The instruction for medical use of Enam Torgovoye medicine a name Enam Mezhdunarodnoye the unlicensed name Enalapril Dosage Form of the Tablet of 2.5 mg, 5 mg and 10 mg Structure One tablet contains active agent – enalapril a maleate of 2.5 mg excipients: lactose anhydrous, maleic acid, zinc stearate One tablet contains active agent – enalapril a maleate of 5 mg excipients: lactose anhydrous, maleic acid, zinc stearate One tablet contains active agent – enalapril a maleate of 10 mg excipients: anhydrous lactose, zinc stearate the Description of the Tablet of round shape, white color, with a facet, with the beaten-out inscription EMT on one party and 2.5 and with riskoy-on other party (for a dosage of 2.5 mg) Tablets of round shape, white color, with a facet, with the beaten-out inscription EMT on one party and 5 and with riskoy-on other party (for a dosage of 5 mg) Tablets of round shape, white or almost white color, with a facet, with the beaten-out inscription EMT on one party and 10 and from risky – on other party (for a dosage of 10 mg) Pharmacotherapeutic group the Drugs influencing a system renin-angiotensin. The angiotensin-converting AKF enzyme inhibitors. Enalapril. The ATX C09AA02 code the Pharmacological Pharmacokinetics Later properties of intake enalapril is soaked up from digestive tract, absorption – 60%. Meal does not influence absorption. The bioavailability of drug is 53 – 74%, linking with proteins of blood plasma – 50%. The maximum concentration in blood is reached in 3 – 4 hours after administration of drug inside. Action duration 12 – 24 hours. Drug is metabolized in a liver, a part is hydrolyzed in enalaprilat therefore at patients with abnormal liver functions time of the maximum action can increase. Enalaprilat easily passes through gistogematichesky barriers, excepting GEB, a small amount gets through a placenta and into breast milk. Elimination half-life (T1/2) of enalaprilat – 11 hours. It is removed mainly by kidneys – 60%, through intestines – 33%. Is removed at a hemodialysis (speed of 62 ml/min.) and peritoneal dialysis. A pharmacodynamics Enam – antihypertensive drug which mechanism of action is connected with oppression of activity of the angiotensin-converting enzyme leading to reduction of formation of angiotensin – II. Enam is pro-medicine of which in an organism the active metabolite enalaprilat is formed. Believe that the mechanism of antihypertensive action is connected with competitive inhibition of activity of APF which leads to reduction in the rate of transformation of angiotensin I into angiotensin II (which has the significant vasoconstrictive effect and stimulates secretion of Aldosteronum in bark of adrenal glands). Reduction of concentration of angiotensin II is resulted by secondary increase in activity of renin of plasma due to elimination of negative feedback at release of renin and direct decrease in secretion of Aldosteronum. Besides, enalaprilat, apparently, affects a kinin-kallikrein system, interfering with bradykinin disintegration. Along with a lowering of arterial pressure, drug reduces before – and an afterload by a myocardium in heart failure, reduces pressure in the right auricle in a small circle of blood circulation, lowers resistance in vessels of kidneys that contributes to normalization of blood circulation in them. Indications – various forms of arterial hypertension, including renovascular hypertensia – chronic heart failure (as a part of combination therapy) Enam appoint the Route of administration and doses inside irrespective of meal time. For the patients who are not receiving diuretics – the recommended initial dose of 5 mg a day. Further the dose is selected individually. Usually the dose from 10 to 40 mg a day in one or two receptions is required. For the patients receiving diuretics – for the purpose of prevention of hypotension for 1 – 2 day before Enam’s appointment, diuretic should be cancelled. In case of impossibility to cancel diuretic, the recommended initial dose of Enam – 2.5 mg. In chronic heart failure it is better to Begin treatment with a dose of 2.5 mg of 1 times a day. The effect of administration of drug should be expected 3 – 4 days. Constant control of arterial blood pressure is necessary. Then reception of 2.5 mg 2 times a day within 3 – 4 days is recommended. Since second week, the dose is increased if necessary to 10 mg of 1 times a day. On 3 – 4 week the dose is increased up to 20 mg in one or two receptions if systolic pressure is not lower than 100 mm Hg. The maximum daily dose – 40 mg. Selection of a dose and further treatment can be carried out on an outpatient basis, at the same time it is necessary to estimate the patient’s condition not less than 1 time a month (only at selection of a dose the survey and control of the doctor is required each 10 days), to carry out control of content of creatinine and electrolytes of blood. Presence of arterial hypotension up to 80/60 mm Hg. against the background of maintenance therapy in the absence of complaints at the patient is not a reason for drug withdrawal. In the arterial hypertension caused by a nephropathy in patients with diabetes the Dosage of drug depends on that, is followed or not a diabetic nephropathy by arterial hypertension. If the diabetic nephropathy proceeds against the background of normal arterial blood pressure, then use small doses of Enam – 2.5 or 5 mg a day. If the nephropathy is followed by arterial hypertension, then doses select as well as in arterial hypertension (as much as possible up to 40 mg a day). In a renal failure For patients from whom clearance of creatinine higher than 30 ml/min. (creatinine