Monopril 20mg tab 28 pc

Description

Composition
Active substance:
1 tablet contains: sodium fosinopril – 20.0 mg.
Excipients:
Anhydrous Lactose 126.0 mg Microcrystalline cellulose 40.0 mg Crospovidone 7.0 mg povidone 4.0 mg, 3.0 mg sodium stearyl fumarate.
Description:
Round, biconvex tablets White or almost white, practically odorless, scored on one side and engraved “609” on the other hand.
Product form:
Tablets 20 mg.
14 tablets in a blister from film PVC / PVDC and aluminum foil. 2 blisters together with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to fosinopril or any other substance included in the formulation; sensitivity to any other ACE inhibitor, a history; hereditary angioneurotic edema and angioedema, idiopathic history, including after receiving other ACE inhibitors; pregnancy; lactation; congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption; age 18 years (effectiveness and safety have been established).
Carefully
Renal failure; hyponatremia (risk of dehydration, hypotension, chronic renal failure); bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; aortic stenosis; condition after kidney transplantation; with desensitization; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma) – increased risk of neutropenia or agranulocytosis; hemodialysis; cerebrovascular diseases (including cerebrovascular insufficiency); coronary artery disease; chronic heart failure III-IV FC (by NYHA classification); diabetes; inhibition of bone marrow hematopoiesis; hyperkalemia; in elderly patients; gout, diet restriction salt; state, accompanied by a decrease in blood volume (including diarrhea, vomiting, diuretics previous treatment).
Dosage
20 mg
Indications
Hypertension: monotherapy or in combination with other antihypertensive agents (in particular with thiazide diuretics);
Chronic heart failure: as part of combination therapy.
Interaction with other drugs
The simultaneous use of antacid (e.g. aluminum or magnesium hydroxide) and an antiflatulent simethicone can reduce the absorption of fosinopril.
Therefore said means is necessary to apply at intervals of not less than 2 hours.
With simultaneous use of ACE inhibitors with the salts of lithium, the lithium content in the blood serum and the risk of lithium intoxication can be increased, so simultaneous use Monopril and lithium preparations with caution.
Recommended careful monitoring of serum lithium content.
It is known that non-steroidal anti-inflammatory agent indomethacin can reduce the antihypertensive effect of ACE inhibitors, particularly in patients with hypertension and low renin activity in blood plasma. Such an effect can have other non-steroidal anti-inflammatory drugs (NSAIDs), e.g., acetylsalicylic acid, and selective cyclooxygenase-2 inhibitors. In patients older than 65 years, from hypovolemia (including the treatment of diuretics), with impaired renal function, co-administration of NSAIDs, including selective inhibitors tsikloosigenazy-2 and ACE inhibitors (including fosinopril) can lead to a deterioration of renal function, up to acute renal failure.
Usually this condition is reversible. It is necessary to carefully monitor renal function in patients taking fosinopril and NSAIDs.
When applied simultaneously with diuretic drug Monopril, especially early in therapy of diuretics, as well in combination with a strict diet, limiting salt intake, dialysis or may develop pronounced decrease
BP, particularly in the first hour after taking the initial dose Monopril drug.
potassium Formulations potassium-sparing diuretics (amiloride, spironolactone, triamterene) increase the risk of hyperkalemia. In patients with heart failure, diabetes, simultaneously receiving potassium-sparing diuretics, potassium, kalisodergaszczye solezameniteli or other means for causing hyperkalemia (e.g., heparin), ACE inhibitors increase the risk of increasing the content of potassium ions in serum.
Fosinopril enhances hypoglycemic effect sulfonylureas, insulin, the risk of leukopenia while the application of allopurinol, cytostatic agents, immunosuppressants, procainamide.
Estrogens attenuate antihypertensive effect Monopril drug because of its ability to retain water.
Antihypertensive drugs, narcotic analgesics, drugs for general anesthesia enhance the antihypertensive effect Monopril drug.
The bioavailability of the preparation when the simultaneous use of chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline bromide, digoxin and warfarin does not change.
Overdose
Symptoms: marked reduction of blood pressure, bradycardia, shock, disturbance of water and electrolyte balance, acute renal failure, stupor.
Treatment: the drug should be stopped, shown gastric lavage, adsorbents (e.g., activated carbon), vasodepressor means, infusion of 0.9% sodium chloride solution and more symptomatic and supportive treatment.
