The instruction for medical use
of VIV FOZINOPRIL medicine the PHARMACEUTICAL
Fozinopril of VIV the PHARMACEUTICAL
name Fozinopril Lekarstvennaya a form
of the Tablet of 10 mg, 20 mg
One tablet contains
active agent – fozinoprit sodium 10 mg or 20 mg,
excipients: lactose anhydrous, cellulose microcrystalline, krospovidon, polyvinylpirrolidone (K30 povidone) and the sodium stearylfumarating.
Round biconvex tablets of white or almost white color, with slanted edges, with risky on one party.
the Drugs influencing a system renin-angiotensin. Angiotenzin-konvertiruyushego Enzyme (AKE) inhibitors. Fozinopril.
The ATX C09AA09 code
Pharmacokinetics Later properties of intake absorption is about 30-40% of digestive tract. Extent of absorption does not depend on meal, but its speed can slow down.
Hydrolytic transformation of a fozinopril under the influence of esterases in fozinoprilat happens happens mainly in a liver. At the broken function of a liver the speed of hydrolysis can be slowed down, and extent of transformation considerably does not change. The maximum concentration in blood plasma is reached approximately in 3 hours and does not depend on the accepted dose. Communication with proteins of blood plasma ³ 95%. Fozinoprilat has rather small volume of distribution and in insignificant degree is connected with cellular components of blood. Does not get through a blood-brain barrier.
Fozinopril is brought from an organism equally through a liver and kidneys. In arterial hypertension at patients with normal function of kidneys and a liver elimination half-life of the fozinoprilat makes about 11.5 hours. In heart failure the elimination half-life makes 14 hours. The clearance of the fozinoprilat at a hemodialysis and peritoneal dialysis averages 2% and 7%, respectively, in relation to values of clearance of urea.
At patients with impaired renal function (clearance of creatinine & lt, 80 ml/min. / 1.73 sq.m) the general clearance of the fozinoprilat from an organism is approximately twice lower, than at patients with normal function of kidneys. While absorption, bioavailability and linking with proteins considerably are not changed. Reduced removal through kidneys is compensated by the increased removal through a liver. Moderate increase in AUC values (the area under a curve of dependence of concentration in blood plasma from time after introduction of a dose of 1 mg) in blood plasma (less than twice in comparison with norm) was observed at patients with a renal failure of various degree, including a renal failure in an end-stage (clearance of creatinine & lt, 10 ml/min. / 1.73 in sq.m). At patients from the liver broken by function (in alcoholic or biliary cirrhosis) the speed of hydrolysis of a fozinopril can be reduced, but extent of hydrolysis considerably does not change. The general clearance of the fozinoprilat is about a half in comparison with patients with normal function of a liver of an organism of such patients.
At men aged from 65 up to 74 years with clinically normal function of kidneys and the liver of noticeable differences in pharmacokinetic parameters of the fozinoprilat in comparison with young patients (20-35 years) is not observed. Fozinopril is found in breast milk.
PHARMACEUTICAL – fozinoprit Active agent of the drug Fozinopril of VIV – ester which is hydrolyzed in an organism under the influence of esterases in active connection fozinoprilat. Fozinopril thanks to specific communication of fosfinatny group with AKF interferes with transformation of angiotensin I into vasoconstrictive substance angiotensin II therefore the angiotonic activity and secretion of Aldosteronum decrease. The last effect can lead to insignificant increase in maintenance of potassium ions in serum (on average 0.1 mekv/l) with simultaneous loss from an organism of ions of sodium and liquid. Drug suppresses synthesis of Aldosteronum, inhibits fabric AKF. Reduces the general peripheric resistance and system arterial blood pressure. The lowering of arterial pressure (ABP) is not followed by change of volume of the circulating blood, a brain and renal blood-groove, blood supply of internals, skeletal muscles, skin, reflex activity of a myocardium. Fozinopril suppresses metabolic degradation of peptide of the bradykinin possessing powerful vasodepressor action, at the expense of it antihypertensive effect of drug can amplify. In arterial hypertension and a hypertrophy of a left ventricle the treatment leads to decrease in mass of a left ventricle and reduction of thickness of an interventricular partition. Long therapy does not lead to metabolic disturbances. In heart failure the positive effects of a fozinopril are reached mainly due to suppression system renin-aldosteronovoy. Suppression angiotensin – the converting enzyme leads both preloads, and an afterload of a myocardium to decrease. Drug improves symptomatology and increases tolerance to physical activity, reduces weight of heart failure and reduces the frequency of hospitalization concerning heart failure.
