Berlipril 10 tablets 10mg №10×3

Name:
Berlipril 10 tab. 10mg in a blister. in pack. No. 10×3
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Tablets 10 mg: round, flat-cylindrical tablets of pale pink color, with a notch for dividing on one side, white blotches are possible. The main active ingredient Enalapril Release form Tablets in a blister 10 pcs.; in a box of 2, 3, 5 or 10 blisters. Precautions Transient hypotension is not a contraindication to continue treatment with the drug after stabilization of blood pressure. In the case of a repeated pronounced decrease in blood pressure, the dose should be reduced or the drug should be discontinued. The use of high-flow dialysis membranes increases the risk of developing an anaphylactic reaction. Correction of the dosing regimen on days free from dialysis should be carried out depending on the level of blood pressure. Before and after treatment with ACE inhibitors, it is necessary to control blood pressure, blood parameters (hemoglobin, potassium, creatinine, urea, liver enzymes), protein in the urine. During the period of treatment, one should refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness is possible, especially after the initial dose of an ACE inhibitor in patients taking diuretics). Pharmacological action Inhibits ACE and as a result reduces the formation of angiotensin II from angiotensin I, thus eliminating the vasoconstrictor effect of the latter. Reduces OPSS, reduces pre- and afterload on the myocardium. Reduces pressure in the right atrium and pulmonary circulation. Pharmacokinetics After oral administration, 60% of the drug is absorbed. Eating does not affect absorption. Plasma protein binding – up to 50%. It is a prodrug, as a result of the hydrolysis of which enalaprilat is formed, which inhibits ACE. It is rapidly metabolized in the liver to form the active metabolite of enalaprilat, which is a more active ACE inhibitor than enalapril. Cmax of enalapril in plasma is achieved after 1 hour, enalaprilat – after 3-4 hours. The bioavailability of enalapril is 80%. Enalaprilat easily passes through histohematic barriers, including the BBB, a small amount passes through the placenta and into breast milk. Enalapril is excreted mainly by the kidneys – 60% (20% – unchanged and 40% – in the form of enalaprilat), through the intestines – 33% (6% – unchanged and 27% – in the form of enalaprilat). It is removed during hemodialysis and peritoneal dialysis. Indications for use Arterial hypertension (including renovascular hypertension), chronic heart failure and asymptomatic left ventricular dysfunction (as part of combination therapy). Dosage and administration Inside, regardless of the meal. With arterial hypertension (monotherapy): the initial dose is 5 mg 1 time per day (1 tab. Berlipril 5, 1/2 tab. Berlipril 10 or 1/4 tab. Berlipril 20); if there is no effect after 1-2 weeks, the dose is increased by 5 mg (after the initial dose, patients should be under medical supervision for 3 hours until blood pressure stabilizes). If necessary and well tolerated, the dose is increased to 40 mg / day in 1-2 doses; after 2-3 weeks, they switch to a maintenance dose – 10-40 mg / day in 1-2 doses. With moderate hypertension: the average daily dose is 10 mg. The maximum daily dose is 40 mg. If prescribed to patients receiving diuretics, diuretic treatment should be discontinued or, if this is not possible, the initial dose should be 2.5 mg / day. With hyponatremia (the concentration of sodium ions in the blood serum is less than 130 mmol / l) or the concentration of creatinine in the blood serum is more than 0.14 mmol / l, the initial dose is 2.5 mg 1 time per day. With renovascular hypertension: initial dose – 2.5-5 mg / day; the maximum daily dose is 20 mg. In chronic heart failure: initial dose – 2.5 mg once, with a gradual increase by 2.5-5 mg every 3-4 days in accordance with the clinical response to the maximum tolerated doses, depending on the value of blood pressure, but not higher than 40 mg / day once or in 2 divided doses. When SBP is less than 110 mm Hg. and in elderly patients, the initial dose is 1.25 mg; dose selection is usually carried out within 2-4 weeks; the average maintenance dose is 5-20 mg / day in 1-2 doses. With asymptomatic dysfunction of the left ventricle: 2.5 mg 2 times a day, then the dose (up to 20 mg / day in 2 divided doses) is selected taking into account tolerability. In chronic renal failure: with Cl creatinine 80-30 ml / min – 5-10 mg / day, 30-10 ml / min – 2.5-5 mg / day, less than 10 ml / min – 1.25-2, 5 mg/day only on dialysis days. With a too pronounced decrease in blood pressure, the dose is gradually reduced. It is used both in monotherapy and in combination with other antihypertensive agents. Use during pregnancy and lactation is contraindicated in pregnancy. At the time of treatment should stop breastfeeding. Precautions: Caution should be used in primary hyperaldosteronism, bilateral renal artery stenosis, solitary kidney artery stenosis, hyperkalemia, kidney transplant condition, aortic stenosis, mitral stenosis (hemodynamically impaired), idiopathic hypertrophic subaortic stenosis, connective tissue disease, ischemic heart disease, cerebrovascular disease , diabetes mellitus, renal failure (proteinuria more than 1 g / day), liver failure, in patients on a salt-restricted diet or on hemodialysis, while taking immunosuppressants and saluretics, in the elderly (over 65 years of age). In patients with a reduced volume of circulating blood (as a result of diuretic therapy, salt restriction, during hemodialysis, diarrhea, vomiting), there is an increased risk of a sudden and pronounced decrease in blood pressure after using even the initial dose of an ACE inhibitor. Patients with severe heart failure, coronary artery disease, and cerebrovascular disease should be carefully monitored, in whom a sharp decrease in blood pressure can lead to myocardial infarction, stroke, or impaired renal function. Sudden withdrawal of treatment does not lead to a withdrawal syndrome (a sharp rise in blood pressure). It is recommended to carefully monitor newborns and infants who have been exposed to ACE inhibitors in utero in order to detect a pronounced decrease in blood pressure, oliguria, hyperkalemia, neurological disorders, possible due to a decrease in renal and cerebral blood flow with a decrease in blood pressure. With oliguria, it is necessary to maintain blood pressure and renal perfusion by introducing appropriate fluids and vasoconstrictors. In patients with reduced renal function, a single dose should be reduced or the intervals between doses should be increased. Before examining the function of the parathyroid glands, the drug should be discontinued. During treatment, it is not recommended to drink alcohol (alcohol enhances the hypotensive effect). Caution should be exercised when exercising in hot weather (risk of dehydration and an excessive decrease in blood pressure due to a decrease in circulating blood volume). Before performing surgical interventions, it is necessary to warn the surgeon and anesthesiologist about the use of ACE inhibitors. Interaction with other drugs When used together with NSAIDs, a decrease in the hypotensive effect is possible; with potassium-sparing diuretics (spironolactone, triamterene, amiloride) – hyperkalemia may develop; with lithium salts – the excretion of lithium slows down (it is necessary to control the concentration of lithium in the blood plasma). Weakens the effect of drugs containing theophylline. Diuretics, beta-blockers, methyldopa, nitrates, BCC, hydralazine, prazosin enhance the hypotensive effect. Immunosuppressants, allopurinol, cytostatics increase hematotoxicity. Drugs that cause bone marrow suppression increase the risk of developing neutropenia and / or agranulocytosis, up to death. Contraindications Hypersensitivity (including to other ACE inhibitors), angioedema associated with treatment with an ACE inhibitor in history, porphyria, pregnancy, breastfeeding period, age up to 18 years (efficacy and safety have not been established) lactose monohydrate; magnesium carbonate light; gelatin; carboxymethyl starch sodium salt; magnesium stearate; brown iron oxide pigment (E172). Treatment: providing the patient with a horizontal position with a low headboard. In mild cases, gastric lavage, oral saline administration, in more severe cases, measures to stabilize blood pressure: intravenous administration of saline, plasma substitutes, if necessary, the introduction of angiotensin II, hemodialysis (enalaprilat excretion rate – 62 ml / min). Side effects From the side of the cardiovascular system and blood (hematopoiesis, hemostasis): excessive decrease in blood pressure, orthostatic collapse, rarely – angina pectoris (retrosternal pain), myocardial infarction (usually associated with a pronounced decrease in blood pressure), arrhythmias (atrial brady or tachycardia, flicker atrial), palpitations, thromboembolism of the branches of the pulmonary artery, pain in the heart, fainting, in some cases – a decrease in hemoglobin, an increase in ESR, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia. From the nervous system and sensory organs: dizziness, headache, weakness, insomnia, anxiety, confusion, fatigue, drowsiness (2-3%), very rarely (when using high doses) – nervousness, depression, paresthesia, vestibular disorders apparatus, hearing, vision, tinnitus. On the part of the digestive tract: dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, pain in the abdomen), intestinal obstruction, pancreatitis, impaired liver function and bile secretion, hepatitis, jaundice. From the respiratory system: unproductive dry cough, interstitial pneumonitis, bronchospasm, shortness of breath, rhinorrhea, pharyngitis. Allergic reactions: skin rash, angioedema of the face, extremities, lips, tongue, glottis and / or larynx, dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria, photosensitivity, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis. Changes in laboratory parameters: hypercreatininemia, increased urea content, increased activity of “liver” transaminases, hyperbilirubinemia, hyperkalemia, hyponatremia. In some cases, a decrease in hematocrit. From the genitourinary system: impaired renal function, proteinuria. Other: decreased libido, flushing of the face. Storage conditionstext Buy Berlipril 10 tablets 10mg No. 10×3