Lisinopril 10mg tab, quinacrine 30 pc

Description

Composition
Active substance:
1 tablet contains: lisinopril dihydrate was 5, 10 or 20 mg.
Excipients:
Ludipress (lactose monohydrate, 93 ± 2% povidone, 3.5 ± 0.5% Crospovidone 3.5 ± 0.5%) 100 mg Microcrystalline cellulose 57 mg / 52 mg / 42 mg Magnesium stearate 3 mg.
Description:
White round pills Valium.
Product form:
Tablets of 5 mg, 10 mg and 20 mg.
At 14 or 15 tablets per blister.
2 blisters 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 ACE inhibitors, hereditary and / or idiopathic angioedema angioedema;
Age 18 years (effectiveness and safety have been established);
Pregnancy and lactation;
The simultaneous use of aliskiren and aliskirensoderzhaschimi drugs in patients with diabetes or renal dysfunction (creatinine clearance less than 60 mL / min);
Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Precautions: renal failure, bilateral renal artery stenosis or stenosis of the artery only kidney condition after kidney transplantation, azotemia, hyperkalemia, aortic stenosis, mitral stenosis, hypertrophic obstructive cardiomyopathy, primary aldosteronism, hypotension, cerebrovascular disease, ischemic heart disease, autoimmune connective tissue disorders, suppression of bone marrow hematopoiesis, state, accompanied by a decrease in circulating kro vi, hypovolemic states, treatment of patients under diet limitation salt, advanced age (over 65 years), the concurrent use of ACE inhibitors with aliskirensoderzhaschimi drugs or antagonists of angiotensin II, diabetes, treatment of blacks patients holding desensitizing therapy poison Hymenoptera, hemodialysis, low-density lipoprotein apheresis using a dextran sulfate, acute myocardial infarction.
Dosage
10 mg
Indications
Arterial hypertension (alone or in combination with other antihypertensive agents); Chronic heart failure (in a combination therapy for the treatment of patients receiving cardiac glycosides and / or diuretics); 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 in the normal blood pressure in patients with type 2 diabetes with hypertension).
Interaction with other drugs
Lisinopril decreases potassium excretion with treatment with diuretics.
Special care is required while applying the drug to: • the potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, Vice-salt containing potassium (increased risk of hyperkalemia, especially with impaired renal function), so they can jointly appoint only on the basis of individual judgment of the prescribing physician with regular monitoring of potassium serum levels and renal function.
Caution may be used together with: – diuretics: with the additional administration of a diuretic to a patient receiving Lisinopril usually occurs additive antihypertensive effect – the risk of significant decrease in blood pressure; – with other antihypertensive agents (additive effect); – a non-steroidal anti-inflammatory drugs (. Indomethacin, etc.), including selective inhibitors tsiklooksigenezy-2 (COX-2), estrogen and adrenostimulyatorov – decrease antihypertensive action lisinopril; – with lithium (lithium selection may be reduced, so should regularly monitor the concentration of lithium in blood serum); – antacids and kolestiraminom – reduce the absorption in the gastrointestinal tract; – insulin and hypoglycemic agents for oral use – risk of hypoglycemia.
Ethanol enhances the effect of the drug.
With simultaneous use of the angiotensin-converting enzyme inhibitors (ACE) and preparations of gold (sodium aurothiomalate) describes a symptom, including facial flushing, nausea, vomiting and reduced blood pressure.
Overdose
Symptoms (occur when receiving a single dose of 50 mg and higher): marked reduction in blood pressure; dry mouth, drowsiness, urinary retention, constipation, anxiety, irritability.
Treatment: symptomatic therapy, intravenous fluids, monitoring blood pressure, fluid and electrolyte balance and normalize the latter.
Lisinopril can be removed from the body by hemodialysis.
pharmachologic effect
Pharmacological group:
An angiotensin-converting enzyme (ACE).
