, hypotensive effect.
Indications
Arterial hypertension, angina pectoris, post-infarction period, arrhythmias, chronic heart failure (moderate, stable without exacerbation during the last 6 weeks).
Contraindications
Hypersensitivity, sinus bradycardia (less than 45-50 beats / min), sinus node syndrome, sinoatrial and AV block II III degree, cardiogenic shock, acute and refractory to treatment severe heart failure, myocardial infarction, acute hypotension (SBP below 90 mmHg) severe obstructive respiratory failure, pregnancy, breastfeeding.
Use during pregnancy and lactation
It is possible if the expected effect of the therapy on the mother outweighs the potential risk to the fetus and the baby (adequate and strictly controlled studies of the safety of use in pregnant and lactating women have not been conducted). Since there is a risk of developing bradycardia, hypotension, hypoglycemia, and respiratory distress (neonatal asphyxia) in newborns, treatment with bisoprolol fumarate should be discontinued 48 ² 72 hours before delivery. If this is not possible, the newborn should be under close medical supervision for 48 ² 72 hours after birth. The secretion of bisoprolol fumarate with breast milk has not been studied, but since it is secreted into breast milk in rats (less than 2%), infants should be under medical supervision.
Composition of
1 tablet contains bisoprolol fumarate 10 mg Excipients: croscarmellose sodium (primellose), povidone (polyvinylpyrrolidone medium molecular weight), pregelatinized starch (1500 starch), aerosol colloidal lactose (colloidal silica) (microcrystalline silica) , magnesium stearate Film composition: Opadry II (polyvinyl alcohol, partially hydrolyzed, titanium dioxide, talc, macrogol (polyethylene glycol 3350), iron dye oxide (II)).
Dosage and administration of
Bisoprolol-Teva is taken orally, without chewing, with a small amount of liquid, in the morning on an empty stomach or during breakfast 1.25-10 mg once a day. The dosing regimen is individual, the dose is increased under the control of blood pressure and pulse. Arterial hypertension and angina pectoris: 5 10 mg mild arterial hypertension (dAD less than 105 mm Hg): 2.5 mg chronic heart failure: 1.25 mg / day (for 1 week), then with good tolerance the dose increase to 2.5 mg / day (1 week), 3.75 mg / day (1 week), 5 mg / day (4 weeks), 7.5 mg / day (4 weeks), then 10 mg / day (target dose). The maximum daily dose for adults is 20 mg.
Side effects
The frequency of side effects is indicated when prescribing doses, not exceeding 40 mg.
From the side of the nervous system and sensory organs: dizziness (3.5%), insomnia (2.5%), asthenia (1.5%), hypesthesia (1.5%), depression (0.2%), drowsiness , anxiety, paresthesia (feeling cold in the extremities), hallucinations, impaired thinking, concentration, orientation in time and space, balance, emotional lability, tinnitus, conjunctivitis, visual disturbances, decreased secretion of lacrimal fluid, convulsions.
From the cardiovascular system and blood (hematopoiesis, hemostasis): bradycardia (0.5%), arrhythmia, palpitations, AV block, hypotension, heart failure, impaired microcirculation in the myocardium and limbs, intermittent claudication, vasculitis, agranulocytosis, thrombocytopenia thrombocytopenic purpura.
From the digestive tract: diarrhea (3.5%), nausea (2.2%), vomiting (1.5%), dry mouth (1.3%), dyspeptic symptoms, constipation, ischemic colitis, mesenteric artery thrombosis.
Respiratory system: cough (2.5%), shortness of breath (1.5%), bronchus and laryngospasm, pharyngitis (2.2%), rhinitis (4%), sinusitis (2.2%), infections respiratory tract (5%), respiratory distress syndrome.
From the genitourinary system: peripheral edema (3%), decreased libido, impotence, Peyronie’s disease, cystitis, renal colic.
From the skin: rash, acne, eczema-like reactions, prurigo, pokra respiratory distress syndrome.
From the genitourinary system: peripheral edema (3%), decreased libido, impotence, Peyronie’s disease, cystitis, renal colic.
From the skin: rash, acne, eczema-like reactions, prurigo, pokra respiratory distress syndrome.
From the genitourinary system: peripheral edema (3%), decreased libido, impotence, Peyronie’s disease, cystitis, renal colic.
From the skin: rash, acne, eczema-like reactions, prurigo, pokraskin removal, hyperhidrosis, dermatitis, alopecia.
From the side of metabolism: increased concentration of liver enzymes (AST, ALT), hyperglycemia or increased glucose tolerance, hyperuricemia, a change in the concentration of potassium in the blood.
Other: pain (headache – 10.9%, arthralgia – 2.7%, myalgia, pain in the abdomen, chest – 1.5%, eyes, ears), weight gain.
Drug Interaction
The likelihood of disorders of automaticity, conduction and contractility of the heart increases (mutually) against the background of amiodarone, diltiazem, verapamil, quinidine drugs, cardiac glycosides, reserpine, alpha-methyldofa. Concomitant administration of calcium dihydropyridine antagonists, especially in patients with latent heart failure, increases the risk of hypotension and decompensation of cardiac activity. Efficiency is reduced by xanthines and sympathomimetics, rifampicin decreases T1 / 2, ergotamine derivatives potentiate peripheral circulation disorders. Incompatible with MAO inhibitors.
Overdose
Symptoms: bradycardia, arrhythmia, hypotension, heart failure (shortness of breath, acrocyanosis, edema), hypoglycemia, in severe cases – collapse.
Treatment: gastric lavage and the appointment of adsorbing agents, symptomatic therapy: atropine, beta-adrenomimetics (isoprenaline), sedatives (diazepam, lorazepam) and cardiotonic (dobutamine, dopamine, epinephrine, norepinephrine) drugs, cardiac glikozykody. – transvenous stimulation, connection of artificial rhythm driver.
Storage conditions
The drug should be stored in a dry, dark place, out of the reach of children, at a temperature not exceeding 25 ° C.
The Expiration of
is 3 years.
Active ingredient
bisoprolol
pharmacy terms for prescription
dosage form
dosage form
tablets
Teva Ltd. Israel
