lisinopril | Lisinopril-Teva tablets 20 mg 20 pcs.

Product form

Tablets

Packing

20 mg tablets: 10 tablets per Al / PVC blister. 2 blisters along with instructions for use in a cardboard pack.

Pharmacological action

An angiotensin-converting enzyme (ACE) inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces total peripheral vascular resistance (OPSS), blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and increased myocardial exercise tolerance in patients with chronic heart failure. Expands arteries to a greater extent than veins. Some effects are attributed to exposure to the renin-angiotensin-aldosterone system (RAAS). With prolonged use, hypertrophy of the myocardium and walls of the arteries of the resistive type decreases. Improves blood supply to the ischemic myocardium.

ACE inhibitors lengthen life expectancy in patients with chronic heart failure (CHF), slow the progression of left ventricular dysfunction in patients after acute myocardial infarction without clinical manifestations of heart failure. The onset of action of the drug is after 1 hour, 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. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1-2 months. therapy. With a sharp abolition of lisinopril, there was no marked increase in blood pressure.

Lisinopril reduces albuminuria. It does not affect the blood glucose concentration in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.

Contraindications

Hypersensitivity to lisinopril, other components of the drug, or other ACE inhibitors history of angioedema (including the use of other ACE inhibitors) hereditary Quincke edema and / or idiopathic angioedema (efficacy and age up to 18 years of age not established) pregnancy and the period of breastfeeding.

Use during pregnancy and lactation

The use of the drug lisinopril-Teva during pregnancy is contraindicated. When diagnosing pregnancy, the drug should be discontinued as soon as possible. Acceptance of ACE inhibitors in the II and III trimesters of pregnancy has an adverse effect on the fetus (a pronounced decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the cranial bones, and intrauterine death are possible). There is no data on the negative effect of the drug on the fetus if used in the first trimester. For newborns and infants who underwent intrauterine exposure to ACE inhibitors, it is recommended to conduct careful monitoring to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia. There is no data on the penetration of lisinopril into breast milk. If it is necessary to use the drug Lisinopril-Teva during lactation, breastfeeding should be discontinued.

Special instructions

The most pronounced decrease in blood pressure occurs with a decrease in the BCC caused by diuretic therapy, a decrease in table salt in food, dialysis, diarrhea, or vomiting. Under the supervision of a doctor, it is recommended to use the drug Lisinopril-Teva in patients with coronary artery disease, cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke. The use of the drug Lisinopril-Teva can lead to impaired renal function, acute renal failure, which is usually irreversible even after discontinuation of the drug.

Transient arterial hypotension is not a contraindication for further use of the drug.

In case of stenosis of the renal artery (especially in case of bilateral stenosis or in the presence of stenosis of a single kidney artery), as well as in peripheral circulatory failure caused by hyponatremia and hypovolemia, the use of the drug Lisinopril-Teva can lead to impaired renal function, acute renal failure, which usually turns out to be irreversible after discontinuation of the drug.

The drug Lisinopril-Teva can be used simultaneously with standard therapy for acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers).

The drug Lisinopril-Teva can be used simultaneously with the intravenous administration of nitroglycerin or with the use of therapeutic transdermal systems of nitroglycerin.

The use of the drug Lisinopril-Teva is not recommended in patients after acute myocardial infarction, if the systolic blood pressure does not exceed 100 mm Hg. Art. With surgical interventions, as well as with 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 / anesthetist should be informed of 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 when determining the dose, despite the fact that there are no differences in the antihypertensive effect of the drug Lisinopril-Teva in elderly and young patients.

Since the potential risk of agranulocytosis cannot be ruled out, periodic monitoring of peripheral blood is required.

Angioedema of the face, limbs, lips, tongue, epiglottis and / or larynx, which may occur at any time during treatment, has rarely been reported 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 the symptoms regress completely. 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 carry out appropriate therapy (0.3-0.5 ml of a 1: 1000 solution of epinephrine (adrenaline) subcutaneously) and / or measures to ensure airway patency. In cases where edema is localized only on the face and lips, the condition most often goes away 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 representatives of other races. The risk of developing angioedema is increased in patients who have a history of angioedema that is not associated with previous treatment with ACE inhibitors. Patients taking ACE inhibitors during the desensitization procedure for hymenoptera venom, extremely rarely, can develop life-threatening anaphylactoid reactions. This can be avoided if you temporarily stop the treatment with an ACE inhibitor before each desensitization procedure on the hymenopter. Anaphylactoid reactions are also observed in patients undergoing hemodialysis using high-flow dialysis membranes (AN69В®), which simultaneously take ACE inhibitors. In such cases, it is necessary to consider the use of a different type of membrane for dialysis or another antihypertensive agent. In patients receiving hypoglycemic drugs for oral administration and insulin, blood glucose should be regularly monitored during the first month of therapy with ACE inhibitors.

