Description
Release form
Tablets
Packaging
30 pcs
Pharmacological action
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 total peripheral vascular resistance, blood pressure (BP), preload, pressure in the pulmonary capillaries, causes an increase in minute blood volume and an increase in myocardial tolerance to stress in patients with chronic heart failure. Expands arteries to a greater extent than veins. Some effects are explained by the effect on the tissue renin-angiotensin-aldosterone system. With prolonged use, hypertrophy of the myocardium and walls of the arteries of the resistive type decreases. Improves blood supply to the ischemic myocardium.
ACE inhibitors lengthen life expectancy in patients with chronic heart failure, slow the progression of left ventricular dysfunction in patients after myocardial infarction without clinical manifestations of heart failure.
Onset of action – after 1 hour. The maximum antihypertensive effect is determined after 6-7 hours and lasts for 24 hours. With arterial hypertension, the effect is observed in the first days after the start of treatment, a stable effect develops after 1-2 months. With a sharp discontinuation of the drug, a marked increase in blood pressure was not noted.
In addition to lowering blood pressure, lisinopril reduces albuminuria. Lisinopril does not affect the blood glucose concentration in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia.
Contraindications
Hypersensitivity to lisinopril or other ACE inhibitors.
History of angioedema, including with the use of ACE inhibitors.
Hereditary Quincke’s edema or idiopathic angioedema.
Pregnancy and lactation.
Age under 18 years (efficacy and safety not established).
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.
Caution
Severe renal impairment, bilateral renal artery stenosis or stenosis of a single kidney artery with progressive azotemia, renal transplant condition, azotemia, hyperkalemia, aortic orifice stenosis, hypertrophic obstructive cardiomyopathy, primary hyperaldosteronosis, including cerebrovascular insufficiency), coronary heart disease, coronary insufficiency, autoimmune systemic diseases tissue (including scleroderma, systemic lupus erythematosus) inhibition of bone marrow hematopoiesis diet with restriction of salt hypovolemic conditions (including as a result of diarrhea, vomiting) old age, hemodialysis using high-flow high-permeability dialysis membranes (AN69В®).
Use during pregnancy and lactation
The use of lisinopril during pregnancy is contraindicated. When pregnancy is established, the drug Lisinopril should be discontinued as soon as possible. Acceptance of 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, hypoplasia of the skull bones, intrauterine death are possible). There are no data on the negative effects of the drug on the fetus if used during the first trimester. For newborns and infants who underwent intrauterine exposure to ACE inhibitors, it is recommended to conduct careful monitoring to timely detect a pronounced decrease in blood pressure, oliguria, hyperkalemia.
Lisinopril crosses the placenta. There is no data on the penetration of lisinopril into breast milk. If taking Lisinopril is necessary during lactation, then breastfeeding must be canceled.
Special instructions
Symptomatic hypotension
Most often, a marked decrease in blood pressure occurs with a decrease in circulating blood volume (BCC) caused by diuretic therapy, a decrease in sodium chloride in food, dialysis, diarrhea or vomiting. In patients with chronic heart failure with simultaneous renal failure or without it, a marked decrease in blood pressure is possible.
Under strict medical supervision, Lisinopril should be used for patients with coronary heart disease, cerebrovascular insufficiency, in whom a sharp decrease in blood pressure can lead to myocardial infarction or stroke. Transient arterial hypotension is not a contraindication for taking the next dose of the drug.
When using the drug 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 stopping treatment.
Before starting treatment with the drug, if possible, normalize the sodium content and / or replenish the bcc, carefully monitor the effect of the initial dose of lisinopril on the patient.
In case of stenosis of the renal arteries (in particular, with bilateral stenosis or in the presence of stenosis of the artery of a single kidney), as well as in case of circulatory failure due to lack of sodium and / or fluid ions, the use of the drug Lisinopril can lead to impaired renal function, acute renal failure, which is usually irreversible even after discontinuation of the drug.
In acute myocardial infarction
The use of standard therapy (thrombolytics, acetylsalicylic acid, beta-blockers) is indicated. Lisinopril can be used in conjunction with intravenous administration or with the use of therapeutic transdermal systems of nitroglycerin.
Surgical intervention / general anesthesia
With extensive surgical interventions, as well as with the use of 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.
In elderly patients, the same dose leads to a higher concentration of the drug in the blood, therefore, special care is required when determining the dose.
