Lisinopril-teva 10mg tab 20 pc

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Lisinopril-teva 10mg tab 20 pc

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Description

Composition
Active substance:
lisinopril dihydrate (Lisinopril) 10.92 mg (10.00 mg)
Excipients:
pregelatinized starch 12,00mg, 40.00 mg maize starch, calcium hydrogen phosphate (anhydrous) 84.88 mg) Mannitol 70.00 mg magnesium stearate 2.20 mg).
Description:
Biconvex oval white. On one side «LSN 10″ engraved on the other – separating risk.
Product form:
Tablets, 10 mg.
10 tablets in a blister made of PVC / PVDC film and aluminum foil blister or 2 together with instructions for use in a cardboard pack.
Contraindications
Hypersensitivity to lizinoprilu, other ingredients or other ACE inhibitors; angioedema history (including the use of other ACE inhibitors); hereditary angioedema and / or angioedema, idiopathic; age 18 years (effectiveness and safety have been established); pregnancy and lactation; simultaneous application of aliskiren and preparations containing aliskiren in patients with diabetes and / or moderate to severe renal function (glomerular filtration rate (GFR) of less than 60 ml / min / 1.73 m2 body surface area); simultaneous application of antagonists of angiotensin II (ARA II) patients with diabetic nephropathy.
Carefully
Bilateral renal artery stenosis or stenosis of the artery only kidneys with progressive azotemia; condition after kidney transplantation; renal failure; vysokoprotochnyh dialysis using dialysis membranes (AN69®); azotemia; hyperkalemia; aortic stenosis; hypertrophic obstructive cardiomyopathy; primary hyperaldosteronism; hypotension;
cerebrovascular diseases (including cerebrovascular insufficiency); Coronary heart disease (CHD); coronary insufficiency; autoimmune connective tissue diseases (including scleroderma, systemic lupus erythematosus); inhibition of bone marrow hematopoiesis; state, accompanied by a decrease in blood volume (CBV) (including those due to diarrhea, vomiting); use in patients who are on a diet with restriction of salt; the use in elderly patients; simultaneous application of potassium preparations, diuretics, other antihypertensive agents, nonsteroidal antiinflammatory drugs (NSAIDs), lithium preparations, antacids, colestyramine, ethanol, insulin, and other hypoglycemic agents, allopurinol, procainamide, gold preparations, antipsychotics, tricyclic antidepressants, barbiturates, beta blockers, calcium channel blockers slow, co-trimoxazole, inhibitors of mTOR (see. the sections “Interaction with other medicinal prepa Atami “and” Cautions “).
Dosage
10 mg
Indications
– Hypertension (in monotherapy or in combination with other antihypertensive agents).
– Chronic heart failure (in a combination therapy).
– Early treatment of acute myocardial infarction (within 24 hours with stable haemodynamics to maintain these parameters and prevent left ventricular dysfunction and heart failure).
– Diabetic nephropathy (albuminuria reduction in patients with type 1 diabetes with normal blood pressure, and in patients with type 2 diabetes with hypertension).
Interaction with other drugs
Caution should be used in conjunction with lisinopril potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium preparations,
salt substitutes containing potassium, cyclosporin – an increased risk of hyperkalemia, especially with impaired renal function. Therefore, these combinations should be used only on the basis of the individual solutions at regular physician monitoring the potassium content in blood serum and renal function.
When applied simultaneously with diuretics and other hypotensive agents antihypertensive effect of lisinopril amplified.
While the use of NSAIDs (including selective inhibitors of cyclooxygenase-2 (COX-2)), acetylsalicylic acid in a dose of 3 g / day of estrogen, and sympathomimetics reduced antihypertensive effect of lisinopril. NSAIDs, including from the group of selective COX-2 inhibitors and ACE inhibitors may increase the content of potassium in blood serum and in certain cases impair kidney function. This effect is usually reversible.
Lisinopril slows excretion of lithium products, so while their application is reversible increase in its concentration in blood plasma, which may increase the likelihood of adverse events, so you should regularly monitor the serum lithium concentration.
While the use of antacids and lisinopril kolestiraminom reduced absorption from the gastrointestinal tract.
Ethanol increases the effects of lisinopril.
While the use of insulin and hypoglycemic agents for intake increases the risk of hypoglycemia.
With simultaneous use of lisinopril with vasodilators, barbiturates, antidepressants blockers “slow” calcium channel blockers, beta-blockers may increase the antihypertensive effect.