Very rarely, with the use of ACE inhibitors, a syndrome was observed that began with cholestatic jaundice and progressed to fulminant liver necrosis, sometimes with a fatal outcome. The mechanism of development of this syndrome is unknown. When jaundice occurs with the use of the drug Lisinopril-Teva or a marked increase in the activity of “liver” transaminases, the drug is canceled and the patient’s condition is monitored.

Cough was observed with ACE inhibitors. The cough is dry, prolonged, which disappears after cessation of treatment with an ACE inhibitor. With a differential diagnosis of cough, cough caused by the use of an ACE inhibitor should be considered.

Influence on the ability to drive vehicles and mechanisms

Caution should be exercised when taking the drug Lisinopril-Teva due to the fact that the development of arterial hypotension, dizziness and drowsiness, which can affect the ability to drive vehicles and work with potentially dangerous mechanisms.

composition

1 tablet contains:

active substance: lisinopril dihydrate - lysine (lisinopril) 84 mg (20.00 mg)

Dosage and administration

The drug Lisinopril-Teva is taken orally 1 time per day, regardless of the time of meal, preferably at the same time of day. The dose is selected individually. With arterial hypertension, patients not receiving other antihypertensive drugs use 5 mg per 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 above 40 mg / day usually does not lead to a further decrease in blood pressure).

Average daily maintenance dose of 20 mg. The maximum daily dose is 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, simultaneous use of the drug with other antihypertensive drugs is possible.

If the patient received preliminary treatment with diuretics, then the administration of these drugs must be stopped 2-3 days before the start of the use of the drug Lisinopril-Teva. If this is not possible, then the initial dose of Lisinopril-Teva should not exceed 5 mg per day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since a marked decrease in blood pressure may occur.

In case of renovascular hypertension associated with increased RAAS activity, it is also advisable to use a low initial dose of 2.5 mg per day in dynamics, under enhanced medical supervision (control of blood pressure, renal function, serum potassium). A maintenance 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 per day, the dose is gradually increased (no more than 10 mg, with an interval of at least 2 weeks), depending on blood pressure. The maximum daily dose is 20 mg.

In the early treatment of acute myocardial infarction on the first day, the dose is 5 mg, then 5 mg every other day, 10 mg after two days and then 10 mg per 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 in patients with low systolic blood pressure (120 mm Hg or lower), a lower dose of Lisinopril-Teva is used - 2.5 mg. If the systolic blood pressure is lower than or equal to 100 mm Hg the drug Lisinopril-Teva is not recommended. With concomitant renal failure (CC less than 80 ml / min.), An appropriate dose adjustment of the drug should be made.

In diabetic nephropathy in patients with type 1 diabetes mellitus, the drug Lisinopril-Teva is used at a dose of 10 mg per day. If necessary, the dose can be increased to 20 mg per day in order to achieve diastolic blood pressure below 75 mm RT. Art. in the sitting position. For patients with type 2 diabetes mellitus, the drug Lisinopril-Teva is used in the same dose in order to achieve a diastolic blood pressure below 90 mm Hg. in the sitting position.

QC (ml / min.)

Initial dose (mg / day)

30-80

5-10

10-29

2.5-5

less than 10 (including patients on hemodialysis)

2.5

In renal failure and in patients on hemodialysis, the initial dose is set depending on the CC. The maintenance dose is determined depending on blood pressure (under the control of renal function, potassium and sodium in the blood)

Side effects

The most common side effects: dizziness, headache, fatigue, diarrhea, dry cough, nausea.

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10% often - at least 1%, but less than 10% infrequently - at least 0.1%, but less than 1% rarely - at least 0.01 %, but less than 0.1% is very rare - less than 0.01%.

From 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 symptoms of heart failure, impaired atrioventricular conduction, chest pain.

From the central nervous system: often - dizziness, headache infrequently - lability of mood, paresthesia, sleep disturbances, stroke rarely - confusion, asthenic syndrome, convulsive twitching of muscles of the limbs and lips, drowsiness.