Since the potential risk of agranulocytosis cannot be ruled out, periodic monitoring of the blood picture is required. When using the drug under dialysis conditions with polyacryl-nitrile membranes, anaphylactic shock can occur, therefore it is recommended that either a different type of membrane for dialysis, or the appointment of other antihypertensive agents.
Influence on the ability to drive vehicles and mechanisms
There is no data on the effect of the drug Lisinopril on the ability to drive vehicles and mechanisms used in therapeutic doses, however, it must be borne in mind that at the beginning of treatment, the development of arterial hypotension can occur, which can affect the ability to drive vehicles and work with potentially dangerous mechanisms, as well as the occurrence of dizziness and drowsiness, so you should be careful nost.
Composition
1 tablet contains:
Active ingredient: lisinopril dihydrate (corresponds to lisinopril) 10 mg,
Excipients: milk sugar (lactose) MCC starch 1500 (pregelatinized) aerosil (silicon dioxide colloidal).
Dosage and administration
Inside, once a day in the morning, regardless of food intake, preferably at the same time.
In case of arterial hypertension, patients not receiving other antihypertensive drugs 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 is 20 mg.
The maximum daily dose is 40 mg.
The full effect usually develops after 2-4 weeks from the start of treatment, which should be considered when increasing the dose. With insufficient clinical effect, it is possible to combine the drug with other antihypertensive drugs.
If the patient has received pre-treatment with diuretics, then the intake of such drugs must be stopped 2-3 days before the start of the drug Lisinopril. If this is not possible, then the initial dose of lisinopril should not exceed 5 mg per day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since there may be a pronounced decrease in blood pressure.
In case of renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 5 mg per day, under enhanced medical supervision (control of blood pressure, renal function, serum potassium ion content). Maintenance dose, continuing strict medical supervision, followed by If this is not possible, then the initial dose of lisinopril should not exceed 5 mg per day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since there may be a pronounced decrease in blood pressure.
In case of renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 5 mg per day, under enhanced medical supervision (control of blood pressure, renal function, serum potassium ion content). Maintenance dose, continuing strict medical supervision, followed by If this is not possible, then the initial dose of lisinopril should not exceed 5 mg per day. In this case, after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since there may be a pronounced decrease in blood pressure.
In case of renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 5 mg per day, under enhanced medical supervision (control of blood pressure, renal function, serum potassium ion content). Maintenance dose, continuing strict medical supervision, followed by after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since a marked decrease in blood pressure may occur.
In case of renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 5 mg per day, under enhanced medical supervision (control of blood pressure, renal function, serum potassium ion content). Maintenance dose, continuing strict medical supervision, followed by after taking the first dose, medical monitoring is recommended for several hours (the maximum effect is achieved after about 6 hours), since a marked decrease in blood pressure may occur.
In case of renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, it is also advisable to prescribe a low initial dose of 5 mg per day, under enhanced medical supervision (control of blood pressure, renal function, serum potassium ion content). Maintenance dose, continuing strict medical supervision, followed by under enhanced medical supervision (control of blood pressure, kidney function, serum potassium ions). Maintenance dose, continuing strict medical supervision, followed by under enhanced medical supervision (control of blood pressure, kidney function, serum potassium ions). Maintenance dose, continuing strict medical supervision, followed byt determine depending on the dynamics of blood pressure.
In case of renal failure due to the fact that lisinopril is excreted by the kidneys, the initial dose should be determined depending on the creatinine clearance. Further, the selection of doses should be made depending on individual reactions with regular monitoring of renal function, serum potassium, sodium.
Creatinine clearance,
ml / min Initial dose,
mg / day
30-70 5-10
10-30 5
(including patients on hemodialysis)
With persistent arterial hypertension, long-term maintenance therapy of 10-15 is indicated mg / day
In chronic heart failure: the initial dose is 2.5 mg per day, with a gradual increase in 3-5 days 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 – 5 mg, then 5 mg every other day, 10 mg after two days and then 10 mg once a day. The course of treatment is at least 6 weeks.
In the case of a prolonged marked decrease in blood pressure (systolic blood pressure less than 90 mm Hg. Art. more than 1 hour), drug treatment should be discontinued.
