Lizinopril-Krka - instructions for use, dose, side effects, contraindications

1 tablet:	5 mg	10 mg	20 mg
Active substance:
Lysinopril dihydrate	5.44 mg	10.89 mg	21.78 mg
(which is equivalent to lisinopril	5.00 mg	10.00 mg	20.00 mg)
Excipients:
Mannitol	42.00 mg	28.00 mg	56.00 mg
Calcium hydrogen phosphate dihydrate	142.19 mg	87.43 mg	174.26 mg
Corn starch
pregelatinized	10.50 mg	5.70 mg	10.60 mg
Croscarmellose sodium	8.40 mg	5.60 mg	11.20 mg
* Dye 1	-	1.40 mg	-
** Coloring agent 2	-	-	4.20 mg
Magnesium stearate	1.47 mg	0.98 mg	1.96 mg

* Dye 1: Corn starch pregelatinized starch 1,258 mg, Iron oxide red oxide (E 172) 0.140 mg, Iron oxide black oxide (E 172) 0.00182 mg, Iron oxide oxide yellow (E 172) 0.00014 mg
** Dye 2: Pregelatinized corn starch 3,435 mg, Iron oxide red oxide (E 172) 0.756 mg, Ferric iron oxide black (E 172) 0.0084 mg Iron oxide oxide yellow (E 172) 0.00042 mg

Description:Tablets 5 mg:
Round flat tablets of white color with a facet and a risk on both sides.
Tablets 10 mg:
Round biconvex tablets are light pink, the color is heterogeneous, with impregnations of a lighter and darker color, with a risk on one side.
Tablets of 20 mg:
Round biconvex tablets are pink, the color is heterogeneous, with impregnations of a lighter and darker color, with a risk on one side.

Pharmacotherapeutic group:Angiotensin-converting enzyme inhibitor.

ATX: & nbsp

C.09.A.A.03 Lisinopril

C.09.A.A ACE Inhibitors

Pharmacodynamics:Lizinopril-KRKA is an inhibitor of peptidyl dipeptidase. It blocks the angiotensin-converting enzyme (ACE), which catalyzes the conversion of angiotensin I into a vasoconstrictor enzyme, angiotensin II. Angiotensin II stimulates the secretion of aldosterone in the adrenal cortex. Suppression of ACE leads to a decrease in angiotensin II concentration, a decrease in vasoconstrictor activity and a decrease in aldosterone secretion. The latter can lead to an increase in the potassium content in the blood plasma.
Despite the fact that the main mechanism by which lisinopril reduces arterial pressure is to suppress the activity of the renin-angiotensin-aldosterone system (RAAS), lisinopril is also effective in patients with low-grade hypertension. ACE is identical to kininase II, an enzyme that destroys bradykinin, resulting in increased bradykinin concentration in the blood plasma. Lisinopril reduces overall peripheral vascular resistance (OPSS), arterial pressure (BP), preload, pressure in pulmonary capillaries, causes an increase in the minute volume of blood and increased tolerance of the myocardium to loads in patients with chronic cardiacinsufficiency (CHF). With prolonged use, myocardial hypertrophy and the walls of arteries of resistive type decrease. Improves the blood supply of the ischemic myocardium. Like other ACE inhibitors, prolongs the life expectancy of patients with CHF, slows the progression of left ventricular dysfunction in patients who underwent myocardial infarction without clinical manifestations of heart failure.
The antihypertensive effect begins in about 1 hour. The maximum effect is determined after 6-7 hours and persists for 24 hours. With arterial hypertension, a stable effect develops after 1-2 months. With a sharp cancellation, there is no pronounced increase in blood pressure.
Reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.

Pharmacokinetics:Suction
After taking the drug, about 25% of lisinopril is absorbed from the gastrointestinal tract. Eating does not affect the absorption of the drug. Absorption is on average 30%, bioavailability is 29%.
Distribution
Almost does not bind to blood plasma proteins. The maximum concentration (C_max) 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. Half-life (T_1/2) is 12 hours.
Pharmacokinetics in selected patient groups
In patients with chronic heart failure, absorption and clearance are reduced, bioavailability is 16%. In patients with renal failure (creatinine clearance less than 30 ml / min), the concentration of lisinopril is several times higher than the plasma concentration in healthy volunteers, with an increase in the time to reach the maximum concentration (TC_max) in blood plasma and an increase T_1/2 - In elderly patients, the concentration of lisinopril in the blood plasma is increased by an average of 60% and the area under the concentration-time curve is 2 times greater than in young patients. In patients with liver cirrhosis, the bioavailability of lisinopril is reduced by 30%, and the clearance is reduced by 50% compared to patients with normal liver function.

