Active substanceHinaprilHinapril
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    NORTH STAR, CJSC     Russia
  • Dosage form: & nbspTablets, film-coated
    Composition:

    1 tablet, film-coated, contains:

    dosage of 5 mg: active substance: quinapril hydrochloride - 5.416 mg in terms of quinapril - 5 mg; auxiliary substances (core): lactose monohydrate (milk sugar) - 28.784 mg; magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic water) - 75.0 mg; croscarmellose sodium (impellose) - 3.0 mg; povidone (medium molecular weight polyvinylpyrrolidone) 6.0 mg; silicon dioxide colloid (aerosil) - 0.6 mg; magnesium stearate - 1.2 mg; adjuvants (shell): Opadry II (polyvinyl alcohol, partially hydrolyzed - 1.6 mg talc - 0.592 mg of titanium dioxide, E 171 - 0.8748 mg macrogol (3350 polietileiglikol) - 0.808 mg Aluminum lacquer dye quinoline yellow - 0.1204 mg aluminum lacquer dye-based yellow sunset - 0.0028 mg ferric oxide colorant (II) yellow - 0.0012 mg aluminum lacquer based dye indigo - 0.0008 mg);

    dosage of 10 mg: active substance: quinapril hydrochloride 10.832 mg in terms of quinapril 10 mg; auxiliary substances (core): lactose monohydrate (sugar milk) - 46.168 mg; magnesium hydroxycarbonate pentahydrate (magnesiumcarbonate basic water) - 125.0 mg; croscarmellose sodium (impellosis) - 5.0 mg; povidone (polyvinylpyrrolidone, medium molecular weight) - 10.0 mg; silicon dioxide colloid (aerosil) - 1.0 mg; magnesium stearate - 2.0 mg; auxiliary substances (shell): Opadrai II (polyvinyl alcohol, partially hydrolysed - 2,4 mg, talc 0,888 mg, titanium dioxide E 171 - 1,3122 mg, macrogol (polyethylene glycol 3350) - 1,212 mg, aluminum varnish based on dye quinoline yellow - 0.1806 mg, aluminum varnish based on the dye sunset yellow - 0.0042 mg, iron oxide dye (II) yellow - 0.0018 mg, aluminum lacquer based on indigo carmine dye 0.0012 mg);

    dosage of 20 mg: active substance: quinapril hydrochloride - 21.664 mg in terms of quinapril - 20 mg; auxiliary substances (core): lactose monohydrate (sugar milk) - 48,736 mg; magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic water) - 157.0 mg; croscarmellose sodium (impellose) - 6.3 mg; povidone (polyvinylpyrrolidone, medium molecular weight) - 12.5 mg; silicon dioxide colloid (aerosil) - 1.3 mg; magnesium stearate - 2.5 mg; auxiliary substances (shell): Opadrai II (polyvinyl alcohol, partially hydrolyzed - 3.2 mg, talc - 1.184 mg, titanium dioxide E 171 - 1.7496 mg, macrogol(polyethylene glycol 3350) 1.616 mg; Aluminum lacquer based on dye quinoline yellow - 0.2408 mg; aluminum lacquer based on the dye sunset sunset yellow - 0.0056 mg; iron dye oxide (II) yellow - 0.0024 mg; aluminum lacquer based on indigo carmine dye - 0.0016 mg);

    dosage of 40 mg: active substance: quinapril hydrochloride 43,328 mg in terms of quinapril 40 mg; auxiliary substances (core): lactose monohydrate (milk sugar) - 70.672 mg; magnesium hydroxycarbonate pentahydrate (magnesium carbonate basic water) - 250.0 mg; croscarmellose sodium (impellosis) - 10.0 mg; povidone (polyvinylpyrrolidone medium molecular weight) - 20.0 mg; silicon dioxide colloid (aerosil) - 2.0 mg; magnesium stearate 4.0 mg; auxiliary substances (shell): Opadrai II (polyvinyl alcohol, partially hydrolyzed - 4.8 mg, talc - 1.776 mg, titanium dioxide E 171 - 2.6244 mg, macrogol (polyethylene glycol 3350) - 2.424 mg, aluminum paint based on dye quinoline yellow 0.3612 mg, aluminum dye-based lacquer sunset yellow 0.0084 mg, iron dye oxide (II) yellow 0.0036 mg, aluminum dye based on indigo carmine dye 0.0024 mg).

