Diropract - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrogen phosphate dihydrate 38.34 mg, mannitol 13.20 mg, corn starch 10.07 mg, croscarmellose sodium 2.00 mg, magnesium stearate 0.75 mg, ferric oxide red oxide (E 172) 0.20 mg.

1 tablet of 10 mg contains:

active substance: lisinopril dihydrate 10.89 mg, which corresponds to 10.00 mg of lisinopril;

Excipients: calcium hydrogen phosphate dihydrate 76.67 mg, mannitol 26.40 mg, corn starch 20.14 mg, croscarmellose sodium 4.00 mg, magnesium stearate 1.50 mg, ferric iron oxide red (E 172) 0.40 mg.

1 tablet of 20 mg contains:

active substance: lisinopril dihydrate 21.78 mg, which corresponds to 20.00 mg of lisinopril;

Excipients: calcium hydrophosphate dihydrate 153.34 mg, mannitol 52.80 mg, corn starch 40.28 mg, croscarmellose sodium 8.00 mg, magnesium stearate 3.00 mg, ferric oxide red oxide (E 172) 0.80 mg.

Description:

Round, convex tablets brownish-pink, with a notch on one side, with impregnations of a lighter and darker color.

Pharmacotherapeutic group:ACE inhibitor

ATX: & nbsp

C.09.A.A.03 Lisinopril

C.09.A.A ACE Inhibitors

Pharmacodynamics:

Lizinopril is an ACE inhibitor that reduces the formation of angiotensin II (a vasoconstrictor enzyme) from angiotensin I. Reducing the concentration of angiotensin II leads to a direct reduction in the secretion of aldosterone, which can lead to an increase in the potassium content in the blood plasma.Reduces the degradation of bradykinin and increases the synthesis of prostaglandins.

Lizinopril reduces the overall peripheral vascular resistance (OPSS), arterial pressure (BP), preload on the heart, pressure in the pulmonary capillaries, causes an increase in the minute volume of blood and increased tolerance of the myocardium to loads in patients with chronic heart failure (CHF). Expands arteries more than veins.

Some of the effects are explained by exposure to tissue renin-angiotensin-aldosterone system (RAAS). With prolonged use regresses myocardial hypertrophy and the walls of arteries of resistive type. Improves the blood supply of ischemic areas of the myocardium.

ACE inhibitors prolong life expectancy in patients with CHF, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure.

After taking the drug inside, the antihypertensive effect begins to appear after about 1 hour, the maximum effect is observed after 6-7 hours and persists for 24 hours. The duration of the effect depends on the amount of the dose.With arterial hypertension, the effect is observed in the first days after the start of treatment, stable action develops after 1-2 months of therapy. With a sharp withdrawal of the drug marked increase in blood pressure is not observed.

In addition to reducing blood pressure, lisinopril reduces the degree of albuminuria.

In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.

Pharmacokinetics:

Suction. After taking the drug inside about 25% lisinopril is absorbed from the gastrointestinal tract (variability is 6-60%). Eating does not affect the absorption of the drug.

Distribution. Virtually does not bind to blood plasma proteins. The maximum concentration in the blood plasma (C_m_Oh) in healthy volunteers (90 ng / ml) is achieved after 6-7 hours. Permeability through the blood-brain and placental barrier is low.

Metabolism. Lisinopril almost does not undergo metabolism.

Excretion. It is excreted by the kidneys unchanged. The half-life (T_1/2) is 12.6 hours.

Pharmacokinetics in selected patient groups

In patients with CHF Absorption and clearance of lisinopril are reduced, bioavailability is 16%.

In patients with renal insufficiency (creatinine clearance (CK) 5-30 ml / min) the concentration of lisinopril several times exceeds the concentration in the blood plasma in healthy volunteers, with an increase in the time to reach the maximum concentration in the blood plasma and an increase in T_1/2.

In patients with marked impairment of liver function (including cirrhosis of the liver) about 30% lisinopril is absorbed from the gastrointestinal tract, and bioavailability is increased by 50% compared with patients with normal liver function.

