Lisinopril Grindeks - instructions for use, dose, side effects, contraindications

Composition:1 tablet contains
active substance: lisinopril (in the form of lisinopril dihydrate) - 10 mg or 20 mg: Excipients:
tablets 10 mg: pregelatinized starch - 6.60 mg. corn starch - 33.0 mg.calcium hydrophosphate, anhydrous - 122.76 mg; mannitol - 44.0 mg, silicon dioxide colloid, anhydrous - 1.10 mg: magnesium stearate - 1.65 mg; tablets 20 mg: pregelatinized starch 6.60 mg, corn starch 33.0 mg. calcium hydrophosphate, anhydrous - 111.87 mg; mannitol-44.0 mg, silicon dioxide colloidal, anhydrous - 1.10 mg: magnesium stearate - 1.65 mg.

Description:Tablets 10 mg: round flat-cylindrical tablets of white color with a facet and a risk (on four parts) on one side.
Tablets of 20 mg: round flat-cylindrical tablets of white color with a bevel.

Pharmacotherapeutic group:Drugs acting on the renin-angiotensin system. Inhibitors of angiotepin-converting enzyme (ACE).

ATX: & nbsp

C.09.A.A.03 Lisinopril

C.09.A.A ACE Inhibitors

Pharmacodynamics:The angiotensin-converting enzyme (ACE) inhibitor reduces the formation of angiotensin II from angiotensin I. Reducing angiotensin II leads to a direct reduction in the release of aldosterone. Lisinopril reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces the overall peripheral resistance of blood vessels, blood pressure (BP), preload, pressure in the pulmonary capillaries,causes an increase in the minute volume of blood and an increase in myocardial tolerance to loads in patients with chronic heart failure. Lisinopril expands arteries more than veins. Some effects are explained by the effect on tissue renin-angiotensin systems. With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease. The drug improves the blood supply of the ischemic myocardium.
ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure. The antihypertensive effect begins in about 6 hours and persists for 24 hours. The duration of the effect also depends on the size of the dose. The beginning of the action is after 1 hour. The maximum effect is determined in 6-7 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, stable action develops after 1-2 months.
With a sharp withdrawal of the drug, there is no pronounced increase in blood pressure.
In addition to reducing blood pressure, lisinopril reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.
Lizinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not increase the incidence of hypoglycemia.

Pharmacokinetics:Suction.
After taking lisinopril orally, it is absorbed slowly and partially into the gastrointestinal tract. On average, 30% of the drug taken is absorbed, but, depending on the individual characteristics of the patient, this value can vary from 6 to 60%. Bioavailability of the drug - 25%.
Distribution.
Almost does not bind to blood plasma proteins. The maximum concentration in blood plasma (90 ng / ml) is achieved after 7 hours. Permeability through the blood-brain and placental barrier is low.
Metabolism.
Lizinopril is not biotransformed in the body.
Excretion.
It is excreted by the kidneys unchanged. The half-life is 12 hours.
Pharmacokinetics in selected patient groups
In patients with chronic heart failure, the absorption and clearance of lisinopril are reduced.
In patients with renal failure, the concentration of lisinopril is several times higher than the plasma concentration in volunteers,with an increase in the time to reach the maximum concentration in the blood plasma and an increase in the half-life.
In elderly patients, the concentration of the drug in the blood plasma and the area under the concentration-time curve is 2 times greater than in young patients.

Indications:- Arterial hypertension (in monotherapy or in combination with other antihypertensive agents);
- Chronic heart failure (as part of combination therapy);
- Early treatment of acute myocardial infarction (within the first 24 hours with stable hemodynamic parameters to maintain these parameters and prevention of left ventricular dysfunction and heart failure);
- Diabetic nephropathy (insulin-dependent reduction of albuminuria in patients with normal blood pressure and insulin dependent patients with hypertension).

Contraindications:Hypersensitivity to lisinopril or other ACE inhibitors, angioedema in the anamnesis, including the use of ACE inhibitors, hereditary edema of Quincke, age under 18 years (efficacy and safety not established).

