Prestarium A dispersible tablets 5 mg, 30 pcs. (Perindopril)

Release form

Tablets.

Packing

30 pcs.

Pharmacological action

PRESTARIUM A - antihypertensive drug, ACE inhibitor. ACE, or kininase, is an exopeptidase, which carries out both the conversion of angiotensin I into a vasoconstrictor substance angiotensin II, and the destruction of bradykinin, which has a vasodilating effect, to an inactive heptapeptide.

Suppression of ACE leads to a decrease in the content of angiotensin II in blood plasma, resulting in increased plasma renin activity (due to inhibition of negative feedback, which prevents the release of renin) and decreased aldosterone secretion. Since ACE inactivates bradykinin, p which inhibits the release of renin) and decreases the secretion of aldosterone. Since ACE inactivates bradykinin, p which inhibits the release of renin) and decreases the secretion of aldosterone. Since ACE inactivates bradykinin, pACE suppression is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin system, while the prostaglandin system is activated. Perindopril reduces OPSS, which leads to a decrease in blood pressure. At the same time, peripheral blood flow accelerates, but heart rate does not increase.

Perindopril has a therapeutic effect due to the active metabolite, perindoprilat. Other metabolites of the drug do not have an inhibitory effect on ACE in vitro.

Arterial hypertension

With arterial hypertension, with the use of the drug, there is a decrease in both systolic and diastolic blood pressure in the supine and standing position. Lowering blood pressure is achieved quite quickly. In patients with a positive response to treatment, normalization of blood pressure occurs within a month. In this case, the effect of addiction is not observed.

Discontinuation of treatment is not accompanied by the development of withdrawal syndrome. Perindopril has a vasodilating effect, helps to restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces left ventricular hypertrophy. Concomitant administration of thiazide diuretics enhances the hypotensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of developing hypokalemia while taking diuretics.

Heart failure

Perindopril normalizes heart function, reducing preload and afterload. In patients with chronic heart failure receiving perindopril, there was a decrease in filling pressure in the left and right ventricles of the heart, a decrease in heart rate, an increase in cardiac output and an increase in cardiac index. A study of the drug compared with placebo showed that changes in blood pressure after the first administration of Prestarium A at a dose of 2.5 mg in patients with mild to moderate heart failure did not statistically significantly differ from changes in blood pressure observed after taking placebo.

Cerebrovascular disease

An international multicenter study (PROGRESS) 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 perindopril tertbutylamine, 2 mg each (equivalent to perindopril arginine 2. 5 mg) 1 time / day for 2 weeks and then 4 mg (equivalent to perindopril arginine 5 mg) 1 time / day for the next two weeks, 6105 patients were randomized into two groups: placebo (n = 3054) and perindopril tertbutylamine 4 mg each (corresponding to 5 mg perindopril arginine) (monotherapy) or in combination with indapamide (n = 3051). Indapamide was additionally prescribed to patients who do not have direct indications or contraindications for the use of diuretics. This therapy was prescribed in addition to standard therapy for stroke and / or arterial hypertension or other pathological conditions. All randomized patients had a history of cerebrovascular disease (stroke or transient ischemic attack) over the past 5 years. The value of blood pressure was not an inclusion criterion: 2916 patients had arterial hypertension and 3189 had normal blood pressure. After 3.9 years of therapy, blood pressure (systolic / diastolic) decreased by an average of 9/4 mm Hg. A significant reduction in the risk of recurrent stroke (both ischemic and hemorrhagic in nature) was also shown to be of the order of 28% (95% CI (17 38), p <0.0001) compared with placebo (10.1% vs13.8%). Additionally, a significant reduction in the risk of fatal or disability-related strokes of major cardiovascular complications, including myocardial infarction, including fatal dementia associated with stroke severe deterioration in cognitive function.

These therapeutic benefits are observed both in patients with arterial hypertension and in normal blood pressure, regardless of age, gender, the presence or absence of diabetes mellitus and the type of stroke.

Stable CHD

A 4-year, international, multicenter, randomized, double-blind, placebo-controlled EUROPA study examined the efficacy of perindopril in patients with stable CHD. The clinical study involved 12218 patients over 18 years of age: 6110 patients took 8 mg perindopril tertbutylamine (equivalent to 10 mg perindopril arginine) and 6108 patients received placebo.

The main evaluation criteria were cardiovascular mortality, nonfatal myocardial infarction and / or cardiac arrest followed by successful resuscitation. Patients with coronary heart disease with established myocardial infarction at least 3 months prior to screening were selected to participate in the study. having undergone coronary revascularization at least 6 months prior to screening, angiographically detected stenosis (at least 70% of narrowing of one or more major coronary arteries) or a positive stress test if there is a history of chest pain. The drug was prescribed in addition to the standard therapy used for hyperlipidemia, arterial hypertension and diabetes mellitus.

