Lipril
Producer: HFZ CJSC NPTs Borshchagovsky Ukraina
Code of automatic telephone exchange: C09A A03
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: lisinopril; 1 tablet contains lisinopril (in the form of dihydrate lisinopril) - 10 mg; excipients: Mannitolum, starch corn, magnesium stearate, hydrophosphate calcium dihydrate, ferrous oxide yellow. Main physical and chemical properties: tablets of cream color, a ploskotsilindrichesky form with slanted edges and risky. On a surface of tablets the mramornost and impregnations is allowed.
Pharmacological properties:
Pharmacodynamics. Drug Lipril concerns to group of APF inhibitors.
Suppresses formation of angiotensin II and reduces its vasoconstrictive action, and also its stimulating influence on products of Aldosteronum in adrenal glands. Under the influence of drug the general peripheric resistance of vessels (GPRV) decreases, the minute volume of blood (MVB) increases, the afterload decreases, pressure in a small circle of blood circulation decreases, the arterial pressure (AP) decreases, the intra renal blood stream slightly amplifies. Lipril does not influence the heart rate (HR).
The hypotensive effect occurs approximately in 1 hour after reception, reaches a maximum approximately in 6 hours and remains within 24 hours. At prolonged treatment efficiency of lisinopril remains. At the sudden termination of administration of drug the withdrawal is not observed.
Pharmacokinetics. After intake it is soaked up in not changed look, meal does not influence drug absorption. Lisinopril does not contact proteins of a blood plasma. Bioavailability of lisinopril makes 25-50%.
The maximum concentration in a blood plasma is reached approximately in 7 hours. In an organism it is not metabolized, allocated with urine in not changed look. An elimination half-life – 12 hours.
Indications to use:
• Arterial hypertension (in the form of monotherapy or with other anti-hypertensive means);
• congestive heart failure (as a part of complex therapy);
• an acute myocardial infarction with ST segment elevation (as a part of complex therapy).
Route of administration and doses:
It is necessary to accept drug 1 time a day in the morning, irrespective of reception of food, it is desirable at the same time.
At arterial hypertension to patients Lipril appoint 5 mg of 1 times a day. In the absence of effect the dose is raised by each 2-3 days on 5 mg to an average therapeutic dose of 20-40 mg/days (increase in a dose usually does not lead over 40 mg/days to a further lowering of arterial pressure). The maximum daily dose – 40 mg.
If Lipril's use in the maximum dose does not cause sufficient therapeutic effect, then perhaps additional purpose of other anti-hypertensive drug.
At the patients receiving previously diuretics it is necessary to cancel them in 2-3 days prior to Lipril's use. At impossibility of cancellation of diuretics the initial dose of Lipril has to make no more than 5 mg/days. In this case after reception of the first dose medical control within several hours (the maximum action is reached approximately in 6 h) since development of symptomatic hypotension is possible is recommended.
At renovascular arterial hypertension Lipril appoint in an initial dose 2,5-5 mg/days (under control of the ABP, function of kidneys, potassium level in blood serum).
At patients with a renal failure and the patients who are on a hemodialysis, the initial dose is established depending on values of clearance of creatinine. The therapeutic dose is defined depending on dynamics of arterial pressure (under control of function of kidneys, level of potassium and sodium in a blood plasma).
Clearance of creatinine (ml/min.) |
Initial dose (mg/days) |
30-70 |
5-10 |
10-30 |
2,5-5 |
<10 (including patients after a hemodialysis) |
2,5 |
At congestive heart failure Lipril's use along with diuretics and/or cardiac glycosides is possible. Whenever possible the dose of diuretic should be reduced prior to Lipril's reception. The initial dose of Lipril makes 2,5 mg/days, further it is gradually increased to 5-20 mg/days. The target dose makes 20 mg/days.
At an acute myocardial infarction with ST segment elevation treatment by Lipril has to begin within 24 hours from the moment of emergence of its symptoms according to the scheme: the initial dose makes 5 mg, the following dose – 5 mg in 24 hours, then 10 mg in 48 hours and further on 10 mg a day. To patients with low systolic arterial pressure (120 mm. рт. St and less) in an initiation of treatment and within 3 days посля a myocardial infarction appoint smaller doses – 2,5 mg. At an acute myocardial infarction therapy by Lipril has to last 6 weeks.
Lipril's tablets on 10 mg do not apply to treatment in a dose 2,5 mg.
Features of use:
Prior to treatment whenever possible it is necessary to normalize the level of sodium and/or to compensate the lost volume of liquid and to carefully control development of anti-hypertensive action.
At patients with malignant arterial hypertension selection and correction of dosing should be carried out in the conditions of a hospital.
Lipril with care appoint at the diseases which are followed by liquid loss (the increased sweating, diarrhea, vomiting) and at the previous therapy by diuretics since the risk of development of arterial hypotension increases. In such cases after reception of the first dose medical control within several hours is shown.
At patients with a diabetes mellitus treatment should be carried out under control of level of glucose to blood, especially within the first month of treatment.
Drug should be used with care to patients with a bilateral renal artery stenosis or a stenosis of an artery of the only kidney, and also to patients with a renal failure, a liver, hemopoiesis disturbance, autoimmune diseases, a mitral or aortal stenosis, an obstructive form of a hypertrophic cardiomyopathy, other diseases with obstruction of outflow tracts from a left ventricle. Lipril's use for patients with these diseases demands constant control of the doctor.
With care appoint drug to patients of advanced age as they increased risk of development of arterial hypotension, including orthostatic, and they can show hypersensitivity to drug even at use of usual doses.
It must be kept in mind that between drugs of group of APF inhibitors there is a cross hypersensitivity.
