Universal reference book for medicines
Product name: LISTRIL® (LISTRIL®)

Active substance: lisinopril

Type: ACE inhibitor

Manufacturer: TORRENT PHARMACEUTICALS (India) promotion of the drug in the Russian Federation DR.
REDDY`S LABORATORIES (India)
Composition, form of production and packaging
Tablets are white, round, flat, with a notch on one side.
1 tab.
lisinopril (in the form of dihydrate) 5 mg
Excipients: mannitol, starch, sodium dihydrogen phosphate (anhydrous), magnesium stearate.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
Tablets of white color, round, flat, with the squeezed out inscription "10" on one side and crosswise notching - on the other.
1 tab.
lisinopril 10 mg
Excipients: mannitol, starch, sodium dihydrogen phosphate (anhydrous), talc, magnesium stearate.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
ACE inhibitor. Reduces the formation of angiotensin II from angiotensin I.
Reducing the content of angiotensin II leads to a decrease in the secretion of aldosterone. Reduces the degradation of bradykinin and induces the synthesis of prostaglandins. Reduces OPSS, AD, preload, pressure in the pulmonary capillaries, causes an increase in cardiac output and increased tolerance of the myocardium to loads in patients with 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 antihypertensive effect begins in about 6 hours and persists for 24 hours. The duration of the effect depends on the amount of the dose.
The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours, 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, there was no pronounced increase in blood pressure.
In addition to lowering blood pressure, Listril reduces albuminuria. In patients with hyperglycemia contributes to the normalization of the function of the damaged glomerular endothelium.
Listril 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 the drug, lisinopril is absorbed from the digestive tract. Eating does not affect the absorption of the drug. Absorption is on average 30%, bioavailability is 29%. T max in blood plasma is reached after approximately 7 hours, C max is 90 ng / ml.
Distribution
Almost does not bind to blood plasma proteins.
Permeability through the BBB and the placental barrier is low.
Metabolism
Lizinopril is not biotransformed in the liver.
Excretion
It is excreted unchanged in the urine.
T 1/2 is 12 hours.
INDICATIONS
- arterial hypertension (in the form of monotherapy or in combination with other antihypertensive agents);
- chronic heart failure (as part of combination therapy in patients taking digitalis preparations 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).
DOSING MODE
The drug should be taken orally.
With 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> 40 mg / day usually does not lead to a further decrease in blood pressure. The maintenance daily dose is 20 mg. The maximum daily dose is 40 mg.
The full effect usually develops in 2-4 weeks from the start of treatment, which should be taken into account when increasing the dose. With insufficient clinical effect, it is possible to combine the drug with other antihypertensive drugs.
If the patient received prior treatment with diuretics, the taking of such medications should be stopped 2-3 days before the application of Listril. If this is not feasible, the initial dose of Listril should not exceed 5 mg / day. In this case, after taking the first dose, medical supervision is recommended for several hours (maximum effect is achieved after about 6 hours), because a marked decrease in blood pressure may occur.
With renascapsular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 2.5-5 mg / day, under enhanced medical supervision (blood pressure control, kidney function, potassium concentration in the blood serum). The maintenance dose, continuing strict medical control, should be determined depending on the dynamics of blood pressure.
In renal failure because lisinopril is excreted through the kidneys, the initial dose should be determined depending on the CK. Then in according to the reaction, a maintenance dose should be established in conditions of frequent monitoring of kidney function, potassium level, sodium in the blood serum.
Table. Dependence of the initial dose on QC (including patients undergoing hemodialysis treatment).
Creatinine clearance (ml / min) Initial dose (mg / day)
30-70 5-10
10-30 2.5-5
<10 2.5
With persistent arterial hypertension , prolonged maintenance therapy of 10-15 mg / day is shown.
In chronic heart failure, lisinopril therapy starts with 2.5 mg 1 time / day, followed by a 2.5 mg dose increase 3-5 days before the usual maintenance dose of 5-20 mg. The maximum daily dose is 20 mg.