– arterial hypertension (it is possible to apply both to monotherapy, and in a combination with other antihypertensive drugs, in particular, with thiazide diuretics)
– heart failure (as a part of combination therapy)
the Route of administration and doses
the Dosage of drug has to be selected individually.
At treatment of arterial hypertension it is necessary to stop, whenever possible, reception of other hypertensive means some days before the beginning of reception Fozinopril of VIV PHARMACEUTICAL. The recommended initial dose of drug makes 10 mg once a day. The dose needs to be selected depending on dynamics of a lowering of arterial pressure. The usual dose makes from 10 to 40 mg once a day. In the absence of sufficient hypotensive effect perhaps additional prescribing of diuretics.
If the Fozinopril drug treatment of VIV PHARMACEUTICAL is begun against the background of the carried-out therapy with diuretic, then its initial dose has to make no more than 10 mg, at careful medical control. For reduction of probability of developing of hypotension diuretics should be cancelled in 2-3 days prior to the Fozinopril drug treatment of VIV PHARMACEUTICAL.
The recommended initial dose makes 10 mg once a day. Depending on therapeutic effectiveness the dose can be raised with a week interval up to the maximum dose 40 mg once a day. Perhaps additional prescribing of diuretic.
Arterial hypertension and heart failure at impaired renal function or a liver
the Recommended initial dose makes 10 mg a day, however, it is necessary to be careful. As removal of drug from an organism happens in two ways, decrease in doses by the patient with impaired renal function or a liver usually is not required.
of Differences in efficiency and safety of drug treatment of patients at the age of 65 years are also more senior and young patients are not observed. However, it is impossible to exclude big susceptibility of patients of advanced age to drug.
– dizziness, a headache
– tachycardia, heartbeat, a lowering of arterial pressure, arrhythmias
– hypotension, orthostatic hypotension
– dry cough, short wind
– nausea, vomiting, diarrhea, dyspepsia,
– stomatitis, a glossitis
– an itching, a Quincke’s disease, dermatitis
– a stethalgia (not cardiological character), weakness
– increase in level alkaline phosphotazy, bilirubin,
a dehydrogenase lactate
– temporary decrease in hemoglobin, decrease in the gemokrit
– a loss of appetite, gout, a hyperpotassemia, a giperkreatininemiya,
increase in concentration of urea, increase in activity of hepatic transaminases, a hyperbilirubinemia, increase in the blood sedimentation rate (BSR)
– insomnia, uneasiness, a depression, confusion of consciousness, paresthesia
when using in high doses
– a brain heart attack, paresthesia, drowsiness, a stroke, a syncope,
changes of taste, a tremor, sleep disorders
– a visual disturbance
– a hearing disorder and sight, sonitus, an ear-ache, a ring in ears,
disturbances from a vestibular mechanism
– stenocardia, a myocardial infarction, a stroke, palpitations, a stop
of warm activity, disturbance of a warm rhythm, conductivity disorder
– hypertensia, shock, tranzitorny ischemia
– dispnoe, short wind, rhinitis, sinusitis, a tracheobronchitis
– a constipation, an abdominal pain, dryness in a mouth, an abdominal distension, intestinal
– a hyperhidrosis, rash
– disturbance of functions of kidneys, a proteinuria, an oliguria, development or aggravation of symptoms of chronic kidney disease
– sexual disorders
– increase in body weight
– increase in urea of blood, increase in serumal creatinine
– temporary anemia, an eosinophilia, a leukopenia, a lymphadenopathy,
a neutropenia, thrombocytopenia
– a dysphasia, a dysmnesia, a disorientation
– rush of blood, bleeding, a disease of peripheral vessels
– a bronchospasm, nasal bleeding, laryngitis, pharyngitis, pulmonary
infiltrates, a dysphonia, pneumonia, stagnation of lungs
– pancreatitis, a language swelling, a dysphagy
– hepatitis, cholestatic jaundice
– an ecchymoma
– dysfunction of a prostate
– slight increase of level of hemoglobin, a hyponatremia
– an agranulocytosis
– intestinal Ilheus
– a liver failure
– an acute renal failure.
– hypersensitivity to the fozinopril or any other substance which is a part of drug
– a hereditary or idiopathic Quincke’s disease, including in the anamnesis, after intake of other AKF inhibitors
– pregnancy (use of AKF inhibitors throughout the second and third trimesters of pregnancy causes damage or even death of the developing fruit)
– a lactation
– a lactose intolerance, deficiency of lactase or glyukozo-galaktozny malabsorption
– children’s age up to 18 years
Antihypertensives, diuretics, narcotic analgetics, means for the general anesthesia strengthen hypotensive action of a fozinopril. Estrogen weakens hypotensive effect of a fozinopril because of its ability to detain liquid.
Drug enhances hypoglycemic effect of derivatives of sulphonylurea, insulin. At simultaneous use with Allopyrinolum, cytostatic means, immunodepressants, procaineamide the risk of development of a leukopenia increases.
Antacids. Simultaneous use of antacids (including aluminum or magnesium of hydroxide, simetikon) can reduce absorption of a fozinopril. Therefore at simultaneous use with antacids it is necessary to take the specified drugs with an interval not less than 2 hours.
Lithium. At simultaneous use of AKF inhibitors with salts of lithium, concentration of lithium in blood serum and risk of developing lithium intoxication can raise therefore it is necessary to apply with care at the same time fozinoprit also lithium.
Non-steroidal anti-inflammatory drugs. When assigning a fozinopril it is necessary to consider that indometacin and other non-steroidal anti-inflammatory drugs (including acetylsalicylic acid in the dose exceeding 3 g and cyclooxygenase-2 inhibitors) can reduce antihypertensive effect of other AKF inhibitors, especially at patients with lowrenine arterial hypertension. Other non-steroidal anti-inflammatory drugs (for example, aspirin) can possess similar action. Non-steroidal anti-inflammatory drugs and estrogen reduce expressiveness of hypotensive effect. Fozinopril can cause false low values of serumal levels of digoxin at quantitative definition with use of a method of coal absorption. Instead, other sets in which the method of the test tube covered with antibodies is used can be used. Therapy by means of a fozinopril has to be suspended some days before carrying out tests for definition of function of epithelial bodies. Fozinopril can be applied at the same time with acetylsalicylic acid (in the recommended dosages), trombolitika, beta-blockers and/or nitrates.
Diuretics. At simultaneous use of a fozinopril with diuretics or in combination with the rigid diet limiting salt consumption or with dialysis, development of the significant hypotensive reaction, especially in the first hour after reception of an initial dose of a fozinopril is possible.
Kaliysberegayushchy diuretics and kaliysoderzhashchy additives. Potassium drugs, kaliysberegayushchy diuretics increase risk of development of a hyperpotassemia. In order to avoid risk of development of a hyperpotassemia, it is necessary to apply fozinoprit along with such drugs as Spironolactonum, amiloride, Triamterenum, etc. It is necessary to use with care drug with potassium additives. It is necessary to define potassium concentration in serum at the patient through short periods. At the patients with chronic heart failure, diabetes who are at the same time accepting the kaliysberegayushchy diuretics, potassium, kaliysoderzhashchy substitutes of salt or other means causing a hyperpotassemia (for example, heparin), AKF inhibitors increase risk of development of a hyperpotassemia.
Interaction with other drugs. The bioavailability of drug at simultaneous use with Chlortalidonum, nifedipine, propranolol, Hydrochlorthiazidum, Cimetidinum, Metoclopramidum, a propantelina bromide, digoxin, aspirin and warfarin does not change.
Patients with a heavy course of arterial hypertension or the accompanying dekompensirovanny chronic heart failure have to begin treatment fozinoprily in the conditions of a hospital. To take to patients with a stenosis of the mitral valve and obstruction of outflow from a left ventricle with caution.
To and during drug treatment the control of the ABP is necessary, functions of kidneys, potassium concentrations, hemoglobin contents, creatinine, urea, concentration of electrolytes and activity of hepatic enzymes in blood at increase in transaminase it is necessary to stop drug uses.
Against the background of reception fozinoprit it is necessary to control periodically quantity of leukocytes in peripheral blood, especially patients with the increased risk have neutropenias: in a renal failure and general diseases of connective tissue.
Because of the increased risk of developing arterial hypotension the patients who are on a low-salt or saltless diet need to be careful when prescribing drug.
Quincke’s disease. It was reported about development of a Quincke’s disease in patients as a result of use of AKF inhibitors, including fozinoprila. In hypostasis of language, a throat or throat the obstruction of airways with a possible lethal outcome can develop. In such cases the fast hypodermic administration of solution of epinephrine (adrenaline) (1:1000) and acceptance of other measures of emergency treatment is necessary. Patients have to be informed on the termination of administration of drug and the immediate message to the attending physician about appearance of hypostases on a face, eyes, lips and language, about a spasm of muscles of a throat or the complicated breath. During intake of AKF inhibitors the hypostasis of a mucous membrane of intestines was in rare instances noted. Hypostasis of a mucous membrane of intestines should be considered at differential diagnostics at patients with complaints to abdominal pains against the background of treatment by AKF inhibitors. Symptoms disappeared after phase-out of AKF inhibitors.
Anaphylactic reactions during desensitization. It is necessary to be careful at treatment of patients with AKF inhibitors during procedures of desensitization.
Anaphylactic reactions during dialysis through high-permeability membranes. Against the background of therapy by AKF inhibitors development of anaphylactic reactions when carrying out a hemodialysis through high-permeability membranes is possible and also during a plasma exchange of lipoproteins of low density with adsorption on a dextran sulfate. In such cases it is necessary to consider the possibility of use of dialysis membranes of other type or other drug treatment.
Neutropenia/agranulocytosis. It was in rare instances reported about cases of development of an agranulocytosis and suppression of function of marrow during treatment by AKF inhibitors. These cases were noted more often at patients with impaired renal function, especially in the presence of general diseases of connective tissue (including a system lupus erythematosus or a scleroderma). Patients with the increased risk have neutropenias before therapy by AKF inhibitors and in the course of treatment carry out control of total number of leukocytes and a leukocytic formula (in the first 3-6 months of treatment and in the first year of use of drug once a month).
Arterial hypotension. For reduction of probability of developing of arterial hypotension diuretics should be cancelled in 2-3 days prior to treatment fozinoprily. To and during treatment fozinoprily it is necessary to control the ABP, function of kidneys, the maintenance of potassium ions, creatinine, urea, concentration of electrolytes and activity of hepatic transaminases in blood. Symptomatic hypotension at use of AKF inhibitors is most probable at patients after intensive treatment with diuretics and/or the diet salt limiting receipt, or when carrying out renal dialysis. Temporary hypotensive reaction is not a contraindication for use of drug after carrying out measures for hydration of an organism. In rare instances at patients with an uncomplicated form of arterial hypertension the development of arterial hypotension was connected with use of a fozinopril.
At patients with chronic heart failure at existence or absence of a renal failure, treatment with AKF inhibitors can cause excess antihypertensive effect which can lead to an oliguria or an azotemia, and in rare instances to an acute renal failure and by a lethal outcome. Therefore at treatment of chronic heart failure fozinoprily it is necessary to watch attentively patients, especially for the first two weeks of treatment and also at any increase in a dose fozinoprit or diuretic.
The diuretic dose decline can be required by patients with the normal or lowered arterial blood pressure who were earlier intensively treated diuretics and with the lowered sodium content in blood. Arterial hypotension is not a contraindication for further use of a fozinopril. Some decrease in system arterial blood pressure is the usual and desired effect at the beginning of use of drug in heart failure. Extent of this decrease is maximum at early stages of treatment and is stabilized within one or two weeks of treatment. Arterial blood pressure usually returns to the values characteristic of the period prior to treatment, without decrease in therapeutic effectiveness.
Abnormal liver function. At emergence of noticeable yellowness and the significant increase in activity of hepatic transaminases fozinoprily it is necessary to stop and appoint treatment corresponding treatment.
Renal failure. At patients with arterial hypertension with a renal artery stenosis of one or both kidneys and also at simultaneous use of diuretics without symptoms of a disease of renal vessels during treatment of AKF inhibitors the level of urea nitrogen of blood and creatinine of serum can increase. These effects are usually reversible and pass after the treatment termination. The dose decline of diuretic can be required and/or fozinoprit. Apply with care in a renal failure, a hyponatremia (risk of dehydration, arterial hypotension, chronic kidney disease), an aortal stenosis, a state after transplantation of a kidney, at desensitization, general diseases of connective tissue (including a system lupus erythematosus, a scleroderma) owing to increase in risk of development of a neutropenia or an agranulocytosis, at a hemodialysis, in cerebrovascular diseases (including insufficiency of cerebral circulation), coronary heart disease, chronic heart failure of the III-IV functional class on classification of NYHA, diabetes, oppression of a marrowy hemopoiesis, hyperpotassemia, at elderly patients, gout, against the background of a diet with salt restriction, at the states which are followed by decrease in volume of the circulating blood (including diarrhea, vomiting, the previous treatment by diuretics).
Before an initiation of treatment it is required to carry out the analysis of the carried-out earlier antihypertensive therapy, extent of increase in the ABP, restriction of a diet on salt and/or liquid and other clinical situations.
Whenever possible, it is necessary to stop the carried-out earlier antihypertensive treatment some days before an initiation of treatment fozinoprily.
At patients with heavy chronic heart failure at whom function of kidneys can depend on activity system renin-angiotensin-aldosteronovoy the treatment with AKF inhibitors can lead to an oliguria or to the progressing azotemia and in rare instances to an acute renal failure and/or a lethal outcome.
Hyperpotassemia. At the patients with heart failure, diabetes who are at the same time accepting kaliysberegayushchy diuretics, potassium additives to a diet, the kaliysoderzhashchy solezamenitel or other drugs increasing concentration of potassium ions in serum (for example, heparin), AKF inhibitors increase risk of increase in concentration of potassium ions in serum.
Surgeries/anesthesia. AKF inhibitors can strengthen antihypertensive effect of the drugs which are applied to carrying out the general anesthesia. Before surgical intervention (including stomatology) it is necessary to warn the anesthesiologist about use of AKF inhibitors.
It is necessary to be careful when performing physical exercises or at hot weather because of risk of dehydration and arterial hypotension owing to reduction of volume of the circulating blood.
The feature of influence on ability to run transport and potentsialnoopasny mechanisms
needs to be careful at control of vehicles or when performing any work requiring special attention because of possible appearance of dizziness, especially after an initial dose of drug at the patients accepting diuretic medicines.
Symptoms: significant decrease in the ABP, bradycardia, shock, disturbance of a water and electrolytic state, acute renal failure, stupor.
Treatment: administration of drug should be stopped, gastric lavage, reception of sorbents (for example, activated carbon), vasodepressor means, infusions of 0.9% of solution of sodium of chloride and further the symptomatic and supporting treatment is shown. At decrease in the ABP – intravenous administration of catecholamines, angiotensin II, in bradycardia – use of a pacemaker. Use of a hemodialysis is inefficient.
The form of release and packing
On 14 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 2 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
A period of storage
not to use drug after the expiry date specified on packing.
According to the prescription.
VIVA FARM LLP producer,
Republic of Kazakhstan 2nd Ostroumova St., 33, Almaty, 050030
ph.: +7 (727) 383 74 63, fax: +7 (727) 383 74 56
The name and the country of the owner of the registration certificate
of VIVA FARM LLP, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of VIVA FARM LLP, 2nd Ostroumova St., 33, Almaty, 050030, Republic of Kazakhstan, ph.: +7 (727) 383 74 63, fax: +7 (727) 383 74 56, e-mail:
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