In elderly patients FROM_m_Oh and the area under the curve "concentration - time" (AUC) in 2 times more, than at patients of young age.

Indications:

- Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);

- chronic heart failure (as part of combination therapy to treat patients taking cardiac glycosides and / or diuretics);

- early treatment of acute myocardial infarction (in the first 24 hours in patients with stable hemodynamic parameters, to maintain these parameters and prevent the development of left ventricular dysfunction and heart failure);

- Diabetic nephropathy (decrease in the degree of albuminuria in patients with type 1 diabetes mellitus and normal BP and type 2 diabetes mellitus and arterial hypertension).

Contraindications:

- Hypersensitivity to lisinopril, other ACE inhibitors or other components of the drug;

- angioedema in anamnesis (including and from the application ACE inhibitors); hereditary angioedema and / or idiopathic angioedema;

- age under 18 years (effectiveness and safety not established);

- pregnancy and the period of breastfeeding;

- hemodialysis or hemofiltration using high-flux membranes (for example, AN69®);

- apheresis of low-density lipoproteins using dextran sulfate;

- desensitizing therapy for venom of Hymenoptera (bees, wasps);

- simultaneous use of ACE inhibitors and / or angiotensin II receptor antagonists (ARA II) with aliskiren in patients with type II diabetes and patients with renal insufficiency (CC less than 60 ml / min).

Carefully:

Severe renal dysfunction; acute myocardial infarction; cardiogenic shock; condition after kidney transplantation; azotemia;hyperkalemia; stenosis of the aortic aorta; mitral stenosis; hypertrophic obstructive cardiomyopathy; primary hyperaldosteronism; arterial hypotension; cerebrovascular diseases (including cerebral circulatory insufficiency); cardiac ischemia; chronic heart failure; autoimmune systemic diseases of connective tissue (including scleroderma, systemic lupus erythematosus); bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney; oppression of bone marrow hematopoiesis; diet with restriction of table salt; hypovolemic conditions (including as a result of diarrhea, vomiting); diabetes; elderly age (over 65 years), use of Negroid race in patients (see section "Special instructions").

Pregnancy and lactation:

Application of the drug Diropress^®when pregnancy is contraindicated. When establishing the fact of pregnancy, the drug should be stopped as soon as possible.

Women planning a pregnancy should not use ACE inhibitors (including lisinopril). Women of childbearing age should be aware of the potential dangers of using ACE inhibitors (including lisinopril).

Admission of ACE inhibitors in the II and III trimester of pregnancy has an adverse effect on the fetus (there may be a marked decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull bones, anuria, reversible and irreversible renal dysfunction, intrauterine death).

Cases of oligohydramnion have been described, presumably due to impaired renal function of the fetus. This complication can lead to limb contracture, craniofacial deformity, and hypoplastic lung development. In addition, the use of ACE inhibitors during the I trimester of pregnancy can increase the risk of birth defects.

For newborns and infants who have undergone intrauterine exposure to ACE inhibitors, careful monitoring is recommended to timely detect a marked decrease in blood pressure, oliguria, and hyperkalemia. Lisinopril penetrates the placenta.

There is no data on the penetration of lisinopril into breast milk. If you need to use the drug during pregnancy, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside 1 time per day, regardless of food intake, it is better in the morning.

With monotherapy arterial hypertension the recommended initial dose is 5-10 mg once a day, depending on the patient's condition. In the absence of effect, the dose is increased every 2 weeks by 5 mg to an average therapeutic dose of 20-40 mg / day (increasing the dose above 40 mg / day usually does not lead to a further decrease in blood pressure). The usual maintenance dose is 20 mg / day. The maximum daily dose is 40 mg.

The therapeutic effect usually develops in 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose. If the clinical effect is insufficient, it is possible to use the drug in combination with other antihypertensive drugs.

If the patient is receiving diuretic therapy, then they should be discontinued 2-3 days before the use of Diropress®. If this is not possible, the initial dose of Diropress® should not exceed 5 mg per day. In this case, after taking the first dose, medical control is recommended for several hours (maximum effect is achieved after about 6 hours), since there may be a marked decrease in blood pressure.