The use of hemodialysis ineffective.
pharmachologic effect
Pharmacological group:
Angiotensin converting enzyme inhibitor.
Pharmacodynamics:
Fosinopril sodium chemically is a sodium salt of an ester of a pharmacologically active compound fozinoprilata. Once in the human body, fosinopril undergoes enzymatic hydrolysis and converted into fozinoprilat. Fozinoprilat, thanks to the phosphinate group is a specific competitive inhibitor of angiotensin converting enzyme (ACE). Because inhibition of ACE prevents the conversion fozinoprilat angiotensin I to angiotensin II, which has vasoconstrictor action. Inhibition of ACE reduces the concentration of angiotensin II in the blood plasma, which causes a decrease in its vasopressor activity and reduced aldosterone secretion. Reduced secretion of aldosterone may lead to a slight increase in the content of potassium ions in serum (average of 0.1 meq / l) and reducing the content of sodium ions and fluid volume. Fozinoprilat slows the metabolism of bradykinin, which has potent vasodilatory action; at the expense of its antihypertensive effect is enhanced. Lowering blood pressure (BP) is not accompanied by changes in circulating blood volume, cerebral and renal blood flow, blood supply to internal organs, skeletal muscle, skin, the reflex activity of the myocardium. After oral antihypertensive effect develops over 1 hour, reaching a maximum after 2-6 hours and lasts 24 hours. The antihypertensive effect of the drug manifested equally in the patient standing or lying. Orthostatic hypotension and tachycardia occasionally been reported in patients with hypovolemia or are on a salt-free diet. To achieve maximum therapeutic effect may take several weeks. Antihypertensive effect of fosinopril and thiazide diuretics are complementary. The effectiveness of antihypertensive effect is not dependent on age, sex and body weight. There is no drug withdrawal syndrome, even with abrupt cessation of treatment. In chronic heart failure the positive effect of the drug Monopril achieved mainly due to inhibition of the renin-angiotensin-aldosterone system. Inhibition of ACE reduces both preload and afterload on the myocardium. The drug enhances exercise tolerance, reducing the degree of severity of congestive heart failure.
Pharmacokinetics:
After oral absorption of approximately 30-40%. The extent of absorption is independent of food intake, but it may slow down the speed while taking the drug at meal times. Enzymatic hydrolysis of fosinopril to form fozinoprilata occurs predominantly in the liver and the mucosa of the gastrointestinal tract. When impaired liver function hydrolysis rate can be slowed, and the conversion does not change significantly. The maximum plasma concentration is reached after about 3 hours and is independent of the dose. Fozinoprilat binds to blood protein in> 95%, it has a relatively low volume of distribution, and to a small extent with the associated cellular components of blood. Fozinoprilat excreted equally through the intestine in bile and kidney.
In patients with hypertension with normal renal function and liver half-life (T1 / 2) fozinoprilata is approximately 11.5 hours. In patients with chronic heart failure the value of T1 / 2 of 14 hours. Fozinoprilata Clearance in hemodialysis and peritoneal dialysis averages 2% and 7%, respectively, relative to the values ​​of urea clearance. Patients with impaired renal function (creatinine clearance less than 80 mL / min / 1.73 m2), total clearance fozinoprilata approximately twice lower than in patients with normal renal function. At the same time, absorption, bioavailability and protein binding is not appreciably changed. Reduced urinary excretion is compensated by an increased excretion through the intestine with bile. A moderate increase in the area under the curve “concentration-time» (AUC) in plasma (less than half, compared with the norm), is observed in patients with renal insufficiency varying degrees, including kidney failure in the terminal stage (creatinine clearance less than 10 (ml / min / 1.73 m2). in patients with impaired liver function (in alcoholic or biliary cirrhosis) fosinopril hydrolysis rate can be reduced, but the degree of hydrolysis does not change appreciably. fozinoprilata Total clearance from the body conditions such patients S THE about half as compared with patients with normal liver function.