Carefully:Severe renal dysfunction, bilateral renal artery stenosis or arterial stenosis of a single kidney with progressive azotemia, condition after kidney transplantation, renal failure, azotemia, hyperkalemia, aortic aortic stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, arterial hypotension, cerebrovascular diseases (v. h. cerebral circulatory insufficiency), coronary heart disease, coronary insufficiency, autoimmune systemic connective diseases (including scleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; diet with sodium restriction; hypovolemic conditions (including as a result of diarrhea, vomiting); elderly age.

Pregnancy and lactation:The use of the drug LIZINOPRIL GRINDEX 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 use LIZINOPRIL GRINDEX should apply reliable methods of contraception.
When establishing a pregnancy, the drug should be stopped as soon as possible.
LIZINOPRIL GRINDEX crosses the placenta.
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, renal pathology (including acute kidney failure), hypoplasia of the skull bones, limb contractures, craniofacial deformities, lung hypoplasia, intrauterine retention development, an open arterial duct, as well as cases of intrauterine fetal death and death of a newborn. 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 appears, blood pressure (BP) and renal perfusion should be maintained.
There is no data on the penetration of the drug LIZINOPRIL GRINDEX into breast milk.If you need to use the drug LIZINOPRIL GREENDEX during lactation, breastfeeding should be discontinued.

Dosing and Administration:Inside. 1 time per day in the morning, regardless of the time of ingestion, preferably at the same time.
Arterial hypertension (in monotherapy or in combination with other antihypertensive drugs): in patients with arterial hypertension, patients who do not receive other antihypertensive drugs are prescribed 5 mg (1/2 tablets 10 mg) once a day. In the absence of a therapeutic effect, the dose is increased every 2-3 days by 5 mg (1/2 tablet of 10 mg) to an average therapeutic dose of 20 mg / day. The usual maintenance daily dose is 20 mg. The maximum daily dose is 40 mg. To fully develop the effect may require 2-4 pedules, which should be taken into account when increasing the dose. If the use of the drug LIZINOPRIL GRINDEX at the maximum dose does not cause a sufficient therapeutic effect, then an additional prescription of another antihypertensive agent is possible.
Patients who received pre-diuretics, they must be canceled 2-3 days before the application of the drug LIZINOPRIL GRINDEX.If it is not possible to cancel diuretics, the initial dose of the drug LYZINOPRIL GRINDEX should not exceed 5 mg (1/2 tablets of 10 mg) per day, and kidney function and potassium ions in the blood serum should also be monitored. If necessary, in the future, you can resume taking diuretics.
In patients with reninvascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system (RAAS) (hypovolemia, diet with restriction of salt intake, cardiac decompensation or severe arterial hypotension), the initial dose of the drug LYZINOPRIL GRINDEX is 2.5-5 mg / day (1 / 4-1 / 2 tablets but 10 mg) (blood pressure, renal function, potassium ion content in blood serum is necessary). The maintenance dose is set depending on the dynamics of blood pressure.
Chronic heart failure (as part of a combination therapy for the treatment of patients taking cardiac glycosides and / or diuretics): an initial dose of 2.5 mg / day (1/4 tablets of 10 mg) with a gradual increase of 2.5 mg (1/4 tablets per 10 mg) in 3-5 days to 5-10 mg / day (1 / 2-1 tablet of 10 mg). The maximum daily dose is 20 mg. If possible, the dose of diuretic should be reduced before starting the drug LIZINOPRIL GRINDEX.
Early treatment of acute myocardial infarction (in the first 24 hours with stable parameters of hemodynamics to maintain the indicators and prevention of left ventricular dysfunction and heart failure): in the first 24 hours after the onset of the first symptoms of acute myocardial infarction with stable hemodynamic parameters (systolic blood pressure not lower than 100 mm Hg. ) - 5 mg (1/2 tablets of 10 mg), then 5 mg (1/2 tablet of 10 mg) every other day, 10 mg after two days and then 10 mg once a day.
At the beginning of treatment or within the first 3 days after acute myocardial infarction, a lower dose of 2.5 mg (1/4 tablet of 10 mg) is prescribed in patients with low systolic blood pressure (120 mm Hg or lower). In the case of a decrease in blood pressure (systolic blood pressure below or equal to 100 mm Hg), the daily dose of 5 mg (1/2 tablet of 10 mg), if necessary, temporarily reduced to 2.5 mg (1/4 tablets of 10 mg). In the case of a long pronounced decrease in blood pressure (systolic blood pressure below 90 mm Hg for more than 1 hour), treatment with DIZI110PRIL GRINDEX is stopped.
Diabetic Nephropathy (a decrease in albuminuria in patients with type 1 diabetes mellitus with normal BP and in patients with type 2 diabetes mellitus with hypertension): an initial dose of 10 mg / day.which if necessary increase to 20 mg / day to achieve the target values of diastolic blood pressure.
Chronic Renal Failure
The dose is determined in accordance with the clearance of creatinine (CC): with KK 30-70 ml / min - 5-10 mg / day (1 / 2-1 tablet 10 mg), with KK - 10-30 ml / min - 2, 5-5 mg / day (1 / 4-1 / 2 tablets of 10 mg), less than 10 ml / min. including patients on hemodialysis - 2.5 mg / day (1/4 tablets of 10 mg). The maintenance dose is determined depending on blood pressure (under the control of kidney function, the content of potassium ions and sodium in the blood). The maximum daily dose is -40 mg.