level in blood is not higher than 3 ml/min.) dose adjustment is not required. At clearance of creatinine less than 30 ml/min. the recommended initial dose no more than 2, 5 mg a day. Further selection of a dose is carried out individually under control of level of creatinine and electrolytes of blood. For the patients who are on a hemodialysis, the initial dose and a dose in days of dialysis should not exceed 2.5 mg a day. Duration of treatment depends on efficiency of therapy. At expressed a lowering of arterial pressure Enam’s dose is gradually reduced. Side effects Very often (≥1/10) – the obscured sight – dizziness – cough – nausea – an asthenia Often (from ≥1/100 to & lt, 1/10): – a headache, a depression – hypotension (including orthostatic hypotension), a faint, stethalgias, disturbances of a rhythm, stenocardia, tachycardia – short wind – diarrhea, an abdominal pain, change of taste – rash, hypersensitivity / a Quincke’s disease of the face, extremities, lips, language, a glottis and/or throat – fatigue – a hyperpotassemia, increase in creatinine in blood plasma Infrequently (from ≥1/1.000 to & lt, 1/100) – anemia (including. aplastic and hemolytic) – a hypoglycemia – confusion of consciousness, drowsiness, insomnia, nervousness, paresthesias, dizziness – heartbeat, a myocardial infarction or cerebral and vascular complications, at patients with the increased risk is a rhinorrhea, a sore throat, hoarseness, bronchospasm/asthma – intestinal impassability, pancreatitis, vomiting, dyspepsia, a constipation, anorexia, irritation of a stomach, dryness in a mouth, a round ulcer – sweating, an itching, urticaria, an alopecia – a renal failure, a renal failure, a proteinuria – impotence – spasms, rushes of blood, sonitus, a general malaise, fever – increase in urea in plasma, a hyponatremia Seldom (from ≥1/10.000 to & lt, 1/1.000) – a neutropenia, a hypohaemoglobinaemia, decrease in gematokritny number, thrombocytopenia, an agranulocytosis, oppression of function of marrow, a pancytopenia, a lymphadenopathy, autoimmune diseases – insomnia, a sleep disorder – Reynaud’s phenomenon – infiltrates in lungs, rhinitis, an allergic alveolitis / eosinophilic pneumonia – stomatitis / aphthous ulcers, a glossitis – a liver failure, hepatitis, including hepatocellular or cholestatic hepatitis, including necrosis, a cholestasia, jaundice – a multiformny erythema, Stephens-Johnson’s syndrome, exfoliative dermatitis, a toxic epidermal necrolysis, a bladderwort, eritroder-a miya – an oliguria – a gynecomastia – increase in enzymes of a liver, increase in bilirubin in blood plasma is Very rare (& lt, 1/10.000) – a Quincke’s disease of intestines Does not know (it cannot be estimated on the basis of the available data) – the syndrome of inadequate secretion of antidiuretic hormone (SNSADG) (Parkhon’s Syndrome) Was noted a complex of symptoms: fever, serositis, vasculitis, myalgia/miositis, arthralgia/arthritis, positive test for antinuclear antibodies (ANA), acceleration SOE, eosinophilia and leukocytosis. Also there can be rash, a photosensitization and other dermatological manifestations. At emergence of serious side effects, treatment should be stopped. Contraindications – hypersensitivity to enalapril, other components of drug – existence in the anamnesis of the Quincke’s disease connected with treatment by APF inhibitors – pregnancy and the period of a lactation – a leukopenia and thrombocytopenia – children’s and teenage age up to 18 years – the bilateral stenosis of renal arteries or a stenosis of arteries of the only kidney – hereditary or idiopathic swelled – a hereditary lactose intolerance, deficiency of Lappa lactose or malabsorption of glucose galactose Medicinal interactions At co-administration of Enam with non-steroidal anti-inflammatory drugs (NPVP) the decrease in hypotensive effect of enalapril is possible, with kaliysberegayushchy diuretics – the hyperpotassemia, with lithium salts – lithium removal delay is possible. The concomitant use of Enam with febrifugal and soothing drugs can reduce Enam’s efficiency. Enam weakens effect of the drugs containing theophylline. Cimetidinum extends Enam’s action. Hypotensive effect of enalapril strengthens diuretics, β-adenoblokator. At simultaneous use with immunodepressants, cytostatics the risk of development of a leukopenia increases. At simultaneous use of kaliysberegayushchy diuretics (including Spironolactonum, Triamterenum, amiloride), the drugs of potassium, substitutes of salt and dietary supplement to food containing potassium development of a hyperpotassemia (especially at patients with renal failures) is possible since APF inhibitors reduce the maintenance of Aldosteronum that leads to a potassium delay in an organism against the background of restriction of removal of potassium or its additional receipt in an organism. At simultaneous use of opioid analgetics and anesthetics the antihypertensive effect of enalapril amplifies. At simultaneous use of ‘loopback’ diuretics, thiazide diuretics the antihypertensive action amplifies. There is a risk of development of a hypopotassemia. Increase in risk of a renal failure. At simultaneous use with Azathioprinum the development of anemia is possible that is caused by oppression of activity of erythropoietin under the influence of APF inhibitors and Azathioprinum. The case of development of anaphylactic reaction and a myocardial infarction at use of Allopyrinolum for the patient receiving enalapril is described. Acetylsalicylic acid in high doses can reduce antihypertensive effect of enalapril. It is not finalized whether acetylsalicylic acid reduces therapeutic