Pharmacodynamics:
ACE inhibitor reduces the 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, blood pressure (BP), preload, the pressure in the pulmonary capillaries, causes an increase in cardiac output and increase tolerance to myocardial stress 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 on the tissue renin-angiotensin system. With prolonged use decreases myocardial hypertrophy of the arteries and resistive type. It improves blood flow to the ischemic myocardium.
ACE inhibitors prolong the life expectancy of patients with chronic heart failure patients, slow the progression of left ventricular dysfunction in patients with myocardial infarction without clinical manifestations of heart failure. The antihypertensive effect starts after approximately 6 hours and stored for 24 hours. Duration of the effect is also dependent on the dose. Valid -. 1 h Maximum effect is determined after 6-7 hours. When hypertension effect noted in the first days after initiating treatment, stable action develops in 1-2 months. With a sharp lifting of the drug was observed pronounced increase in blood pressure.
In addition to lowering blood pressure lisinopril reduces albuminuria. Patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.
Lisinopril does not affect the concentration of blood glucose in patients with diabetes mellitus and does not lead to increased incidence of hypoglycemia.
Pharmacokinetics:
Suction. After taking the drug inside lisinopril about 25% absorbed from the gastrointestinal tract. Food intake does not affect absorption of the drug. Bioavailability – 29%.
Distribution. Almost does not bind to plasma proteins. Maximum plasma concentration (90 ng / mL) was reached after 7 hours. 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. half-life is 12 hours.
Pharmacokinetics in specific patient groups
In patients with chronic heart failure of absorption and clearance of lisinopril reduced.
In patients with renal insufficiency lisinopril concentrations several times greater than plasma concentrations of the volunteers, the marked increase in the time to reach maximum plasma concentration and increased half-life.
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.
Pregnancy and breast-feeding
The use of lisinopril during pregnancy is contraindicated. In establishing pregnancy the drug should be stopped as soon as possible. ACE inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (expressed may decrease blood pressure, renal failure, hyperkalemia, skull hypoplasia, intrauterine death). Information about the negative effects of the drug on the fetus when used during the I trimester there. For newborns and infants who have been exposed to intrauterine ACE inhibitor should be closely monitored for timely detection of significant decrease in blood pressure, oliguria and hyperkalemia.
Lisinopril crosses the placenta. No data on the penetration of lisinopril passes into breast milk. For the period of treatment with the drug should be abolished breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
The most common side effects are dizziness, headache, fatigue, diarrhea, dry cough, nausea.
Cardio-vascular system: marked reduction of blood pressure, chest pain, rarely – orthostatic hypotension, tachycardia, bradycardia, worsening symptoms of heart failure, impaired atrioventricular conduction, myocardial infarction, heart palpitations.
On the part of the central nervous system: mood lability, confusion, paraesthesia, somnolence, jerking of the limbs and lips, rare – asthenic syndrome.
From hemopoiesis system: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, anemia (decreased hemoglobin concentration, hematocrit, erythropenia).
Laboratory findings: hyperkalemia, hyponatremia, rarely – increased activity of “liver” enzymes, hyperbilirubinemia, increased levels of urea and creatinine.
The respiratory system: dyspnea, bronchospasm.
On the part of the digestive tract: dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.
For the skin: rash, increased sweating, itching, alopecia, photosensitivity.
With the genitourinary system: renal failure, oliguria, anuria, acute renal failure, uremia, proteinuria, reduced potency.
Allergic reactions: angioneurotic edema of face and extremities, lips, tongue, epiglottis and / or throat, skin rashes, itching, fever, positive results of the test for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), eosinophilia, leukocytosis. In very rare cases – interstitial angioedema.
Other: myalgia, arthralgia / arthritis, vasculitis.
special instructions
Symptomatic hypotension
In most pronounced decrease in blood pressure occurs with a decrease in fluid volume caused by the diuretic therapy, reducing the amount of salt in the diet, dialysis, vomiting or diarrhea. In patients with chronic heart failure with concurrent renal failure or without her, perhaps marked reduction in blood pressure. She often diagnosed in patients with severe stage of chronic heart failure as a result of application of high doses of diuretics, hyponatremia or impaired renal function. In these patients, treatment with lisinopril should start under close medical supervision (with caution in the selection of dose and diuretics).