With simultaneous use of ACE inhibitors and gold preparations intravenously (sodium aurotiamalat) describes a symptom, including facial flushing, nausea, vomiting and reduced blood pressure.
Joint application with allopurinol, procainamide, cytostatics can lead to leukopenia.
Dual blockade of the RAAS using angiotensin II receptor antagonists (ARA II), ACE inhibitors or aliskiren (renin inhibitor) is associated with an increased risk of arterial hypotension, syncope, hyperkalemia, and renal dysfunction (including acute renal failure) as compared with monotherapy. Requires regular monitoring of blood pressure, renal function and blood electrolytes content. See. Also section “Special Instructions”.
While the use of inhibitors of mTOR, e.g., sirolimus, everolimus, temsirolimus, may increase the risk of angioedema,
accompanied by swelling of the throat or tongue, which may lead to airway obstruction (see. section “Special Instructions”).
While the use of co-trimoxazole (trimethoprim + sulfamethoxazole) may increase the risk of hyperkalemia (see. “Special Instructions” section).
While the use of inhibitors of dipeptidyl peptidase type IV (DPP-IV) (gliptinami), e.g., sitagliptin, saxagliptin, vildagliptin, linagliptinom increases the risk of angioedema.
In an application with ratsekadotrilom increased risk of angioedema.
When applied simultaneously with estramustine is also increased risk of angioedema.
Overdose
Symptoms: marked decrease in blood pressure, dryness of the oral mucosa, disruption of water-electrolyte balance, renal insufficiency, increased respiration, tachycardia,
palpitations, bradycardia, dizziness, anxiety, irritability, cough, drowsiness, urinary retention, constipation, collapse,
hyperventilation.
Treatment: the specific antidote is available. Gastric lavage, application enterosorbents and laxatives. Results Intravenous administration of 0.9% sodium chloride solution. In the case of bradycardia resistant treatment is necessary to use artificial “driver” rhythm. Necessary to monitor blood pressure, indicators of water and electrolyte balance. Hemodialysis is effective.
pharmachologic effect
Pharmacological group:
angiotensin converting enzyme inhibitor
Pharmacodynamics:
Angiotensin converting enzyme (ACE) reduces formation of angiotensin II from angiotensin I. Reduction of angiotensin II leads to a direct decrease in aldosterone release. Reduce bradykinin degradation and increases the synthesis of prostaglandins. , Decreases total peripheral vascular resistance (TPR), blood pressure (BP), preload, the pressure in the pulmonary capillaries, causes an increase in cardiac output and increase tolerance to myocardial load in patients with chronic heart failure patients. It expands the artery to a greater extent than the vein. Some effects are explained by the influence of the renin-angiotensin-aldosterone system (RAAS). With prolonged use decreases myocardial hypertrophy of the arteries and resistive type. It improves blood flow to the ischemic myocardium.
ACE inhibitors lengthen the life expectancy of patients with chronic heart failure (CHF), slow the progression of left ventricular dysfunction in patients with acute myocardial infarction without clinical manifestations of heart failure. Onset of action – after 1 h, the maximal antihypertensive effect is reached after 6-7 hours, and stored for 24 hours.
Duration of the effect is also dependent on the size of the dose. When hypertension effect noted in the first days after initiating treatment, stable action develops in 1-2 months. therapy. When the abrupt cancellation of lisinopril was no pronounced increase in blood pressure.
Lisinopril reduces albuminuria. Does not affect the concentration of blood glucose in patients with diabetes mellitus and c does not lead to increased incidence of hypoglycemia.
Pharmacokinetics:
Suction.
After ingestion lisinopril absorbed from the gastrointestinal tract (GIT) by an average of 25%, but the absorption can vary from 6 to 60%. Bioavailability is 29%. Maximum plasma concentration (Cmax) is achieved after 7 hours.
Food intake does not affect the absorption of lisinopril.
Distribution.
Lisinopril slightly bound to plasma proteins.
The permeability of the blood-brain and the placental barrier is low.
Metabolism.
Lisinopril is not biotransformed in the body.
Withdrawal.
Excreted by the kidneys unchanged. The half-life (T1 / 2) is 12.6 hours. Clearance lisinopril is 50 ml / min. Reduced serum levels of lisinopril occurs in two phases. The main part of lisinopril output during the initial alpha-phase (the effective T1 / 2 – 12 hours), followed by the remote terminal beta phase (about 30 hours).
Pharmacokinetics in specific patient groups
In patients with CHF, absorption and clearance of lisinopril reduced bioavailability is 16%.
In patients with renal failure (creatinine clearance (CC) of less than 30 ml / min), the concentration of lisinopril is several times the concentration in plasma in healthy volunteers, the marked increase in Cmax achieve time in the blood plasma and increased T1 / 2.
In elderly patients the drug concentration in blood plasma and the area under the curve “concentration-time” in 2 times more than in younger patients.
In patients with cirrhosis the bioavailability of lisinopril reduced by 30% and clearance – 50% compared to patients with normal liver function.
In elderly patients, the concentration of lisinopril in the blood increased by an average of 60%.
Pregnancy and breast-feeding
Use of the drug Lisinopril-Teva during pregnancy is contraindicated. In the diagnosis of pregnancy should be discontinued as soon as possible to the drug.
ACE inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (expressed may decrease blood pressure, renal failure,
hyperkalemia, hypoplasia of the skull bones, fetal death). Information about the negative impact of the drug on the fetus if I trimester of application no. For newborns and infants who have been exposed in utero ACE inhibitors,
should be closely monitored for timely detection of significant decrease in blood pressure, oliguria and hyperkalemia. the penetration of data lisinopril passes into breast milk is not. If necessary, the drug Lisinopril-Teva during lactation should stop breastfeeding.
Conditions of supply of pharmacies
Prescription.
side effects
The most common side effects are dizziness, headache, fatigue, diarrhea, dry cough, nausea.
The frequency of adverse events classified according to the recommendations
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%; very rarely – less than 0.01%.
Cardio-vascular system: often – a marked decrease in blood pressure, orthostatic hypotension; rarely – acute myocardial infarction, tachycardia, palpitations, Raynaud’s syndrome; rarely – bradycardia, tachycardia, worsening heart failure symptoms in violation of atrioventricular conduction, pain in the chest.
Central nervous system: often – dizziness, headache; infrequently – mood lability, paresthesia, sleep disturbances, stroke; rare – confusion, asthenic syndrome, jerking of the limbs and lips, drowsiness; the frequency is unknown – depression, fainting.
From the hematopoietic system and lymphatic system: rare – decrease in hemoglobin, hematocrit; very rarely – leukopenia, neutropenia, agranulocytosis, thrombocytopenia, eosinophilia, erythropenia, haemolytic anemia, lymphadenopathy, autoimmune diseases, suppression of bone marrow function.
The respiratory system: often – cough; rarely – rhinitis; very rarely – sinusitis, bronchospasm, allergic alveolitis / eosinophilic pneumonia, shortness of breath.
From the digestive system: often – diarrhea, vomiting; infrequently – indigestion, changes in taste, abdominal pain; rarely – dryness of the oral mucosa; very rarely – pancreatitis, jaundice (hepatocellular and cholestatic), hepatitis, liver failure, intestinal edema, anorexia.
For the skin: rarely – itching, rash; rarely – angioedema face, extremities, lips, tongue, throat, rash, alopecia, psoriasis; very rarely – increased sweating, vasculitis, pemphigus, photosensitivity, toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme syndrome
Stevens-Johnson syndrome, cutaneous pseudolymphoma.
From the urinary system: often – renal dysfunction; infrequently –
uremia, acute renal failure; very rarely – anuria, oliguria, proteinuria.
On the part of the reproductive system: rarely – impotence; rare – a gynecomastia.
From a metabolism: very rarely – hypoglycemia.
From the laboratory parameters: Infrequent – increased concentration of urea in the blood, hypercreatininemia, hyperkalemia, increased 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 – while the use of gold drugs intravenously described symptom, including facial flushing, nausea, vomiting and decreased blood pressure (see.
See “Interaction with other medicinal products”).
special instructions
In most pronounced decrease in blood pressure occurs with a decrease in CBV induced by therapy with diuretics, reduction of salt content in food, dialysis, vomiting or diarrhea. Under the supervision of a physician is recommended to use Lisinopril-Teva drug in patients with coronary artery disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to heart attack or stroke. Use of the drug
Lisinopril-Teva may impair renal function, acute renal failure, which is usually reversible after discontinuation of therapy.
Transient hypotension is not a contraindication for further use of the drug.
In the case of renal artery stenosis (especially when bilateral stenosis or in the presence of a single kidney artery stenosis), as well as peripheral circulatory insufficiency, and hyponatremia arisen due to hypovolemia, use of the drug Lisinopril-Teva may impair kidney function,
acute renal failure, which is usually reversible after discontinuation of the drug.
The drug Lisinopril-Teva may be used simultaneously with the standard therapy of acute myocardial infarction (thrombolytics, aspirin as antiplatelet drugs, beta-blockers).
The drug Lisinopril-Teva may be used simultaneously with intravenous nitroglycerine or using therapeutic transdermal nitroglycerin systems.
We do not recommend the use Lisinopril-Teva drug in patients with acute myocardial infarction, if the systolic blood pressure less than 100 mm Hg
With surgical intervention, as well as the use of other drugs that cause reduced blood pressure, lisinopril, blocking the formation of angiotensin II, may cause unpredictable marked decrease in blood pressure. Prior to surgery (including dental surgery) should inform the surgeon / anesthetist on the use of an ACE inhibitor.
Elderly patients use of standard dose leads to a higher concentration of drug in the blood, so extra care is required in determining the dose, despite the fact that the differences in the antihypertensive effect of the drug Lisinopril-Teva in elderly and younger patients have been identified.
Since it is impossible to eliminate the potential risk of agranulocytosis, requires periodic monitoring of peripheral blood.
Angioneurotic edema of the face, extremities, lips, tongue, epiglottis and / or throat, which may occur at any time during treatment, rarely observed in patients treated with ACE inhibitors, including lisinopril. In this case, treatment with the drug as soon as possible to stop, and the patient be placed under observation until complete regression of symptoms. Angioneurotic edema, laryngeal edema can be lethal.
Edema language epiglottis or larynx may be the cause of airway obstruction, however, immediately implement appropriate therapy (0.3-0.5 ml of a 1: 1000 solution of epinephrine (adrenaline) s.c.) and / or measures to ensure airway patency. In cases where the swelling is localized only on the face and lips, the condition often goes untreated, however, possible to use antihistamines. ACE inhibitors often cause the development of angioedema in patients blacks than in other races.
Risk of angioedema is increased in patients who have a history of angioedema unrelated to previous treatment with ACE inhibitors.
The risk of angioedema also increases while the use of inhibitors of mTOR.
У пациентов, принимающих ингибиторы АПФ, во время процедуры десенсибилизации на яд перепончатокрылых крайне редко могут развиваться опасные для жизни анафилактоидные реакции. Этого можно избежать, если временно прекращать лечение ингибитором АПФ перед каждой процедурой десенсибилизации на гименоптеру.
Анафилактоидные реакции отмечаются и у пациентов, находящихся на гемодиализе с использованием высокопроточных диализных мембран (AN69®), которые одновременно принимают ингибиторы АПФ. В таких случаях надо рассмотреть возможность применения другого типа мембраны для диализа или другого гипотензивного средства.
У пациентов, получающих гипогликемические препараты для приема внутрь и инсулин, в течение первого месяца терапии ингибиторами АПФ следует регулярно контролировать глюкозу крови.
Очень редко при применении ингибиторов АПФ наблюдали синдром, который начинался с холестатической желтухи и прогрессировал до фульминантного некроза печени, иногда с летальным исходом. Механизм развития данного синдрома неизвестен. При появлении желтухи на фоне применения препарата Лизиноприл-Тева или выраженного повышения активности «печеночных» трансаминаз, препарат отменяют и проводят наблюдения за состоянием пациента.
При применении ингибиторов АПФ отмечался кашель. Cough dry, long, which disappear after cessation of treatment with an ACE inhibitor. При дифференциальном диагнозе кашля надо учитывать и кашель, вызванный применением ингибитора АПФ.
Одновременное применение ингибиторов АПФ, АРА II или алискирена повышает риск развития гипотензии, гиперкалиемии и нарушения функции почек (в том числе острой почечной недостаточности).
Двойная блокада РААС при применении ингибиторов АПФ, АРА II или алискирена не рекомендуется.
Одновременное применение с препаратами, содержащими алискирен, противопоказано у пациентов с сахарным диабетом и/или умеренной или тяжелой почечной недостаточностью (СКФ менее 60 мл/мин/1,73 м2 площади поверхности тела) и не рекомендуется у других пациентов.
Одновременное применение ингибиторов АПФ с антагонистами рецепторов АРА II противопоказано у пациентов с диабетической нефропатией и не рекомендуется у других пациентов.
В случаях если двойная блокада РААС считается абсолютно необходимой, лечение должно происходить только под контролем специалистов и должно сопровождаться тщательным и частым мониторингом функции почек, содержания электролитов и артериального давления.
Ингибиторы АПФ и АРА II не должны применяться одновременно у пациентов с диабетической нефропатией.
У некоторых пациентов, принимавших ингибиторы АПФ, включая лизиноприл, отмечалось повышение концентрации калия в сыворотке крови. Факторы риска развития гиперкалиемии включают почечную недостаточность, диабет, гипоальдостеронизм, одновременное применение калийсберегающих диуретиков, а также препаратов калия или калийсодержащих заменителей пищевой соли и других препаратов, способствующих повышению содержания калия в крови (например, гепарин, ко-тримоксазол).
The effect on the ability of control of vehicles and mechanisms
Следует соблюдать осторожность при приеме препарата Лизиноприл-Тева в связи с тем, что возможно развитие артериальной гипотензии, головокружения и сонливости, которые могут повлиять на способность к управлению транспортными средствами и работу с потенциально опасными механизмами.
Storage conditions
Store at a temperature not higher than 25 ° C.
Keep out of the reach of children!
Dosing and Administration
Препарат Лизиноприл-Тева принимают внутрь 1 раз в сутки, независимо от времени приема пищи, предпочтительно в одно и то же время суток. Доза подбирается индивидуально.
При артериальной гипертензии пациентам, не получающим другие гипотензивные средства, применяют по 5 мг в сутки. При отсутствии терапевтического эффекта дозу повышают каждые 2-3 дня на 5 мг до дозы 20-40 мг/сутки (увеличение дозы свыше 40 мг/сутки обычно не ведет к дальнейшему снижению АД).
Средняя суточная поддерживающая доза 20 мг. Максимальная суточная доза 40 мг.
Терапевтический эффект развивается обычно через 2-4 недели от начала лечения, что следует учитывать при увеличении дозы. При недостаточном эффекте возможно одновременное применение препарата с другими гипотензивными средствами.
Если пациент получал предварительное лечение диуретиками, то прием этих препаратов необходимо прекратить за 2-3 дня до начала применения препарата Лизиноприл-Тева. Если это невозможно, то начальная доза препарата Лизиноприл-Тева не должна превышать 5 мг в сутки. В этом случае после приема первой дозы рекомендуется врачебный контроль в течение нескольких часов (максимум действия достигается примерно через 6 часов), так как может возникнуть выраженное снижение АД.
При реноваскулярной гипертензии, связанной с повышенной активностью РААС, в динамике целесообразно применять также низкую начальную дозу 2,5 мг в сутки, под усиленным врачебным контролем (контроль АД, функции почек, содержания калия в сыворотке крови). Maintenance dose, continuing strict medical control, should be determined depending on the dynamics of blood pressure.
При хронической сердечной недостаточности начальная доза 2,5 мг в сутки, дозу постепенно увеличивают (не более чем на 10 мг, с интервалом не менее 2 недель) в зависимости от АД. The maximum daily dose is 20 mg.
При раннем лечении острого инфаркта миокарда в первые сутки доза составляет 5 мг, затем 5 мг через сутки, 10 мг через двое суток и затем 10 мг в сутки в качестве поддерживающей терапии. У пациентов с острым инфарктом миокарда препарат следует применять в течение не менее 6 недель. В начале лечения или в течение первых 3-х суток после инфаркта миокарда у пациентов с низким систолическим АД (120 мм рт. ст. или ниже) применяют меньшую дозу препарата Лизиноприл-Тева – 2,5 мг. В случае, если систолическое
АД ниже или равно 100 мм рт. ст., препарат Лизиноприл-Тева применять не рекомендуется.
При сопутствующей почечной недостаточности (КК менее 80 мл/мин.) следует произвести соответствующую коррекцию дозы препарата.
При диабетической нефропатии у пациентов с сахарным диабетом 1 типа препарат
Лизиноприл-Тева применяется в дозе 10 мг в сутки. При необходимости дозу можно повысить до 20 мг в сутки с целью достижения диастолического АД ниже 75 мм рт. Art. in the “sitting” position. Пациентам с сахарным диабетом 2 типа препарат Лизиноприл-Тева применяют в той же дозе, с целью достижения диастолического АД ниже 90 мм рт.ст. in the “sitting” position.
При почечной недостаточности и у пациентов, находящихся на гемодиализе, начальную дозу устанавливают в зависимости от КК. Поддерживающая доза определяется в зависимости от АД (под контролем функции почек, содержания калия и натрия в крови).
КК (мл/мин.) Начальная доза (мг/сутки)
30-80 5-10
10-29 2,5-5
менее 10 (включая пациентов, находящихся 2,5
на гемодиализе)
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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