Side effects:The most common side effects: dizziness, headache, fatigue, diarrhea, dry cough, nausea, vomiting, orthostatic hypotension, skin rash, chest pain.
From the immune system: angioedema (facial, upper and lower extremities, lips, tongue, throat or epiglottis), a syndrome including an increase in erythrocyte sedimentation rate (ESR), arthralgia, the appearance of antinuclear antibodies.
From the cardiovascular system: a pronounced decrease in blood pressure, orthostatic hypotension, palpitation, tachycardia, myocardial infarction,cerebrovascular stroke in patients with an increased risk of the disease due to a marked decrease in blood pressure, impaired renal function.
From the central nervous system: increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, asthenic syndrome, mood lability, confusion, impotence.
On the part of the hematopoiesis system: possible leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with long-term treatment - a small decrease in hemoglobin, hematocrit, erythrocytopenia.
From the digestive tract: dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, genotocellular or cholestatic jaundice, hepatitis.
From the skin: urticaria, increased sweating, itching, alopecia.
From the urinary system: renal dysfunction, oliguria, anuria, acute renal failure, uremia, proteinuria.
Laboratory indicators: hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of "hepatic" transaminases, especially if there is a history of kidney disease, diabetes mellitus, and renovascular hypertension.
Other: myalgia, fever, impaired development of the fetus.

Overdose:Symptoms (occur when taking a single dose of 50 mg and above): a marked decrease in blood pressure; dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
Treatment: symptomatic therapy, intravenous fluid administration, control of blood pressure, water-electrolyte balance and normalization of the latter.

Lizinopril can be removed from the body by hemodialysis.

Interaction:Lisinopril reduces the excretion of potassium from the body when treated with diuretics.
Special care is required when using the drug simultaneously with:
- potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, potassium salt substitutes containing potassium (the risk of developing hyperkalemia increases, especially with impaired renal function), so they can be jointly administered only on the basis of an individual decision of the treating physician with regular monitoring of serum potassium and kidney function .
With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate) describes a symptom complex, which includes facial flushing, nausea, vomiting and lowering blood pressure.
Cautiously can be applied together:
- with diuretics: with additional administration of a diuretic to a patient receiving lisinopril, as a rule, there is an additive antihypertensive effect - the risk of a pronounced decrease in blood pressure;
- with other antihypertensive agents (additive effect);
- with non-steroidal anti-inflammatory drugs (indomethacin and others), estrogens, as well as adrenostimulators - a decrease in the antihypertensive effect of lisinopril;
- with lithium (liberation of lithium may decrease, therefore, the concentration of lithium in the blood serum should be monitored regularly);
- with antacids and colestyramine - reduce absorption in the gastrointestinal tract. Insulin and oral hypoglycemic drugs are a risk of developing hypoglycemia.
Ethanol enhances the effect of the drug.

