Lisinopril Teva pills 20mg N30
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Active ingredients
Lisinopril
Release form
Pills
Composition
1 tablet contains: Active ingredient: lisinopril (in the form of dihydrate) 20 mg.
Pharmacological effect
An 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 prostaglandin synthesis. Reduces total peripheral vascular resistance (OPSS), blood pressure, preload, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increase the tolerance of the myocardium to the load in patients with chronic heart failure. Expands arteries to a greater extent than veins. Some effects are attributed to effects on the renin-angiotensin-aldosterone system (RAAS). With prolonged use, hypertrophy of the myocardium and the walls of resistive arteries is reduced. It improves blood supply to ischemic myocardium. ACE inhibitors prolong life expectancy in patients with chronic heart failure (CHF), slow down the progression of left ventricular dysfunction in patients who have had an acute myocardial infarction without clinical manifestations of heart failure. The onset of action of the drug - after 1 h, the maximum antihypertensive effect is achieved after 6-7 hours and lasts for 24 hours. The duration of the effect also depends on the size of the dose taken. In case of arterial hypertension, the effect is noted in the first days after the start of treatment, a stable action develops after 1-2 months. therapy. With abrupt cancellation of lisinopril, there was no pronounced increase in blood pressure. Lysinopril reduces albuminuria. Does not affect the concentration of glucose in the blood of patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.
Pharmacokinetics
Absorption After ingestion, lisinopril is absorbed from the gastrointestinal tract by an average of 25%, but the absorption can vary from 6 to 60%. Bioavailability is 29%. Cmax in plasma is reached after 7 hours. Eating does not affect the absorption of lisinopril. Distribution Lysinopril is not significantly bound to plasma proteins. The permeability through the hematoencephalic and placental barrier is low. Metabolism Lysinopril does not biotransform in the body. Excretion is excreted by the kidneys unchanged. T1 / 2 is 12.6 hours. The clearance of lisinopril is 50 ml / min. The decrease in serum lisinopril concentration occurs in two phases.The main part of lisinopril is derived during the initial alpha phase (effective T1 / 2 is 12 hours), followed by the terminal distant beta phase (about 30 hours). Pharmacokinetics in certain groups of patients In patients with CHF, the absorption and clearance of lisinopril is reduced, bioavailability is 16%. In patients with renal insufficiency (creatinine clearance (CC) less than 30 ml / min), lisinopril concentration is several times higher than plasma concentration in healthy volunteers, and there is an increase in the time it takes Cmax in plasma and T1 / 2 increase. In elderly patients, the concentration of the drug in the blood plasma and the area under the concentration-time curve is 2 times greater than in young patients. In patients with cirrhosis of the liver, the bioavailability of lisinopril is reduced by 30% and clearance is 50% compared with patients with normal liver function. In elderly patients, the concentration of lisinopril in the blood is increased, on average, by 60%.
Indications
- arterial hypertension (in monotherapy or in combination with other antihypertensive drugs); - chronic heart failure (as part of combination therapy); - early treatment of acute myocardial infarction (in the first 24 hours with stable hemodynamic indicators to maintain these indicators and prevent left ventricular dysfunction and heart failure); - diabetic nephropathy (reduction of albuminuria in patients with type 1 diabetes mellitus under normal blood pressure, and in patients with type 2 diabetes with hypertension).
Contraindications
- Hypersensitivity to lisinopril, other components of the drug or other ACE inhibitors; - Angioedema edema in history (including from the use of other ACE inhibitors); - Hereditary angioedema and / or idiopathic angioedema; - Age 18 years ( efficacy and safety have not been established); - pregnancy and breastfeeding period. With caution: bilateral renal artery stenosis or arterial stenosis of a single kidney with progressive azotemia; condition after kidney transplantation; renal failure; hemodialysis using high-flow dialysis membranes (AN69); azotemia; hyperkalemia; aortic stenosis; hypertrophic obstructive cardiomyopathy; primary hyper aldosteronism; hypotension; cerebrovascular diseases (including cerebrovascular insufficiency); CHD; coronary insufficiency; autoimmune diseases of the connective tissue (includingscleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; conditions accompanied by a decrease in circulating blood volume (BCC) (including as a result of diarrhea, vomiting); use in patients on a diet with salt restriction; in elderly patients; simultaneous application of potassium preparations, diuretics, other antihypertensive agents, NSAIDs, lithium preparations, antacids, colestyramine, ethanol, insulin, and other hypoglycemic agents, allopurinol, procainamide, drugs of gold, antipsychotics, tricyclic antidepressants, barbiturates, beta-blockers, blockers, slow calcium channels.
