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Pharmacological action of the drug Lisinopril
ACE inhibitor, reduces the formation of angiotensin II from angiotensin I. A decrease in the content of 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 total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in the minute blood volume and an increase in myocardial tolerance to stress in patients with chronic heart failure. Expands arteries more than veins. Some of the effects are attributed to the effect on tissue renin-angiotensin systems. With prolonged use, the hypertrophy of the myocardium and the walls of the resistive arteries decreases. Improves blood supply to the ischemic myocardium.
ACE inhibitors prolong life expectancy in patients with chronic heart failure, slow down the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure. The antihypertensive effect begins after about 6 hours and lasts for 24 hours. The duration of the effect also depends on the dose. The onset of action is after 1 hour. The maximum effect is determined after 6-7 hours. With arterial hypertension, the effect is noted in the first days after the start of treatment, a stable effect develops after 1-2 months. With abrupt withdrawal of the drug, no pronounced increase in blood pressure was observed.
In addition to lowering blood pressure, lisinopril reduces albuminuria. In patients with hyperglycemia, it helps to normalize 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 lead to an increase in cases of hypoglycemia.
After oral administration, about 25% of lisinopril is absorbed from the gastrointestinal tract. Food intake does not affect the absorption of the drug. Absorption averages 30%, bioavailability - 29%.
Almost does not bind to blood plasma proteins. Cmax in blood plasma (90 ng / ml) is achieved after 7 hours. Permeability through the blood-brain and placental barriers is low.
Lisinopril is not biotransformed in the body.
It is excreted by the kidneys unchanged. T1/2 is 12 hours.
Pharmacokinetics in certain groups of patients
In patients with chronic heart failure, absorption and clearance of lisinopril are reduced.
In patients with renal insufficiency, the concentration of lisinopril is several times higher than the concentration in the blood plasma of volunteers, and there is an increase in the time to reach Cmax in blood plasma and an increase in T1/2.
In elderly patients, the concentration of the drug in the blood plasma and the area under the curve are 2 times greater than in young patients.
Indications of the drug Lisinopril
arterial hypertension (in monotherapy or in combination with other antihypertensive drugs);
chronic heart failure (as part of combination therapy for the treatment of patients taking digitalis drugs and / or diuretics);
early treatment of acute myocardial infarction (in the first 24 hours with stable hemodynamic parameters to maintain these parameters and prevent left ventricular dysfunction and heart failure);
diabetic nephropathy (decrease in albuminuria in insulin-dependent patients with normal blood pressure and non-insulin-dependent patients with arterial hypertension).
Dosing regimen of the drug Lisinopril
Inside, regardless of food intake. In case of arterial hypertension, patients who are not receiving other antihypertensive drugs are prescribed 5 mg once a day. In the absence of an 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 over 40 mg / day usually does not lead to a further decrease in blood pressure). The usual daily maintenance dose is 20 mg. The maximum daily dose is 40 mg.
The full effect usually develops within 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 has received prior treatment with diuretics, then taking such drugs should be discontinued 2-3 days before the start of Lisinopril use. If this is not feasible, then the initial dose of Lisinopril should not exceed 5 mg / day. In this case, after taking the first dose, medical supervision is recommended for several hours (the maximum effect is achieved after about 6 hours), since a pronounced decrease in blood pressure may occur.
In renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is advisable to prescribe a low initial dose of 2.5-5 mg / day, under enhanced medical supervision (control of blood pressure, kidney function, potassium concentration in serum). The maintenance dose, while continuing strict medical supervision, should be determined depending on the dynamics of blood pressure.
In renal failure, due to the fact that lisinopril is excreted through the kidneys, the initial dose should be determined depending on the creatinine clearance, then, in accordance with the reaction, a maintenance dose should be established under conditions of frequent monitoring of renal function, potassium and sodium levels in serum.
With persistent arterial hypertension , long-term maintenance therapy of 10-15 mg / day is indicated.
In chronic heart failure - start with 2.5 mg 1 time / day, followed by an increase in the dose by 2.5 mg after 3-5 days to the usual, maintenance daily dose of 5-20 mg. The dose should not exceed 20 mg / day.
In elderly people , a more pronounced long-term hypotensive effect is often observed, which is associated with a decrease in the rate of excretion of lisinopril (it is recommended to start treatment with 2.5 mg / day).