Most patients took antiplatelet agents, lipid-lowering drugs and beta-blockers. By the end of the study, the ratio of the number of patients taking these groups of drugs was 91%, 69% and 63%, respectively. After 4.2 years, the result of therapy with perindopril tertbutylamine at a dose of 8 mg 1 time / day was a significant decrease in the relative risk by 20% (95% CI) of the development of predefined complications: in 488 (8%) patients from the perindopril tertbutylamine group, and in 603 (9.9%) patients from the placebo group (p = 0.0003).

The result was not dependent on gender, age, blood pressure or a history of myocardial infarction.

Indications

arterial hypertension

chronic heart failure

prophylaxis of re-stroke (combination therapy with indapamide) in patients who have had a stroke or transient ischemic

type stable coronary artery disease: to reduce cardiovascular risk.

Contraindications

history of angioedema (congenital / idiopathic or associated with previous treatment with an ACE inhibitor)

pregnancy

lactation period (breastfeeding)

hypersensitivity to other components of the drug

hypersensitivity to other components of the drug glucose / galactose malabsorption (due to the fact that the composition of the excipients of the drug includes lactose monohydrate).

Special instructions

Diuretic agents

In the initial period of treatment in some patients with diuretic therapy, especially with excessive excretion of liquid and / or salts, an excessive decrease in blood pressure can be observed at the very beginning of perindopril therapy, the risk of which can be reduced by canceling the diuretic, introducing an increased amount of water and / or sodium chloride, and also prescribing an ACE inhibitor at lower doses . A further increase in the dose of perindopril should be carried out with caution.

Potassium-sparing diuretics or potassium preparations, potassium-containing products and food additives

In the presence of ACE inhibitor therapy, as a rule, the serum potassium content remains within the normal range, but hyperkalemia can sometimes develop.

Combined use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamteren and amiloride) and potassium preparations, potassium-containing foods and food additives can lead to a significant increase in the concentration of potassium in the blood serum. In this regard, their joint appointment with ACE inhibitors is not recommended. These combinations should be prescribed only in case of hypokalemia, observing safety precautions and constantly monitoring the serum potassium content.

Lithium

Co-administration of ACE inhibitors and lithium preparations can lead to a reversible increase in serum lithium concentration and the development of lithium toxicity.

The additional use of thiazide diuretics in combination with lithium and ACE inhibitors increases the existing risk of lithium

toxicity. Co-administration of ACE inhibitors and lithium is not recommended. If it is impossible to avoid this combination, regular monitoring of serum lithium levels is necessary.

Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) 3 g / day.

NSAIDs may be associated with a weakening of the antihypertensive effect of ACE inhibitors. Moreover, it was found that NSAIDs and ACE inhibitors have an additive effect on the increase in serum potassium levels, while impaired renal function is also possible. As a rule, these effects are reversible. In rare cases, acute renal failure may develop, which occurs, as a rule, with an already existing impaired renal function in elderly patients or against the background of dehydration.

Antihypertensive and vasodilators

The antihypertensive effect of drugs may be enhanced by the combined use with ACE inhibitors. The use of nitroglycerin and / or other vasodilators may lead to an additional hypotensive effect.

Allopurinol, immunosuppressants, including cytotoxic drugs and systemic glucocorticosteroids, procainamide

Joint use with ACE inhibitors may increase the risk of leukopenia.

Hypoglycemic agents

Prescription of ACE inhibitors can enhance the hypoglycemic effect of insulin and oral hypoglycemic agents, up to the development of hypoglycemia. As a rule, this phenomenon is observed in the first weeks of the combined use of these drugs and in patients with renal failure.

Tricyclic antidepressants / Antipsychotics (antipsychotics) / General anesthesia

Co-administration with ACE inhibitors can lead to an increase in the hypotensive effect.

Sympathomimetics

May weaken the antihypertensive effect of ACE inhibitors. In the appointment of such a combination should regularly evaluate the effectiveness of ACE inhibitors.

Antacids

Reduce the bioavailability of ACE inhibitors.

Acetylsalicylic acid, thrombolytic agents, beta-blockers, nitrates

Perindopril may be prescribed together with acetylsalicylic acid (as a thrombolytic), thrombolytic agents, beta-blockers and / or nitrates.

Alcohol enhances the hypotensive effect of ACE inhibitors.

Composition

The active substance of the tablet Prestarium A contains: - perindopril arginine 5 mg, respectively. 3.395 mg perindopril.

Excipients: Lactose monohydrate, magnesium stearate, maltodextrin, colloidal hydrophobic silicon dioxide, sodium carboxymethyl starch, glycerol, hypromellose, macrogol 6000, titanium dioxide.

5 mg and 10 mg tablets contain copper dye, chlorophyllin (E141ii).