effectiveness of APF inhibitors at patients with an ischemic heart disease and heart failure. The nature of this interaction depends on a course of the disease. Acetylsalicylic acid, inhibiting COG and synthesis of prostaglandins, can cause vasoconstriction that leads to reduction of warm emission and aggravation of symptoms of the patients with heart failure receiving APF inhibitors. At simultaneous use of beta blockers, Methyldopums, nitrates, blockers of calcium channels, a gidralazin, Prazozinum strengthening of antihypertensive action is possible. At simultaneous use with NPVS (including with indometacin) antihypertensive effect of enalapril, apparently, owing to inhibition under the influence of NPVS of synthesis of prostaglandins decreases (which as believe, play a part in development of hypotensive effect of APF inhibitors). Risk of developing renal failures increases, the hyperpotassemia is seldom observed. At simultaneous use of insulin, hypoglycemic means of derivatives of sulphonylurea development of a hypoglycemia is possible. At simultaneous use of APF inhibitors and interleukin-3 there is a risk of developing arterial hypotension. At simultaneous use with clozapine there are messages about development to a syncope. At simultaneous use with klomipraminy it is reported about strengthening of action of a klomipramin and development of toxic effects. At simultaneous use with co-trimoxazole cases of development of a hyperpotassemia are described. At simultaneous use from lithium a carbonate concentration of lithium in blood serum which is followed by intoxication symptoms lithium increases. At simultaneous use with orlistaty the antihypertensive effect of enalapril decreases that can lead to substantial increase of the ABP, development of hypertensive crisis. Believe that at simultaneous use with procaineamide the increase in risk of development of a leukopenia is possible. At simultaneous use with enalapril the effect of the drugs containing theophylline decreases. There are messages about development of an acute renal failure in patients after renal transplantation at simultaneous use with cyclosporine. At simultaneous use with Cimetidinum T1/2 of enalapril increases and its concentration in blood plasma increases. Believe that reduction of efficiency of antihypertensive drugs at simultaneous use with erythropoietins is possible. At simultaneous use with ethanol the risk of developing arterial hypotension increases. During treatment it is forbidden to take alcoholic beverages as alcohol strengthens hypotensive effect of drug. Special instructions not to apply to the persons who are not transferring lactose. With extra care apply at patients with autoimmune diseases, diabetes, abnormal liver functions, a severe form of a stenosis of an aorta, a subaortal muscular stenosis of not clear genesis, a hypertrophic cardiomyopathy, at loss of liquid and salts. In case of the previous treatment by saluretics, in particular at patients with chronic heart failure, risk of developing orthostatic hypotension therefore before an initiation of treatment enalapril it is necessary to offset loss of liquid and salts increases. At long-term treatment by enalapril it is necessary to control a pattern of peripheral blood periodically. The sudden termination of intake of enalapril does not cause sharp increase in the ABP. At surgical interventions during treatment by enalapril development of arterial hypotension which should be korrigirovat introduction of enough liquid is possible. Before a research of function of epithelial bodies enalapril should be cancelled. Safety and efficiency of use of enalapril for children are not established. The care at control of vehicles or performance of other work requiring special attention since dizziness, especially after reception of an initial dose of enalapril Overdose Symptoms is possible Is necessary for feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms: excessive hypotension, development of a myocardial infarction, an acute disorder of cerebral circulation and tromboembolic episodes against the background of sharp decrease in the ABP. Treatment: intravenous administration of isotonic solution of sodium of chloride and at an opportunity – angiotensin II infusion, is possible removal of enalaprilat by means of a hemodialysis. A form of release and packing On 10 tablets in planimetric bezjyacheykovy packing from a film of the polyvinylchloride and printing aluminum foil varnished. On 2 or 3 bezjyacheykovy packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard bandbox. On 10 cardboard packs place in a group cardboard pack. To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C. To store in the places inaccessible for children! 2 years After an expiration date not to apply a period of storage. Prescription status According to the prescription the Producer / packer: The Dr. of Reddi’s Laboratoris Limited, India the Owner of the registration certificate the Dr. of Reddi’s Laboratoris Limited, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality
of a roduktion Representative office Dr. of Reddi’s Laboratoris Limited in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45, post office box 7, ph.: 8 (727) 3941688, 3941689, fax: 3941294 The address of the organization, responsible in the territory of the Republic of Kazakhstan for post-registration observation of safety of medicine Representative office Dr. of Reddi’s Laboratoris Limited in the Republic of Kazakhstan: 050057 Almaty, 22nd Line St., 45, a post office box 7, ph.: 8 (727) 3941688, 3941689, fax: 3941294 (110)
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