Avapro
Avapro
Avapro (Irbesartan)Pharmacological action
The antihypertensive preparation, the specific antagonist of receptors of angiotensin II. Eliminates vasoconstrictive action of angiotensin II and reduces concentration of Aldosteronum in a blood plasma.
Blocks all physiologically significant effects of angiotensin II realised through a receptor of type AT1, irrespective of a source or a way of synthesis of angiotensin II. Specific opposing action concerning receptors of angiotensin II (AT1) leads to augmentation of concentration of a renin and angiotensin II in a blood plasma and to depression of concentration of Aldosteronum in a blood plasma. At application of the recommended doses of a preparation concentration of an ion of a potassium in blood serum essentially does not vary. For implication of the Avapro effect does not demand metabolic activation.
The maximum depression of a BP is reached through 3-6 h after preparation reception inside, and the hypotensive effect remains at least throughout 24 h. Through 24 h after reception in the recommended doses BP depression makes 50-70 % in comparison with the maximum depression of a diastolic and systolic BP in reply to preparation application.
Degree of depression of a BP at preparation application in a dose of 150 mg/sut identical both at unitary reception, and at separation of this dose into two receptions.
Hypotensive action of Avapro preparation develops within 1-2 weeks, and the maximum therapeutic effect is reached by 4-6 weeks after the treatment beginning. The antihypertensive effect remains in the conditions of long treatment. After the termination of treatment of a BP gradually comes back to initial size, a withdrawal it was not observed.
Hypotensive Avapro effects has additive character.
Avapro does not render influence on the maintenance of urinary acid in blood serum or on allocation of urinary acid with urine.
Indications
- An arterial hypertensia.
Dosage regimen
Initial and maintenance doses make 150 mg of 1 times/days If necessary a dose it is possible to enlarge to 300 mg of 1 times/sut or to prescribe the combined antihypertensive therapy.
To the patients who are on a hemodialysis, or elderly patients 75 years the recommended initial dose aged is more senior makes 75 mg/days
The preparation can be accepted during meal or on an empty stomach. Tablets should be swallowed entirely, washing down with water.
At patients with renal insufficiency (without disturbances of an electrolytic exchange), the easy or moderately expressed disturbances of function of a liver of correction of a dose do not require.
Disturbances of a vodno-electrolytic exchange should be corrected prior to the beginning of Avapro therapy.
It is recommended to accept a preparation every day approximately at a time. At the casual admission of reception of a preparation the following daily dose should not be doubled.
The combined therapy by Avapro preparation in a combination to diuretics or other antihypertensive preparations is possible.
Side effect
At the description of by-effects following criteria of frequency of occurrence were used: very often (more than 10 %), are frequent (more than 1 %, but less than 10 %); sometimes (more than 0.1 %, but less than 1 %); seldom (more than 0.01 %, but less than 0.1 %); very seldom (less than 0.01 %) (including separate reports). Frequency of by-effects did not depend on a dose (in the recommended interval of doses), a sex, age, race of the patient or from duration of therapy.
In platsebo-supervised researches following collateral reactions have been noted.
From party TSNS: often - giddiness.
From cardiovascular system: sometimes - a tachycardia, inflow.
From respiratory system: sometimes - tussis.
From the alimentary system: often - a nausea, vomiting; sometimes - a diarrhoeia, a dyspepsia, a heartburn.
From sexual system: sometimes - sexual dysfunction.
From an organism as a whole: often - fatigue; sometimes - a pain in a thorax.
At patients with an arterial hypertensia and a diabetes of type 2 and a microalbuminuria with normal function of kidneys orthostatic giddiness and an orthostatic hypotension became perceptible at 0.5 % of patients. At sick of a diabetes with the raised BP with a microalbuminuria and normal renal function a hyperpotassemia (more than 5.5 % of mmol/l) met at 29.4 % of patients in the group Avapro receiving in a dose of 300 mg.
At sick of an arterial hypertensia with a diabetes, chronic renal insufficiency and the expressed proteinuria at 2 % of patients following additional collateral reactions more often.
From party TSNS: often - orthostatic giddiness.
From cardiovascular system: often - an orthostatic hypotension.
From osteomuscular system: often - ostealgias and in muscles.
From laboratory indicators: the hyperpotassemia (more than 5.5 % of mmol/l) met at 46.3 % of sick patients in the group, Avapro receiving. Depression of level of haemoglobin which was not clinically significant, became perceptible at 1.7 % of the patients Avapro receiving.
During the post-marketing period following collateral reactions also have been taped:
Allergic reactions: seldom - an eruption, an urticaria, a Quincke's disease (as well as at other antagonists of receptors of angiotensin II).