Acute myocardial infarction (as part of combination therapy)
On the first day - 5 mg orally, then 5 mg every other day, 10 mg every two days and then 10 mg 1 time / day. In patients with acute myocardial infarction, the drug should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after acute myocardial infarction in patients with low systolic blood pressure (120 mm Hg or lower), a lower dose should be prescribed - 2.5 mg. In the case of a decrease in blood pressure (systolic blood pressure is less than or equal to 100 mm Hg), the daily dose of 5 mg can, if necessary, be temporarily reduced to 2.5 mg. In the case of a prolonged pronounced decrease in blood pressure (systolic blood pressure below 90 mm Hg for more than 1 hour), treatment with Lisinopril should be discontinued.
In patients with non-insulin dependent diabetes mellitus, 10 mg of Lisinopril is used 1 time / day. The dose may, if necessary, be increased to 20 mg 1 time / day. in order to achieve values of diastolic blood pressure below 75 mm Hg. in a sitting position. In patients with insulin-dependent diabetes mellitus, the dosage is the same in order to achieve diastolic blood pressure values below 90 mm Hg. in a sitting position.
Contraindications to the use of a
history of angioedema, incl. and from the use of ACE inhibitors;
hereditary Quincke's edema;
age up to 18 years (efficacy and safety have not been established);
hypersensitivity to lisinopril or other ACE inhibitors.
The tablets contain lactose; therefore, the drug should not be taken by patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
With care: severe renal dysfunction, bilateral stenosis of the renal arteries or stenosis of an artery of a single kidney with progressive azotemia, condition after kidney transplantation, renal failure, azotemia, hyperkalemia, aortic stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronism, cerebrovascular disease, cerebrovascular accident including insufficiency of cerebral circulation), ischemic heart disease, coronary insufficiency, autoimmune systemic diseases of the connective tissue (including scleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; diet with limited sodium: hypovolemic conditions (including as a result of diarrhea, vomiting); elderly age.
Application during pregnancy and lactation
The use of lisinopril during pregnancy is contraindicated. When pregnancy is established, the drug should be discontinued as early as possible. Taking ACE inhibitors in the II and III trimester of pregnancy has an adverse effect on the fetus (a pronounced decrease in blood pressure, renal failure, hyperkalemia, cranial hypoplasia, intrauterine death are possible). There is no data on the negative effects of the drug on the fetus when used during the first trimester. For newborns and infants who have been exposed to intrauterine exposure to ACE inhibitors, it is recommended to closely monitor for the timely detection of a pronounced decrease in blood pressure, oliguria, hyperkalemia.
Lisinopril crosses the placenta. There is no data on the penetration of Lisinopril into breast milk. For the period of drug treatment, it is necessary to cancel breastfeeding.
The use in disorders of renal function
Precautions: severe renal impairment, bilateral renal artery stenosis or artery stenosis only kidneys with progressive azotemia, condition after kidney transplantation, renal insufficiency, azotemia, hyperkalemia.
Use in children
contraindication: age up to 18 years (efficacy and safety have not been established);
Most often, a pronounced decrease in blood pressure occurs with a decrease in fluid volume caused by diuretic therapy, a decrease in the amount of salt in food, dialysis, diarrhea or vomiting. In patients with chronic heart failure with or without concurrent renal failure, a marked decrease in blood pressure is possible. It is more often detected in patients with severe chronic heart failure, as a result of the use of high doses of diuretics, hyponatremia, or impaired renal function. In such patients, treatment with Lisinopril should be started under the strict supervision of a physician (with caution, select the dose of the drug and diuretics).
Similar rules must be followed when prescribing patients with coronary heart disease, cerebrovascular insufficiency, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke.
A transient hypotensive reaction is not a contraindication for taking the next dose of the drug.
When using Lisinopril in some patients with chronic heart failure, but with normal or low blood pressure, a decrease in blood pressure may occur, which is usually not a reason for discontinuation of treatment.
Before starting treatment with Lisinopril, if possible, you should normalize the sodium concentration and / or replenish the lost volume of fluid, carefully monitor the effect of the initial dose of Lisinopril on the patient.
