Lisinopril tablets 10mg №10×6

Name Lisinopril tabl. Tablets with a dosage of 10 mg are engraved with “10”. The main active substance Lisinopril Release form tablets Dosage 10 mg Special indications The occurrence of symptomatic arterial hypotension is more likely in patients with more severe heart failure, receiving high doses of loop diuretics, with hyponatremia or impaired renal function. In patients with an increased risk of symptomatic hypotension, the initiation of therapy and dose adjustment should be carefully monitored. Similar measures apply to patients with ischemic heart disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or stroke. Often, hypotension, especially after the first dose, may develop in patients with severe forms of heart failure, this should be taken into account when prescribing lisinopril. If hypotension occurs, the patient should be placed on his back, if necessary, an infusion of 9 mg / ml of sodium chloride solution should be carried out. A short-term hypotensive reaction is not a contraindication to further doses, which can usually be administered without difficulty after the restoration of effective blood volume and the disappearance of a fleeting hypotensive reaction. Arterial hypotension in acute myocardial infarction. In acute myocardial infarction, treatment with Lisinopril should not be started if, through the preliminary use of vasodilators, there is a risk of further serious hemodynamic disturbances. This applies to patients with systolic blood pressure of 100 mm Hg. Art. or less, or cardiogenic shock. During the first 3 days after myocardial infarction, the dose of the drug should be reduced if the systolic pressure does not exceed 120 mm Hg. Art. If the systolic blood pressure is equal to or less than 100 mm Hg. Art., selected doses should be reduced to 5 mg or temporarily to 2.5 mg. If, after taking Lisinopril, prolonged arterial hypotension is observed (systolic pressure remains less than 90 mm Hg for more than 1 hour), treatment with Lisinopril should be discontinued. Aortic and mitral valve stenosis/hypertrophic cardiomyopathy. As with other ACE inhibitors, Lisinopril should be used cautiously in patients with mitral valve stenosis or left ventricular ejection obstruction such as aortic stenosis or hypertrophic cardiomyopathy. Impaired kidney function. In case of renal insufficiency (creatinine clearance <80 ml / min), the initial dose of Lisinopril must be adjusted according to the patient's creatinine clearance (see table), and then depending on the patient's response to treatment. In these patients, serum potassium levels and creatinine clearance should be monitored daily. In patients with heart failure, hypotension after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. In such cases, the development of acute renal failure, usually reversible, has been reported. In some patients with bilateral renal artery stenosis or stenosis of the renal artery to a solitary kidney who were taking ACE inhibitors, elevated serum urea and creatinine levels usually returned to normal after discontinuation of therapy. More often, levels rose in patients with renal insufficiency. In the presence of renovascular hypertension, the risk of developing severe arterial hypotension and renal failure increases. Treatment of such patients should be started under the supervision of a physician, low doses and careful selection. Since diuretic therapy can contribute to all of the above, their use should be discontinued and renal function monitored during the first weeks of treatment with Lisinopril. In some patients with arterial hypertension without obvious vascular disease of the kidneys, Lisinopril, especially against the background of diuretics, causes an increase in the level of urea in the blood and creatinine in the blood serum. These changes are usually minor and transient. More common in patients with a history of renal insufficiency. In this case, it may be necessary to reduce the dose of the drug and / or stop taking the diuretic and / or Lisinopril. Treatment of acute myocardial infarction with Lisinopril is not indicated in patients with signs of kidney dysfunction, in which there is an elevated serum creatinine level > 177 µmol / l and / or proteinuria > 500 mg / day. If renal failure develops during treatment with lisinopril (serum creatinine concentration > 265 µmol/l or a 2-fold increase in pre-treatment levels), then the doctor may consider discontinuing lisinopril. Hypersensitivity / angioedema. In very rare cases, angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with ACE inhibitors. During treatment, angioedema may occur at any time. In such cases, the drug should be stopped immediately, appropriate therapy initiated and monitored to ensure the complete disappearance of symptoms. In cases where the edema is localized in the region of the tongue, which does not lead to respiratory failure, the patient may require long-term observation, since therapy with antihistamines and corticosteroids may not be