Pregnancy and breast-feeding
Monoprix is ​​contraindicated in pregnancy. The use of ACE inhibitors in pregnancy may cause impaired development or fetal death. If pregnancy is detected during treatment with the drug Monopril, it should be as soon as possible to stop. If (in rare cases), ACE inhibitors, an alternative for the treatment of patients there should be informed about the potential dangers of the treatment on fetal development and a thorough ultrasound to identify fetal distress. Upon detection oligogidroamniona treatment with Monopril not cancel only if it is carried out for health reasons. However, it should be borne in mind that oligogidroamnion sometimes detected only in the presence of irreversible damage to the fetus. Neonates whose mothers took ACE inhibitors during pregnancy, marked hypotension, oliguria, hyperkalemia. Newborns whose mothers took ACE inhibitors during pregnancy, should be carefully examined with respect to hypotension, oliguria and hyperkalemia. If the newborn is marked oliguria need to focus efforts on the control of blood pressure and renal perfusion support. Exchange transfusion or dialysis may be necessary for a blood pressure reduction and the replacement of impaired kidney function. Fosinopril is slowly eliminated from the circulating blood of adults during hemodialysis and peritoneal dialysis. Experience in the removal of fosinopril from the circulating blood of newborns there.
Since fosinopril is found in breast milk, the drug should not be used during breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
Cardio-vascular system: marked reduction of blood pressure, orthostatic hypotension, tachycardia, syncope, arrhythmia, palpitations, angina pectoris, myocardial infarction, “tides” of blood to the skin, impaired cardiac conduction, high blood pressure, sudden death, cardiac arrest, peripheral edema.
From the urinary system: renal failure, proteinuria, prostate pathology (hyperplasia, BPH), polyuria, oliguria.
On the part of the central nervous system: stroke, brain ischemia, dizziness, balance disorders, headache, fatigue, impaired memory; sleep disorders, anxiety, depression, confusion, drowsiness, paresthesia.
From the senses: hearing and vision, ear pain, tinnitus, taste alteration.
From the digestive system: nausea, diarrhea, intestinal obstruction, pancreatitis, hepatitis, cholestatic jaundice, abdominal pain, vomiting, constipation, anorexia, stomatitis, glossitis, dysphagia, bloating, disturbance of appetite, body weight change, dryness of the oral mucosa, bleedings .
The respiratory system: pneumonia, dry cough, pulmonary infiltrates, bronchospasm, dyspnea, rhinorrhea, sinusitis, laryngitis, pharyngitis, tracheobronchitis, dysphonia, epistaxis. Two patients had symptom: bronchospasm, cough, eosinophilia.
On the part of the circulatory and lymphatic systems: inflammation of the lymph nodes.
On the part of the musculoskeletal system: arthritis, myalgia, musculoskeletal pain, muscle weakness in metabolic konechnostyahNarusheniya: exacerbation of gout.
Allergic reactions: skin rash, pruritus, angioedema, dermatitis.
Other: fever, rash, impaired sexual function.
Changes in laboratory parameters: hypercreatininemia, increasing urea content, increased activity of “liver” enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia; decrease in hemoglobin and hematocrit, increased erythrocyte sedimentation rate (ESR), leukopenia, neutropenia, eosinophilia.
Effect on the fetus: violation of fetal kidneys, reduced blood pressure of the fetus and newborn, renal dysfunction, hyperkalemia, hypoplasia of bones of the skull, oligogidroamnion contracture limbs, lung hypoplasia.
special instructions
Before treatment requires an analysis of earlier antihypertensive therapy, a degree of increase in blood pressure, limit salt diet and / or liquid, and other clinical circumstances. If possible, discontinue wire before antihypertensive therapy a few days before the start of treatment with Monopril.
To reduce the likelihood of hypotension diuretic should be discontinued for 2-3 days prior to treatment with Monopril.
Prior to treatment and during therapy is necessary to monitor blood pressure, renal function, the content of potassium ions, creatinine, urea, electrolytes and Activity “liver” enzymes in the blood.
Angioedema. It reported on the development of angioneurotic edema of the extremities, face, lips, mucous membranes, tongue, throat or larynx in patients with the use of the drug Monopril. Edema tongue, pharynx or larynx may develop airway obstruction which can be fatal. In such cases, discontinuation of the drug and carrying out urgent measures, including subcutaneous epinephrine solution (adrenaline) (1: 1000), as well as other measures of emergency treatment. In most cases, facial edema, mucous membranes of the mouth, lips and extremities discontinuation of the drug led to a normalization condition; however, sometimes it required the appointment of appropriate therapy.