Indications:- Arterial hypertension (monotherapy or in combination with other antihypertensive drugs);
- Chronic heart failure (as part of combination therapy for the treatment of patients taking cardiac glycosides and / or diuretics);
- 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 (to reduce albuminuria in patients with type 1 diabetes mellitus with normal BP and patients with type 2 diabetes with arterial hypertension).

Contraindications:Hypersensitivity to lizinoprilu, other ingredients or other ACE inhibitors, angioneurotic edema history, including by use of ACE inhibitors, hereditary angioedema and idiopathic angioneurotic edema, age 18 years (efficacy and safety have not been established), pregnancy, breastfeeding (in Russia, the use of lisinopril is unresolved, regardless of trimesters).

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

Pregnancy and lactation:The use of lisinopril-CRKA during pregnancy is not allowed. Lisinopril penetrates the placental barrier. When establishing a pregnancy, the drug should be stopped as soon as possible. ACE inhibitors in the II and III trimester of pregnancy has adverse effects on the fetus (expressed may decrease blood pressure, renal failure, hyperkalemia, skull hypoplasia, intrauterine death). Data on the negative effects of the drug on the fetus, if applied during the first trimester, are not present.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.
There is no data on the penetration of lisinopril into breast milk. If you need to use the drug Lizinopril-KRKA during lactation breastfeeding should be discontinued.

Dosing and Administration:Inside, 1 time per day, preferably at the same time, regardless of food intake.
The dose is set individually.
Arterial hypertension
With arterial hypertension, patients who do not receive other antihypertensives are prescribed 5 mg once a day. In the absence of effect, the dose is increased every 2-3 days 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 daily maintenance dose of 20 mg.
The maximum daily dose is 40 mg. If the patient received a preliminary treatment with diuretics, the use of such drugs should be stopped 2-3 days before the Lizinopril-CRKA.If this is not feasible, the initial dose of lisinopril-CRKA should not exceed 5 mg per day. In this case, after taking the first dose, medical supervision is recommended for several hours (maximum effect is achieved after about 6 hours), since there may be a pronounced decrease in blood pressure.
Renovascular hypertension or other conditions with increased function of RAAS: The initial dose is 2.5-5 mg per day, under medical supervision (blood pressure control, kidney function, potassium concentration in blood serum).
The maintenance dose, continuing strict medical control, should be determined depending on the dynamics of blood pressure.
Patients taking diuretics
Therapy begins with caution, since such patients may have a deficiency of electrolytes and / or hypovolemia.
Against the background of the use of the drug Lizinopril-KRKA, control of the kidney and potassium function of blood serum is necessary. The use of a diuretic should be discontinued 2 - 3 days before the start of treatment with Lysinopril-Krka.
Patients with hypertension who can not be canceled diuretic, the dose of the drug Lizinopril-Krka should not exceed 5 mg per day.After taking the drug, within a few hours, you need medical control because of the possible development of symptomatic arterial hypotension. In the future, the dose of lisinopril-CRKA is determined depending on the indices of blood pressure. If necessary, you can resume the use of a diuretic.
Chronic heart failure
In patients with heart failure, lisinopril-CRKA should be used as an adjunct to therapy with diuretics and / or cardiac glycosides, beta-blockers.
The initial dose is 2.5 mg (1/2 tablet 5 mg) once a day, under / control of blood pressure. Then the dose can be gradually increased, depending on the effectiveness of therapy to the usual maintenance dose of 5-20 mg per day.
The maximum daily dose of 20 mg.
The dose of Lysinopril-Krka should be increased at intervals of 2-4 weeks.
Against therapy, regular monitoring of blood pressure, kidney function, sodium and potassium content in blood serum is necessary.
Early treatment of acute myocardial infarction
The drug Lizinopril-KrKA is used as part of a combination therapy.
Therapy with lisinopril-CRKA can be started for the first time 24 hours after the onset of symptoms of myocardial infarction. Treatment can be initiated at a systolic blood pressure level of at least 100 mm Hg. Art.
In the first 24 hours - 5 mg, then 5 mg after 1 day, 10 mg after two days and then 10 mg once a day. Patients with low systolic pressure (120 mm Hg or less) at the beginning of treatment or for the first time 3 days after acute myocardial infarction should receive a dose of 2.5 mg (1/2 tablet 5 mg).
With the development of arterial hypotension (systolic blood pressure 100 mm Hg or lower), the maintenance dose is reduced to 5 mg per day, which can be reduced to 2.5 mg if necessary. With prolonged persistent arterial hypotension (systolic blood pressure below 90 mm Hg for more than 1 hour), the use of lisinopril-Krka should be discontinued.
The course of treatment is at least 6 weeks.
With the development of signs of heart failure, it is necessary to continue the use of the drug Lizinopril-KRKA.
Diabetic Nephropathy
In patients with type 2 diabetes mellitus, the drug Lizinopril-KRKA is administered at a dose of 10 mg.
1 time per day. The dose may, if necessary, be increased to 20 mg once daily to achieve diastolic blood pressure values below 75 mm Hg. Art. in the "sitting" position. In patients with type 1 diabetes, the dosage is the same, in order to achieve diastolic blood pressure values below 90 mm Hg. Art. in the "sitting" position.
Impaired renal function
Due to the fact that lisinopril the initial dose should be determined depending on the creatinine clearance, then, in accordance with the response to treatment, a maintenance dose should be established in conditions of frequent monitoring of kidney function, potassium content, sodium in the blood serum.