sufficient. Anaphylactic reactions in patients undergoing hemodialysis. Anaphylactic reactions have been reported in patients undergoing hemodialysis using high-flow membranes (eg, AN 69) and concomitantly treated with ACE inhibitors. These patients should be offered to change their dialysis membranes to another type of membrane or use a different class of antihypertensive agent. Desensitization. Patients taking ACE inhibitors during desensitizing therapy (eg, hymenoptera venom) develop persistent anaphylactoid reactions. These reactions were avoided in these patients by temporarily discontinuing ACE inhibitors, but after inadvertent re-use of the drug, the reactions were restored. Liver failure. Very rarely, ACE inhibitors have been associated with a syndrome that begins with cholestatic jaundice and progresses rapidly to necrosis and (sometimes) death. The mechanism of this syndrome has not been identified. Patients who develop jaundice or a significant increase in liver enzymes while taking lisinopril should stop taking the drug and provide appropriate medical attention. Neutropenia/agranulocytosis. Cases of neutropenia/agranulocytosis, thrombocytopenia and anemia have been reported in patients treated with ACE inhibitors. In patients with normal renal function and in the absence of other complicating factors, neutropenia is rarely observed. After discontinuation of the ACE inhibitor, neutropenia and agranulocytosis are reversible. It is necessary to take lisinopril with extreme caution in patients with vascular collagenosis, as well as in patients receiving immunosuppressive therapy, in the treatment of allopurinol or procainamide, or a combination of these complicating factors, especially against the background of impaired renal function. When using the drug in such patients, it is recommended to periodically monitor the number of leukocytes in the blood and warn the patient about the need to report any signs of infection. Cough. Cough may occur after the use of ACE inhibitors. Usually, the cough is non-productive and stops after discontinuation of therapy. ACE inhibitor-induced cough should be considered in the differential diagnosis of cough as one of the possible options. Surgery/anesthesia. In patients undergoing general surgery or anesthesia with agents that cause hypotension, lisinopril may block the formation of angiotensin II after compensatory renin secretion. If arterial hypotension is observed due to this mechanism, it is necessary to correct the level of BCC. Hyperkalemia. Several cases of elevated serum potassium levels have been reported in patients treated with ACE inhibitors, including lisinopril. Patients at high risk of developing hyperkalemia include those with renal insufficiency, diabetes mellitus, or concomitant use of potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes, or patients taking other drugs that increase serum potassium levels (eg, heparin). If the simultaneous use of these drugs is considered appropriate, regular monitoring of serum potassium levels is recommended. Patients with diabetes mellitus. In patients with diabetes mellitus taking oral antidiabetic drugs or insulin, careful glycemic control should be carried out during the first month of therapy with ACE inhibitors. Anaphylactoid reactions occurring during low-density lipoprotein (LDL) apheresis. Since the use of ACE inhibitors during LDL apheresis with dextran sulfate can lead to life-threatening anaphylactic reactions, ACE inhibitors should be temporarily discontinued before each use. Racial affiliation. ACE inhibitors may cause more pronounced angioedema in dark-skinned patients than in Caucasian patients. Also, in this group of patients, the hypotensive effect of lisinopril is less pronounced due to the predominance of low renin fractions. Lithium. The combination of lithium and lisinopril is not recommended. Double blockade of the renin-angiotensin-aldosterone system (RAAS). Dual blockade of the RAAS is associated with an increased risk of hypotension, hyperkalemia, and impaired renal function (including acute renal failure) compared with monotherapy. Dual RAAS blockade with an ACE inhibitor, ARB II, or aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This also applies to the appointment of candesartan or valsartan as additional therapy to ACE inhibitors in patients with heart failure. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy. Use in elderly patients From the same dose of Lisinopril, a higher plasma concentration of lisinopril can be created, therefore, special care is required when selecting the dosage in this case, despite the fact that differences in the antihypertensive effect of lisinopril-containing drugs between elderly and young patients not found. For patients over 65 years of age, an initial dose of lisinopril 2.5 mg/day is recommended, as well as monitoring of blood pressure and renal function. Use in children Reception is contraindicated in children under 6 years of age. Pharmacological properties Pharmacodynamics ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in the content of angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. It reduces the total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and an increase in myocardial tolerance to stress in patients with chronic heart failure. Expands arteries more than veins. Some effects are explained by the effect on the tissue renin-angiotensin systems. With prolonged use, hypertrophy of the myocardium and walls of resistive arteries decreases. Improves blood supply to ischemic myocardium. The duration of the effect also depends on the dose. The beginning of action – in 1 hour. The maximum effect is determined after 6-7 hours. The action lasts 24 hours. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. In patients with chronic heart failure, Lisinopril, by reducing the total peripheral vascular resistance, reduces the afterload on the heart, increases the stroke and minute volume of the heart without increasing the heart rate, and increases exercise tolerance. In addition, Lisinopril reduces preload, reduces pressure in the pulmonary circulation and in the right atrium, and causes regression of myocardial hypertrophy. Two large randomized trials, ONTARGET and VA NEPHRON-D, studied the combination of ACE inhibitors and angiotensin II receptor blockers in patients with cerebrovascular disease and type II diabetes mellitus with target organ damage or diabetic nephropathy. These studies did not reveal a significant benefit for patients in terms of preservation of renal function, cardiovascular outcomes and mortality, but, at the same time, were accompanied by an increase in the frequency of impaired renal function, hypotension compared with monotherapy. Given the similar characteristics of all ACE inhibitors, the results of these studies can be extended to the entire group of drugs. The ALTITUDE study examined the addition of aliskiren to ACE inhibitor or angiotensin II receptor blocker therapy in patients with type 2 diabetes mellitus and kidney or heart disease. The study was terminated early due to a high rate of adverse outcomes (the risk of cardiovascular death or stroke was higher in the aliskiren group). Also, the study found an increased incidence of adverse effects in the aliskiren group (hyperkalemia, hypotension and impaired renal function). Pharmacokinetics Absorption After oral administration, lisinopril is absorbed from the gastrointestinal tract. Cmax of lisinopril in plasma is achieved within 6-8 hours. Eating does not affect the absorption of the drug. Absorption averages 30%, bioavailability – 29%. Distribution Does not bind to plasma proteins. Css of lisinopril during the course of taking the drug is established after 3 days. Permeability through the blood-brain and placental barrier is low. Metabolism Lisinopril is not biotransformed in the body. Withdrawal Excreted by the kidneys unchanged. The half-life is 12 hours. Pharmacokinetics in special clinical situations In patients with severely impaired renal function, an increase in the time to reach Cmax and Css of lisinopril was noted; the dosing regimen for this category of patients must be adjusted taking into account the indicators of creatinine clearance. Indications for use Arterial hypertension (including symptomatic); chronic heart failure (as part of combination therapy); acute myocardial infarction (in the first 24 hours as part of combination therapy). See also sections “Contraindications”, “Special instructions”, “Interaction with other drugs”, “Pharmacodynamics”. Dosage and administration Lisinopril is recommended to be taken orally 1 time per day, at about the same time. Eating does not affect the absorption of lisinopril tablets. The dose should be determined individually according to the patient’s response and blood pressure. Arterial hypertension Lisinopril can be used as monotherapy and in combination with other antihypertensive drugs. See also sections “Contraindications”, “Special instructions”, “Interaction with other drugs”, “Pharmacodynamics”. starting dose. For patients with arterial hypertension, the recommended initial dose is 10 mg. Patients with a very active renin-angiotensin-aldosterone system (in particular with renovascular hypertension, increased salt excretion from the body and / or reduced interstitial fluid volume, heart failure or severe arterial hypertension) may experience a significant decrease in blood pressure after taking the initial dose. For such patients, the recommended dose is 2.5-5 mg, the start of treatment should take place under the direct supervision of a physician. A reduction in the starting dose is also recommended in renal failure (see table below). maintenance dose. The usual recommended maintenance dose is 20 mg once daily. If the appointment of this dose does not give a sufficient therapeutic effect within 2-4 weeks, it can be increased. The maximum daily dose is 80 mg. Treatment of arterial hypertension in children aged 6–16 years The recommended starting dose is 2.5 mg once daily in patients