Such rules must be followed in the appointment of patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to heart attack or stroke.
Transient hypotensive response is not a contraindication to receive the next dose.
In applying the drug Lisinopril-Akrikhin in some patients with chronic heart failure, but a normal or low blood pressure levels can be marked reduction of blood pressure, which is usually not a cause for discontinuation of treatment.
Prior to treatment with Lisinopril-Akrikhin, if possible, should be to normalize the concentration of sodium and / or make up for the lost volume of liquid, the action of carefully controlled initial dose lisinopril patient.
Renal function
In patients with renal impairment (creatinine clearance less than 80 mL / min) starting Lisinopril dose-Akrikhin formulation should be selected according to the QC (see. The section “Method of administration and dose”). Regular monitoring the potassium content and creatinine concentration in blood plasma is mandatory tactic treating such patients. In patients with CHF hypotension may result in deterioration of renal function. In these patients, there have been cases of acute renal failure, usually reversible.
In the case of renal artery stenosis (especially when bilateral stenosis or in the presence of artery stenosis single kidney) and circulatory failure due to lack of sodium and / or liquid, use of the drug Lisinopril-Akrikhin may lead to renal failure, acute renal failure which is usually irreversible after drug withdrawal.
In patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, the treatment with ACE inhibitors in some cases there is an increased concentration of blood urea nitrogen and serum creatinine plasma. These changes are almost always reversible and disappeared after discontinuation of the ACE inhibitor. These complications are particularly common in patients with existing impaired renal function. If the patient has a renovascular hypertension, the risk of severe hypotension and renal insufficiency increases. In this category of patients should begin treatment with lower doses of the drug under medical supervision.
Increasing the concentration of urea nitrogen in blood plasma and serum creatinine also noted in hypertensive patients without concomitant renal dysfunction, especially while the use of lisinopril and diuretics. These changes were mild in severity and indicators returned to normal after withdrawal of lisinopril or a diuretic.
In acute myocardial infarction
Shows the use of standard therapy (thrombolytics, aspirin, beta-blockers). The drug-Lisinopril Akrikhin may be used in conjunction with intravenous or using therapeutic transdermal nitroglycerin systems.
Surgery / general anesthesia
With extensive surgical procedures, 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.
kidney transplantation
Data on the use of lisinopril in patients after kidney transplantation, no.
Abnormal liver function
ACE inhibitors can lead to the development of cholestatic jaundice with the progression up to fulminant hepatic necrosis (and in rare cases, death), so it is necessary to stop taking the drug with an increase in “liver” transaminases and the appearance of symptoms of cholestasis.
Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy
Lisinopril as other ACE inhibitors must be administered with caution to patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive cardiomyopathy), as well as patients with mitral stenosis.
Anaphylactic reactions during apheresis low density lipoprotein (LDL)
In rare cases, patients receiving ACE inhibitors during LDL apheresis procedure using the dextran sulfate may develop life-threatening anaphylactoid reactions. To prevent anaphylactoid reactions should be temporarily discontinue therapy with ACE inhibitors before each apheresis procedure.
Anaphylactoid reactions during desensitizing
There are some reports about the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy, eg Hymenoptera venom. ACE inhibitors should be used with caution in patients predisposed to allergic reactions, undergoing desensitization procedure. It should avoid the use of ACE inhibitors to patients receiving immunotherapy with bee venom. However, this reaction can be avoided by temporary discontinuation of ACE inhibitor prior to the desensitization treatment.
Hypersensitivity / angioedema
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 tongue, epiglottis and larynx can be the cause airway obstruction and death, so it is necessary to immediately carry out the appropriate therapy (0.3-0.5 ml of a 1: 1000 solution of epinephrine (adrenaline) s.c.) and / or to ensure airway patency measures ways. In cases where the swelling is localized only on the face and lips, the condition often goes untreated, however, possible to use antihistamines.
Risk of angioedema is increased in patients who have a history of angioedema unrelated to previous treatment with ACE inhibitors.