Swelling of the intestinal mucosa. While receiving ACE inhibitors rarely observed swelling of the intestinal mucosa. Patients complained of abdominal pain (wherein the nausea and vomiting could be) in some cases arisen intestine without face edema activity of C1-esterase edema mucosa was normal. Symptoms disappeared after discontinuation of ACE inhibitors. Swelling of the intestinal mucosa to be included in the differential diagnosis of patients on ACE inhibitors, complained of abdominal pain on.
Anaphylactic reactions during dialysis using membranes of high permeability. Anaphylactic reactions can occur in patients treated with ACE inhibitors during hemodialysis using high permeability membranes, as well as during low-density lipoprotein apheresis adsorption on dextran sulfate. In these cases, you should consider using a different type of dialysis membrane or the use of antihypertensive drugs other class.
Anaphylactic reactions during desensitization. Two patients at the time of the venom desensitization in patients receiving Hymenoptera inhibitor
ACE enalapril were observed life-threatening anaphylactoid reactions. In the same patients these reactions could be avoided by the timely suspension of an ACE inhibitor; however, they appeared again after resumption of reception unintentional ACE inhibitor. Special care should be exercised during the desensitization patients taking inhibitors
ACE.
Neutropenia / agranulocytosis. Possible development of agranulocytosis and bone marrow suppression during treatment with ACE inhibitors. These cases are more common in patients with impaired renal function, especially in the presence of systemic diseases of connective tissue (systemic lupus erythematosus or scleroderma). Перед началом терапии ингибиторами АПФ и в процессе лечения проводят определение лейкоцитов и лейкоцитарной формулы (1 раз в месяц в первые 3-6 месяцев лечения и в первый год применения препарата у пациентов с повышенным риском нейтропении).
Артериальная гипотензия. У пациентов с неосложненной формой артериальной гипертензии возможно развитие артериальной гипотензии в связи с применением препарата МОНОПРИЛ.
Симптоматическая артериальная гипотензия при применении ингибиторов АПФ чаще развивается у пациентов на фоне интенсивного лечения диуретиками, диеты, связанной с ограничением поваренной соли, или при проведении диализа. Транзиторная артериальная гипотензия не является противопоказанием для применения препарата после проведения мер по восстановлению объема циркулирующей крови (ОЦК).У пациентов с хронической сердечной недостаточностью лечение ингибиторами АПФ может вызывать избыточный антигипертензивный эффект, который может привести к олигурии или азотемии и в редких случаях – к острой почечной недостаточности с летальным исходом. Поэтому при лечении хронической сердечной недостаточности препаратом МОНОПРИЛ необходимо внимательно наблюдать за пациентами, особенно на протяжении первых 2 недель лечения, а также при любом увеличении дозы препарата
МОНОПРИЛ или диуретика.
Может потребоваться снижение дозы диуретика у пациентов с нормальным или низким
АД, ранее получавших терапию диуретическими средствами или имеющих гипонатриемию. Артериальная гипотензия как таковая не является противопоказанием для дальнейшего применения препарата МОНОПРИЛ при хронической сердечной недостаточности.
Некоторое снижение системного АД является обычным и желательным эффектом в начале применения препарата при хронической сердечной недостаточности. Степень этого снижения максимальна на ранних этапах лечения и стабилизируется в пределах одной или двух недель от начала лечения. АД обычно возвращается к исходному уровню без снижения терапевтической эффективности.
Abnormal liver function. В редких случаях при применении ингибиторов АПФ отмечается синдром, первым проявлением которого является холестатическая желтуха.
Затем следует молниеносный некроз печени, иногда с летальным исходом. Механизм развития данного синдрома не изучен. При появлении заметной желтушности и выраженном повышении активности ферментов печени лечение препаратом МОНОПРИЛ следует прекратить и назначить соответствующее лечение.
У пациентов с нарушениями функции печени может отмечаться повышенная концентрация фозиноприла в плазме крови. При циррозе печени (в том числе алкогольном) кажущийся общий клиренс фозиноприлата снижен, а площадь под кривой приблизительно в 2 раза выше, чем у пациентов без нарушений функции печени.
Impaired renal function. У пациентов артериальной гипертензией с одно- или двусторонним стенозом почечных артерий или стенозом артерии единственной почки во время лечения ингибиторами АПФ может повышаться концентрация азота мочевины крови и креатинина сыворотки крови. Эти эффекты обычно обратимы и проходят после прекращения лечения. Необходим контроль функции почек у таких пациентов в первые недели лечения. У некоторых пациентов повышение концентраций азота мочевины крови и креатинина сыворотки крови (обычно небольшое и преходящее) может наблюдаться даже без очевидного нарушения функции почек при одновременном применении препарата МОНОПРИЛ и диуретиков. Может потребоваться снижение дозы препарата
МОНОПРИЛ.
У пациентов с тяжелой хронической сердечной недостаточностью функция почек может зависеть от активности ренин-ангиотензин-альдостероновой системы, поэтому лечение ингибиторами АПФ может сопровождаться олигурией и/или прогрессирующей азотемией, и в редких случаях – к острой почечной недостаточности и летальному исходу.
Гиперкалиемия. Отмечались случаи повышения содержания ионов калия в сыворотке крови пациентов, принимающих ингибиторы АПФ, в том числе фозиноприл. Группу риска в этом отношении составляют пациенты с почечной недостаточностью, сахарным диабетом 1-ого типа, а также принимающие калийсберегающие диуретики, калийсодержащие пищевые добавки или другие препараты, повышающие содержание ионов калия в сыворотке крови (например, гепарин).
Cough. При применении ингибиторов АПФ, включая фозиноприл, отмечался непродуктивный, упорный кашель, проходящий после отмены терапии. При появлении кашля у пациентов, принимающих ингибиторы АПФ, следует рассматривать эту терапию как возможную причину в рамках проведения дифференциального диагнозаХирургические вмешательства/общая анестезия. Ингибиторы АПФ могут усиливать антигипертензивное действие средств, применяющихся для проведения общей анестезии.
Перед хирургическим вмешательством (включая стоматологию) необходимо предупредить врача/анестезиолога о применении ингибиторов АПФ.
Следует соблюдать осторожность при выполнении физических упражнений или при жаркой погоде из-за риска дегидратации и артериальной гипотензии вследствие уменьшения объема циркулирующей жидкости.
Effects on ability to drive vehicles and mechanisms
Необходимо соблюдать осторожность при управлении транспортными средствами или выполнении другой работы, требующей повышенного внимания, так как возможно возникновение головокружения.
Storage conditions
Stored in a dry place at a temperature of from 15 to 25 ° C.
Dosing and Administration
Inside. Дозировка препарата должна подбираться индивидуально. Для деления пополам на таблетку нанесена риска
Arterial hypertension
Рекомендуемая начальная доза препарата составляет 10 мг (1/2 таблетки по 20 мг) 1 раз в день. Дозу необходимо подбирать в зависимости от динамики снижения артериального давления. Обычная доза составляет от 10 до 40 мг 1 раз в день. При отсутствии достаточного антигипертензивного эффекта возможно дополнительное назначение диуретиков.
Если лечение препаратом МОНОПРИЛ начинают на фоне проводимой терапии диуретиками, то его начальная доза должна составлять не более 10 мг (1/2 таблетки по 20 мг) при регулярном врачебном контроле за состоянием пациента.
The maximum daily dose is 40 mg.
Chronic heart failure
Рекомендуемая начальная доза препарата составляет 10 мг (1/2 таблетки по 20 мг) 1 раз в день. Лечение начинают под обязательным медицинским контролем. Если начальная доза хорошо переносится, ее можно постепенно увеличивать с недельными интервалами, до 40 мг 1 раз в день (максимальная суточная доза). Препарат следует назначать в сочетании с диуретиком. Одновременное применение дигоксина необязательно.
Применение при нарушениях функции почек или печени
Поскольку выведение препарата из организма происходит двумя путями, коррекции доз пациентам с нарушением функции почек или печени обычно не требуется.
elderly patients
Различий в эффективности и безопасности лечения препаратом пациентов в возрасте 65 лет и старше и молодых пациентов не наблюдается, поэтому коррекции дозы для пожилых пациентов обычно не требуется. Однако нельзя исключить большую восприимчивость у некоторых пациентов пожилого возраста к препарату, в связи с возможными явлениями передозировки из-за замедленного выведения препарата.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist