Lisinopril tablets 10mg, No. 20 Teva

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Expiration Date: 05/2027

Russian Pharmacy name:

Лизиноприл таблетки 10мг, №20 Тева

Lisinopril tablets 10mg, No. 20 Teva

- arterial hypertension

- chronic heart failure (as part of complex therapy with diuretics and cardiac glycosides)

- acute myocardial infarction in patients with stable hemodynamics without signs of renal dysfunction.

Arterial hypertension :

Treatment should start at 5 mg daily in the morning. The dose should be adjusted in such a way as to provide optimal control of the blood pressure level. The time interval between dose increases should be at least 3 weeks. The usual maintenance dose is 10Ц20 mg of lisinopril once a day, with a maximum daily dose of 40 mg once a day.

Heart failure :

Lisinopril-Teva is prescribed in addition to the existing therapy with diuretics and digitalis. The starting dose is 2.5 mg in the morning. The maintenance dose should be set in increments of 2.5 mg at intervals of 2-4 weeks. The usual maintenance dose is 5Ц20 mg once a day. Do not exceed the maximum dose of 35 mg lisinopril / day.

Acute myocardial infarction in patients with stable hemodynamics :

Treatment with Lisinopril-Teva can begin within 24 hours after the onset of symptoms, provided that hemodynamics are stable (systolic pressure is more than 100 mm Hg, without signs of renal dysfunction), in addition to standard heart attack therapy (thrombolytic drugs, acetylsalicylic acid, beta-blockers, nitrates). The initial dose is 5 mg, after 24 hours - another 5 mg, after 48 hours - 10 mg. Then the dose is 10 mg of lisinopril 1 time per day.

Patients with low systolic pressure (? 120 mm Hg) before starting therapy or within the first 3 days after a heart attack should receive a lower therapeutic dose for treatment - 2.5 mg of Lisinopril-Teva. If the systolic pressure is less than 90 mm Hg. Art. more than 1 hour, you should abandon Lisinopril-Teva.

Treatment should continue for 6 weeks. The minimum maintenance dose is 5 mg per day. Patients with symptoms of heart failure should continue to be treated with Lisinopril-Teva. The drug can be given simultaneously with nitroglycerin (intravenously or as a skin patch).

In myocardial infarction, lisinopril should be given in addition to the usual standard therapy (thrombolytic agents, acetylsalicylic acid, beta-blockers), preferably together with nitrates.

Elderly patients :

In elderly patients, the dosage should be adjusted based on the creatinine level (to assess renal function), which is calculated using the Cockcroft formula:

Creatinine clearance =

(140 - age)? body weight (kg)

0.814? serum creatinine concentration (?mol / l)

(For women, the result obtained using this formula must be multiplied by 0.85).

Dosage in patients with moderately limited renal function (creatinine clearance 30 - 70 ml / min) :

The initial dose is 2.5 mg of the drug in the morning, the maintenance dose is 5-10 mg per day. Do not exceed the maximum dose of 20 mg of lisinopril per day.

Lisinopril-Teva can be taken with or without food, but with sufficient fluid, once a day, preferably at the same time.

One tablet contains:

active substance - lisinopril dihydrate - 10.89 mg, equivalent to anhydrous lisinopril - 10 mg

excipients: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized starch, PB-24823 dye, croscarmellose sodium, magnesium stearate.

- increased susceptibility to the active substance or other ACE inhibitors or one of the excipients

- renal artery stenosis (bilateral or unilateral with one kidney)

- a history of angioedema due to previous therapy with an ACE inhibitor and hereditary / spontaneous angioedema

- simultaneous use of lisinopril with products containing aliskiren in patients with diabetes mellitus or renal failure (GFR <60 ml / min / 1.73 m2)

- severe renal dysfunction (creatinine clearance <30 ml / min).

- hemodynamically relevant stenosis of the aorta or mitral valve or hypertrophic cardiomyopathy

- acute myocardial infarction in patients with unstable hemodynamics

- systolic pressure? 100 mmHg Art. before starting treatment

- lactation

- pregnancy and lactation period

- cardiogenic shock

- children under 18 years old

- primary hyperaldosteronism

- condition after kidney transplantation

Tradename

Lisinopril-Teva

International non-proprietary name

Lisinopril

Dosage form

Tablets 5 mg, 10 mg, 20 mg

Composition:

One tablet contains:

active substance - lisinopril dihydrate 5.44 mg, 10.89 mg or 21.78 mg, equivalent to anhydrous lisinopril 5 mg, 10 mg, 20 mg,

excipients : mannitol, calcium hydrogen phosphate dihydrate, pregelatinized starch, PB-24823 dye, croscarmellose sodium, magnesium stearate.