In rare cases during treatment with ACE inhibitors develop intestinal swelling. In this case, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases with no prior facial angioedema and with normal C1-esterase. Diagnosis is established via CT abdominal ultrasound or during surgery. Symptoms disappear after discontinuation of ACE inhibitors. In patients with pain in the abdomen, taking ACE inhibitors in the differential diagnosis should consider the possibility of angioneurotic edema of the intestine.
Hemodialysis
In patients on hemodialysis using vysokoprotochnyh membranes (eg, AN69®), it has been observed cases of anaphylactic reactions during therapy with ACE inhibitors. Should be avoided when using ACE inhibitors of similar type membranes.
Neutropenia / agranulocytosis / thrombocytopenia / anemia
While taking ACE inhibitors may occur neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and no other aggravating factors neutropenia is rare. With special caution should be used Lisinopril-Akrikhin drug in patients with systemic connective tissue diseases, in patients receiving immunosuppressive agents, allopurinol or procainamide, especially in patients with impaired renal function.
In some patients there were serious infections, in some cases, resistant to intensive antibiotic therapy. When administering the drug to such patients it is recommended to periodically monitor blood leukocytes. Patients should inform the doctor about any symptoms of infectious diseases (eg, sore throat, fever).
Dry cough
With the use of ACE inhibitors coughing was observed. Cough dry, long, which disappear after cessation of treatment with an ACE inhibitor. The differential diagnosis of cough should be considered, and cough caused by ACE inhibitors.
ethnic differences
Следует учитывать, что у пациентов негроидной расы риск развития ангионевротического отека более высок. Как и другие ингибиторы АПФ, лизиноприл менее эффективен в отношении снижения АД у пациентов негроидной расы. Данный эффект возможно связан с выраженным преобладанием низкоренинового статуса у пациентов негроидной расы с артериальной гипертензией.
Двойная блокада РААС
Сообщалось о случаях артериальной гипотензии, обмороке, инсульте, гиперкалиемии и нарушениях функции почек (включая острую почечную недостаточность) у восприимчивых пациентов особенно при одновременном применении с лекарственными препаратами, которые влияют на эту систему. Поэтому совместное применение ингибитора АПФ и антагониста рецепторов ангиотензина II или алискиреном не рекомендуется.
Сочетание с алискиреном противопоказано у пациентов с сахарным диабетом или нарушениями функции почек (КК менее 60 мл/мин).
Diabetes
При применении препарата пациентам с сахарным диабетом, получающим гипогликемические средства для приема внутрь или инсулин, в течение первого месяца терапии необходимо регулярно контролировать концентрацию глюкозы в крови.
hyperkalemia
Во время терапии ингибиторами АПФ, в том числе лизиноприлом, может развиться гиперкалиемия. Факторами риска гиперкалиемии являются почечная недостаточность, пожилой возраст, сахарный диабет, некоторые сопутствующие состояния (например, снижение ОЦК, острая сердечная недостаточность, метаболический ацидоз), одновременный прием калийсберегающих диуретиков (таких как спиронолактон, эплеренон, триамтерен, амилорид), а также препаратов калия или калийсодержащих заменителей пищевой соли и применение других препаратов, способствующих повышению содержания калия в плазме крови (например, гепарин). Гиперкалиемия может привести к серьезным нарушениям сердечного ритма, иногда с летальным исходом. Одновременное применение перечисленных выше препаратов необходимо проводить с осторожностью. Рекомендован регулярный мониторинг содержания калия в сыворотке крови.
У пациентов пожилого возраста та же самая доза приводит к более высокой концентрации препарата в крови, поэтому требуется особая осторожность при определении дозы.
Since it is impossible to eliminate the potential risk of agranulocytosis, requires periodic monitoring of blood picture.
При применении препарата в условиях диализа с полиакрил-нитрил-мембраной может возникать анафилактический шок, поэтому рекомендуется либо другой тип мембраны для диализа, либо назначение других антигипертензивных средств.