In the case of renal artery stenosis (especially with bilateral stenosis, or in the presence of stenosis of an artery of a single kidney), as well as in case of circulatory insufficiency due to sodium and / or fluid deficiency, the use of Lisinopril can also lead to impaired renal function, acute renal failure, which usually is irreversible after drug withdrawal.
In acute myocardial infarction, the use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers) is shown. Lisinopril can be used in conjunction with intravenous administration or with the use of therapeutic transdermal systems of nitroglycerin.
Surgical intervention / general anesthesia
In major surgical interventions, as well as with the use of other drugs that cause a decrease in blood pressure, lisinopril, by blocking the formation of angiotensin II, can cause a pronounced unpredictable decrease in blood pressure.
In elderly patients, the same dose leads to a higher concentration of the drug in the blood, so special care is required in determining the dose.
Since the potential risk of agranulocytosis cannot be excluded, periodic monitoring of the blood picture is required. When using the drug under dialysis conditions with a polyacryl-nitrile membrane, anaphylactic shock may occur, therefore, either another type of membrane for dialysis, or the appointment of other antihypertensive drugs is recommended.
Influence on the ability to drive vehicles and mechanisms
There is no data on the effect of lisinopril on the ability to drive vehicles and mechanisms, used in therapeutic doses, however, it should be borne in mind that dizziness may occur, so caution should be exercised.
Symptoms (occur when taking a single dose of 50 mg or more): pronounced decrease in blood pressure; dry mouth, drowsiness, urinary retention, constipation, anxiety, irritability.
Treatment: symptomatic therapy, intravenous fluid administration, blood pressure control, water-electrolyte balance and normalization of the latter. Lisinopril can be removed from the body using hemodialysis.
Lisinopril reduces the excretion of potassium from the body during treatment with diuretics.
Special care is required with the simultaneous use of the drug with:
potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, table salt substitutes containing potassium (the risk of developing hyperkalemia increases, especially with impaired renal function), therefore, they can be co-administered only on the basis of an individual decision by the attending physician with regular monitoring of serum potassium levels and kidney function.
It can be usedcaution:
withwith diuretics: with additional administration of a diuretic to a patient taking Lisinopril, as a rule, an additive antihypertensive effect occurs - the risk of a pronounced decrease in blood pressure;
with other antihypertensive drugs (additive effect);
with NSAIDs (indomethacin, etc.), estrogens, as well as adrenostimulants - a decrease in the antihypertensive effect of lisinopril;
with lithium (the release of lithium may decrease, therefore, the concentration of lithium in the blood serum should be regularly monitored);
with antacids and cholestyramine - reduce absorption in the gastrointestinal tract.
Alcohol enhances the effect of the drug.
The most common side effects: dizziness, headache (in 5-6% of patients), weakness, diarrhea, dry cough (3%), nausea, vomiting, orthostatic hypotension, skin rash, chest pain (1-3%) ).
Other side effects (frequency <1%):
From the immune system: (0.1%) angioedema (face, lips, tongue, larynx or epiglottis, upper and lower extremities).
From the side of the cardiovascular system: a marked decrease in blood pressure, orthostatic hypotension, impaired renal function, heart rhythm disturbances, palpitations.
From the side of the central nervous system: increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips.
From the side of the hematopoietic system:are leukopenia, neutropenia, agranulocytosis, thrombocytopeniapossible, with prolonged treatment - a slight decrease in the concentration of hemoglobin and hematocrit, erythrocytopenia.
Laboratory indicators: hyperkalemia, azotemia, hyperuricemia, hyperbilirubinemia, increased activity of hepatic enzymes, especially in the presence of a history of kidney disease, diabetes mellitus and renovascular hypertension.
Rare side effects (less than 1%):
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.
From the digestive tract: dry mouth, anorexia, dyspepsia, taste changes, abdominal pain, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis.
On the part of the skin: urticaria, increased sweating, pruritus, alopecia.
From the urinary system: impaired renal function, oliguria, anuria, acute renal failure, uremia, proteinuria.
On the part of the immune system: a syndrome that includes an accelerated erythrocyte sedimentation rate (ESR), arthralgia and the appearance of antinuclear antibodies.
From the side of the central nervous system: asthenic syndrome, mood lability, confusion, decreased potency.
Others: myalgia, fever, fetal malformation