During treatment by drug it is necessary to control a pattern of peripheral blood.
It must be kept in mind that patients with a renal failure and autoimmune diseases have an increased risk of emergence of hematologic disturbances.
During treatment by Lipril it is not recommended to take alcohol.
At arterial hypotension (systolic arterial pressure less or equally to 100 mm. рт. the St) should reduce Lipril's dose to 2,5 mg a day. If hypotension is not compensated (systolic arterial pressure less or equally to 90 mm. рт. the St) should cancel drug.
In need of carrying out an anesthesia it is necessary to inform the doctor on what the patient applies Lipril.
At extensive surgical interventions or at use of the opioid analgetik causing arterial hypotension, Lipril blocks formation of angiotensin II at compensatory release of a renin. The arterial hypotension caused by this mechanism is eliminated with compensation of the lost liquid (infusion of isotonic solution of sodium of chloride).
At use of drug in the conditions of dialysis about polyacryle - a nitrile membrane development of an acute anaphylaxis therefore it is recommended to use other membranes is possible or to appoint other anti-hypertensive drugs.
Lipril patients should appoint with care with a myocardial infarction within 6-12 hours after introduction of Streptokinasa (the risk of development of arterial hypotension increases).
At patients with primary hyper aldosteronism drugs of group of APF inhibitors are inefficient.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Lipril can influence (especially at the beginning of therapy) ability to manage vehicles and to work with mechanisms.
The question of an opportunity to be engaged in potentially dangerous types of activity should be solved only after assessment of individual reaction of the patient to drug.
Use during pregnancy or feeding by a breast.
It is contraindicated to use drug during pregnancy.
In need of drug use by the women nursing feeding is recommended to be stopped.
Children.
Efficiency and safety of use of drug at children's and teenage age were not investigated therefore Lipril it is necessary to apply only at adults.
Side effects:
From the central nervous system: dizziness, headache, lability of mood, confusion of consciousness.
From digestive tract: anorexia, diarrhea, nausea, vomiting, dryness in a mouth, a dysgeusia (disturbance of flavoring feelings), pancreatitis, hepatitis, jaundice.
From cardiovascular system: pain in a breast, arterial hypotension, including orthostatic, disturbance of a heart rhythm, tachycardia.
From urinogenital system: renal failure, uraemia, oliguria and/or anury, acute renal failure, impotence.
Allergic reactions: skin rash, Quincke's disease.
Changes of laboratory indicators: a neutropenia, an agranulocytosis, decrease in level of hemoglobin and an indicator of a hematocrit, thrombocytopenia, a hyperpotassemia, increase in level of creatinine and an urea nitrogen in blood serum (especially in the presence of diseases of kidneys, a diabetes mellitus, renovascular hypertensia), increase in activity of hepatic transaminases.
Others: feeling of weakness, dry cough, bronchitis, asthma, sinusitis, glossitis, arthralgia.
Interaction with other medicines:
At simultaneous use of Lipril:
- with drugs of lithium removal of lithium from an organism can decrease and amplify its toxic action therefore it is regularly necessary to control lithium level in plasma;
- with kaliysberegayushchy diuretics (Spironolactonum, Triamterenum, amiloride), the drugs of potassium or substitutes of edible salt containing potassium the risk of development of a hyperpotassemia increases (especially at patients with renal failures). Therefore these combinations are appointed with care, under control of level of potassium in plasma and function of kidneys;
- with diuretics, anti-hypertensive drugs the additional anti-hypertensive effect is noted and correction of doses of drugs can be required;
- with non-steroidal anti-inflammatory drugs (NPVP), especially with indometacin, decrease in efficiency of Lipril is noted;
- with the means oppressing function of marrow the risk of development of a neutropenia and/or agranulocytosis increases;
- with Allopyrinolum, cytostatics, immunodepressants, glucocorticosteroids, procaineamide the risk of development of a leukopenia increases;
- with sympathomimetics Lipril's efficiency decreases;
- with estrogen at the expense of a liquid delay in an organism anti-hypertensive efficiency of Lipril can decrease.
Lipril strengthens effect of ethanol.
Contraindications:
• Hypersensitivity to lisinopril or to other components of drug;
• idiopathic, hereditary Quincke's disease;
• a Quincke's disease after reception of other APF inhibitors;
• pregnancy;
• feeding period breast;
• children's age.
Overdose:
From the central nervous system: dizziness, headache, lability of mood, confusion of consciousness.
From digestive tract: anorexia, diarrhea, nausea, vomiting, dryness in a mouth, a dysgeusia (disturbance of flavoring feelings), pancreatitis, hepatitis, jaundice.
From cardiovascular system: pain in a breast, arterial hypotension, including orthostatic, disturbance of a heart rhythm, tachycardia.
From urinogenital system: renal failure, uraemia, oliguria and/or anury, acute renal failure, impotence.
Allergic reactions: skin rash, Quincke's disease.
Changes of laboratory indicators: a neutropenia, an agranulocytosis, decrease in level of hemoglobin and an indicator of a hematocrit, thrombocytopenia, a hyperpotassemia, increase in level of creatinine and an urea nitrogen in blood serum (especially in the presence of diseases of kidneys, a diabetes mellitus, renovascular hypertensia), increase in activity of hepatic transaminases.
Others: feeling of weakness, dry cough, bronchitis, asthma, sinusitis, glossitis, arthralgia.
Storage conditions:
To store in dry, protected from light and the place, unavailable to children, at a temperature not above 25ºС.
Period of validity - 3 years.
Issue conditions:
According to the recipe
Packaging:
On 10 tablets in the blister, on 3 blisters in a pack.