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Use during pregnancy and lactation
The use of the drug Lisinopril-Teva during pregnancy is contraindicated. When diagnosing pregnancy, the drug should be stopped as soon as possible. Acceptance of ACE inhibitors in the II and III trimesters of pregnancy has an adverse effect on the fetus (pronounced reduction in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull bones, fetal death) are possible. There is no data on the negative effect of the drug on the fetus in the case of use in the first trimester. For newborns and infants who have been exposed to intrauterine effects of ACE inhibitors, it is recommended to conduct careful monitoring to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia. Data on the penetration of lisinopril into breast milk is not.If necessary, the use of the drug Lisinopril-Teva during lactation breastfeeding should be stopped.
Dosage and administration
The drug Lisinopril-Teva is ingested 1 time / day, regardless of the time of the meal, preferably at the same time of day. The dose is selected individually. In hypertension patients who do not receive other antihypertensive drugs, use 5 mg / day. In the absence of a therapeutic effect, the dose is increased every 2–3 days by 5 mg to a dose of 20–40 mg / day (increasing the dose over 40 mg / day usually does not lead to a further decrease in blood pressure). The average daily maintenance dose is 20 mg. The maximum daily dose of 40 mg. The therapeutic effect usually develops after 2-4 weeks from the start of treatment, which should be considered when increasing the dose. With insufficient effect, it is possible to simultaneously use the drug with other antihypertensive drugs. If the patient has received prior treatment with diuretics, then these medications should be stopped for 2-3 days before starting to use Lisinopril-Teva. If this is not possible, the initial dose of Lisinopril-Teva should not exceed 5 mg / day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the action maximum is reached after about 6 hours), as a pronounced decrease in blood pressure may occur. In case of renovascular hypertension associated with an increased activity of the RAAS, it is advisable to apply a low initial dose 2.5 mg / day under enhanced medical control (control of blood pressure, kidney function, serum potassium content). Maintaining a dose, continuing strict medical supervision, should be determined depending on the dynamics of blood pressure. In chronic heart failure, the initial dose of 2.5 mg / day, the dose is gradually increased (no more than 10 mg, with an interval of at least 2 weeks), depending on HELL. The maximum daily dose is 20 mg. With early treatment of acute myocardial infarction, the dose is 5 mg on the first day, then 5 mg every other day, 10 mg after two days and then 10 mg / day as maintenance therapy. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after myocardial infarction, patients with low systolic blood pressure (120 mm Hg or lower) use a lower dose of Lisinopril-Teva - 2.5 mg. If systolic blood pressure is less than or equal to 100 mm Hg, Lisinopril-Teva is not recommended.With concomitant renal failure (QA less than 80 ml / min.), Appropriate dose adjustment should be made. In diabetic nephropathy in patients with type 1 diabetes, Lisinopril-Teva is used at a dose of 10 mg / day. If necessary, the dose can be increased to 20 mg / day in order to achieve a diastolic blood pressure below 75 mm Hg. st. in the sitting position. In type 2 diabetes mellitus, Lisinopril-Teva is used in the same dose in order to achieve a diastolic blood pressure below 90 mm Hg. in the sitting position.
Side effects
The most common side effects are: dizziness, headache, fatigue, diarrhea, dry cough, nausea. The frequency of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often not less than 1%, but less than 10%; infrequently - not less than 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%. From the side of the cardiovascular system: often - a pronounced decrease in blood pressure, orthostatic hypotension; infrequently - acute myocardial infarction, tachycardia, palpitations; Raynaud's syndrome; rarely - bradycardia, tachycardia, worsening of the symptoms of CHF, impaired atrioventricular conduction, chest pain. From the central nervous system: often - dizziness, headache; infrequently - mood lability, paresthesias, sleep disorders, stroke; rarely - confusion, asthenic syndrome, convulsive twitching of the muscles of the extremities and lips, drowsiness. From the hematopoietic system and lymphatic system: rarely - decrease in hemoglobin, hematocrit; very rarely - leukopenia, neutropenia, agranulocytosis, thrombocytoia, eosinophilia, erythropenia, hemolytic anemia, lymphadenopathy, autoimmune diseases, bone marrow function suppression. From the side of the respiratory system: often - cough, infrequently - rhinitis, very rarely - sinusitis, parasites, bronchitis, bronchitis, bronchitis, bronchitis, bronchitis. eosinophilic pneumonia, shortness of breath. On the part of the digestive system: often - diarrhea, vomiting; infrequently - dyspepsia, changes in taste, pain in the abdomen; rarely, dryness of the oral mucosa; very rarely - pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis, liver failure,intestinal edema, anorexia. On the skin side: infrequently - pruritus, rash; rarely - angioedema of the face, extremities, lips, tongue, larynx, urticaria, alopecia, psoriasis; very rarely - increased sweating, vasculitis, pemphigus, photosensitivity, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, Stevens-Johnson syndrome. On the part of the urinary system: often renal dysfunction; infrequently - uremia, acute renal failure; very rarely - anuria, oliguria, proteinuria. On the reproductive system: infrequently - impotence, rarely - gynecomastia. On the side of metabolism: very rarely - hypoglycemia. activity of "liver" transaminases, rarely - hyperbilirubinemia, hyponatremia, increased erythrocyte sedimentation rate, false-positive test results for antinuclear antibodies. On the part of the musculoskeletal system: rarely - arthralgia / arthritis, myalgia. Other: rarely - with simultaneous use with gold preparations, a symptom complex is described, including facial flushing, nausea, vomiting and a decrease in blood pressure (see the section "Drug Interactions").
Overdose
Symptoms: marked reduction in blood pressure, dry oral mucosa, impaired water and electrolyte balance, renal failure, increased breathing, tachycardia, feeling of heartbeat, bradycardia, dizziness, anxiety, irritability, coughing, drowsiness, urinary retention, constipation, collapse, lung hyperventilation. Treatment: no specific antidote. Gastric lavage, the use of enterosorbents and laxatives. Intravenous administration of 0.9% sodium chloride solution is shown. In the case of treatment-resistant bradycardia, it is necessary to use an artificial “pacemaker”. It is necessary to control blood pressure, indicators of water and electrolyte balance. Hemodialysis is effective.
Interaction with other drugs
Lisinopril should be used with caution at the same time as potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium preparations, salt substitutes containing potassium, cyclosporine - the risk of hyperkalemia increases, especially with impaired renal function.Therefore, these combinations should be used only on the basis of an individual physician's decision with regular monitoring of serum potassium and kidney function. With simultaneous use with diuretics and other antihypertensive drugs, the antihypertensive effect of lisinopril is enhanced. With simultaneous use with NSAIDs (including selective cyclooxygenase-2 inhibitors (COX-2)), acetylsalicylic acid at a dose of more than 3 g / day, estrogen, and also sympathomimetics, decreases the antihypertensive effect of lisinopril. NSAIDs, including COX-2, and ACE inhibitors increase the content of potassium in the blood serum and may impair kidney function. This effect is usually reversible. Lisinopril slows down the excretion of lithium, therefore, with simultaneous use, there is a reversible increase in its concentration in the blood plasma, which can increase the likelihood of developing adverse events, so you should regularly monitor the concentration of lithium in the blood serum. Ethanol enhances the effect of lisinopril. When used simultaneously with insulin and hypoglycemic agents for oral administration, p increases lawsuit of hypoglycemia. With simultaneous use of lisinopril with vasodilators, barbiturates, antipsychotics (neuroleptics), tricyclic antidepressants, blockers of “slow” calcium channels, beta-adrenergic blockers, the antihypertensive effect can be increased. a symptom complex has been described, including facial flushing, nausea, vomiting, and a decrease in blood pressure. Combined use with allopurinol, procainamide, itostatikami can lead to leukopenia.
special instructions
Most often, a pronounced decrease in blood pressure occurs with a decrease in BCC, caused by diuretic therapy, a decrease in the content of table salt in food, dialysis, diarrhea, or vomiting. Under the supervision of a physician, it is recommended to use the drug Lisinopril-Teva in patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to a myocardial infarction or stroke.The use of the drug Lisinopril-Teva can lead to impaired renal function, acute renal failure, which usually is irreversible even after discontinuation of the drug. Transient arterial hypotension is not a contraindication for further use of the drug. In the case of renal artery stenosis (especially in bilateral stenosis or in the presence of stenosis of the only kidney artery), as well as in peripheral circulatory failure due to hyponatremia and hypovolemia, the use of Lisinopril-Teva may lead to impaired renal function, acute renal failure, which usually turns out to be irreversible after drug withdrawal. The preparation Lisinopril -Teva may be used simultaneously with standard therapy of acute myocardial infarction (thrombolytic agents, acetylsalicylic acid as an antiplatelet agent, beta-blockers). The preparation Lisinopril-Teva can be used simultaneously with the intravenous administration of nitroglycerin or with the use of therapeutic transdermal systems of nitroglycerin. - Teva in patients with acute myocardial infarction, if systolic blood pressure does not exceed 100 mm Hg. In surgical interventions, as well as the use of other drugs that cause a decrease in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a pronounced unpredictable decrease in blood pressure. Before surgery (including dental surgery), the surgeon / anesthesiologist should be informed about the use of an ACE inhibitor. In elderly patients, the use of standard doses leads to a higher concentration of the drug in the blood, therefore, special care is required in determining the dose, despite the fact that there are differences in antihypertensive action of the drug Lisinopril-Teva in elderly and young patients has not been identified. Since the potential risk of agranulocytosis cannot be ruled out, iodic control of peripheral blood. Angioedema of the face, extremities, lips, tongue, epiglottis, and / or larynx, which can occur during any period of treatment, was rarely seen in patients taking an ACE inhibitor, including lisinopril.In this case, treatment with the drug should be stopped as soon as possible, and the patient should be monitored until symptoms are fully regressed. Angioedema with laryngeal edema can be fatal. Swelling of the tongue, epiglottis, or larynx can be the cause of airway obstruction, therefore, it is necessary to immediately conduct appropriate therapy (0.3-0.5 ml of 1: 1000 solution of epinephrine (adrenaline) subcutaneously) and / or measures to ensure the airway patency. In cases where the edema is localized only on the face and lips, the condition most often passes without treatment, however, it is possible to use antihistamines. ACE inhibitors more often cause the development of angioedema in patients of the Negroid race than in other races. The risk of developing angioedema is increased in patients who have a history of angion edema that is not associated with previous treatment with ACE inhibitors. Patients taking ACE inhibitors during the desensitization procedure for hymenoptera poison, extremely rarely, can develop life-threatening anaphylactoid reactions. This can be avoided by temporarily stopping the treatment with an ACE inhibitor before each desensitization procedure on the hymenopter. Anaphylactoid reactions are also observed in patients on hemodialysis using high-flow dialysis membranes (AN69), who simultaneously take ACE inhibitors. In such cases, it is necessary to consider the possibility of using another type of membrane for dialysis or another antihypertensive agent. In patients receiving hypoglycemic drugs for oral and insulin, blood glucose should be regularly monitored during the first month of treatment with ACE inhibitors. It was very rare with ACE inhibitors that a syndrome started with cholestatic jaundice and progressed to fulminant necrosis of the liver, sometimes fatal . The mechanism of development of this syndrome is unknown. When jaundice appears on the background of the use of the drug Lisinopril-Teva or a pronounced increase in the activity of liver transaminases, the drug is canceled and the patient is monitored. When using ACE inhibitors, cough was noted.The cough is dry, long-lasting, which disappears after stopping treatment with an ACE inhibitor. In the differential diagnosis of cough, cough caused by the use of an ACE inhibitor should also be taken into account. ability to drive vehicles and work with potentially dangerous machinery.