Creatinine clearance (ml / min)	Initial dose (mg / day)
Less than 10 ml / min (including the need for dialysis)	2.5 mg *
10-30 ml / min	2.5-5 mg
31-80 ml / min	5-10 mg

* The dose and / or frequency of application are set depending on changes in blood pressure indicators.
The dose of the drug can be increased to a maximum dose of 40 mg per day.
In elderly patients, dosage adjustment is not required.

Side effects:Classification of the incidence of adverse events (WHO):
very often> 1/10
often from> 1/100 to <1/10
infrequently from> 1/1000 to <1/100
rarely from> 1 / 10,000 to <1/1000
very rarely from <1/10000, including individual messages.
In each group, unwanted effects are presented in order of decreasing severity.
From the nervous system:
very often: headache, dizziness, increased fatigue; infrequently: vertigo, taste disorder, sleep disorders, depression; rarely: increased drowsiness, muscular fasciculation of the extremities and lips, asthenia,emotional lability, confusion, weakness;
very rarely: paresthesia, impaired sense of smell, fainting, stroke;
From the cardiovascular system: infrequently: orthostatic decrease in blood pressure; rarely: arrhythmias, aggravation of symptoms of chronic heart failure, violation of AV conduction, palpitation, tachycardia, myocardial infarction;
From the respiratory system: often: a "dry" cough;
rarely: pain in the chest, bronchospasm, rhinitis, sinusitis, eosinophilic pneumonia, allergic alveolitis;
From the digestive system: often: diarrhea; infrequently: nausea; rarely: bowel dysfunction, mucosal gingivitis, dryness of the oral mucosa, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis, decreased appetite, vomiting; very rarely: intestinal edema of the intestine;
From the hematopoiesis:
rarely: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, erythropenia; reduction of hemoglobin and hematocrit, hemolytic anemia, lymphadenopathy;
From the skin:
rarely: urticaria, increased sweating, alopecia, erythema multiforme; skin itch, rash, photosensitivity, skin flushing **, angioedema, facial, extremities, lips, tongue, pharynx and / or larynx, psoriasis;
very rarely: pemphigus, toxic epidermal necrolysis, Stevens-Johnson syndrome;
From the genitourinary system:
rarely: renal dysfunction, frequent urination, oliguria, anuria, acute renal failure, uremia, proteinuria, decreased potency;
From the musculoskeletal system: rarely: arthralgia, myalgia;
very rarely: edema in the ankle;
Laboratory indicators:
rarely: hyperkalaemia, hypercreatininaemia, urea increase, hyponatremia, activity of "hepatic" enzymes, hyperbilirubinemia, increase in the titer of antinuclear antibodies, increased ESR;
Other:
rarely: fever *.
* There are reports of the development of lupus-like syndrome, which may include fever, vasculitis, myalgia, arthralgia / arthritis, positive antinuclear antibodies, increased ESR, eosinophilia, and leukocytosis.Rashes, photosensitivity reactions, or other skin manifestations may also develop.
** A symptom complex is described that includes flushing of the facial skin, nausea, vomiting and a decrease in blood pressure that occurs with simultaneous application of gold preparationssodium aurotomy malate) and ACE inhibitors.

Overdose:Symptoms: marked decrease in blood pressure, vascular collapse, water-electrolyte balance disorders, renal failure, hyperventilation of the lungs, tachycardia, palpitations, bradycardia, dizziness, dryness of the oral mucosa, delayed urination, drowsiness, anxiety, cough.
Treatment: if the drug Lisinopril-KRKA was adopted recently, it is necessary to take measures to remove it from the gastrointestinal tract (artificial vomiting, gastric lavage, the introduction of absorbents). 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 (Trendelenburg position). Further, make up the BCC by intravenous injection of 0.9% sodium chloride solution or other plasma-substituting solutions. If necessary, decide on the use of vasopressor drugs.It is also necessary to monitor the functions of the cardiovascular and respiratory systems, blood pressure, bcc, urea, creatinine, water-salt balance.
Hemodialysis is effective.
With bradycardia, resistant to ongoing therapy, it is recommended that an artificial pacemaker (pacemaker) be staged.

Interaction:Diuretics
With the combined use of lisinopril with diuretics, the hypotensive effect may increase.
The risk of developing arterial hypotension can be reduced by eliminating the diuretic before using lisinopril.
Potassium-sparing diuretics, potassium preparations or potassium-containing substitutes for table salt
Against the background of combined use with lisinopril may develop hyperkalemia. Risk factors for hypercapia are renal failure, diabetes mellitus, and simultaneous use of potassium-sparing diuretics (such as, spironolactone, triamterene, amiloride, eplerenone), Potassium-containing preparations or potassium salt substitutes, which can cause a significant increase in the potassium content in blood serum, especially in patients with impaired renal function.With the simultaneous use of lisinopril with diuretics that cause the excretion of potassium, hypokalemia due to a diuretic may increase.
Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, more than 300 mg per day
Prolonged intake of NSAIDs may reduce the antihypertensive effect of ACE inhibitors. NSAIDs and ACE inhibitors have unidirectional effects, increasing the potassium content in the serum, which can lead to impaired renal function. These effects are usually reversible. In rare cases, acute renal failure may develop, especially in patients with reduced renal function (elderly patients or patients with hypovolemia).
NSAIDs (including selective inhibitors of COX-2), estrogens, adrenomimetics reduce the antihypertensive effect of lisinopril.
Indomethacin can reduce the antihypertensive effect of lisinopril.
Possible simultaneous use of lisinopril with acetylsalicylic acid (as antiplatelet agents), thrombolytic agents, nitrates.
In some patients with impaired renal function taking non-steroidal anti-inflammatory drugs,simultaneous use of an ACE inhibitor can aggravate renal dysfunction. These effects are usually reversible.
Because the lisinopril can slow the excretion lithium, when used simultaneously with lithium preparations, it is necessary to monitor the concentration of lithium in the blood plasma.
When used simultaneously with antacids and colestyramine ACE inhibitors slow the absorption in the digestive tract.
When used simultaneously with vasodilators, barbiturates, phenothiazines, antidepressants, amidarone, quinidine, ethanol increases the antihypertensive effect of lisinopril.
The simultaneous use of lisinopril with beta-adrenoblockers, blockers of "slow" calcium channels, diuretics and other antihypertensive drugs increases the severity of the antihypertensive effect.
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.
With simultaneous use of ACE inhibitors with insulin and hypoglycemic agents for oral administration the risk of developing hypoglycemia increases.

Special instructions:The risk of arterial hypotension and / or renal insufficiency (in patients with CHF, a violation of the water-electrolyte balance, etc.)
With cirrhosis of the liver accompanied by edema and ascites, arterial hypotension, CHF, there may be a significant activation of RAAS, especially with pronounced hypovolemia and a decrease in the electrolyte content in the blood plasma (against a background of a salt-free diet or a long-term intake of diuretics).
The use of an ACE inhibitor causes blockade of the RAAS; in this connection, a sharp decrease in blood pressure and / or an increase in serum creatinine concentration, indicating the development of acute renal failure, is more likely to occur with the first dose of lisinopril-CRKA or within the first two weeks of therapy .
In patients with coronary heart disease, cerebrovascular insufficiency, treatment with the drug Lizinopril-KRKA should be started under the strict supervision of the doctor (with care to select the dose of the drug and diuretics), as a sharp decrease in blood pressure in them can lead to myocardial infarction or stroke. Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.Before the treatment with Lysinopril-KrKA, if possible, the sodium concentration should be normalized and / or the volume of the circulating fluid should be replenished, and the effect of the initial dose of lisinopril on the patient should be closely monitored.
Acute myocardial infarction
Therapy with lisinopril-KRKA should not be started in patients with acute myocardial infarction, who are at risk of developing hemodynamic disorders. Such patients include those with systolic blood pressure of 100 mm Hg. Art. or lower, or patients with cardiogenic shock. In acute myocardial infarction, the use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers). The first 3 days after myocardial infarction, a smaller dose should be used if the systolic pressure does not exceed 120 mm Hg. Art. At a systolic pressure of 100 mm Hg. Art. or lower the maintenance dose should be reduced to 5 mg or temporarily to 2.5 mg. With stable arterial hypotension (systolic blood pressure below 90 mm Hg for more than 1 hour), the drug lisinopril-CRKA should be discontinued.
Renal impairment
In patients with renal damage (CC less than 80 ml / min), the initial dose of the drug Lizinopril-KRKA should be changed in accordance with QC.Regular monitoring of potassium content and serum creatinine concentration is a mandatory tactic for treating such patients.
In patients with chronic heart failure, arterial hypotension at the beginning of treatment can lead to impaired renal function. In such patients, there were cases of acute renal failure, usually reversible.
In some patients with renal artery stenosis or renal artery stenosis of a single kidney taking ACE inhibitors, there was an increase in serum urea and creatinine concentrations, usually reversible after the withdrawal of therapy. These changes occur more often in patients with renal insufficiency. In patients with renovascular hypertension, there is an increased risk of severe arterial hypotension and renal failure. In such patients, therapy should begin under medical supervision, with small doses of the drug and with a gradual increase in doses.
Since the development of these conditions can cause and diuretics, during the first weeks of therapy with the drug Lizinopril-KRKA, the use of a diuretic should be canceled and the kidney function regularly monitored.
In some patients with hypertension without concomitant renal diseases, there was a small temporary increase in the concentration of urea and creatinine in the blood serum, especially with the use of the drug Lysinopril-Krka and diuretic. In this case, a dose reduction or elimination of lisinopril-CRKA and / or diuretic may be required.
In acute myocardial infarction, therapy with lisinopril-CRKA should not be initiated 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 / 24 hours. If the kidney function is disrupted by the use of the drug Lysinopril-Krka (creatinine concentration exceeds 265 μmol / L or doubles its value before treatment), it is necessary to solve the problem of cancellation of the drug LYZINOPRIL-CRC
Impaired liver function
ACE inhibitors can lead to the development of cholestatic jaundice with progression to fulminant liver necrosis, 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
Hemodialysis
Patients receiving ACE inhibitors during hemodialysis using vysokoprotochnyh membranes (e.g., AN69®) anafilaktodnye reactions were noted.Therefore, it is desirable to use a different type of membrane or to use an antihypertensive drug of another pharmacotherapeutic group.
Hyperkalemia
It can develop during treatment with ACE inhibitors, including lisinopril. Risk factors for hyperkalemia are renal failure, elderly age, diabetes mellitus, certain concomitant conditions (reduced BCC, acute heart failure, metabolic acidosis), simultaneous intake of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as preparations of potassium or potassium-containing substitutes for edible salt and the use of other drugs that increase the level of potassium 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.
Hypersensitivity / angioedema (angioedema)
When taking ACE inhibitors, including lisinopril, in rare cases development of angioedema, lip, tongue, tongue of the upper palate, and / or larynx can be observed.If these symptoms appear, the drug should be stopped immediately, the patient should be observed until the signs of edema 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 swelling of the tongue or larynx, can lead to airway obstruction and death.
When such symptoms occur, immediately enter subcutaneously epinephrine (adrenaline) (at 1: 1000 dilution (0.3 or 0.5 mL) and / or provide airway patency.
In patients who have an anamnesis. marked edema Quincke, not associated with. the use of ACE inhibitors may increase the risk of its development with the use of drugs of this 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 at a normal level of C-1-esterase.The diagnosis is established by means of computed tomography of the abdominal cavity, ultrasound examination or at the time of surgical intervention. Symptoms disappear after stopping the intake of ACE inhibitors. In patients with abdominal pain receiving ACE inhibitors, the differential diagnosis should take into account the possibility of developing angioedema of the intestine.
Anaphylactoid reactions during desensitization procedures
There are separate reports on the development of long-term, life-threatening anaphylactoid reactions in patients receiving ACE inhibitors during desensitizing therapy with the poison of Hymenoptera insects (bees, wasps). ACE inhibitors should be used with caution in patients prone to allergic reactions undergoing desensitization procedures. The appointment of an ACE inhibitor should be avoided for patients receiving immunotherapy with venom of Hymenoptera. Nevertheless, the development of anaphylactoid reactions can be avoided by the temporary withdrawal of the ACE inhibitor at least 24 hours before the desensitization procedure begins.
Anaphylactoid reactions during apheresis, low-density lipoprotein (LDL)
In rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions in LDL-apheresis using dextran sulfate. To prevent the anaphylactoid reaction, ACE inhibitor therapy should be discontinued before each procedure for LDL apheresis using high-flow membranes.
Cough
Against the background of therapy with an ACE inhibitor, a dry cough may occur, which disappears after the withdrawal of this group. When dry cough occurs, remember the possible association of this symptom with the administration of an ACE inhibitor. If the doctor believes that therapy with an ACE inhibitor is necessary for the patient, the drug lisinopril-CRKA may be continued.
Surgical procedures / General anesthesia
The use of ACE inhibitors in patients undergoing surgery with the use of general anesthesia can lead to a marked decrease in blood pressure, especially with the use of general anesthetics, which have an antihypertensive effect.
It is recommended to stop the use of ACE inhibitors, including lisinopril, 12 hours before surgery, warning the anesthetist about the use of ACE inhibitors.
Hypoglycemic agents
Based on the results of epidemiological studies, it is assumed that simultaneous administration of ACE inhibitors and insulin, as well as hypoglycemic agents 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 the glycemic profile, especially during the first month of therapy with an ACE inhibitor.
During the period of treatment it is not recommended to drink alcoholic beverages, since alcohol enhances the hypotensive effect of the drug.
Agranulocytosis
Because the potential risk of agranulocytosis can not be ruled out, periodic monitoring of the blood picture is required.
Use in children
Safety and efficacy in children (under 18 years of age) have not been established.
Elderly patients
Before starting Lizinopril-KRKA, the kidney function and the potassium content in the blood plasma should be evaluated. The initial dose of lisinopril-CRKA is selected depending on the degree of BP reduction, especially with a decrease in BCC and CHF (IV functional class according to the NYHA classification). Such measures allow to avoid a sharp decrease in blood pressure.

Effect on the ability to drive transp. cf. and fur:During the period of application of the drug Lizinopril-KRKA, care must be taken when driving vehicles and engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets 5 mg, 10 mg and 20 mg.

Packaging:For 10 tablets or 14 tablets in a blister of the combined material PVC / PVDH-aluminum foil.
For 2, 3, 6 blisters (blister for 10 tablets) or 1, 2, 4 blisters (blister for 14 tablets) are placed in a pack of cardboard along with instructions for use.

Storage conditions:At a temperature of no higher than 25 ° C, in the original packaging.
Keep out of the reach of children.

Shelf life:3 years.
Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000941

Date of registration:18.10.2011 / 11.09.2012

Expiration Date:18.10.2016

The owner of the registration certificate:KRKA-PHARMA, doo, Zagreb, CroatiaKRKA-PHARMA, doo, Zagreb, Croatia Croatia

Manufacturer: & nbsp

KRKA-FARMA, d.o.o. Croatia

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp2016-11-14

Illustrated instructions

Instructions

Lisinopril-Krka (Lisinopril-KRKA)