Acute myocardial infarction (as part of combination therapy)
The first day - 5 mg orally, then 5 mg every other day, 10 mg after two days and then 10 mg 1 time / 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, a lower dose of 2.5 mg should be given in patients with low systolic blood pressure (? 120 mm Hg).
With a decrease in blood pressure (systolic blood pressure? 100 mmHg), a daily dose of 5 mg can be temporarily reduced to 2.5 mg if necessary. With a long-term decrease in blood pressure (systolic BP <90 mm Hg> 1 h), Litril treatment should be discontinued.
Elderly patients often have a more pronounced prolonged hypotensive effect, which is associated with a decrease in the rate of excretion of lisinopril, so it is recommended to start treatment with a dose of 2.5 mg / day.
SIDE EFFECT
The most common side effects: dizziness, headache (5-6%), weakness, diarrhea, dry cough (3%), nausea, vomiting, orthostatic hypotension, skin rash, chest pain (1-3%).
Other side effects (frequency <1%):
From the cardiovascular system: a marked decrease in blood pressure, orthostatic hypotension, a violation of kidney function.
From the central nervous system and peripheral nervous system: increased fatigue, drowsiness, convulsive twitching of the muscles of the extremities and lips.
From the hemopoietic system: possibly - leukopenia, neutropenia, agranulocytosis, thrombocytopenia; with long-term treatment - a small decrease in the concentration of hemoglobin and hematocrit, erythrocytopenia.
Laboratory parameters: hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of hepatic enzymes, especially in the presence of a history of kidney disease, diabetes and renoscular hypertension.
Allergic reactions: 0.1% - angioedema (face, lips, tongue, larynx or epiglottis, upper and lower extremities).
Rarely occurring side effects (<1%):
From the side of the central nervous system: asthenic syndrome, lability of mood, confusion.
From the cardiovascular system: palpitations, tachycardia, myocardial infarction: cerebrovascular stroke in patients with an increased risk of the disease due to a pronounced decrease in blood pressure.
On the part of the digestive system: dry mouth, anorexia, dyspepsia, changes in taste, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.
From the urinary system: a violation of kidney function, oliguria, anuria, acute renal failure, uremia, proteinuria.
Dermatological reactions: urticaria, increased sweating, itching, alopecia.
Allergic reactions: a syndrome that includes the acceleration of ESR, arthralgia and the appearance of antinuclear antibodies.
Other: myalgia, fever, impaired development of the fetus, decreased potency.
CONTRAINDICATIONS
- angioedema in the anamnesis (including and due to the use of ACE inhibitors);
- hereditary edema of Quincke;
- children and adolescents under 18 years of age (efficacy and safety not established);
- hypersensitivity to lisinopril;
- Hypersensitivity to other ACE inhibitors.
With caution apply the drug with severe renal dysfunction, bilateral renal artery stenosis or arterial stenosis of a single kidney with progressive azotemia, a condition after kidney transplantation, renal insufficiency, azotemia, hyperkalaemia, aortic aortic stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, arterial hypotension, cerebrovascular diseases (including cerebral circulatory insufficiency), coronary heart disease, coronary insufficiency, autoimmune systemic diseases (including scleroderma, SLE), suppression of medullary hemopoiesis, with sodium diet restriction, hypovolemic states (including those resulting from diarrhea, vomiting), in elderly patients.
PREGNANCY AND LACTATION
The use of lisinopril during pregnancy is contraindicated.
When establishing a pregnancy, the drug should be stopped as soon as possible. Admission of ACE inhibitors in the II and III trimester of pregnancy has an adverse effect on the fetus: a marked decrease in blood pressure, renal failure, hyperkalemia, hypoplasia of the skull, intrauterine death. Data on the negative effects of the drug on the fetus when used during the first trimester of pregnancy there.
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.