Special instructions:Double blockade of RAAS with angiotensin receptor antagonists, ACE inhibitors, including LIZINOPRIL GRINDEX, is associated with an increased risk of arterial hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy with these drugs.It is necessary to carefully monitor blood pressure, kidney function and water-electrolyte balance in patients receiving lisinopril and other agents affecting the RAAS (also LIZINOPRIL GRINDEX).
The pronounced decrease in blood pressure on the background of treatment most often occurs with a decrease in the volume of circulating blood caused by diuretic therapy, restriction of consumption of table salt, dialysis, diarrhea, vomiting, or in patients with severe rsnin-dependent hypertension. This effect is not a contraindication for the further administration of the drug LIZINOPRIL GRINDEX.
In patients with chronic heart failure, severe arterial hypotension can lead to impaired renal function.
In some patients with chronic heart failure with normal or low blood pressure, LIZINOPRIL GRINDEX may cause an additional reduction in blood pressure. This effect is also not a contraindication for the continued use of the drug LIZINOPRIL GRINDEX.
In patients with bilateral renal artery stenosis or stenosis of the single kidney artery in treatment with AIF 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 inhibitors of AMP. These complications are especially characteristic of patients with impaired renal function. If the patient also has Renovascular hypertension, the risk of severe arterial hypotension and renal failure increases. In this category of patients, treatment should begin with smaller doses of the drug LIZINOPRIL GRIIDEX under medical supervision. Since the simultaneous use of diuretics is an additional risk factor for the development of arterial hypotension, they should be canceled and during the first week to monitor the function of the kidneys.
An increase in the concentration of urea nitrogen in the blood and serum creatinine was also noted in patients with hypertension without concomitant renal impairment, especially with simultaneous use of the drug LIZINOPRIL GRIIDEX and diuretics. These deviations were mild, and the rates returned to normal after the withdrawal of the drug LYZINOPRIL GRINDEX or diuretic.
In patients with acute myocardial infarction, drug therapy LIZINOPRIL GRIDEX ns should be started if there are signs of impaired renal function, such as an increase in plasma creatinine levels above 177 μmol / L and / or proteinuria above 500 mg / day. If the violation of kidney function develops on the background of taking the drug LIZINOPRIL GRIDEX (concentration of creatinine in the blood plasma is higher than 265 μmol / l or doubled with respect to the values before the start of therapy), the doctor should consider the possibility of its cancellation.
Treatment with the drug LIZINOPRIL GRINDEX in acute myocardial infarction is performed against the background of standard therapy (thrombolytics, acetylsalicylic acid (as an antiplatelet agent), beta-blockers). LYSINOPRIL GRINDEX can be used with a solution of nitroglycerin for intravenous administration or with nitroglycerin for administration by therapeutic transdermal systems.
It is not recommended to use the drug LIZINOPRIL GRINDEX in patients who underwent an acute myocardial infarction if the systolic blood pressure does not exceed 100 mm Hg. Art.
When using drugs that reduce blood pressure. in patients with extensive surgical intervention or during general anesthesia, LIZINOPRILGRINDEX may block the formation of angiotensin II, secondary to the compensatory release of renin. Before surgery (including dental surgery), stop taking the drug LYZINOPRIL GREENDEX for 24 hours and inform the surgeon / anesthesiologist about the use of an ACE inhibitor.
Based on the results of epidemiological studies, it is assumed that simultaneous administration of ACE inhibitors and insulin, as well as hypoglycemic drugs for oral administration may lead to the development of hypoglycemia. The greatest risk of development is observed during the first weeks of combination therapy, as well as in patients with impaired renal function. Patients with diabetes require careful monitoring of glycemia, especially during the first month of therapy with an ACE inhibitor.