Description

Tablets are white, round, biconvex, scored on one side (for a dosage of 5 mg).

Tablets are light pink, round, biconvex, with a score on one side (for a dosage of 10 mg).

Pink tablets, round, biconvex with a scored on one side (for a dosage of 20 mg).

Pharmacotherapeutic group

Drugs affecting the renin-angiotensin system. Angiotensin-converting enzyme (ACF) inhibitors. Lisinopril.

Pharmacological properties

Pharmacokinetics

The maximum plasma concentration is reached approximately 7 hours after oral administration. Food intake does not affect the rate of absorption of lisinopril. Lisinopril does not bind to blood plasma proteins. The absorbed biologically active substance is completely and unchanged excreted through the kidneys. The effective half-life was 12.6 hours. Lisinopril crosses the placenta.

Pharmacodynamics

Lisinopril-Teva is an angiotensin converting enzyme (ACE inhibitor) inhibitor. The suppression of ACE leads to a reduced formation of angiotensin II (with a vasoconstrictor effect) and to a decrease in the secretion of aldosterone. Lisinopril-Teva also blocks the breakdown of bradykinin, a powerful vasodepressor peptide. As a result, it lowers blood pressure, total peripheral vascular resistance, pre- and afterload on the heart, increases minute volume, cardiac output and increases myocardial tolerance to stress and improves blood supply to the ischemic myocardium. In patients with acute myocardial infarction, Lisinopril-Teva, together with nitrates, reduces the formation of left ventricular dysfunction or heart failure.

Indications

- arterial hypertension

- chronic heart failure (as part of complex therapy with diuretics and cardiac glycosides)

- acute myocardial infarction in patients with stable hemodynamics without signs of renal dysfunction.

Method of administration and dosage

Arterial hypertension :

Treatment should start at 5 mg daily in the morning. The dose should be adjusted in such a way as to provide optimal control of the blood pressure level. The time interval between dose increases should be at least 3 weeks. The usual maintenance dose is 10Ц20 mg of lisinopril once a day, with a maximum daily dose of 40 mg once a day.

Heart failure :

Lisinopril-Teva is prescribed in addition to the existing therapy with diuretics and digitalis. The starting dose is 2.5 mg in the morning. The maintenance dose should be set in increments of 2.5 mg at intervals of 2-4 weeks. The usual maintenance dose is 5Ц20 mg once a day. Do not exceed the maximum dose of 35 mg lisinopril / day.

Acute myocardial infarction in patients with stable hemodynamics :

Treatment with Lisinopril-Teva can begin within 24 hours after the onset of symptoms, provided that hemodynamics are stable (systolic pressure is more than 100 mm Hg, without signs of renal dysfunction), in addition to standard heart attack therapy (thrombolytic drugs, acetylsalicylic acid, beta-blockers, nitrates). The initial dose is 5 mg, after 24 hours - another 5 mg, after 48 hours - 10 mg. Then the dose is 10 mg of lisinopril 1 time per day.

Patients with low systolic pressure (120 mm Hg) before starting therapy or within the first 3 days after a heart attack should receive a lower therapeutic dose for treatment - 2.5 mg of Lisinopril-Teva. If the systolic pressure is less than 90 mm Hg. Art. more than 1 hour, you should abandon Lisinopril-Teva.

Treatment should continue for 6 weeks. The minimum maintenance dose is 5 mg per day. Patients with symptoms of heart failure should continue to be treated with Lisinopril-Teva. The drug can be given simultaneously with nitroglycerin (intravenously or as a skin patch).

In myocardial infarction, lisinopril should be given in addition to the usual standard therapy (thrombolytic agents, acetylsalicylic acid, beta-blockers), preferably together with nitrates.

Elderly patients :

In elderly patients, the dosage should be adjusted based on the creatinine level (to assess renal function), which is calculated using the Cockcroft formula:

Creatinine clearance =

(140 - age)? body weight (kg)

0.814? serum creatinine concentration (?mol / l)

(For women, the result obtained using this formula must be multiplied by 0.85).