Lizinopril penetrates the placenta. Data on the isolation of lisinopril with breast milk is absent. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution apply the drug in severe violations of kidney function, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney with progressive azotemia, a condition after kidney transplantation, and kidney failure.
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. In patients with chronic heart failure with / without renal failure, a marked decrease in blood pressure is possible.
Often, symptomatic arterial hypotension is detected in patients with a severe stage of chronic heart failure due to the use of large doses of diuretics, hyponatremia or impaired renal function. In such patients Listril 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 followed when prescribing the drug to patients with IHD, cerebrovascular insufficiency, since a sharp decrease in blood pressure can lead to myocardial infarction or stroke.
Transient hypotensive reaction is not a contraindication for taking the next dose of the drug.
When Listril is used in some patients with chronic heart failure, but with normal or low blood pressure, a decrease in blood pressure can occur, which is usually not a reason for stopping treatment.
Before the treatment of Listril, if possible, should normalize the concentration of sodium and / or replenish the lost volume of fluid, from the beginning of treatment should carefully monitor the effect of the prescribed dose of Listril on the patient.
In the case of renal artery stenosis (especially with bilateral stenosis, in the presence of stenosis of the artery of a single kidney), as well as inadequate circulation due to lack of sodium and / or liquid, the use of Listril can lead to impaired renal function, acute renal failure, which is usually irreversible after drug discontinuation.
Acute myocardial infarction
The use of standard therapy (thrombolytics, acetylsalicylic acid, beta-adrenoblockers) is shown. Listril can be used simultaneously with intravenous administration or application of therapeutic transdermal systems of nitroglycerin.
Surgery / general anesthesia
With extensive surgical interventions, as well as using other drugs that cause a decrease in blood pressure, lisinopril, blocking the formation of angiotensin II, can cause a pronounced unpredictable decrease in blood pressure.
Since the potential risk of agranulocytosis is not excluded, periodic monitoring of the blood picture is required.
When the drug is used in dialysis with a polyacrylonitrile membrane, anaphylactic shock may occur, so another type of membrane for dialysis or the appointment of other antihypertensive agents is recommended.
In elderly patients, the same dose as in young patients leads to a higher concentration of the drug in the blood, so special care is required in determining the dose, despite the absence of differences in the antihypertensive effect of Listril between the elderly and young people.
Impact on the ability to drive vehicles and manage mechanisms
Data on the effect of Listril, applied in therapeutic doses, on the ability to drive vehicles and mechanisms are not available, but it must be taken into account that there may be dizziness, so care should be taken.
OVERDOSE
Symptoms: occur when taking a single dose of 50 mg - a marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
Treatment: symptomatic therapy, intravenous fluids, blood pressure control, control and normalization of water-electrolyte balance. Listril can be removed from the body by hemodialysis.
DRUG INTERACTION
With simultaneous use of Listril with potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium, salt substitutes containing potassium, special caution is required, as the risk of hyperkalemia increases (especially with impaired renal function). Combined application of the above mentioned drugs is possible only on the basis of the individual decision of the attending physician with regular monitoring of potassium level in the blood serum and kidney function.
With the simultaneous use of Listril with diuretics and other antihypertensive agents, there may be an additive antihypertensive effect, which increases the risk of a marked decrease in blood pressure.
With the simultaneous use of Listril with NSAIDs (including indomethacin), estrogens, adrenostimulators, a decrease in the antihypertensive effect of lisinopril may be possible.
With the simultaneous use of Listril with lithium, the secretion of the latter may decrease, therefore, the concentration of lithium in serum should be monitored regularly.
With the simultaneous use of Listril with antacids and colestyramin, suction of lisinopril in the digestive tract decreases.
Ethanol enhances the action of Listril.
With the simultaneous use of Listril with diuretics, the excretion of potassium from the body decreases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children, protected from moisture at a temperature of no higher than 30 ° C. Shelf life - 3 years.
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