The effect on the ability of control of vehicles and mechanisms
Нет данных о влиянии лизиноприла на способность к управлению транспортными средствами и механизмами, примененного в терапевтических дозах, однако необходимо учитывать, что возможно возникновение головокружения, поэтому следует соблюдать осторожность.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, regardless of the meal.
При артериальной гипертензии пациентам, не получающим другие антигипертензивные средства, назначают по 5 мг 1 раз в сутки. При отсутствии эффекта дозу повышают каждые 2-3 дня на 5 мг до средней терапевтической дозы 20-40 мг/сутки (увеличение дозы свыше 40 мг/сутки обычно не ведет к дальнейшему снижению АД). Обычная суточная поддерживающая доза – 20 мг. Максимальная суточная доза – 40 мг.
The full effect usually develops within 2-4 weeks after the start of treatment, which should be considered when increasing the dose. При недостаточном клиническом эффекте возможно комбинирование препарата с другими антигипертензивными средствами.
Если пациент получал предварительное лечение диуретиками, то прием таких препаратов необходимо прекратить за 2-3 дня до начала применения препарата Лизиноприл-Акрихин. Если это неосуществимо, то начальная доза препарата Лизиноприл-Акрихин 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 или других состояниях с повышенной активностью ренин-ангиотензин-альдостероновой системы целесообразно назначать также низкую начальную дозу – 2,5-5 мг в день, под усиленным врачебным контролем (контроль АД, функции почек, концентрации калия в сыворотке крови). Maintenance dose, continuing strict medical control, should be determined depending on the dynamics of blood pressure.
При почечной недостаточности ввиду того, что лизиноприл выделяется через почки, начальная доза должна быть определена в зависимости от клиренса креатинина, затем в соответствии с реакцией на проводимую терапию, следует установить поддерживающую дозу в условиях регулярного контроля функции почек, уровня калия, натрия в сыворотке крови: клиренс креатинина 30-80 мл/мин-начальная доза 5-10 мг/день клиренс креатинина 10-30 мл/мин-начальная доза 2,5-5 мг/день клиренс креатинина менее 10 мл/мин-начальная доза 2,5 мг/день
When hypertension resistant shows long-term maintenance of 10-15 mg / day therapy.
Для обеспечения режима дозирования лизиноприла в дозе 2,5 мг следует применять препараты лизиноприла в дозировках 2,5 мг или 5 мг (таблетки с риской) других производителей.
При хронической сердечной недостаточности – начинают с 2,5 мг 1 раз в сутки, с последующим увеличением дозы на 2,5 мг через 3-5 дней до обычной, поддерживающей суточной дозы 5-20 мг. Доза не должна превышать 20 мг в сутки.
У людей пожилого возраста часто наблюдается более выраженное длительное гипотензивное действие, что связано с уменьшением скорости выведения лизиноприла (рекомендуется начинать лечение с 2,5 мг/сут).
Острый инфаркт миокарда (в составе комбинированной терапии при стабильных показателях гемодинамики, систолическое АД не менее 100 мм рт ст)
В первые сутки – 5 мг внутрь, затем 5 мг через сутки, 10 мг через двое суток и затем 10 мг 1 раз в сутки. У пациентов с острым инфарктом миокарда препарат применять не менее 6 недель.
В начале лечения или в течение первых 3-х суток после острого инфаркта миокарда у пациентов с низким систолическим АД (120 мм рт. ст. или ниже) надо назначать меньшую дозу – 2,5 мг. В случае снижения АД (систолическое АД ниже или равно 100 мм рт. ст. ), суточную дозу в 5 мг можно, если необходимо, временно снизить до 2,5 мг. В случае длительного выраженного снижения АД (систолическое АД ниже 90 мм рт. ст. более 1 часа), лечение препаратом Лизиноприл-Акрихин надо прекратить.
Диабетическая нефропатия.
У пациентов с сахарным диабетом 1 типа препарат применяется в дозе 10 мг в сутки, при необходимости дозу можно увеличить 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 принимают в той же дозе с целью достижения диастолического АД ниже 90 мм рт. Art. in the “sitting” position.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist