Active substanceLisinoprilLisinopril
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  • Dosage form: & nbsppills
    Composition:

    Tablets 2.5 mg: one tablet contains the active substance: lisinopril dihydrate in terms of lisinopril anhydrous 2.5 mg, as well as auxiliary substances: mannitol, calcium phosphate dihydrate, corn starch, corn pregelatinized starch, silicon dioxide colloid, magnesium stearate.

    Tablets 5 mg: one tablet contains the active substance: lisinopril dihydrate in terms of lysinopril anhydrous 5 mg, and also auxiliary substances: mannitol, calcium phosphate dihydrate, corn starch, corn pregelatinized starch, silicon dioxide colloid, magnesium stearate.

    Tablets 10 mg: one tablet contains the active substance: lisinopril dihydrate in terms of lisinopril anhydrous 10 mg, as well as auxiliaries: mannitol, calcium phosphate dihydrate, corn starch, corn pregelatinized starch, iron oxide yellow oxide (E 172), silicon dioxide colloid, magnesium stearate.

    Tablets of 20 mg: one tablet contains the active substance: lisinopril dihydrate in terms of lisinopril anhydrous 20 mg, as well as auxiliaries: mannitol, calcium phosphate dihydrate, corn starch, corn pregelatinized starch, iron oxide yellow oxide (E 172), iron oxide pigment red (E 172 ), silicon dioxide colloid, magnesium stearate.

    Description:

    Tablets 2.5 mg: round, biconvex tablets of white color, with a risk on one side, tablets 5 mg: round, flat-cylindrical tablets of white color with a risk on one side.

    Tablets 10 mg: round, flat-cylindrical pills of light yellow color with a risk on one side.

    Tablets of 20 mg: round, flat-faced peach-colored tablets with a risk on one side.

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

    C.09.A.A.03   Lisinopril

    C.09.A.A   ACE Inhibitors

    Pharmacodynamics:

    The ACE inhibitor reduces the formation of angiotensin II from angiotensin I. Reducing angiotensin II leads to a direct decrease in the release of aldosterone. Reduces the degradation of bradykinin and increases the synthesis of prostaglandins. Reduces the overall peripheral vascular resistance, arterial pressure (BP), preload, 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. 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.

    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 beginning of the action is after 1 h. The maximum effect is determined after 6-7 hours, the duration is 24 hours. With arterial hypertension, the effect is observed in the first days after the beginning of treatment, stable effect develops in 1-2 months. With a sharp withdrawal of the drug, no pronounced increase in blood pressure was observed. 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. Lisinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not increase the incidence of hypoglycemia.

    Pharmacokinetics:

    After taking the drug inside about 25% of lisiopril is absorbed from the gastrointestinal tract. Eating does not affect the absorption of the drug. Absorption is on average 30%, bioavailability is 29%. After oral administration, the maximum concentration of lysiopril in the blood plasma is reached after 6-8 hours.

    Poorly binds to blood plasma proteins.

    Metabolism. Lisinopril not biotransformed in the body.

    Half-life is 12 hours.

    Lizinopril weakly penetrates the blood-brain barrier.

    Indications:

    - Hypertension (in monotherapy or in combination with other anti hypertensive agents).

    - Chronic heart failure (in a combination therapy for the treatment of patients taking digitalis and / or diuretics).

    - Early treatment of acute myocardial infarction in combination therapy (in the first 24 hours with stable hemodynamics to maintain these figures 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 lizinoprilu or other ACE inhibitors, angioneurotic edema history, including the use of ACE inhibitors, hereditary angioedema or idiopathic edema, age 18 years (effectiveness and safety installed)pregnancy, lactation.
    Carefully:Aortic stenosis, cerebrovascular diseases (including cerebral circulatory insufficiency), coronary heart disease, coronary insufficiency, severe autoimmune systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma), oppression of bone marrow hematopoiesis, diabetes mellitus, hyperkalemia , bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, condition after kidney transplantation, renal failure, azotemia, primary aldosteronism, hypertrophic constructively cardiomyopathy, hypotension, salt diet restriction state, accompanied by a decrease in blood volume (including diarrhea, vomiting), advanced age.
    Pregnancy and lactation:

    The use of lisinopril during pregnancy is contraindicated. When establishing pregnancy, treatment should be stopped as soon as possible.

    The intake of ACE inhibitors by pregnant women in the second and third trimesters can cause fetal and newborn death. For newborns and infants who have undergone intrauterine exposure to ACE inhibitors,it is recommended to carefully monitor for the timely detection of a marked decrease in blood pressure, oliguria, gyerculomyemia. In newborns, hypoplasia of the skull bones, oligohydramnion, deformation of the bones of the skull and face, hypoplasia of the lungs, development of fetus nights can develop.

    Lizinopril penetrates the placenta. There is no data on the penetration of lisinopril into breast milk. For the period of treatment the drug should be abolished breastfeeding.

    Dosing and Administration:

    Inside.

    The drug should be taken 1 time a day in the morning, before or after eating, preferably at the same time.

    In the case of essential hypertension, the preparation IRUMED® is administered at an initial dose of 10 mg per day. The maintenance dose is 20 mg per day. The maximum daily dose is 40 mg.

    To fully develop the effect may require a 2-4-week course of treatment with the drug (this should be taken into account when increasing the dose). If the use of the drug at the maximum dose does not cause a sufficient therapeutic effect, then an additional prescription of another anti-hypertensive agent is possible.

    Patients who received pre-diuretics, they must be canceled 2-3 days before the start of the drug.If it is not possible to cancel diuretics, the initial dose of lisinopril should not exceed 5 mg per day.

    In the case of renovascular hypertension or other conditions with an increased function of the renin-angiotensin-aldosterone system, the preparation IRUMED® is administered at an initial dose of 2.5 to 5 mg per day under the control of arterial pressure, renal function, potassium concentration in the blood serum.

    The maintenance dose is set depending on the blood pressure.

    In patients with renal insufficiency and patients on hemodialysis, the initial dose is set depending on the level of creatinine clearance (CK). The maintenance dose is determined depending on blood pressure (under the control of kidney function, the level of potassium and sodium in the blood).

    Creatinine clearance, ml / min

    Initial dose, mg / day

    30-70

    5-10

    10-30

    2,5-5

    Less than 10

    2,5

    With chronic heart failure it is possible to use lisinopril simultaneously with diuretics and / or cardiac glycosides. If possible, the dose of diuretic should be reduced before the start of lisinopril. The initial dose is 2.5 mg once a day, then gradually (2.5 mg after 3-5 days) is increased to 5-10 mg per day. The maximum daily dose is 20 mg.

    Acute myocardial infarction (as part of combination therapy in the first 24 hours with stable hemodynamic parameters)

    In the first 24 hours - 5 mg orally, then 5 mg every other day, 10 mg after two days and then 10 mg once a day. In patients with acute myocardial infarction, the drug should be applied for at least 6 weeks.

    At the beginning of treatment or within the first 3 days after an acute myocardial infarction in patients with low systolic BP (120 mm Hg or lower), a smaller dose of 2.5 mg should be given. 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 can, if necessary, temporarily reduce to 2.5 mg. In the case of a long pronounced decrease in blood pressure (systolic blood pressure below 90 mm Hg for more than 1 hour), the drug should be discontinued.

    Diabetic Nephropathy

    In patients with non-insulin-dependent diabetes mellitus, 10 mg of lisinopril is administered once a day. The dose may, if necessary, be increased to 20 mg once a day in order to achieve diastolic blood pressure values ​​below 75 mmHg. in the sitting position. In patients with insulin-dependent diabetes mellitus, the dosage is the same for the purpose of achieving diastolic blood pressure values ​​below 90 mm Hg. in the sitting position.

    Side effects:

    The most common side effects: dizziness, headache, fatigue, diarrhea, dry cough, nausea.

    From the cardiovascular system: marked decrease in blood pressure, chest pain, rarely - orthostatic hypotension, tachycardia, bradycardia, worsening of symptoms of heart failure, violation of atrioventricular conduction, myocardial infarction, heart palpitations.

    From the central nervous system: lability of mood, confusion, paresthesia, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely - asthenic syndrome.

    On the part of the hematopoiesis system: leukopenia, neutropenia, agranulocytosis, thrombocytopenia, anemia (decrease in the concentration of hemoglobin, hematocrit, erythrocytopenia).

    Laboratory indicators: hyperkalemia, hyponatremia, rarely - increased activity of "hepatic" enzymes, hyperbilirubinemia, increased levels of urea and creatinine.

    From the respiratory system: dyspnea, bronchospasm.

    From the digestive tract: dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.

    From the skin: urticaria, increased sweating, pruritus, alopecia, photosensitivity.

    From the genitourinary system: impaired renal function, oliguria, anuria, acute renal failure, uremia, proteinuria, decreased potency.

    Allergic reactions: angioedema, facial edema, extremities, lips, tongue, epiglottis and / or larynx, skin rashes, itching, fever, positive test results for antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), eosinophilia, leukocytosis. In very rare cases - interstitial angioedema.

    Other: myalgia, arthralgia / arthritis, vasculitis.

    Overdose:

    Symptoms: marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.

    Treatment: symptomatic therapy, intravenous injection of 0.9% sodium chloride solution and, if possible, the use of vasopressors, blood pressure control, water-electrolyte balance. It is possible to use hemodialysis (see SPECIAL INSTRUCTIONS - Patients on hemodialysis).

    Interaction:

    When used simultaneously with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium preparations, salt substitutes, containing potassium-a risk of hyperkalemia is increased, especially in patients with impaired renal function. At simultaneous application with diuretics - the expressed depression of a BP.

    With simultaneous use with other antihypertensive drugs - additive effect.

    When used simultaneously with non-steroidal anti-inflammatory drugs (indomethacin and others), estrogens, as well as address-stimulants - a decrease in the hypotensive effect of lisinopril.

    With simultaneous application with lithium - slowing the excretion of lithium from the body, with antacids and colestyramine - reduce absorption in the gastrointestinal tract.

    Alcohol enhances the effect of the drug.

    Special instructions:

    Symptomatic hypotension

    Most often, a marked decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, a decrease in salt in the diet, dialysis, diarrhea, or vomiting (see INTERACTION WITH OTHER MEDICINES AND ADVERSE EFFECTS). In patients with chronic heart failure with simultaneous renal failure or without it, the development of symptomatic arterial hypotension is possible.It was more often detected in patients with a severe stage of heart failure, as a result of the use of large doses of diuretic, hyponatremia or impaired renal function. In such patients, treatment should be started under the strict supervision of a doctor (with care to select the dose of the drug and diuretics). Similar rules should be adhered to when assigning patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.

    In the case of a pronounced decrease in blood pressure, the patient should be placed in a supine position and, if necessary, intravenously administered 0.9% sodium chloride solution. Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.

    With the use of the drug in some patients with chronic heart failure, a nose with normal or lowered blood pressure, there may be a decrease in blood pressure, which is usually not a reason for stopping treatment. In the event that arterial hypotension turns into symptomatic, it is necessary to reduce the dose of the drug or stop treatment with the drug.

    With acute myocardial infarction

    The use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers).

    IRUMED® can be used in conjunction with intravenous nitroglycerin or with the use of transdermal nitroglycerin systems.

    Treatment with lisinopril should not begin in patients with acute myocardial infarction who have a risk of further serious hemodynamic deterioration after using vasodilators. These are patients with a systolic blood pressure of 100 mm Hg. or lower or with cardiogenic shock. During the first 3 days after a heart attack, the dose should be reduced if systolic blood pressure is 120 mm Hg. or lower. Maintenance doses should be reduced to 5 mg or temporarily to 2.5 mg if systolic blood pressure is 100 mm Hg or lower. If arterial hypotension persists (systolic blood pressure less than 90 mm Hg for more than 1 hour), then the preparation IRUMED® should not be used.

    Impaired renal function

    In patients with chronic heart failure, a marked decrease in blood pressure after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. Cases of acute renal failure are noted.

    In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single night receiving ACE inhibitors, there was an increase in urea and serum creatinine, usually reversible after discontinuation of treatment. It was more common in patients with renal insufficiency.

    Lizinopril is not used for acute infarction in patients with severe renal dysfunction, which is determined by a change in the serum creatinine concentration exceeding 177 mmol / l and / or proteinuria exceeding 500 mg / day. If renal dysfunction develops during the use of the drug (serum creatinine concentration greater than 265 mmol / L or doubling the value with pre-treatment values), the physician should assess the need for further use of the IRUMED® preparation.

    Hypersensitivity / Angioedema

    The angioedema of the face, limbs, lips, tongue, epiglottis and / or larynx that may occur during any treatment period was rarely seen in patients treated with an ACE inhibitor, including lisinopril. In this case, treatment with the drug should be stopped as soon as possible and for the patient to establish an observation until the symptoms regress completely.In cases where edema occurs only on the face and lips, the condition often passes without treatment, but it is possible to prescribe antihistamines. Angioedema with edema of the larynx can be fatal. Swelling of the tongue, epiglottis or larynx can be the cause of airway obstruction, therefore it is necessary to immediately carry out appropriate therapy (0.3-0.5 ml of 1: 1000 epinephrine (adrenaline) solution subcutaneously) and / or measures to ensure airway patency. It was noted that in patients of the Negroid race, taking ACE inhibitors, angioedema developed more often than in patients of other races.

    Patients who have had an angioneurotic edema that is not associated with previous treatment with ACE inhibitors may be at increased risk of developing it during treatment with an ACE inhibitor (see also CONTRAINDICATIONS).

    Anaphylactoid reactions during desensitization to the hymenoptera In patients taking ACE inhibitors during desensitization to the hymenoptera, it may very seldom appear a life-threatening anaphylactoid reaction. This can be avoided by temporarily discontinuing treatment with an ACE inhibitor before each desensitization.

    Patients on hemodialysis

    Anaphylactoid reactions are also observed in patients undergoing hemodialysis with a membrane of high permeability (NA 69), which simultaneously take ACE inhibitors. In such cases, one should consider the possibility of using another type of membrane for dialysis or another antihypertensive agent.

    Cough

    When an ACE inhibitor was used, a cough was noted. Cough is dry, prolonged, which disappears after discontinuing treatment with an ACE inhibitor. With a differential diagnosis of cough, one should also consider a cough caused by the use of an ACE inhibitor.

    Surgery / General Anesthesia

    When using agents that reduce blood pressure in patients with extensive surgery or during general anesthesia lisinopril can block the formation of angiotensin II, secondary to the compensatory release of renin.

    The pronounced decrease in blood pressure, which is considered a consequence of this mechanism, can be eliminated by increasing the volume of circulating blood.

    Before surgery (including dental surgery), the surgeon / anesthesiologist should be informed of the use of an ACE inhibitor.

    Serum potassium

    In some cases, hyperkalemia was noted.

    Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, and simultaneous use of potassium-sparing diuretics (spironolactone, triamterene or amiloride), potassium or salt substitutes containing potassium, especially in patients with impaired renal function.

    If simultaneous use of lisinopril and the above mentioned drugs is considered necessary, they should be used with caution, regularly monitoring potassium in the serum.

    In patients who have a risk of symptomatic hypotension (on a low-salt or salt-free diet) with or without hyponatremia, as well as in patients who received high doses of diuretics, the above conditions must be compensated before the start of treatment (loss of fluid and salts).

    It is necessary to control the effect of the initial dose of the preparation IRUMED® on the value of blood pressure.

    Effect on the ability to drive transp. cf. and fur:There is no evidence of the effect of the IRUMED ® drug, applied in therapeutic doses, on the ability to drive vehicles and mechanisms,However, it must be taken into account that there may be dizziness, so care must be taken when driving vehicles.
    Form release / dosage:Tablets 2.5 mg, 5 mg, 10 mg, 20 mg.
    Packaging:For 30 tablets in PVC / PVDC-Al blister. 1 blister is placed together with instructions for use in a cardboard box.
    Storage conditions:

    List B.

    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.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-005760/08
    Date of registration:22.07.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia
    Manufacturer: & nbsp
    Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia
    Information update date: & nbsp28.11.2017
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