With Renovascular Hypertension or other conditions with increased activity of RAAS, it is advisable to prescribe a lower initial dose of 2.5-5 mg (recommended the use of lisinopril in the dosage form of a 2.5 mg tablet or 1/2 tablet of 5 mg with a risk) per day, carefully monitoring the patient's condition control of blood pressure, kidney function, potassium content in blood plasma). The maintenance dose, continuing regular monitoring, should be selected depending on the dynamics of blood pressure.

With renal insufficiency due to the fact that lisinopril is allocated by the kidneys, the initial dose should be determined depending on the QC.

Further, the selection of doses should be made depending on individual reactions with frequent monitoring of kidney function, potassium and sodium in blood plasma.

Creatinine clearance ml / min	Initial dose of mg / day
30-80	5-10
10-30	2,5-5
less than 10 *	2,5

* including patients on hemodialysis.

With persistent arterial hypertension, prolonged maintenance therapy of 10-15 mg / day is shown.

With CHF the initial daily dose is 2.5 mg (the use of lisinopril in the dosage form of a 2.5 mg tablet or 1/2 tablet of 5 mg with a risk is recommended) once a day, followed by a 2.5 mg dose increase 1-2 weeks before usual, supporting a daily dose of 5-20 mg.The maximum daily dose of 20 mg.

In elderly patients (older than 65 years), a more prolonged antihypertensive effect is often observed, which is associated with a decrease in the rate of excretion of lisinopril (it is recommended to begin treatment with 2.5 mg / day (recommended use of lisinopril in the dosage form of a tablet 2.5 mg or 1/2 tablet 5 mg with risk).

Early treatment of acute myocardial infarction (in the first 24 hours, in patients with stable hemodynamics, to maintain these parameters and prevent the development of left ventricular dysfunction and heart failure) as part of combination therapy

Treatment with Diropress ® can be started within 24 hours from the onset of symptoms of myocardial infarction. The initial dose of lisinopril on the first day is 5 mg orally, then 5 mg at 24 hours from the first dose, 10 mg at 48 hours, then 10 mg once a day. In patients with acute myocardial infarction, the course of treatment with the drug should be at least 6 weeks.

At the beginning of treatment or within the first 3 days after acute myocardial infarction in patients with baseline low systolic blood pressure (120 mm Hg or lower)prescribe a smaller dose - 2.5 mg (recommended the use of lisinopril in the dosage form of a tablet 2.5 mg or 1/2 tablet 5 mg with a risk). In the case of a decrease in systolic blood pressure ≤100 mm Hg. The daily dose of 5 mg can be reduced or reduced if necessary to 2.5 mg (recommended use of lisinopril in the dosage form of a tablet 2.5 mg or 1/2 tablet 5 mg with a risk). In the case of a long pronounced decrease in systolic blood pressure <90 mm Hg. Art. for more than 1 hour the drug should be discontinued.

Diabetic Nephropathy

In patients with type 2 diabetes mellitus, a dose of 10 mg of Diropress® is administered once a day. The dose may optionally be increased to 20 mg once daily to achieve diastolic blood pressure values <75 mm Hg. Art. in the "sitting" position. In patients with type 1 diabetes, the dose is the same, in order to achieve diastolic blood pressure values <90 mm Hg. Art. in the "sitting" position.

Side effects:

According to the World Health Organization (WHO) The undesirable effects are classified according to their development frequency as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥ 1/10000, <1/1000) and very rarely (<1/10000), including individual messages, the frequency is unknown (the frequency can not be determined from the available data).

Violations from the blood and lymphatic system

rarely: reduction of hemoglobin, decrease in hematocrit;

rarely: oppression of bone marrow function, anemia, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, lymphadenopathy, autoimmune diseases.

Disorders from the endocrine system

rarely: syndrome of inadequate secretion of antidiuretic hormone (SNA ADH).