Dosage in patients with moderately limited renal function (creatinine clearance 30 - 70 ml / min) :

The initial dose is 2.5 mg of the drug in the morning, the maintenance dose is 5-10 mg per day. Do not exceed the maximum dose of 20 mg of lisinopril per day.

Lisinopril-Teva can be taken with or without food, but with sufficient fluid, once a day, preferably at the same time.

Side effects

Sometimes

- headaches, dizziness, feeling of weakness, visual disturbances, fatigue

- dry cough, sore throat

- nausea, loss of appetite, diarrhea, constipation, vomiting

- allergic rash

Seldom

- stunned consciousness, depression, sleep disturbances, tinnitus, disturbances in the sense of balance, nervousness, changes in taste

- peripheral neuropathy with paresthesias, muscle cramps, hot flush, sweating

- shortness of breath, bronchospasm, allergic alveolitis

- tachycardia, cardiac arrhythmias, cardiogenic shock, chest pain, orthostatic hypotension

- cholestatic jaundice, proteinuria and increased serum bilirubin and liver enzymes

- anemia, thrombocytopenia, neutropenia, eosinophilia, in some cases agranulocytosis or pancytopenia; an increase in the concentration of urea, creatinine and potassium and a decrease in the concentration of sodium in the blood serum (in patients with impaired renal function)

- in some cases: hemolytic anemia in patients with a significant deficiency of glucose-3-phosphate dehydrogenase

- pruritus, urticaria, angioedema, pemphigus, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrosis, psoriasis, photosensitivity, alopecia, onycholysis

- Raynaud's syndrome

- impotence

Rarely

- arthralgia

Contraindications

- increased susceptibility to the active substance or other ACE inhibitors or one of the excipients

- renal artery stenosis (bilateral or unilateral with one kidney)

- a history of angioedema due to previous therapy with an ACE inhibitor and hereditary / spontaneous angioedema

- simultaneous use of lisinopril with products containing aliskiren in patients with diabetes mellitus or renal failure (GFR <60 ml / min / 1.73 m2)

- severe renal dysfunction (creatinine clearance <30 ml / min).

- hemodynamically relevant stenosis of the aorta or mitral valve or hypertrophic cardiomyopathy

- acute myocardial infarction in patients with unstable hemodynamics

- systolic pressure? 100 mmHg Art. before starting treatment

- lactation

- pregnancy and lactation period

- cardiogenic shock

- children under 18 years old

- primary hyperaldosteronism

- condition after kidney transplantation

Drug interactions

With the simultaneous use of Lisinopril-Teva tablets and:

- lithium excretion of lithium from the body can be reduced, therefore it is necessary to carefully monitor the concentration of lithium in the blood serum

- analgesics, non-steroidal anti-inflammatory drugs (for example, acetylsalicylic acid, indomethacin) - the hypotensive effect of lisinopril may be weakened

- baclofen - it is possible to increase the hypotensive effect of lisinopril; diuretics - it is possible to increase the hypotensive effect of lisinopril

- potassium-sparing diuretics (spironolactone, triamterene or amiloride) and potassium supplements increase the risk of hyperkalemia

- antihypertensive drugs - it is possible to enhance the hypotensive effect of lisinopril

- anesthetics, drugs, sleeping pills - a sharp drop in blood pressure is possible

- allopurinol, cytostatics, immunosuppressants, systemic corticosteroids, procainamide - the risk of developing leukopenia increases

- oral antidiabetic drugs (sulfonylurea derivatives, biguanides) and insulin - an increase in the hypotensive effect is possible, especially in the first weeks of combination therapy.

- amifostine - an increase in the hypotensive effect is possible

- антацидных средств - уменьшение биодоступности лизиноприла

- симпатомиметиков - возможно усиление гипотензивного эффекта

- алкогол¤ - возможно усиление действи¤ алкогол¤

- поваренной соли - ослабление гипотензивного действи¤ лизиноприла и по¤вление симптомов сердечной недостаточности.

ќсобые указани¤

ѕациентам, получающим несколько диуретиков или диуретики в высокой дозировке (> 80 мг фуросемида/день), пациентам с гиповолемией, гипонатриемией (содержание натри¤ в сыворотке < 130 ммоль/л), существовавшей до этого гипотензией, нестабильной сердечной недостаточностью, ограниченной функцией почек, высокодозированной терапией сосудорасшир¤ющими средствами и пациентам в возрасте 70 лет и старше, рекомендуетс¤ начинать терапию Ћизиноприлом-“ева стационарно.

ќдновременное применение ингибиторов јѕ‘, блокаторов рецептора ангиотензина II или алискирена повышает риск гипотензии, гиперкалиемии и сниженной почечной функции (включа¤ острую почечную недостаточность). ѕоэтому двойна¤ блокада системы ренин-ангиотензин-альдостерона из-за комбинированного применени¤ ингибиторов јѕ‘, блокаторов рецептора ангиотензина II или алискирена не рекомендована.

?сли терапи¤ с двойной блокадой абсолютно необходима, это должно происходить только под наблюдением специалиста и при тщательном мониторинге функции почек, электролитов и кров¤ного давлени¤. »нгибиторы јѕ‘ и блокаторы рецептора ангиотензина II не должны примен¤тьс¤ одновременно у пациентов с диабетической нефропатией.

ѕри развитии гипотензии необходимо строгое врачебное наблюдение, прием диуретиков в низких дозах и тщательным растиранием дозы лекарственного препарата в порошок при одновременном контроле функции почек и уровн¤ кали¤. ?сли это возможно, следует временно прекратить терапию диуретиками за 2-3 дн¤ до начала терапии лизиноприлом. Ёто также следует принимать во внимание пациентам со стенокардией или другими сердечно-сосудистыми заболевани¤ми, при которых из-за чрезмерного снижени¤ кров¤ного давлени¤ может развитьс¤ инфаркт миокарда или инсульт.

ѕри развитии гипотензии больного следует положить на спину, при необходимости провод¤т возмещение объема потер¤нной жидкости. ѕри брадикардии назначаетс¤ атропин.

vемодиализ / ЋѕЌѕ-липидный-аферез / “ерапи¤ дл¤ десенсибилизации

ѕри одновременном применении лизиноприла и диализа с полиакрил-нитриловой мембраной или ЋѕЌѕ (липопротеин низкой плотности)-афереза с помощью сульфата декстрана или десенсибилизации против ¤дов насекомых (пчел, ос) возможно развитие анафилактического шока.

–екомендуетс¤ использовать другую мембрану дл¤ диализа или следует временно заменить Ћизиноприл-“ева другими антигипертензивными препаратами (не ијѕ‘).

јнгионевротический отек

ѕри развитии ангиневротического отека лица, губ назначаютс¤ антигистаминные средства. ќтек ¤зыка, голосовой щели и/или гортани могут угрожать жизни, поэтому проводитс¤ экстренное лечение, с немедленной подкожной инъекцией 0,3Ц0,5 мг эпинефрина или медленным внутривенным вводом 0,1 мг эпинефрина (соблюдайте указани¤ по разбавлению), с мониторированием Ё v и кров¤ного давлени¤.

ќсобенности вли¤ни¤ лекарственного препарата на способность управл¤ть транспортным средством или потенциально опасными механизмами

Ќеобходимо контролировать уровень артериального давлени¤, т.к. в св¤зи с индивидуальными особенност¤ми у некоторых больных возможно развитие гипотензии и, как следствие, нарушение способности управл¤ть автотранспортом и обслуживать движущиес¤ механизмы.

ѕередозировка

—имптомы: т¤жела¤ гипотони¤, шок, брадикарди¤.

Ћечение: пациент должен находитьс¤ под строгим врачебным наблюдением, предпочтительно в отделении интенсивной терапии. —ледует часто контролировать концентрации электролитов и креатинина в сыворотке крови. ћеропри¤ти¤, преп¤тствующие абсорбции, такие как промывание желудка, назначение адсорбентов и сульфата натри¤, должны предприниматьс¤ в течение 30 минут после приема препарата. Ћизиноприл удал¤етс¤ гемодиализом.

‘орма выпуска и упаковка

ѕо 10 таблеток в контурную ¤чейковую упаковку из пленки ѕ¬’ и алюминиевой фольги. ѕо 3 или 5 контурных упаковок вместе с инструкцией по применению на государственном и русском ¤зыках помещают в пачку из картона.

”слови¤ хранени¤

’ранить при температуре не выше 25?—.

’ранить в недоступном дл¤ детей месте!

—рок хранени¤

4 года

Ќе примен¤ть по истечении срока годности.

”слови¤ отпуска из аптек

ѕо рецепту

'

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