From a metabolism: very seldom - a hyperpotassemia.
From party TSNS: very seldom - a headache, a ring in ears.
From the alimentary system: very seldom - a dyspepsia, disturbances of function of a liver, a hepatitis.
Contraindications
- Pregnancy;
- A lactemia;
- Children's and teenage age till 18 years;
- A hypersensibility to preparation components.
With care prescribe at a dehydration, a hyponatremia, hemodialysis carrying out, to the persons who are on a diet with restriction of consumption of table salt, at a diarrhoeia, vomiting, a unilateral or bilateral stenosis of renal arteries, renal insufficiency, an aortal or mitral stenosis, an obstructive hypertrophic cardiomyopathy, chronic heart failure III-IV of a functional class on classification NYHA.
Pregnancy and lactemia
Avapro is contraindicative to application at pregnancy. At offensive of pregnancy during treatment the preparation should be cancelled immediately.
Transition to corresponding alternative therapy should be spent prior to the beginning of pregnancy planning.
In need of appointment of a preparation in a lactemia it is necessary to solve a question on the termination of thoracal feeding, whether since it is not known it is allocated Avapro with thoracal milk.
Special indicatings
Disturbances of water-salt balance
At a dehydration and-or at deficiency of ions of sodium (as a result of intensive treatment by diuretics, a diarrhoeia or vomiting, restriction of entering of salt with nutrition), and also at the patients who are on a hemodialysis, the symptomatic arterial hypotension, especially after reception of the first dose of a preparation can develop. The specified pathological conditions are necessary for correcting before the beginning of application of Avapro preparation.
Renovascular hypertensia
Patients with a bilateral stenosis of renal arteries or a stenosis of an artery of the unique kidney, the accepting other preparations influencing system a renin-angiotensin-Aldosteronum, concern group of the raised risk concerning development of a serious arterial hypotension or renal insufficiency. Though development of such complications for Avapro preparation is not described, similar effect it is possible to expect and at use of antagonists of receptors of angiotensin II.
Renal insufficiency and transplantation of kidneys
At Avapro application for patients with renal insufficiency the periodic control of level of a potassium and a blood serum creatinine is recommended. There are no clinical data concerning Avapro application for the patients who have transferred transplantation of kidneys.
Hyperpotassemia
Hyperpotassemia development is possible at Avapro application (as well as at application of other agents influencing system a renin-angiotensin-Aldosteronum), especially at patients with renal insufficiency and-or heart diseases. For patients from risk group the adequate control of level of a potassium in blood serum is recommended.
Stenosis of the aortal or mitral valve, obstructive hypertrophic cardiomyopathy
It is necessary to accept special safety measures at application for patients with an aortal either mitral stenosis or an obstructive hypertrophic cardiomyopathy.
Primary aldosteronism
Patients with a primary aldosteronism usually do not react to the antihypertensive preparations inhibiting systems of renin-angiotensin. Therefore Avapro application in such cases is not recommended. In group of patients at which the vascular tonus and function of kidneys in prevailing degree depend on activity of system a renin-angiotensin-Aldosteronum (for example, at patients with a chronic heart failure III and IV functional class on classification NYHA or with corresponding disease of kidneys, including a renal artery stenosis), treatment by the medical products influencing this system, has been bound to an acute arterial hypotension, an azotemia, an oliguria and in rare instances - with acute renal insufficiency. As well as at application of other antihypertensive agents, depression of the raised BP at patients from an ischemic heart disease can lead as a result to a myocardial infarction or occurrence of an attack of a stenocardia. Treatment should be carried out under the BP control.
Use in pediatrics
Safety and efficiency of application of a preparation at children are not established.
Influence on ability to driving of motor transport and to management of mechanisms
Avapro influence on ability to be engaged in the kinds of activity demanding special attention, was not studied, however, the preparation should not influence this ability. At motor transport driving it is necessary to take into consideration, that during treatment of an arterial hypertensia giddiness and the raised weariness is sometimes possible.
Overdosage
At preparation reception in a dose to 900 mg/sut throughout 8 weeks it is not taped any toxicity.
Symptoms: most possibly expressed depression of a BP, a tachycardia, a bradycardia.
Treatment: at casual reception of a preparation in high doses the gastric lavage, the activated coal, carrying out of symptomatic therapy is shown. Avapro does not leave from an organism at a hemodialysis.
Medicinal interaction
Previous treatment by diuretics in high doses can lead to dehydration of an organism and raises risk of occurrence of an arterial hypotension in the beginning of treatment by Avapro preparation.
Conditions and periods of storage
B.Preparat's list should be stored in a dry place inaccessible to children, at temperature more low 30 C. The Period of validity - 3 years.
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