From the hemopoietic system and the lymphatic system: rarely - a decrease in hemoglobin, hematocrit is very rare - leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, erythropenia, hemolytic anemia, lymphadenopathy, autoimmune diseases, inhibition of bone function.

From the respiratory system: often - cough, infrequently - rhinitis, very rarely - sinusitis, bronchospasm, allergic alveolitis / eosinophilic pneumonia, shortness of breath.

From the digestive system: often - diarrhea, vomiting infrequently - dyspepsia, taste changes, abdominal pain rarely - dry oral mucosa very rarely - pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis, liver failure, intestinal edema, anorexia.

From the skin: infrequently - itching, rash rarely - angioedema of the face, limbs, lips, tongue, larynx, urticaria, alopecia, psoriasis very rarely - increased sweating, vasculitis, pemphigus, photosensitivity, toxic epidermal necrolysis (syndrome) , erythema multiforme, Stevens-Johnson syndrome.

From the urinary system: often - impaired renal function infrequently - uremia, acute renal failure is very rare - anuria, oliguria, proteinuria.

From the reproductive system: infrequently - impotence, rarely - gynecomastia.

From the side of metabolism: very rarely - hypoglycemia.

On the part of laboratory indicators: infrequently - increased blood urea concentration, hypercreatininemia, hyperkalemia, increased activity of "liver" transaminases, rarely - hyperbilirubinemia, hyponatremia, increased erythrocyte sedimentation rate, false positive test results for antinuclear antibodies.

From the musculoskeletal system: rarely - arthralgia / arthritis, myalgia.

Other: rarely - with simultaneous use with gold preparations, a symptom complex is described intravenously, including facial flushing, nausea, vomiting and decreased blood pressure (see section “Interaction with other medicinal products”).

Drug interaction

With caution, lisinopril should be used simultaneously with potassium-sparing diuretics (spironolactone, triamteren, amiloride, eplerenone), potassium preparations, salt substitutes containing potassium, cyclosporine - the risk of hyperkalemia is increased, especially with impaired renal function. Therefore, these combinations should be used only on the basis of an individual doctor’s decision with regular monitoring of serum potassium and kidney function.

When used simultaneously with diuretics and other antihypertensive drugs, the antihypertensive effect of lisinopril is enhanced.

When used simultaneously with NSAIDs (including selective cyclooxygenase-2 (COX-2) inhibitors), acetylsalicylic acid at a dose of more than 3 g / day, estrogens, as well as sympathomimetics, the antihypertensive effect of lisinopril is reduced. NSAIDs, including COX-2, and ACE inhibitors increase serum potassium and may impair renal function. This effect is usually reversible. Lisinopril slows the elimination of lithium preparations, therefore, with simultaneous use, a reversible increase in its concentration in blood plasma occurs, which can increase the likelihood of the development of adverse events, so you should regularly monitor the concentration of lithium in blood serum.

With simultaneous use with antacids and colestyramine, absorption of lisinopril from the gastrointestinal tract is reduced. Ethanol enhances the effect of lisinopril.

When used with insulin and hypoglycemic agents for oral administration, the risk of hypoglycemia increases.

With the simultaneous use of lisinopril with vasodilators, barbiturates, antipsychotics (antipsychotics), tricyclic antidepressants, “slow” calcium channel blockers, beta-blockers, an antihypertensive effect may be enhanced.

With the simultaneous use of ACE inhibitors and intravenous gold preparations (sodium aurothiamalate), a symptom complex has been described, including facial flushing, nausea, vomiting, and a decrease in blood pressure.

Joint use with allopurinol, procainamide, cytostatics can lead to leukopenia.

overdose

Symptoms: marked decrease in blood pressure, dryness of the oral mucosa, impaired hydro-electrolyte balance, renal failure, respiratory failure, tachycardia, palpitations, bradycardia, dizziness, sunburn constipation, collapse, pulmonary hyperventilation.

Treatment: There is no specific antidote. Gastric lavage, the use of enterosorbents and laxatives. The intravenous administration of 0.9% sodium chloride solution is shown. In the case of bradycardia resistant to treatment, the use of an artificial rhythm driver is required. It is necessary to control blood pressure, water-electrolyte balance. Hemodialysis is effective.

Storage conditions

Do not store above 25 РC. Keep out of reach of children!

Shelf life

2 years.

Active substance

Lisinopril

Dosage form

tablets

Possible product names

lisinopril-Teva tablets 20 mg 20 pcs.