Universal reference book for medicines
Name of the preparation: PRESTARIUM В® A (PRESTARIUM В® A)

Active substance: perindopril arginine

Type: ACE inhibitor

Manufacturer: Les Laboratoires Servier (France) manufactured by Les Laboratoires Servier Industrie (France)
Composition, form of production and packaging
The tablets covered with a film cover,
white color, round, biconcave.

1 tab.

perindopril arginine 2.5 mg,

which corresponds to the content of perindopril 1.6975 mg

Excipients: lactose monohydrate - 36.29 mg, magnesium stearate 0.225 mg, maltodextrin 4.5 mg, silicon colloidal hydrophobic dioxide 0.135 mg, sodium carboxymethyl starch 1.35 mg.

Composition of the coating: premix for a white sheath film Sepifilm 37781 RBC (glycerol (E422a) - 4.5%, hypromellose (E464) - 74.8%, macrogol 6000 - 1.8%, magnesium stearate 4.5%, titanium dioxide (E171) 14.4%) - 0.966 mg, macrogol 6000 - 0.034 mg.

30 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
The film-coated tablets are light green in color, oblong, rounded on both sides, with notches on two sides and engraved in the form of a company logo on one of the facial sides.

1 tab.

perindopril arginine 5 mg,

which corresponds to the content of perindopril 3.395 mg

Excipients: lactose monohydrate - 72.58 mg, magnesium stearate - 0.45 mg, maltodextrin - 9 mg, silicon dioxide colloid hydrophobic - 0.27 mg, sodium carboxymethyl starch - 2.7 mg.

Composition of the coating: premix for a film-colored shell of light green color Sepifilm 4193 (glycerol (E422a) 4.5%, hypromellose (E464) 74.8%, macrogol 6000 1.8%, magnesium stearate 4.5%, titanium dioxide (E171) 14.328% , copper chlorophyllin (E141 (ii)) - 0.072%) - 1.931 mg, macrogol 6000 - 0.069 mg.

14 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
29 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
30 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
Packages for hospitals:

30 pcs.
- polypropylene bottles with a dispenser (3) - packs of cardboard with the control of the first opening.
The tablets covered with a film cover, green color, round, biconcave, with an engraving in the form of heart on one side and a logo of firm - on another.

1 tab.

perindopril arginine 10 mg,

which corresponds to the content of perindopril 6.79 mg

Excipients: lactose monohydrate - 145.16 mg, magnesium stearate - 0.9 mg, maltodextrin - 18 mg, silicon dioxide colloidal hydrophobic - 0.54 mg, sodium carboxymethyl starch - 5.4 mg.

Composition of the coating: premix for the film shell of green color Sepifilm NT 3407 (glycerol (E422a) - 4.5%, hypromellose (E464) - 74.8%, macrogol 6000 - 1.8%, magnesium stearate 4.5%, titanium dioxide (E171) 14.11% copper chlorophyllin (E141 (ii)) - 0.29%) - 4.828 mg, macrogol 6000 - 0.172 mg.

29 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
30 pcs.
- polypropylene bottles with a dispenser (1) - packs of cardboard with control of the first opening.
Packages for hospitals:

30 pcs.
- polypropylene bottles with a dispenser (3) - packs of cardboard with the control of the first opening.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Perindopril is an ACE inhibitor.
ACE, or kininase II, is an exopeptidase that carries out both the conversion of angiotensin I into a vasoconstrictor substance, angiotensin II, and the destruction of bradykinin, which has a vasodilating action, to an inactive heptapeptide.
Inhibition of ACE leads to a decrease in the concentration of angiotensin II in the blood plasma, which causes an increase in plasma renin activity (by the mechanism of negative feedback) and a decrease in the secretion of aldosterone.

Since ACE inactivates bradykinin, ACE inhibition is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin system, and the system of prostaglandins is also activated.
It is possible that this effect is part of the mechanism of antihypertensive action of ACE inhibitors, as well as the mechanism of development of some side effects of drugs of this class (for example, cough).
Perindopril has a therapeutic effect due to the active metabolite, perindoprilat.
Other metabolites of the drug have no inhibitory effect on ACE in vitro.
Clinical efficacy and safety

Arterial hypertension

Perindopril is effective in the treatment of arterial hypertension of any severity.
Against the background of the use of the drug there is a decrease in both systolic and diastolic blood pressure in the position of the patient lying down and standing. Perindopril reduces OPSS, which leads to a decrease in blood pressure, while peripheral blood flow accelerates without changing the heart rate.
As a rule, perindopril leads to an increase in renal blood flow, while GFR does not change.

Antihypertensive effect of the drug reaches a maximum after 4-6 hours after a single oral intake and persists for 24 hours. After 24 hours after ingestion, a residual (about 87-100%) residual inhibition of ACE is observed.
Decrease in blood pressure is achieved quickly enough. In patients with a positive response to treatment, the normalization of BP occurs within a month and persists without the development of tachyphylaxis.
The cessation of treatment is not accompanied by the development of the "rebound" effect.

Perindopril has a vasodilating effect, helps restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces left ventricular hypertrophy.

Simultaneous administration of thiazide diuretics increases the severity of the antihypertensive effect.
In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of developing hypokalemia with diuretics.
Cerebrovascular diseases

The results of the PROGRESS study, which evaluated the effect of active perindopril therapy (monotherapy or in combination with indapamide) for 4 years on the risk of recurrent stroke in patients with a history of cerebrovascular disease.
After the introductory period of 2 mg perindopril of tert-butylamine (equivalent to perindopril arginine 2.5 mg) 1 time / day for 2 weeks and then 4 mg (equivalent of perindopril arginine 5 mg) 1 time / day for a further 2 weeks, 6105 patients were randomized into two groups: placebo (n = 3054) and perindopril tretbutylamine 4 mg (corresponding to 5 mg perindopril arginine) (monotherapy) or in combination with indapamide (n = 3051). Indapamide was additionally assigned to patients who did not have direct indications or contraindications for the use of diuretics. This therapy was prescribed in addition to standard therapy of stroke and / or hypertension or other pathological conditions. All randomized patients had a history of cerebrovascular disease (stroke or transient ischemic attack) during the last 5 years. The value of AD was not an inclusion criterion: 2916 patients had arterial hypertension and 3189 had normal BP. After 3.9 years of therapy, the blood pressure (systolic / diastolic) decreased by an average of 9/4 mm Hg. There was also a significant reduction in the risk of recurrent stroke (both ischemic and hemorrhagic 28% compared with placebo (10.1% and 13.8%).
Additionally, a significant reduction in the risk of fatal or disabling strokes was shown;
major cardiovascular complications, including myocardial infarction, incl. with lethal outcome; dementia associated with stroke; serious deterioration of cognitive functions.
This was noted both in patients with arterial hypertension and at normal BP, regardless of age, sex, the presence or absence of diabetes mellitus and the type of stroke.

Stable ischemic heart disease

The efficacy of perindopril in patients (12,218 patients over 18 years old) with stable coronary artery disease without clinical symptoms of chronic heart failure was studied in a 4-year study.
90% of study participants had previously suffered acute myocardial infarction and / or revascularization procedure. Most patients received standard therapy in addition to the test drug, including antiaggregants, lipid-lowering drugs and beta-blockers. The combined end point, including cardiovascular mortality, nonfatal myocardial infarction, and / or cardiac arrest with successful resuscitation was chosen as the main efficacy criterion.
Perindopril therapy with erbumine at a dose of 8 mg / day (equivalent to 10 mg perindopril arginine) resulted in a significant reduction in the absolute risk of the combined endpoint's attack by 1.9% (a relative risk reduction of 20%).
In patients who had previous myocardial infarction or revascularization procedure, absolute risk reduction was 2.2% (relative risk reduction - 22.4%) compared with placebo group.
Patients under the age of 18 years

The efficacy and safety of perindopril in children and adolescents under the age of 18 years is not established.

There are data from clinical trials involving 62 patients with arterial hypertension aged 2 to 15 years with GFR> 30 ml / min / 1.73 m 2 body surface area who received perindopril at a dose of 0.07 mg / kg on average.
The dose was selected individually, depending on the general condition of the patient and the indices of his BP in response to therapy, with the maximum dose being 0.135 mg / kg / day.
59 patients participated in the study for 3 months and 36 patients completed the extended study period, which was at least 24 months (the average duration of participation in the study was 44 months).

The systolic and diastolic blood pressure indices remained stable throughout the study period (from the moment of inclusion in the studies to the final evaluation) in patients who had previously received other antihypertensive drugs and decreased in patients who had not previously received antihypertensive therapy.

More than 75% of children under the last definition had systolic and diastolic blood pressure less than the 95th percentile.

The safety data obtained in this study are consistent with the information already available on the safety of perindopril.

Double blockade of RAAS

There are data from clinical trials of combined therapy with ACE inhibitor and angiotensin II receptor antagonist (ARA II).

A clinical study was conducted involving patients with a history of cardiovascular or cerebrovascular disease, or type 2 diabetes mellitus, accompanied by confirmed lesion of the target organ, as well as studies involving patients with type 2 diabetes and diabetic nephropathy.

These studies did not reveal a significant positive effect of combination therapy on the occurrence of renal and / or cardiovascular events and mortality, while the risk of hyperkalemia, acute renal failure, and / or hypotension increased compared to monotherapy.

Taking into account similar intra-group pharmacodynamic properties of ACE inhibitors and APA II, these results can be expected for the interaction of any other drugs, representatives of classes of ACE inhibitors and APA II.
Therefore, ACE inhibitors and ARA II should not be used simultaneously in patients with diabetic nephropathy.
There is evidence from a clinical trial to study the beneficial effects of the addition of aliskiren to standard therapy with an ACE inhibitor or ARA II in patients with type 2 diabetes and chronic kidney disease or cardiovascular disease or a combination of these diseases.
The study was terminated early due to the increased risk of adverse outcomes. Cardiovascular death and stroke were more common in the group of patients receiving aliskiren compared with the placebo group; and adverse events and serious adverse events of special interest (hyperkalemia, arterial hypotension, and renal dysfunction) were more frequent in the aliskiren group than in the placebo group.
PHARMACOKINETICS

Absorption and Metabolism

After oral administration, perindopril is rapidly absorbed from the gastrointestinal tract, C max in the blood plasma is reached after 1 hour. T 1/2 perindopril from the blood plasma is 1 hour. Perindopril has no pharmacological activity.
Approximately 27% of the total amount of absorbed perindopril enters the bloodstream as an active metabolite of perindoprilate. C max perindoprilata in blood plasma is achieved after 3-4 hours. In addition to perindoprilata, metabolites form 5 metabolites that do not possess pharmacological activity.
Eating slows the conversion of perindopril to perindoprilat, thus affecting the bioavailability of the drug.
Therefore, the drug should be taken orally 1 time per day, in the morning, before eating.
It was shown that the relationship between the dose of perindopril and its concentration in the plasma is linear.

Distribution

The binding of perindoprilat to plasma proteins, mainly with ACE, is 20% and is dose-dependent.
V d of free perindoprilate is approximately 0.2 l / kg.
Excretion

Perindoprilat is excreted by the kidneys, the final T 1/2 of the free fraction is approximately 17 hours, as a result, the equilibrium state is reached within 4 days.

Pharmacokinetics in special clinical cases

The excretion of perindoprilat is delayed in old age, as well as in patients with cardiac and renal insufficiency.

The dialytic clearance of perindoprilat is 70 ml / min.

In patients with cirrhosis of the liver, the liver clearance of perindopril decreases twofold.
Nevertheless, the amount of perindoprilat formed does not decrease and dose adjustment is not required (see the sections "Dosage regimen" and "Special instructions").
INDICATIONS

- arterial hypertension;

- Chronic heart failure;

- prevention of recurrent stroke (combination therapy with indapamide) in patients who underwent a stroke or transient cerebral circulation disorder according to the ischemic type;

- stable ischemic heart disease: to reduce the risk of cardiovascular complications.

DOSING MODE

Inside 1 tablet 1 time / day, preferably in the morning, before eating.

When choosing a dose, it is necessary to take into account the peculiarities of the clinical situation (see the section "Special instructions") and the degree of BP reduction on the background of the therapy.

Arterial hypertension

Prestarium В® A can be used both as a monotherapy and as part of a combination therapy (see the sections "Contraindications", "Special instructions" and "Pharmacological action").

The recommended initial dose is 5 mg 1 time / day.
If necessary, a month after the start of therapy, you can increase the dose of the drug to 10 mg 1 time / day. The maximum daily dose is 10 mg.
In patients with severe RAAS activity (especially with renovascular hypertension, hypovolemia and / or a decrease in the content of plasma electrolytes, decompensation of chronic heart failure or severe hypertension), after a first dose, a marked decrease in blood pressure can develop.
At the beginning of therapy, such patients should be under close medical supervision. The recommended initial dose for such patients is 2.5 mg 1 time / day.
At the beginning of therapy with Prestarium В® A, symptomatic arterial hypotension may occur.
In patients receiving diuretics concomitantly, the risk of developing arterial hypotension is higher due to possible hypovolemia and a decrease in the content of plasma electrolytes. Care should be taken when using Prestarium В® A in this group of patients. It is recommended, if possible, to stop taking diuretics 2-3 days before the proposed initiation of therapy with Prestarium В® A (see section "Special instructions").
If it is not possible to cancel diuretics, the initial dose of Prestarium В® A is 2.5 mg.
In this case, it is necessary to monitor kidney function and potassium content in the blood serum. In the future, if necessary, the dose of the drug may be increased. If necessary, the use of diuretics can be resumed.
In elderly patients, treatment should begin with a dose of 2.5 mg / day.
If necessary, a month after the start of therapy, the dose can be increased to 5 mg / day, and then to the maximum dose of 10 mg / day, taking into account the state of kidney function (see table).
Heart failure

Treatment of patients with chronic heart failure with Prestarium В® A in combination with non-potassium-sparing diuretics and / or digoxin and / or beta-blockers is recommended to begin under close medical supervision, prescribing the drug at an initial dose of 2.5 mg 1 time / day in the morning.
After 2 weeks of treatment, the dose of the drug can be increased to 5 mg 1 time / day, provided that the dose is well tolerated 2.5 mg and a satisfactory response to the therapy.
In patients with severe heart failure and also in patients at high risk (patients with impaired renal function and a tendency to disrupt the electrolyte balance, patients who are concurrently receiving diuretics and / or vasodilator drugs), treatment should be started under close medical supervision (see section "Special instructions").

In patients with a high risk of developing symptomatic arterial hypotension, for example, with a reduced electrolyte content with or without hyponatremia, hypovolemia, or taking diuretics, before the start of Prestarium В® A, if possible, the listed conditions should be adjusted.
Such indicators as the magnitude of blood pressure, renal function and potassium contents in blood plasma should be monitored both before and during therapy.
Prophylaxis of recurrent stroke (combination therapy with indapamide)
In patients with cerebrovascular diseases in history, therapy with Prestarium В® A should begin with a dose of 2.5 mg in the first 2 weeks, then increasing the dose up to 5 mg for a further 2 weeks before the application of indapamide.
Therapy should be initiated at all (from 2 weeks to several years) after suffering a stroke.
Coronary artery disease: reduction in risk of cardiovascular events in patients with previous myocardial infarction and / or coronary revascularization
When stable coronary artery diseasetherapy with Prestarium В® A should begin with a dose of 5 mg 1 time / day. After 2 weeks, if tolerated, and in the condition of kidney function, the dose may be increased to 10 mg 1 time / day.
In elderly patients should start treatment at a dose of 2.5 mg 1 time / day for 1 week, then 5 mg 1 time / day for the next week. Then, given the state of the kidneys, the dose can be increased to 10 mg 1 time / day (see. Table). Increase the dose of the drug is possible only when it is well tolerated in the previously recommended dose.
Special patient groups
In patients with renal insufficiency, the dose of the drug Prestarium В® A should be selected based on QC.
Table. Dosage Prestarium preparation В® A in renal failure
QC (ml / min) The recommended dose
QC? 60 5 mg / day
30 <CC <60 2.5 mg / day
15 <CC <30 2.5 mg every other day
hemodialysis patients * QC <15 2.5 mg daily dialysis
* perindoprilat dialysis clearance of 70 ml / min. The drug should be taken after dialysis.
In appointing the drug to patients with hepatic impairment Dose adjustment is not required (see. Forums "Pharmacokinetics" and "Cautions").
Prestarium В® A should not be given to children and adolescents under the age of 18 yearsdue to lack of data on efficacy and safety of the drug in patients in this age group (see. section "Contraindications"). Currently, there is insufficient data on the safety and efficacy of perindopril in children and adolescents under the age of 18 years. Available data are described in the section "Mode of action" does not allow you to make recommendations for the application and dosage of the drug in patients in this age group.
SIDE EFFECT

The safety profile consistent with perindopril ACE inhibitors safety profile.
The most common adverse events reported in clinical trials and have been observed in the application of perindopril are: dizziness, headache, paresthesia, vertigo, blurred vision, ringing in the ears, excessive reduction of blood pressure, cough, shortness of breath, abdominal pain, constipation, diarrhea, taste disturbance, indigestion, nausea, vomiting, itching, skin rash, muscle spasms and asthenia.
Determination of the frequency of adverse reactions (according to WHO recommendations), which have been observed in clinical studies and / or post-registration application perindopril: very often (1/10?);
often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000); very rarely (<1/10 000); frequency (frequency can not be calculated from available data).
From the blood and lymphatic system: rarely * - eosinophilia; very rare - decrease in hemoglobin and hematocrit, thrombocytopenia, leucopenia / neutropenia, agranulocytosis, pancytopenia, haemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase (see "Cautions".).
On the part of metabolism: rarely * - hypoglycemia (see "Cautions" and "Drug Interactions."), Hyperkalemia, reversible after discontinuation of the drug (see section "Special instructions".), Hyponatremia.
CNS: often - paresthesia, headache, dizziness, vertigo; infrequently - sleep disturbances, mood lability, drowsiness * swoon *; very rarely - confusion.
From the senses:often - blurred vision, tinnitus.
Cardio-vascular system: often - an excessive fall in blood pressure and related symptoms; * infrequently - vasculitis, tachycardia, palpitations; very rarely - cardiac arrhythmia, angina pectoris, myocardial infarction and stroke, possibly due to excessive loss of blood pressure in patients at high risk (see section "Special instructions".).
The respiratory system: often - cough, shortness of breath; rarely - bronchospasm; very rarely - eosinophilic pneumonia, rhinitis.
From the digestive system: often - constipation, nausea, vomiting, abdominal pain, taste disturbance, indigestion, diarrhea; infrequently - dryness of the oral mucosa;very rarely - pancreatitis.

Of the liver and biliary tract: very rarely - hepatitis (cholestatic or cytolytic) (see section "Special instructions".).
For the skin and subcutaneous fat: often - itching, rash; * rarely - photosensitivity, pemphigus, increased sweating;
very rarely erythema multiforme.
Allergic reactions: infrequently - angioneurotic edema of the face, lips, upper and lower extremities, mucous membranes, tongue, vocal cords and / or the larynx, urticaria (see "Special instructions.").
On the part of the musculoskeletal system: often - muscle spasms; * rarely - arthralgia, myalgia.
The kidneys and the urinary tract: infrequently - renal failure; very rarely - acute renal failure.
Reproductive system: Infrequent - erectile dysfunction.
General disorders and symptoms: often - asthenia; infrequently - chest pain *, peripheral edema *, fatigue *, Fever *, * the fall.
From the laboratory parameters:rarely - increased activity of hepatic transaminases and bilirubin in blood serum; * rarely - increasing concentrations of urea and creatinine in the blood plasma.
* Evaluation of the frequency of adverse reactions identified by spontaneous reports, carried out on the basis of data from clinical studies.
Adverse events reported in clinical trials
The EUROPA study was conducted registration only serious adverse events. Serious adverse events were reported in 16 (0.3%) patients in group perindopril and in 12 (0.2%) patients in the placebo group. In the group of perindopril in 6 patients noted marked reduction of blood pressure in 3 patients - angioedema, 1 patient - sudden cardiac arrest. The frequency of discontinuation due to coughing, pronounced decrease in blood pressure or other cases of intolerance was higher in the group of perindopril as compared with the placebo group.
CONTRAINDICATIONS

- increased sensitivity to the active agent, other ACE inhibitors and auxiliary substances (see "Structure and Composition.") Forming part of the formulation;
- angioedema (Quincke's edema) in the history associated with the reception of an ACE inhibitor;
- Hereditary / idiopathic angioedema;
- simultaneous application of aliskiren and aliskirensoderzhaschimi drugs in patients with diabetes or impaired renal function (GFR <60 mL / min / 1.73 m 2 body surface area) (refer to "Pharmacological effect" and "Drug Interactions.");
- pregnancy (see "Pregnancy and lactation.)
- lactation (see." Pregnancy and lactation);
- age under 18 years (efficiency and safety not established).

- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

With caution (see also section "Special instructions" and "Drug Interactions.") Use in patients with bilateral renal artery stenosis, or there is only one functioning kidney;
renal failure; systemic connective tissue diseases (including systemic lupus erythematosus, scleroderma); therapy with immunosuppressors, allopurinol, procainamide (risk of neutropenia, agranulocytosis); reduced BCC (diuretics, salt-free diet, vomiting, diarrhea); angina pectoris; cerebrovascular diseases; Renovascular hypertension; diabetes mellitus; congestive heart failure NYHA class IV classification; concomitant use of potassium-sparing diuretics, potassium preparations, potassium-based salt substitutes food, drugs lithium; hyperkalemia; surgical intervention / general anesthesia; hemodialysis using high-flow membranes; desensitizing therapy; apheresis of LDL; condition after kidney transplantation; aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyopathy; in patients of the Negroid race.
PREGNANCY AND LACTATION

Prestarium В® A contraindicated in pregnancy (see. The section "Contraindications").
At the moment, there is no conclusive epidemiological data on the teratogenic risk when taking ACE inhibitors in the I trimester of pregnancy. However, we can not exclude a small increase in the risk of disorders of the fetus. When planning a pregnancy or at the time of the occurrence of the drug Prestarium В® A should immediately stop taking the drug and, if necessary, appoint another antihypertensive therapy with a proven safety profile application in pregnancy.
It is known that the effect of ACE inhibitors on the fetus in the II and III trimester of gestation may lead to disruption of its development (reduction of renal function, oligohydramnios, slowing ossification of bones of the skull) and the development of complications in the newborn (renal failure, hypotension, hyperkalaemia).
If the patient has received an ACE inhibitor in the II and III trimester of pregnancy, it is recommended to conduct ultrasound to assess the status of the skull bone and kidney function.
Newborns whose mothers received ACE inhibitors during pregnancy, should be monitored because of the risk of hypotension.
Breastfeeding period

Currently not known whether perindopril into breast milk is released. Due to the lack of information regarding the use of perindopril during breast feeding, it is not recommended. Preferably used with other drugs studied more safety profile during breast-feeding, especially when feeding infants or premature infants.
Fertility

In preclinical studies it has been shown no effects of perindopril on the reproductive function in rats of both sexes.
APPLICATION FOR FUNCTIONS OF THE LIVER

With caution should be used when the drug bilateral renal artery stenosis or the presence of only one functioning kidney; renal insufficiency.
Data on the use of the drug Prestarium В® A in patients after transplantation of a kidney.
When kidney function dose preparation Prestarium В® A should be adjusted according to the degree of renal failure and for the regular control of potassium and QC.
CC (ml / min) The recommended dose
QC? 60 5 mg / day
30 <CC <60 2.5 mg / day
15 <CC <30 2.5 mg every other day
hemodialysis patients * QC <15 2.5 mg per day of dialysis
* Dialysis clearance perindoprilat: 70 ml / min. The drug should be taken after dialysis.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with liver cirrhosis hepatic clearance of perindopril reduced by 2 times. Nevertheless, the number of perindoprilat formed is not reduced and changes in dose are required.
When administering the drug to patients with impaired liver function , dose change is required.
APPLICATION FOR CHILDREN

Do not use this drug in patients under the age of 18 years (effectiveness and safety have not been established).
APPLICATION IN ELDERLY PATIENTS

When arterial hypertension in elderly patients , treatment should begin with a dose of 2.5 mg / day. If necessary, one month after initiation of therapy dose can be increased up to 5 mg / day and then to a maximum dose - 10 mg / day in the condition of kidney function.
In CHD for reducing the risk of cardiovascular complications in patients previously suffered a myocardial infarction and / or coronary revascularization, elderly patients should start treatment at a dose of 2.5 mg 1 time / day for 1 week, then 5 mg 1 time / day over the next week. Then, given the state of the kidneys, the dose can be increased to 10 mg 1 time / day (see table). Increase the dose of the drug is possible only when it is well tolerated in the previously recommended dose.
SPECIAL INSTRUCTIONS

Coronary artery disease: reduction in risk of cardiovascular events in patients with previous myocardial infarction and / or coronary revascularization
In unstable angina during the first month of therapy with Prestarium В® A, should assess the benefits and risks before proceeding with treatment.
hypotension
ACE inhibitors may cause a sharp decrease in blood pressure. Symptomatic hypotension is rarely seen in patients with uncomplicated hypertension. The risk of excessive reduction of blood pressure is elevated in patients with reduced BCC that can be observed during therapy with diuretics, subject to strict salt-free diet, hemodialysis, with vomiting and diarrhea, as well as in patients with severe hypertension with high renin activity (see. Forums " Drug interaction "and" Side effect "). Symptomatic hypotension may occur in patients with symptomatic heart failure, with the presence of, or without renal failure. This risk is more likely in patients with heart failure, severe, in response to receiving "loop"diuretics at higher doses, hyponatremia or functional renal failure. In patients with increased risk of symptomatic hypotension should be carefully monitored blood pressure, renal function and potassium content in blood serum during therapy with PrestariumВ® A
similar approach is used in patients with ischemic heart disease and cerebrovascular diseases in which severe hypotension can lead to myocardial infarction or cerebral circulation.
In case of hypotension the patient should be placed in a horizontal position with a low headboard. If necessary, make up bcc using on / in a 0.9% sodium chloride solution. Transient hypotension is not a hindrance to further use of the drug. After restoring the bcc and BP treatment may be continued.
Some patients with chronic heart failure and normal or reduced blood pressure Prestarium В®A further reduction can cause AD. This effect is predictable and usually does not require discontinuation of therapy. If you have symptoms of significant decrease in blood pressure, reduce the dose or stop taking it.
Mitral stenosis / aortic stenosis / hypertrophic obstructive cardiomyopathy
Prestarium В® A, as well as other ACE inhibitors should be used with caution in patients with obstruction of the left ventricular outflow tract (aortic stenosis, hypertrophic obstructive
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