weighing 20 to <50 kg and 5 mg in patients weighing ≥50 kg. Dosage should be adjusted individually up to a maximum daily dose of 20 mg for children weighing 20 to <50 kg and a maximum daily dose of 40 mg for patients weighing ≥50 kg. There are no data on the use of doses above 0.61 mg / kg (above 40 mg) in children. In children with reduced renal function, a lower initial dose and an increase in the interval between doses of the drug are required. Patients taking diuretic drugs Symptomatic hypotension may occur after initiation of treatment with Lisinopril. This is likely in patients taking diuretics while on Lisinopril. Such patients are advised to take the drug with caution due to the likelihood of increased excretion of salt from the body and / or a decrease in the volume of interstitial fluid. If possible, it is necessary to stop treatment with diuretics 2-3 days before the start of therapy with Lisinopril. For patients with arterial hypertension who cannot stop diuretic treatment, therapy should be started with a dose of 5 mg. It is necessary to monitor kidney function and serum potassium levels. Subsequent doses of Lisinopril should be titrated according to the blood pressure response. If necessary, diuretic therapy can be resumed. Use during pregnancy and lactation Lisinopril is contraindicated for use during pregnancy and lactation (breastfeeding). The use of the drug in the II and III trimester of pregnancy can lead to a decrease in the amount of amniotic fluid, manifestations of anuria, arterial hypotension, and disorders in the formation of the bones of the fetal skull. Influence on the ability to drive a car and work with mechanisms During the period of treatment, one should refrain from driving and performing potentially hazardous activities that require concentration of attention and increased speed of psychomotor reactions, since dizziness is possible, especially at the beginning of therapy. Interaction with other drugs Diuretics. With the simultaneous use of the drug with diuretics, a sharp decrease in blood pressure is possible, with other antihypertensive drugs, an additive effect is observed (caution is required in combination therapy). Potassium preparations, potassium-sparing diuretics. With simultaneous use with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes and dietary supplements containing potassium, hyperkalemia may develop, especially in patients with impaired renal function. When using such combinations, regular monitoring of the content of potassium in the blood and kidney function is required. Lithium. Reversible increases in serum lithium levels and toxicity have been reported during co-administration of lithium with ACE inhibitors. The concomitant use of thiazide diuretics with ACE inhibitors may further increase the risk of lithium toxicity. The simultaneous use of lisinopril with lithium is not recommended, but if such a combination is necessary, careful monitoring of the content of lithium in the blood serum is necessary. Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid 3 g/day. When ACE inhibitors are used simultaneously with non-steroidal anti-inflammatory drugs (eg, acetylsalicylic acid in the anti-inflammatory dosing regimen, COX-2 inhibitors and non-selective NSAIDs), a weakening of the antihypertensive effect may occur. The concomitant use of ACE inhibitors and NSAIDs may lead to an increased risk of worsening renal function, including the possibility of acute renal failure, as well as an increase in serum potassium concentration, especially in patients with impaired renal function. These effects are usually reversible. Combinations of ACE inhibitors and NSAIDs should be used with caution, especially in the elderly. Patients should maintain adequate fluid balance; after the course of therapy, it is necessary to check the function of the kidneys. Preparations of gold. Nitrate-like reactions (symptoms of vasodilation, including flushing, nausea, dizziness, and hypotension, which can be very severe) may occur more frequently when ACE inhibitors are given concomitantly with injectable gold preparations. Other antihypertensive drugs. The simultaneous use of these drugs may increase the hypotensive effect of lisinopril. Simultaneous use with nitroglycerin and other nitrates or other vasodilators may further lower blood pressure. Tricyclic antidepressants/neuroleptics/anesthetics. The simultaneous use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors may lead to a further decrease in blood pressure. Sympathomimetics. Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors. Antidiabetic drugs. Epidemiological studies have shown that the simultaneous use of ACE inhibitors and antidiabetic drugs (insulin, oral hypoglycemic agents) can enhance the hypoglycemic effect of the latter with the risk of hypoglycemia. This effect is more likely during the first weeks of combined treatment and in patients with renal insufficiency. Acetylsalicylic acid, thrombolytics, beta-blockers, nitrates. Lisinopril can be used simultaneously with acetylsalicylic acid (in dosages that provide antiplatelet effect), thrombolytics, beta-blockers and / or nitrates. Double blockade of the renin-angiotensin-aldosterone system (RAAS). Based on the available data, dual blockade of the RAAS with an ACE inhibitor, ARB II, or aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal impairment (GFR < 60 ml/min/1.73 m2), concomitant use of aliskiren with an ACE inhibitor or ARB II is contraindicated. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Contraindications (see also sections "Interaction with other drugs and other forms of interaction", "Pharmacological properties") hypersensitivity to lisinopril; angioedema (local swelling of the skin, subcutaneous tissue and / or mucous membranes in combination with urticaria or without it) in history, including the use of ACE inhibitors; simultaneous use of angiotensin-converting enzyme inhibitors or ATII receptor blockers with aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2) is contraindicated; hereditary angioedema ; children's age up to 6 years; pregnancy; breastfeeding. Composition One tablet contains: active ingredient - lisinopril 5 mg and 10 mg; excipients: potato starch, microcrystalline cellulose, stearic acid, povidone, lactose monohydrate. Overdose Symptoms: arterial hypotension, circulatory shock, bradycardia, water and electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, dizziness, anxiety and cough. Treatment: intravenous administration of saline solutions. In cases of arterial hypotension, the patient must be placed in a horizontal position. If possible, administration of angiotensin II and I or administration of catecholamines can be used. If the drug has been used recently, take measures to remove lisinopril from the body (for example, induce vomiting, gastric lavage, use of absorbents and sodium sulfate). The use of a pacemaker is indicated for resistance to bradycardia therapy. It is necessary to frequently check the indicators of vital organs, the concentration of electrolytes and creatinine in the blood serum. Lisinopril can be removed from the body by hemodialysis, and the use of high-permeability polyacrylonitrile sodium-2-methylsulfonate membranes (eg AN 69) should be avoided. Side effects When using Lisinopril, as well as other ACE inhibitors, a number of side effects may occur with the following frequency: very frequent (1/10), frequent (1/100<1/10), infrequent (1/1000<1/100), rare (1/10000 <1/1000), very rare (<1/10000), unknown (cannot be estimated based on available data). Disorders of the blood and lymphatic system: rare - decrease in hemoglobin, decrease in hematocrit, very rare - bone marrow depression, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune diseases. Nutritional and metabolic disorders: very rare - hypoglycemia. Disorders of the nervous system and psyche: frequent - dizziness, headache, infrequent - mood swings, paresthesia, dizziness, taste disorder, sleep disorder, rare - confusion, olfactory disorders, frequency not known - symptoms of depression, loss of consciousness. Cardiac and vascular disorders: common - orthostatic effects, including hypotension, infrequent - myocardial infarction or cerebrovascular disorders, secondary hypotension may develop in high-risk patients, palpitations, tachycardia, Raynaud's syndrome. Respiratory and chest disorders: common - cough, infrequent - rhinitis, very rare - bronchospasm, sinusitis, allergic alveolitis / eosinophilic pneumonia. Gastrointestinal disorders: common - diarrhea, vomiting, infrequent - nausea, abdominal pain, dyspepsia, rare - dry mouth, very rare - pancreatitis, intestinal angioedema, hepatitis - or hepatocellular or cholestatic, jaundice and liver failure. Skin and subcutaneous tissue disorders: infrequent - redness, itching, hypersensitivity / angioedema (angioedema of the face, lips, tongue, pharynx and / or larynx), rare - urticaria, alopecia, psoriasis, very rare - sweating, pemphigus, toxic necrolysis of the epidermis, Stevens-Johnson syndrome, erythema multiforme, cutaneous pseudolymphoma. A symptom complex has been reported including one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, antinuclear antibodies, elevated ESR, eosinophilia and leukocytosis, skin rash, skin photosensitivity, and other skin manifestations. Renal and urinary tract disorders Common: Renal dysfunction Rare: Uremia, renal failure Very rare: Oliguria/anuria Endocrine disorders: the frequency is not known - inadequate secretion of antidiuretic hormone. Disorders of the reproductive system and mammary glands: infrequent - impotence, rare - gynecomastia. General disorders and disorders at the injection site: infrequent - fatigue, asthenia. Laboratory tests: infrequent - increase in blood urea, increase in serum creatinine, increase in liver enzymes, hyperkalemia, rare - increase in serum bilirubin, hyponatremia. Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Lisinopril tablets 10mg No. 10x6 Price for Lisinopril tablets 10mg No. 10x6