    Description:

    Dosage 5 mg

    The tablets covered with a film cover of yellow color, round, biconcave with a risk. On the cross section, the core of the tablet is white or almost white in color.

    Dosage of 10 mg, 20 mg and 40 mg

    The tablets covered with a film cover of yellow color, round, biconcave. On the cross section, the core of the tablet is white or almost white in color.

    Pharmacotherapeutic group:Angiotensin-converting enzyme (ACE) inhibitor
    ATX: & nbsp

    C.09.A.A.06   Hinapril

    Pharmacodynamics:

    ACE is an enzyme that catalyzes the conversion of angiotensin I into angiotensin II, which has a vasoconstrictive effect and increases the tone of the vessels, including by stimulating the secretion of aldosterone with the adrenal cortex. Hinapril competitively inhibits ACE and causes a decrease in vasopressor activity and aldosterone secretion. Elimination of the negative effect of angiotensin II on renin secretion by the feedback mechanism leads to an increase in renin plasma activity. At the same time, lowering blood pressure (BP) is accompanied by a decrease in the total peripheral vascular resistance (OPSS) and resistance of renal vessels, while changes in the heart rate (HR), cardiac output, renal blood flow, glomerular filtration rate and filtration fraction are minor or absent . Hinapril increases tolerance to physical activity.With prolonged use contributes to the reverse development of myocardial hypertrophy in patients with arterial hypertension; improves the blood supply of the ischemic myocardium. Strengthens coronary and renal blood flow. Reduces the aggregation of platelets. The onset of action after taking a single dose - after 1 hour, maximum - after 2-4 hours, the duration of action depends on the amount of the dose taken (up to 24 hours). Clinically pronounced effect develops a few weeks after the initiation of therapy.

    Pharmacokinetics:

    The concentration of quinapril in the blood plasma after ingestion reaches a maximum for 1 hour, quinaprilat - 2 hours. Food intake does not affect the degree of absorption, but can increase the time to reach the maximum concentration (TCmOh) (fatty foods can reduce the speed and degree of absorption of quinapril). Taking into account the excretion of quinapril and its metabolites by the kidneys, the degree of absorption is approximately 60%. Under the influence of "liver" enzymes quinapril is rapidly metabolized to quinaprilate by cleavage of the ester group (the main metabolite is dibasic acid of quinapril), which is an ACE inhibitor.About 38% of the ingested dose of quinapril circulates in the blood plasma in the form of quinaprilate. The half-life (T1/2) of quinapril from the blood plasma is about 1-2 hours, quinaprilat - 3 hours. It is excreted by the kidneys - 61% (56% in the form of quinapril and quinaprylate) and through the intestine - 37%. Approximately 97% Hinapril and quinaprilate circulate in blood plasma in a protein form. Hinapril and its metabolites do not penetrate the blood-brain barrier.

    In patients with renal insufficiency, T1 / 2 of quinaprilat increases with decreasing creatinine clearance (CK). The excretion of quinaprilat is also reduced in elderly patients (over 65 years) and closely correlates with impaired renal function, however, in general, there is no difference in the efficacy and safety of treatment in elderly and younger patients.

    In patients with alcoholic cirrhosis of the liver, the concentration of quinaprilat is reduced by the violation of the de-esterification of quinapril.

    Indications:

    Arterial hypertension (in monotherapy or in combination with thiazide diuretics and beta-blockers).

    Chronic heart failure (as part of combination therapy).

    Contraindications:

    Contraindications

    - Hypersensitivity to any component of the drug.

    - Angioedema in history as a result of previous therapy with ACE inhibitors, hereditary and / or idiopathic angioedema.

    - Age to 18 years.

    - Pregnancy and the period of breastfeeding.