Before beginning treatment, it is necessary to compensate for the loss of fluid and salts. Patients with risk factors for symptomatic arterial hypotension (patients who follow a diet with restricted consumption of table salt with or without hyponatremia, patients with psovoltmia or who receive diuretic therapy) should, if possible, adjust the condition data before starting treatment with the drug LIZINOPRIL GRINDEX.Risk factors for the development of hyperkalemia include chronic renal failure, diabetes mellitus, and simultaneous use of potassium-sparing diuretics (spironolactone, epsilenone, triamterene or amiloride), potassium or salt substitutes containing potassium ions, as well as the use of drugs that are associated with an increase in serum potassium (for example, heparin). It is recommended to periodically monitor the content of potassium ions in the blood plasma. An angioneurotic edema of the face, limbs, lips, tongue, mucous membranes, epiglottis and / or larynx was noted with the use of ACE inhibitors, including LYZINOPRIL GRINDEX. This side effect can occur at any stage of therapy. In such cases, it is necessary to urgently cancel the use of the drug and prescribe adequate therapy. The patient should be under the supervision of a physician until the symptoms of the edema are completely regressed. It should be borne in mind that even in cases where there is only swelling of the tongue, the patient should also be under the supervision of a doctor, since therapy with antihistamines and corticosteroids may not be sufficient.
Angioedema with involvement of the larynx can lead to death.
Patients who have previously undergone surgical intervention on the respiratory organs have a higher risk of developing angioedema of the larynx or tongue.
Patients who underwent angioedema, not associated with the administration of ACE inhibitors, are at greater risk of developing such a complication with the administration of ACE inhibitors.
In patients using ACE inhibitors when desensitizing to a gimenonter (wasps, bees), the appearance of a life threatening anaphylactic reaction is extremely possible. It is necessary to temporarily stop treatment with an ACE inhibitor before starting the course of desensitization.
Anaphylactic 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 with simultaneous hemodialysis using high-flow membranes (including AN69®). Therefore, similar combinations should be avoided, using either other antihypertensive drugs, or alternative membranes for hemodialysis.Dry cough that occurs with the use of ACE inhibitors is unproductive, persistent and occurs after discontinuation of treatment. In the differential diagnosis of cough, its possible association with ACE inhibitors should be considered.
The safety and effectiveness of the use of the drug LYZINOPRIL GRINDEX in children is not established.
Very rarely there were cases of the development of the syndrome, which began with the development of cholestatic jaundice, progressed to fulminant necrosis and in some cases resulted in death. The mechanism of development of this syndrome is not clear. The use of the drug LIZINOPRIL GRINDEX in patients with signs of jaundice development or a significant increase in the activity of "liver" enzymes should be discarded and appropriate monitoring of laboratory indicators and patient condition should be carried out.
There have been cases of development of neutropenia / agranulocytosis, thrombocytopenia and anemia with the administration of ACE inhibitors. Such cases are quite rare in patients with normal renal function.
Neutropenia and agranulocytosis disappear after the withdrawal of ACE inhibitors.LYSINOPRILE GRINDEX should be used with extreme caution in patients with systemic connective tissue diseases receiving immunosuppressive therapy, treatment with allopurinol or procainamide, or these risk factors are present simultaneously, especially in patients with impaired renal function. In these patients, in some cases, may develop infections that are resistant to antibiotics. In the case of the use of the drug LIZINOPRIL GRINDEX, in such patients, regular monitoring of blood leukocytes should be carried out.
If any symptoms of infection (eg, sore throat, fever) occur, the patient should immediately consult a doctor, as they may be a manifestation of neutropenia.

Effect on the ability to drive transp. cf. and fur:In connection with the danger of developing dizziness or weakness, LYZINOPRIL GREENDEX should be carefully administered to patients who administer transportation and engage in activities that require increased concentration of attention and rapid motor reaction.

Form release / dosage:Tablets 10 mg and 20 mg.

Packaging:For 14 tablets in a blister (PVC / foil).
2 blisters together with instructions for use in the pack.

Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life:5 years.
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008637/08

Date of registration:30.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:GRINDEX, JSC GRINDEX, JSC Latvia

Manufacturer: & nbsp

Grindeks, JSC Latvia

Information update date: & nbsp2016-11-20

Illustrated instructions

Instructions

Lisinopril Grindeks (Lisinopril Grindex)