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Non-selective beta-adrenoblocker. It has antihypertensive, antianginal and antiarrhythmic effects. Due to blockade of β-adrenoreceptors it decreases catecholamine-stimulated formation of cAMP from ATP; as a result, it decreases intracellular supply of calcium ions, has negative chrono-, dromo-, batmo- and inotropic effect (decreases HR, inhibits conduction and excitability, decreases myocardial contractility). At the beginning of beta-adreno-blocker use, HRP increases during first 24 hours (as a result of reciprocal increase of α-adrenoreceptor activity and elimination of β2-adrenoreceptor stimulation in skeletal muscles), but after 1-3 days it returns to baseline and decreases with prolonged use.
Hypotensive effect is associated with decreased minute blood volume, sympathetic stimulation of peripheral vessels, decreased activity of renin-angiotensin system (important in patients with initial renin hypersecretion), sensitivity of aortic arch baroreceptors (their activity is not increased in response to BP decrease) and the effect on CNS. Hypotensive effect is stabilized by the end of 2 weeks of treatment.
Antianginal effect is due to reduction of myocardial oxygen demand (due to negative chronotropic and inotropic effect). Decrease of HR leads to prolongation of diastole and improvement of myocardial perfusion. By increasing left ventricular end-diastolic pressure and increasing ventricular muscle fiber stretch can increase oxygen demand, especially in patients with chronic heart failure.
Antiarrhythmic effect is caused by the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of CAMF, arterial hypertension), reduction of the rate of spontaneous excitation of sinus and ectopic pacemakers and slowdown of AV conduction. Inhibition of impulse conduction is marked mainly in antegrade and, to a lesser extent, in retrograde direction through AV node and along additional pathways. It belongs to the II class of antiarrhythmic drugs. Reduction of the severity of myocardial ischemia - by reducing myocardial oxygen demand, postinfarction mortality can also be reduced due to antiarrhythmic action.
The ability to prevent the development of headache of vascular genesis is due to a decrease in the severity of cerebral artery dilation due to beta-adrenoblockade of vascular receptors, inhibition of catecholamine-induced platelet aggregation and lipolysis, reduction of platelet adhesiveness, prevention of clotting factor activation during adrenaline release, stimulation of oxygen supply to tissues and reduction of renin secretion.
Reduction of tremor against the background of propranolol administration is mainly due to blockade of peripheral β2-adrenoreceptors.
Increases the atherogenic properties of blood. Increases uterine contractions (spontaneous and induced by agents stimulating the myometrium). Increases the tone of the bronchi. In high doses causes a sedative effect.
The potential mechanisms of action of propranolol for infantile hemangioma include the following interrelated therapeutic effects: Local hemodynamic effect (vasoconstriction due to beta-adrenergic blockade and reduction of blood flow to the hemangioma focus); anti-angiogenic effect (decrease of proliferation, neovascularization and tubulogenesis of endothelial cells due to decrease of activity of the key factor of migration of endothelial cells - matrix metalloproteinase MMP-9); apoptosis induction effect in endothelial cells due to blockade of β-adrenoreceptors. It is known that stimulation of β2-adrenoreceptors can lead to the release of vascular endothelial growth factors VEGF and bFGF and induce proliferation of endothelial cells. By blocking β2-adrenoceptors, propranololol suppresses the expression of VEGF and bFGF and inhibits angiogenesis. The therapeutic efficacy of propranolol has been defined as complete or almost complete involution (resorption) of hemangiomas. Results of clinical studies demonstrate that propranololol efficacy did not significantly differ in subgroups divided by age (35-90 days/91-150 days), sex and hemangioma location (head/body); 88% of patients showed a positive trend after 5 weeks of propranololol treatment.
After oral administration, about 90% of the administered dose is absorbed, but bioavailability is low due to metabolism during "first passage" through the liver. Cmax in plasma is reached after 1-1.5 hours. Protein binding is 93%. T1/2 is 3-5 hours. Excreted by the kidneys mainly as metabolites, unchanged less than 1%.