Diabetic nephropathy: in patients with type 2 diabetes, 10 mg of the drug Lisinopril is used once a day. The dose can, if necessary, be increased to 20 mg once a day in order to achieve diastolic blood pressure values below 75 mm Hg. in the sitting position. In patients with type 1 diabetes mellitus, the dose is the same, in order to achieve diastolic blood pressure values below 90 mm Hg. in the sitting position.
Side effects
The frequency of side effects is characterized as often (1%), rarely (1%).
The most common side effects: dizziness, headache, fatigue, diarrhea, dry cough, nausea.
From the cardiovascular system: often – a marked decrease in blood pressure, orthostatic hypotension rarely – chest pain, tachycardia, bradycardia, exacerbation of symptoms of chronic heart failure, impaired atrioventricular conduction, myocardial infarction.
From the central nervous system: often – paresthesia, lability of mood, confusion, drowsiness, convulsive twitching of the muscles of the limbs and lips, rarely – asthenic syndrome.
From the hemopoietic organs: rarely – leukopenia, neutropenia, agranulocytosis, thrombocytopenia, with prolonged treatment – anemia (decreased hemoglobin, hematocrit, erythropenia).
From the respiratory system: rarely – shortness of breath, bronchospasm.
From the digestive system: rarely – dry oral mucosa, anorexia, dyspepsia, taste changes, abdominal pain, pancreatitis, jaundice (hepatocellular or cholestatic), hepatitis.
From the skin: rarely – urticaria, pruritus, increased sweating, alopecia, photosensitivity.
From the genitourinary system: rarely – impaired renal function, oliguria, anuria, acute renal failure, uremia, proteinuria, decreased potency.
Laboratory indicators: often – hyperkalemia, hyponatremia rarely – hyperbilirubinemia, increased activity of “liver” enzymes, hypercreatininemia, increased concentration of urea and creatinine.
Allergic reactions: rarely – angioedema of the face, limbs, lips, tongue, epiglottis and / or larynx, skin rashes, skin itching, fever, false-positive antinuclear antibody test results, increased erythrocyte sedimentation rate (ESR), eosinophilia, leukocytes. In rare cases – intestinal angioedema.
Other: arthralgia / arthritis, vasculitis, myalgia.
Drug interaction
With the simultaneous use of the drug with potassium-sparing diuretics (spironolactone, triamteren, amiloride), potassium preparations, salt substitutes containing potassium, cyclosporine, the risk of hyperkalemia increases, especially with impaired renal function, so they can only be used together with regular impaired renal function monitoring serum potassium ions and kidney function.
The combined use of lisinopril with beta-blockers, “slow” calcium channel blockers (BMCC), diuretics, tricyclic antidepressants / antipsychotics and other antihypertensive drugs increases the severity of the hypotensive effect.
Lisinopril slows the elimination of lithium preparations. Therefore, when used together, it is necessary to regularly monitor the concentration of lithium in the blood serum.
Antacids and colestyramine decrease the absorption of lisinopril in the gastrointestinal tract.
When combined with insulin and hypoglycemic agents for oral administration, there may be a risk of hypoglycemia.
Nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective cyclooxygenase-2 inhibitors (COX-2)), estrogens, adrenergic agonists reduce the hypotensive effect of lisinopril.
With the simultaneous use of ACE inhibitors and gold preparations intravenously (sodium aurothiomalate), a symptom complex has been described, including facial flushing, nausea, vomiting, and a decrease in blood pressure.
When used together with selective serotonin reuptake inhibitors, it can lead to severe hyponatremia.
Joint use with allopurinol, procainamide, cytostatics can lead to leukopenia.
Overdose
Symptoms (occur with single dose of 50 mg): marked decrease in blood pressure, dry mouth, drowsiness, urinary retention, constipation, anxiety, increased irritability.
Treatment: There is no specific antidote. Symptomatic therapy. Gastric lavage, the use of enterosorbents and laxatives. The intravenous administration of 0.9% sodium chloride solution is shown. In the case of bradycardia resistant to treatment, the use of an artificial rhythm driver is required. It is necessary to control blood pressure, water-electrolyte balance. Hemodialysis is effective.
Storage conditions
In a dry, dark place at a temperature not exceeding 25 C.
Shelf life
2 years
Deystvuyushtee substance
Lisinopril
Terms and conditions
prescription
Dosage form
tablets
Possible product names
lisinopril-Teva tablets 10 mg 30 pcs.
Teva Ltd., Israel