Disturbances from the nervous system

often: dizziness, headache;

infrequently: lability of mood, paresthesia, vertigo, sleep disturbance, taste perversion, hallucinations;

rarely: oppression of consciousness, violation of smell;

frequency is unknown: depression, syncope, confusion, drowsiness, convulsive twitching of the muscles of the extremities and lips.

Disorders from the cardiovascular system

often: orthostatic hypotension;

infrequently: myocardial infarction, cerebral circulation disorder (due to pronounced blood pressure lowering in patients at increased risk), palpitations, tachycardia, Raynaud phenomenon;

frequency is unknown: expressed lowering blood pressure, chest pain, bradycardia, worsening of symptoms of heart failure, violation of atrioventricular conduction.

Disturbances from the respiratory system

often: "dry cough;

infrequently: rhinitis;

rarely: sinusitis, dyspnea, bronchospasm, allergic alveolitis / eosinophilic pneumonia.

Violations with the sides of the digestive system

often: diarrhea, vomiting;

infrequently: nausea, dyspepsia, pain in the abdomen;

rarely: dryness of the oral mucosa;

rarely: pancreatitis, intestinal angioedema edema, hepatitis, hepatic-cell or cholestatic jaundice, hepatic insufficiency.

Disturbances from the skin and mucous membranes

infrequently: skin rash, itching;

rarely: urticaria, alopecia, psoriasis, photosensitivity, hypersensitivity reactions, angioedema, hyperemia of the facial skin, extremities, lips, tongue, throat and / or larynx;

rarely: increased sweating, pemphigus (Pemphigus), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exudative erythema multiforme, pseudolymphoma of the skin.

Disorders from the genitourinary system

often: impaired renal function;

infrequently: decreased potency;

rarely: uremia, acute renal failure, gynecomastia;

rarely: oliguria, anuria;

frequency is unknown: proteinuria.

Laboratory and instrumental data

infrequently: increased urea concentration, creatinine clearance, increased activity of "hepatic" transaminases, hyperkalemia;

rarely: an increase in the concentration of bilirubin in the blood, hyponatremia;

rarely: a decrease in the concentration of glucose in the blood (hypoglycemia), an increase in the titer of antinuclear antibodies, an increase in the rate of erythrocyte sedimentation (ESR).

Other

infrequently: asthenia, fatigue;

frequency is unknown: anorexia, fever.

A symptom complex is described, which may include fever, vasculitis, myalgia, arthralgia / arthritis, an increase in the titer of antinuclear antibodies, an increase in ESR, eosinophilia, leukocytosis, rash, photosensitivity reactions or other skin manifestations.

With simultaneous use of ACE inhibitors and gold preparations for intravenous administration (sodium aurotomy malate) describes a symptom complex, which includes facial flushing, nausea, vomiting and lowering blood pressure.

Overdose:

Symptoms: a marked decrease in blood pressure until the collapse, a violation of water-electrolyte balance, dryness of the oral mucosa, drowsiness, urinary retention, constipation, anxiety, increased irritability, renal failure, tachycardia, palpitations, bradycardia, dizziness, dry cough, impairment water electrolyte balance, collapse, hyperventilation of the lungs.

Treatment: there is no specific antidote. If the drug Diropress® was recently adopted, then it is necessary to take measures to remove the drug from the gastrointestinal tract (provocation of vomiting, gastric lavage, the use of enterosorbents and laxatives). With a pronounced decrease in blood pressure, it is necessary to transfer the patient to the "lying" position on the back with the legs raised upwards (Trendelburg position). It is further shown to fill the volume of circulating blood by intravenous administration of 0.9% sodium chloride solution or other plasma-substituting solutions. If necessary, decide on the use of vasopressor drugs. In the case of development of a bradycardia resistant to treatment, it is necessary to use an artificial pacemaker.It is necessary to monitor the function of the cardiovascular and respiratory systems, blood pressure, urea concentration, creatinine clearance, water-electrolyte balance.

Hemodialysis is effective.

Interaction:

Simultaneous use of ACE inhibitors with other agents acting on the renin-angiotensin-aldosterone system (RAAS) increases the risk of arterial hypotension, hyperkalemia and renal dysfunction (double blockade of RAAS). It is recommended to regularly measure blood pressure, monitor kidney function and electrolyte levels in patients taking lisinopril, as well as other means of influencing RAAS.

Simultaneous use of ACE inhibitors and / or APA II with aliskiren is contraindicated in patients with type II diabetes and patients with renal insufficiency (CC less than 60 ml / min).

With the simultaneous use of the drug with potassium-sparing diuretics (spironolactone, triamterene, amiloride, eplerenone), potassium preparations, salt substitutes containing potassium, cyclosporine, as well as diabetes mellitus, increases the risk of hyperkalemia, especially in cases of impaired renal function, so they can be jointly administered only with regular monitoring of potassium levels in the blood plasma and kidney function.

Simultaneous use of lisinopril with beta adrenoblockers, blockers of "slow" calcium channels, diuretics, antipsychotic drugs, anaesthetics, tricyclic antidepressants / neuroleptics and other antihypertensive drugs increases the severity of antihypertensive action.

Lizinopril slows the excretion of lithium preparations and, consequently, increases their toxicity, which can increase the risk of side effects. The simultaneous use of lisinopril with lithium preparations is not recommended. When these medicines are used together, it is necessary to regularly monitor the concentration of lithium in the blood plasma.

The simultaneous use of thiazide diuretics can further increase the toxicity of lithium.

Antacids and colestramine reduce the absorption of lisinopril in the gastrointestinal tract.

When combined with insulin and hypoglycemic agents for oral administration, the risk of developing hypoglycemia increases. This effect is most often observed in the first weeks of simultaneous application drug Diropress® with antidiabetic drugs, as well as in patients with impaired renal function.

When used simultaneously with non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid as antiplatelet agents at a dose of more than 3 g / day, inhibitors of COX-2, estrogen sympathomimetics reduces antihypertensive action lisinopril.

Simultaneous use of NSAIDs and ACE inhibitors can lead to impaired renal function until acute renal failure, contributes to an increase in potassium in the blood plasma, especially in patients with pre-existing renal impairment. This effect is usually reversible. Care must be taken, especially in elderly patients, to provide periodic monitoring of kidney function, to maintain a sufficient amount of fluid.

Ethanol enhances the action of lisinopril.

Co-administration with selective serotonin reuptake inhibitors can lead to severe hyponatraemia.

Co-administration with allopurinol, procainamide, cytostatics may increase the risk of leukopenia.

The use of lisinopril in combination with acetylsalicylic acid as an antiplatelet agent, thrombolytic agents, beta-blockers and / or nitrates is not contraindicated.

Special instructions:

Symptomatic arterial hypotension

Most often, a marked decrease in blood pressure occurs with a decrease in the volume of circulating blood (BCC), caused by diuretic therapy, reduction of table salt in the diet, dialysis, diarrhea or vomiting, as well as in patients suffering from severe renin-dependent hypertension. In patients with CHF with simultaneous renal failure or without it, a marked decrease in blood pressure is possible. Most often, such symptoms are observed in patients with severe heart failure due to the use of large doses of "loop" diuretics, hyponatremia and impaired renal function.

Patients with ischemic heart disease, cerebrovascular insufficiency,in which a sharp decrease in blood pressure can lead to myocardial infarction or to a stroke, Diropress® can be prescribed only under the strict supervision of a doctor. Transient arterial hypotension is not a contraindication for taking the next dose of the drug.

With the use of Diropress ® in some patients with CHF, but with normal or low blood pressure, there may be a decrease in blood pressure, which is usually not the reason for discontinuing treatment.

Before the start of treatment with the drug, if possible, the sodium content should be normalized and / or replenished with BCC, and carefully monitor the effect of the initial dose of Diropress® on the patient.

Acute myocardial infarction

The use of standard therapy (thrombolytics, acetylsalicylic acid as an antiaggregant agent, beta-blockers). Diropress® can be used in conjunction with intravenous administration or with the use of nitroglycerin sublingually. In the first 3 days after myocardial infarction, a lower dose should be used if the systolic blood pressure does not exceed 120 mm Hg. Art. With stable arterial hypotension (systolic blood pressure below 90 mm Hg.for more than 1 hour), the drug Diropress® must be discontinued.

Stenosis of the aorta and mitral valve mouth / hypertrophic cardiomyopathy

As with other ACE inhibitors, Diropress® should be used with caution in patients with mitral valve stenosis and obstruction of the left ventricular outflow pathway (with aortic estrone stenosis or hypertrophic cardiomyopathy).

Impaired renal function

In patients with impaired renal function (CC less than 80 ml / min), the initial dose of Diropress ® should be selected according to the QC (see "Method of administration and dose"). Regular monitoring of potassium content and creatinine concentration in the blood plasma is an obligatory tactic for treating such patients.

In patients with CHF, arterial hypotension caused by the use of ACE inhibitors, in particular, the drug Diropress®, can lead to impaired renal function. In such patients, there were cases of acute renal failure, usually reversible.

With stenosis of the renal arteries (especially with bilateral stenosis or in the presence of stenosis of the artery of a single kidney),as well as inadequate blood circulation due to lack of sodium and / or liquid, the use of Diroprase® can lead to an increase in the serum creatinine and urea concentration in the blood, impaired renal function, acute renal failure, which usually regresses after drug withdrawal.

With acute myocardial infarction, therapy with Diropress® should not be started in patients with signs of impaired renal function, i.e. with a creatinine concentration of 177 μmol / L and / or proteinuria of more than 500 mg / day in the blood plasma. If the kidney function is disturbed by the use of the drug Diropress® (creatinine concentration exceeds 265 μmol / L or doubles its value before treatment), it is necessary to decide whether to cancel the drug Diropress®.

Hyperkalemia can develop during treatment with ACE inhibitors, including lisinopril. Risk factors for hyperkalemia include renal failure, advanced age, diabetes mellitus, certain concomitant conditions (eg, reduced bcc, acute heart failure, metabolic acidosis), simultaneous intake of potassium-sparing diuretics (such as spironolactone, eplerenone, triamteryi, amiloride), as well as preparations of potassium or potassium-containing substitutes for edible salt and the use of other drugs that increase the potassium content in the blood plasma (for example, heparin). Hyperkalemia can lead to serious heart rhythm disturbances, sometimes with a fatal outcome. Combined use of the above drugs should be done with caution. Regular monitoring of the potassium content in serum is recommended.

Impaired liver function

ACE inhibitors can lead to the development of cholestatic jaundice with progression up to fulminant liver necrosis and (in rare cases) a lethal outcome, therefore it is necessary to stop taking the drug with an increase in the activity of "liver" transaminases and the appearance of symptoms of cholestasis.

Hypersensitivity / angioedema

With the use of ACE inhibitors, including lisinopril, in rare cases development of angioedema of the extremities, face, lips, tongue, throat and / or larynx can be observed. If these symptoms appear, the drug should be discontinued immediately, the patient should be under the supervision of the doctor until the symptoms disappear completely.If angioedema affects only the face and lips, then its manifestations usually go away alone or antihistamines may be used to treat its symptoms.

Angioedema, accompanied by edema of the tongue, larynx and pharynx, can lead to airway obstruction and death (especially in patients with surgical interventions on the respiratory tract in anameneze). When such symptoms occur, immediately enter subcutaneously epinephrine (epinephrine) in a dilution of 1: 1000 (0.3 or 0.5 ml) and / or provide airway patency. The patient should be under careful medical supervision until the symptoms disappear completely.

Even in cases where the edema affects only the tongue without disturbing breathing, prolonged observation of the patient may be necessary, since therapy with antihistamines and corticosteroids may not be sufficient.

Patients with a history of angioedema not associated with the administration of ACE inhibitors may be at increased risk of developing it with the drugs of this pharmacotherapeutic group.

In rare cases, against the background of therapy with ACE inhibitors, angioedema develops in the intestine. In this case, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases without a previous angioedema and a normal content of C-1-esterase. The diagnosis is established using computed tomography of the abdominal cavity, ultrasound examination or at the time of surgery. Symptoms disappear after stopping the intake of ACE inhibitors. In patients with abdominal pain taking ACE inhibitors, the differential diagnosis should take into account the possibility of angioedema edema development.

Anaphylactoid reactions

In patients with the use of ACE inhibitors and hemodialysis using high-permeability membranes (e.g., AN69®), anaphylactoid reactions were noted. Therefore, it is desirable to use membranes of a different type or to use an antihypertensive drug of another pharmacotherapeutic group.

In rare cases in the conduct of apheresis of low-density lipoproteins using dextrin sulfate In patients receiving ACE inhibitors, life-threatening anaphylactoid reactions may develop. To prevent the development of an anaphylactoid reaction, the use of an ACE inhibitor should be discontinued before each apheresis session.

There are separate reports on the development of long-term, life-threatening anaphylactoid reactions in patients taking ACE inhibitors during desensitizing therapy to the venom of Hymenoptera (bees, wasps). The use of ACE inhibitors by patients should be avoided when desensitizing therapy is administered to the venom of Hymenoptera. Nevertheless, the development of anaphylactoid reactions can be avoided by temporarily lifting the ACE inhibitor at least 24 hours before the desensitization procedure begins.

Against the background of treatment with ACE inhibitors there may be a "dry" cough, which disappears after the withdrawal of drugs of this pharmacotherapeutic group. If the doctor believes that therapy with an ACE inhibitor is necessary patient, taking Diropress® can be continued.

Hypoglycemic drugs

With the simultaneous use of ACE inhibitors and insulin, as well as hypoglycemic drugs for oral administration, may lead to the development of hypoglycemia.

The greatest risk of developing hypoglycemia is observed during the first two weeks of combination therapy, as well as in patients with impaired renal function.

Patients with diabetes require careful monitoring of the glycemic profile, especially during the first month of therapy with ACE inhibitors.

Neutropenia / agranulocytosis

Neutropenia / agranulocytosis caused in patients with normal renal function receiving ACE inhibitors are generally reversible.

With extreme caution must be used Diropress® drug in patients with connective tissue diseases receiving immunosuppressive therapy in combination with allopurinol and procainamide, especially patients with impaired renal function. In these patients, due to the greater likelihood of severe neutropenia and agranulocytosis have an increased risk of serious infection, in some cases resistant to intensive antibiotic therapy. Therefore, it is necessary to regularly monitor the clinical analysis of blood with the counting of the formed elements, as well as to advise the patient that if the first clinical signs of the infection occur, immediately consult a doctor.

DiROPRESS® and other ACE inhibitors are less effective patients Negroid race, due to the prevalence of patients with hypertension with low renin activity. In patients of the Negroid race angioneurotic edema with the use of the drug Diropress® is more common than in patients of other races.

Surgery / general anesthesia

With extensive surgical interventions, as well as with the use of other means that cause a decrease in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a pronounced unpredictable a decrease in blood pressure.

It is recommended to stop taking ACE inhibitors, including lisinopril, 12 hours before surgery, warning an anesthesiologist about the use of ACE inhibitors.

In elderly patients before the start of taking Diropress^® should evaluate the function of the kidneys and the content of potassium in the blood plasma. The initial dose of Diropress^® are selected depending on the degree of BP reduction, especially with a decrease in BCC and weighting of CHF flow (IV functional class by classification NYHA). Such measures allow to avoid a sharp decrease in blood pressure.

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

During the treatment with Diropress®, dizziness, headache, fatigue can occur, therefore, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, 5 mg, 10 mg and 20 mg.

Packaging:

For 7 or 10 tablets in a blister of PVC / aluminum foil.

For 1, 2, 3, 4 or 5 blisters in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use the medicine after the expiry date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-010713/09

Date of registration:28.12.2009 / 28.10.2014

Expiration Date:Unlimited

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp09.11.2016

Illustrated instructions

Instructions

Diropress® (Diropress®)