    - Deficiency of lactase, lactose intolerance and glucose-galactose malabsorption syndrome.

    - Simultaneous use with aliskiren and aliskiren-containing agents or with antagonists of angiotensin II receptor (ARA II) or with other drugs inhibiting the renin-angiotensin-aldosterone system (RAAS) (double blockade of RAAS):

    - in patients with diabetes mellitus or in patients with diabetes mellitus with lesion of target organs (diabetic nephropathy);

    - in patients with impaired renal function (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m2);

    - in patients with hyperkalemia (more than 5 mmol / l);

    - in patients with chronic heart failure and arterial hypotension.

    Carefully:

    Symptomatic arterial hypotension in patients who had previously taken diuretics and followed a diet with reduced intake of table saltsalts; severe heart failure in patients with a high risk of hypotension; severe chronic heart failure; conditions, accompanied by a decrease in the volume of circulating blood (bcc) (including vomiting and diarrhea); hyperkalemia; oppression of bone marrow hematopoiesis; aortic stenosis, hypertrophic obstructive cardiomyopathy, mitral stenosis; cerebral circulatory insufficiency, ischemic heart disease, coronary insufficiency - a sharp decrease in blood pressure on the background of therapy with ACE inhibitors, can worsen the course of these diseases; bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, condition after kidney transplantation; impaired renal function; in patients on hemodialysis (CC less than 10 ml / min) (data on the use of quinapril in such patients is not enough); autoimmune systemic diseases of connective tissue (including systemic lupus erythematosus, scleroderma); violations of the liver (especially with simultaneous use with diuretics); with simultaneous use with potassium-sparing diuretics; diabetes; extensive surgical interventions and general anesthesia; simultaneous administration of other antihypertensive drugs,as well as inhibitors of mTOR and DPP-4 enzymes.

    Pregnancy and lactation:

    The use of the drug Hinapril-SZ is contraindicated during pregnancy, in women planning pregnancy, as well as in women of reproductive age who do not use reliable methods of contraception.

    Women of reproductive age who take Hinapril-SZ should use reliable methods of contraception.

    When diagnosing pregnancy, Hinapril-SZ should be discontinued as early as possible.

    The use of ACE inhibitors during pregnancy is accompanied by an increased risk of anomalies from the cardiovascular and nervous systems of the fetus. In addition, against the background of taking ACE inhibitors during pregnancy, cases of low blood pressure, premature birth, birth of children with arterial hypotension, kidney pathology (including acute kidney failure), hypoplasia of the skull bones, contractures of the limbs, craniofacial deformities, lung hypoplasia, delay intrauterine development, an open arterial duct, as well as cases of intrauterine fetal death and newborn death.Often, anhydration is diagnosed after the fetus has been irreversibly damaged.

    Newborns who have been exposed to ACE inhibitors in utero should be monitored for the purpose of identifying arterial hypotension, oliguria, and hyperkalemia. When oliguria occurs, blood pressure and renal perfusion should be maintained.

    The drug Hinapril-SZ should not be administered during breastfeeding because the ACE inhibitors, including quinapril, to a limited extent penetrate into breast milk. Given the possibility of developing serious adverse events in a newborn, Hinapril-SZ should be canceled during lactation or to stop breastfeeding.

    Dosing and Administration:

    Take inside, without chewing, regardless of the time of eating, squeezed with water.

    Arterial hypertension

    Monotherapy: the recommended initial dose of the drug Hinapril-SZ in patients not receiving diuretics is 10 mg 1 time per day. Depending on the clinical effect, the dose can be increased (doubling) to a maintenance dose of 20 or 40 mg / day, which is usually prescribed in 1 or 2 doses.As a rule, the dose should be changed at intervals of 4 weeks. In most patients, the use of the drug Hinapril-SZ once a day can achieve a persistent therapeutic response. The maximum daily dose is 80 mg / day.

    When used simultaneously with diuretics, the recommended initial dose of the drug Hinapril-SZ in patients who continue to take diuretics is 5 mg 1 time per day; in the subsequent it is increased (as indicated above) until the optimal therapeutic effect is achieved (see the section "Interaction with other medicinal products").

    Chronic heart failure

    The recommended initial dose of the drug Hinapril-SZ is 5 mg 1 or 2 times a day.

    After taking the drug, the patient must be under medical supervision to detect symptomatic arterial hypotension. In case of good tolerability of the initial dose of the drug Hinapril-SZ, it can be increased to 10-40 mg / day by dividing into 2 doses. Use in patients with impaired renal function.

    Given the clinical and pharmacokinetic data in patients with impaired renal function, the initial dose should be selected as follows:

    QC Recommended initial dose

    (ml / min) (mg)

    more than 60 10

    30-60 5

    10-30 2.5 (1/2 tablet 5 mg)

    If tolerability of the initial dose is good, then the drug Hinapril-SZ can be used 2 times a day. The dose of the drug Hinapril-SZ can be gradually, not more often than once a week, increase, taking into account clinical, hemodynamic effects, as well as kidney function.

    Application in elderly patients: The recommended initial dose of Hinapril-SZ in elderly patients is 10 mg once a day; in the subsequent it is increased until the optimal therapeutic effect is achieved.

    Side effects:

    Undesirable phenomena with the use of quinapril are usually mild and transitory. The most common symptoms are headache (7.2%), dizziness (5.5%), coughing (3.9%), fatigue (3.5%), rhinitis (3.2%), nausea and / or vomiting (2.8%) and myalgia (2.2%). It should be noted that in a typical case, cough is unproductive, persistent and occurs after discontinuation of treatment.

    The incidence of withdrawal of quinapril as a result of side effects was observed in 5.3% of cases.

    Below is a list of undesirable reactions, distributed according to organ systems and frequency of occurrence (classification of the World Health Organization):

    very often - more than 1/10,

    often from more than 1/100 to less than 1/10,

    infrequently - from more than 1/1000 to less than 1/100,

    rarely from more than 1/10000 to less than 1/1000,

    very rarely - from less than 1/10000, including individual messages.

    From the nervous system

    Often: headache, dizziness, insomnia, paresthesia, increased fatigue.

    Infrequently: depression, increased excitability, drowsiness, vertigo.

    From the side of the digestive tract

    Often: nausea and / or vomiting, diarrhea, dyspepsia, abdominal pain. Infrequently: dryness of the mucous membrane of the mouth or throat, flatulence, pancreatitis *, angioedema, intestinal edema, gastrointestinal bleeding.

    Rarely: hepatitis.

    General disorders and disorders at the site of administration

    Infrequently: edema (peripheral or generalized), malaise, viral infections.

    From the side of the circulatory and lymphatic systems

    Infrequently: hemolytic anemia *, thrombocytopenia *.

    From the side of the cardiovascular system Often: marked decrease in blood pressure.

    Infrequently: angina, palpitations, tachycardia, heart failure, myocardial infarction, stroke, increased blood pressure, cardiogenic shock, postural hypotension *, fainting *, symptoms of vasodilation.

    On the part of the respiratory system, the organs of the thorax and the mediastinum Often: cough, dyspnea, pharyngitis, chest pain.

    From the skin and subcutaneous tissues

    Infrequently: alopecia *, exfoliative dermatitis *, increased sweating, pemphigus *, photosensitivity reactions *, skin itching, rash.

    From the musculoskeletal and connective tissue Often: backache.

    Infrequently: arthralgia.

    From the side of the kidneys and urinary tract

    Infrequently: urinary tract infection, acute renal failure. From the genitals and breast Infrequently: decreased potency.

    From the side of the organ of vision:

    Infrequently: impaired vision.

    From the immune system:

    Infrequently: anaphylactic reactions.

    Rarely: angioedema.

    Other:

    Rarely: eosinophilic pneumonitis.

    Laboratory indicators:

    very rarely noted agranulocytosis and neutropenia, although the cause-and-effect relationship with the use of hinapril has not yet been established. Hyperkalemia: (see "Special instructions").

    Creatinine and blood urea nitrogen: an increase (more than 1.25 times in comparison with the upper limit of the norm) of serum creatinine and blood urea nitrogen was observed in 2% and 2% of patients receiving quinapril monotherapy, respectively.The likelihood of an increase in these parameters in patients receiving diuretics simultaneously is higher than when one quinapril is used. With further therapy, the indicators often return to normal.

    * - less frequent adverse events or those noted during post-marketing research.

    With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate, intravenously), a symptom complex is described, including facial flushing, nausea, vomiting, and lowering blood pressure.

    Overdose:

    Symptoms: marked decrease in blood pressure, dizziness, weakness, visual impairment.

    Treatment: symptomatic. The patient should take a horizontal position, it is advisable to carry out intravenous infusion with a 0.9% solution of sodium chloride (to increase the BCC). Hemodialysis and peritoneal dialysis are ineffective.

    Interaction:

    Tetracycline and other drugs that interact with magnesium: simultaneous use of tetracycline with quinapril reduces the absorption of tetracycline by approximately 28-37% due to the presence of magnesium carbonate as an auxiliary component of the drug.At simultaneous application it is necessary to consider the possibility of such interaction. Lithium: patients who simultaneously received lithium preparations and ACE inhibitors observed an increase in serum lithium and signs of lithium intoxication due to increased sodium excretion. Use these drugs simultaneously with caution; the treatment shows regular determination of lithium content in blood serum. The simultaneous use of diuretics can increase the risk of lithium intoxication.

    Diuretics: while simultaneous use of quinapril with diuretics, there is an increase in antihypertensive action (see section "Special instructions").

    Preparations. increasing the content of potassium in the blood serum: if the patient receiving quinapril, potassium-sparing diuretics are shown (for example, spironolactone, triamterene or amiloride), potassium preparations and salt substitutes containing potassium, then they should be used carefully under the control of potassium in the blood serum.

    Ethanol (drinks, containing alcohol): ethanol strengthens antihypertensive effect of quinapril.

    Hypoglycemic agents for ingestion and insulin: therapy with ACE inhibitors is sometimes accompanied by the development of hypoglycemia in patients with diabetes mellitus receiving insulin or hypoglycemic agents for oral ingestion. Hinapril enhances the effect of hypoglycemic agents for ingestion and insulin.

    Other drugs: signs of clinically significant pharmacokinetic interaction of quinapril with propranolol, hydrochlorothiazide, digoxin or cimetidine was not revealed. The use of quinapril 2 times a day did not significantly affect the anticoagulant effect of warfarin when it was applied once (evaluated on the basis of prothrombin time).

    With simultaneous repeated use of atorvastatin in a dose of 10 mg with quinapril at a dose of 80 mg did not lead to significant changes in the equilibrium pharmacokinetic parameters of atorvastatin.

    Hinapril increases the risk of developing leukopenia with concomitant use with allopurinol, cytostatic agents, immunosuppressants, procainamide.

    Hypotensive drugs, narcotic analgesics, drugs for general anesthesia increase the antihypertensive effect of quinapril.

    Estrogens, non-steroidal anti-inflammatory drugs (NSAIDs) (including selective inhibitors of cyclooxygenase-2 (COX-2)) weaken the antihypertensive effect of quinapril due to fluid retention. In addition, in elderly patients, in patients with reduced BCC (including patients receiving diuretic therapy) or in patients with impaired renal function, concurrent use of NSAIDs (including selective inhibitors of COX-2), with ACE inhibitors, including quinapril, may lead to impairment of renal function, including possible acute renal failure. It is necessary to regularly monitor the status of kidney function in patients receiving both NSAIDs and quinapril.

    The use of ARA II, ACE inhibitors or aliskiren can lead to a "double" blockade of RAAS activity. This effect can be manifested by lowering blood pressure, hyperkalemia and changes in kidney function (including acute renal failure) compared with monotherapy.

    Do not use quinapril with aliskiren and aliskiren-containing agents or with ARA II or with other preparations inhibiting RAAS (double blockade of RAAS):

    - in patients with diabetes mellitus or in patients with diabetes mellitus with lesion of target organs (diabetic nephropathy);

    - in patients with impaired renal function (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m2);

    - in patients with hyperkalemia (more than 5 mmol / l);

    - in patients with chronic heart failure and hypertension.

    Drugs that cause depression of bone marrow function increase the risk of developing neutropenia and / or agranulocytosis.

    With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate, intravenously), a symptom complex is described, including facial flushing, nausea, vomiting, and lowering blood pressure.

    Patients simultaneously receiving therapy with enzyme inhibitors mTOR (eg, tessirolimus) or inhibitors of DPP-4 (sitagliptin, vildagliptin, alogliptin, saxagliptin, linaglyptin) or estramustine may be at greater risk of developing angioedema. Care should be taken when using these drugs with Hinapril-SZ at the same time.

    Special instructions:

    In the treatment of ACE inhibitors, cases of angioedema in the head and neck, including 0.1% of patients who received quinapril. When a laryngeal whistle or angioedema of the face, tongue, or vocal cords quinapril should be immediately canceled. The patient should be given adequate treatment and observed before the regression of the symptoms of edema. To reduce the symptoms can be used antihistamines. Angioedema with involvement of the larynx can lead to death. If edema of the tongue, vocal cords or larynx threatens with the development of airway obstruction, adequate emergency therapy, including subcutaneous injection of an epinephrine (adrenaline) solution 1: 1000 (0.3-0.5 ml), is necessary. In the treatment of ACE inhibitors, cases of angioedema of the intestine are also described. Patients noted abdominal pain (with / without nausea or vomiting); in some cases without a previous angioedema and a normal activity of C1-esterase. The diagnosis was established using computed tomography of the abdominal region, ultrasound examination or at the time of surgery. Symptoms disappeared after discontinuation of ACE inhibitors. Therefore, in patients with abdominal pain taking ACE inhibitors,When establishing a differential diagnosis, it is necessary to take into account the possibility of developing angioedema edema of the intestine.

    Patients who have a history of angioedema, not associated with an ACE inhibitor, may be at increased risk of developing it when treated with drugs of this group.

    Patients receiving ACE inhibitors during desensitizing therapy with Hepaticoptera venom can develop life-threatening anaphylactoid reactions. By temporarily stopping the use of ACE inhibitors, these reactions could be avoided, but they arose again with the occasional administration of these drugs.

    Anaphylactoid reactions can also develop with the use of ACE inhibitors in patients who have undergone apheresis of low-density lipoproteins by absorption with dextran sulfate or in patients on hemodialysis using high-flow membranes, such as polyacrylonitrile (for example, AN69). Therefore, similar combinations should be avoided, using either other antihypertensive drugs, or alternative membranes for hemodialysis.Symptomatic arterial hypotension is rare in the treatment of quinapril in patients with uncomplicated arterial hypertension, but it can develop as a result of therapy with ACE inhibitors in patients with reduced BCC, for example, with a diet with limited intake of salt, hemodialysis. In case of symptomatic arterial hypotension, it is necessary to conduct symptomatic therapy (the patient should take a horizontal position and, if necessary, administer an intravenous infusion with 0.9 % solution of sodium chloride). Transient arterial hypotension is not a contraindication to the further use of the drug, however in such cases it is necessary to reduce its dose or assess the advisability of simultaneous therapy with diuretics.

    Other causes of BCC reduction, such as vomiting or diarrhea, can also lead to a marked decrease in blood pressure. In such cases, patients should consult a doctor.

    In patients receiving diuretics, the use of quinapril may also lead to the development of symptomatic arterial hypotension.It is advisable for such patients to temporarily stop taking a diuretic 2-3 days before the start of treatment with quinapril, except for patients with malignant or difficult to treat hypertension. If monotherapy with quinapril does not provide the necessary therapeutic effect, diuretic treatment should be resumed. If you can not cancel a diuretic, then quinapril used in a low initial dose.

    In patients with chronic heart failure, who are at increased risk of severe arterial hypotension, treatment with quinapril should be started with the recommended dose under the close supervision of the doctor; patients should be observed during the first two weeks of treatment, as well as in all cases when the dose of quinapril is increased.

    When therapy with ACE inhibitors in patients with uncomplicated hypertension patients in rare cases develop agranulocytosis, which is more common in patients with impaired renal function and connective tissue diseases. In the treatment of quinapril, agranulocytosis rarely developed. When using quinapril (as well as other ACE inhibitors) in patients with connective tissue diseases and / or kidney disease, the number of leukocytes in the blood should be monitored.

    In susceptible patients, suppression of RAAS activity can lead to impaired renal function.

    In patients with severe chronic heart failure, whose renal function may be affected by RAAS activity, treatment with ACE inhibitors, including quinapril, may be accompanied by oliguria and / or progressive azotemia, and in rare cases, with acute renal failure and / or death. The use of ARA II, ACE inhibitors or aliskiren can lead to a "double" blockade of RAAS activity. This effect can be manifested by lowering blood pressure, hyperkalemia and changes in kidney function (including acute renal failure) compared with monotherapy. Care should be taken to monitor blood pressure, kidney function and electrolyte content in blood plasma in patients taking quinapril and other drugs that affect RAAS. It is necessary to avoid simultaneous use of RAAS-active agents and quinapril. If this combination is necessary, it is necessary to evaluate the ratio of the expected benefit to the possible risk of the combination and regularly monitor the function of the kidneys and potassium content in each individual case.

    In patients with chronic heart failure or hypertension with unilateral or bilateral stenosis of the renal artery, in the treatment of ACE inhibitors in some cases, an increase in the concentration of urea nitrogen in the blood and serum creatinine was observed. These changes were almost always reversible and disappeared after the withdrawal of the ACE inhibitor and / or diuretic. In such cases, during the first few weeks of treatment, kidney function should be monitored.

    The half-life of quinaprilate increases with decreasing CC. In patients with SC less than 60 ml / min quinapril should be used at a lower initial dose. In such patients, the dose of the drug should be increased taking into account the therapeutic effect, with regular monitoring of kidney function, although in clinical studies there was no further deterioration in renal function in drug treatment.

    Hinapril in combination with diuretics should be used with caution in patients with impaired function or progressive liver disease, since small changes in the water-electrolyte balance can cause the development of hepatic coma.

    ACE inhibitors, including quinapril, can increase the potassium content in the blood serum.

    Hinapril can reduce hypokalemia caused by thiazide diuretics with simultaneous application. The use of quinapril in combination therapy with potassium-sparing diuretics has not been studied. Given the risk of further increase in serum potassium, combined therapy with potassium-sparing diuretics should be carried out with caution, under the control of potassium in the blood serum.

    Patients with diabetes may need more careful observation and correction of a dose of hypoglycemic agents for ingestion and insulin, and control of glycemia, especially during the first month of therapy with an ACE inhibitor, including quinapril.

    In the treatment of ACE inhibitors, including quinapril, noted the development of cough. In a typical case, it is unproductive, persistent and passes after discontinuation of therapy. In the differential diagnosis of cough, its possible association with ACE inhibitors should be considered.

    Before surgery (including dentistry), it is necessary to alert the surgeon / anesthesiologist about the use of ACE inhibitors.

    If any symptoms of infection (eg acute tonsillitis, fever) appear, the patient should consult a doctor immediately, as they may be a manifestation of neutropenia.

    Effect on the ability to drive transp. cf. and fur:

    When using Hinapril-SZ, caution should be exercised when driving vehicles or doing other work that requires special attention, especially at the beginning of treatment, due to the danger of developing arterial hypotension and dizziness.

    Form release / dosage:

    Tablets, film-coated, 5 mg, 10 mg, 20 mg, 40 mg.

    Packaging:

    For 10 or 30 tablets in a planar cell package.

    For 30 tablets in a plastic can or in a polymer bottle. Each bank or vial, 3, 6 contour cell packs of 10 tablets or 1, 2 contour packs of 30 tablets, together with instructions for use in a cardboard bundle.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date indicated on the packaging.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002951
    Date of registration:09.04.2015
    The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.09.2015
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