Contraindications to use
Class II and III AV-blockade, sinoatrial block, significant bradycardia (<50 bpm), arterial hypotension, decompensated acute or chronic heart failure, acute myocardial infarction (systolic BP less than 100 mm Hg), cardiogenic shock and pulmonary edema. st), cardiogenic shock, pulmonary edema, CCSU, Prinzmetal angina, cardiomegaly (without signs of heart failure), severe peripheral vascular disorders, metabolic acidosis (incl. including diabetic acidosis), pheochromocytoma (without concomitant use of alpha-adrenoblockers), bronchial asthma, chronic obstructive pulmonary disease, tendency to bronchospastic reactions, concomitant use with antipsychotics and anxiolytics (chlorpromazine, trioxazine and others), MAO inhibitors.
For newborns and infants. HR slower than the following limits: in children aged 0 to 3 months - 100 beats/min, from 3 months to 6 months - 90 beats/min, from 6 months to 12 months - 80 beats/min; BP lower than the following limits: in children aged 0 to 3 months - 65/45 mm Hg, from 3 months to 6 months - 70/50 mm Hg, from 6 months to 12 months - 80/55 mm Hg. Breast-fed children, in case the mother takes drugs that are not recommended to be used simultaneously with propranololol.
Hypersensitivity to propranololol.
Use during pregnancy and lactation
The use of propranolol in pregnancy is possible only when the anticipated benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use it during this period, the fetal state should be closely monitored and propranolol should be withdrawn 48-72 h before delivery.
Be aware of possible adverse effects on the fetus: intrauterine growth retardation, hypoglycemia, bradycardia.
Propranolol is excreted with the breast milk. If it is necessary to use during lactation, the child should be under medical supervision or breastfeeding should be stopped.
Use in patients with hepatic impairment
Caution should be exercised when using in patients with hepatic impairment.
Administration in patients with impaired renal function
Use with caution in patients with renal insufficiency.
Administration in children
Caution when used in children (effectiveness and safety have not been determined).
Administration in elderly patients
Use with caution in elderly patients.
Indications of the active substance PROPRANOLOL
Arterial hypertension; angina pectoris, unstable angina pectoris; sinus tachycardia (incl. hyperthyroidism, supraventricular tachycardia, atrial fibrillation, supraventricular and ventricular extrasystoles, essential tremor, migraine prophylaxis, alcohol withdrawal (agitation and tremor), anxiety, pheochromocytoma (adjuvant treatment), diffuse-toxic goiter and thyrotoxic crisis (as an adjuvant, incl. Thyreostatic drugs intolerance), sympathoadrenal crises against diencephalic syndrome.
Proliferating infantile hemangioma requiring systemic therapy: hemangioma with life-threatening or adverse effect on the functioning of body systems; ulcerative hemangioma characterized by pain and/or unresponsiveness to previous ulcerative treatment measures; hemangioma with potential risk of permanent scarring or deformity.
In adults, when administered orally, the initial dose is 20 mg, the single dose is 40-80 mg, the frequency of administration is 2-3 times a day.
By IV shot slowly - the initial dose is 1 mg; then the same dose is administered again after 2 minutes. Repeat injections are possible if there is no effect.
Maximal doses: when administered orally - 320 mg/day; when repeatedly administered by IV fluids, the total dose is 10 mg (under control of BP and ECG).
In children aged from 35 days to 150 days on the date of initiation of treatment, it is intended for oral administration in a special dosage form. For premature infants, the appropriate age should be determined by subtracting the number of weeks of prematurity from the value of the child's actual age. The initial dose is 1 mg/kg/day in 2 doses (0.5 mg/kg in the morning and 0.5 mg/kg in the evening). The recommended therapeutic dose is 3 mg/kg/day in 2 doses (1.5 mg/kg in the morning and 1.5 mg/kg in the evening). The interval between two doses should be at least 9 hours. Dose titration scheme: 1 mg/kg/day in week 1; 2 mg/kg/day in week 2; from week 3 - 3 mg/kg/day. When dose titration is completed, the amount of drug administered is adjusted according to the child's body weight. Clinical control of the child's condition and dose adjustment should be carried out at least once a month. On the first day of treatment and on the days of increasing the dose, the child should be in a medical facility under the supervision of the attending physician for 2 hours after administration of the drug. It is necessary to measure HR and assess the general condition of the child at least every 60 minutes during the first 2 hours after the drug administration. Duration of treatment is 6 months. Discontinuation of the drug does not require gradual reduction of the dose. In case of disease relapse after completion of therapy, treatment may be repeated if there is a satisfactory response.