Dosage and administration

The drug is prescribed orally 1 time / day in the morning, before meals.

Side effects

Frequent side effects> 1/100, <1/10

Rare side effects> 1/1000, <1/100

Extremely rare side effects <1 / 10,000

Urinary system: rarely - Decreased renal function, extremely rare - Acute renal failure

Respiratory organs: often - Cough, shortness of breath, rarely - Bronchospasm, angioedema, extremely rare - Eosinophilic pneumonia, rrditis

Digestive system: often - Nausea, vomiting, abdominal pain , taste disorder diarrhea, constipation, loss of appetite, rarely - Dry mouth, extremely rare - Cholestatic or cytolytic jaundice, pancreatitis

Allergic reactions: often - Skin rash, skin itching, rarely - Urticaria, extremely rare - Erythema multiforme еema

Nervous system: often - Headache, asthenia, dizziness, tinnitus, visual impairment, muscle cramps, paresthesias, rarely - Decreased mood, sleep disturbances, extremely rare - Confusion

Other: rarely - Sweating. Sexual dysfunction

Cardiovascular disorders: excessive decrease in blood pressure and related symptoms. It is extremely rare: arrhythmia, angina pectoris, myocardial infarction and stroke, the development of secondary severe arterial hypotension in patients at risk is possible.

Laboratory findings: extremely rare: decreased hemoglobin and hematocrit concentrations, thrombocytopenia, leukopenia / neutropenia, isolated cases of agranulocytosis or pancytopenia. The possibility of developing hemolytic anemia against a background of deficiency of glucose-6-phosphate dehydrogenase. Rarely: increased levels of urea and creatinine in blood plasma, passing hyperkalemia, especially against the background of renal failure, increased activity of “liver” enzymes and liver bilirubin.

Drug interaction

In the initial period of treatment, some patients treated with diuretics, especially with excessive excretion of fluid and / or salts, may experience an excessive decrease in blood pressure, the risk of which can be reduced by canceling the diuretic, introducing an increased amount of water and / or chloride sodium, as well as prescribing an ACE inhibitor in lower doses. A further increase in the dose of perindopril should be carried out with caution.

During therapy with ACE inhibitors, as a rule, the potassium content in the blood serum remains within the normal range, but hyperkalemia can sometimes develop. The combined use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamteren and amiloride) and potassium preparations, potassium-containing foods and food additives can lead to a significant increase in the concentration of potassium in the blood serum. In this regard, their joint appointment with ACE inhibitors is not recommended. These combinations should be used only in case of hypokalemia, taking precautions and constantly monitoring the content of potassium in the blood serum.

Co-administration of ACE inhibitors and lithium preparations can lead to a reversible increase in serum lithium concentration and the development of lithium toxicity. The additional use of thiazide diuretics against the background of the combined use of lithium and ACE inhibitors increases the already existing risk of lithium toxicity. Co-administration of ACE inhibitors and lithium is not recommended. If this combination cannot be avoided, regular monitoring of serum lithium levels is necessary.

NSAIDs may be associated with a weakening of the antihypertensive effect of ACE inhibitors. Moreover, it was found that NSAIDs and ACE inhibitors have an additive effect on the increase in potassium in the blood serum, while it is also possible deterioration of renal function. As a rule, these effects are reversible. In rare cases, acute renal failure may develop, which occurs, as a rule, with an already existing impaired renal function in elderly patients or against the background of dehydration.

The antihypertensive effect of drugs may be enhanced by the combined use with ACE inhibitors. The use of nitroglycerin and / or other vasodilators may lead to an additional hypotensive effect.

With simultaneous use with ACE inhibitors, allopurinol, immunosuppressants, including cytostatic agents and systemic corticosteroids, procainamide may increase the risk of developing leukopenia.

Prescription of ACE inhibitors can enhance the hypoglycemic effect of insulin and oral hypoglycemic agents, up to the development of hypoglycemia. As a rule, this phenomenon is observed in the first weeks of the combined use of these drugs and in patients with renal failure.

Co-administration with ACE inhibitors of tricyclic antidepressants, antipsychotics (antipsychotics), general anesthesia drugs can lead to an increase in the hypotensive effect.

Sympathomimetics may attenuate the antihypertensive effect of ACE inhibitors. In the appointment of such a combination should regularly evaluate the effectiveness of ACE inhibitors.

Antacids reduce the bioavailability of ACE inhibitors.

Perindopril can be prescribed together with acetylsalicylic acid (as a thrombolytic), thrombolytic agents, beta-blockers and / or nitrates.

Ethanol enhances the hypotensive effect of ACE inhibitors.

Overdose

Symptoms: marked decrease in blood pressure, shock, electrolyte imbalance (such as increased potassium ion concentration, decreased sodium), renal failure, hyperventilation, tachycardia, dizziness, bradycardia, anxiety and cough.

Treatment: with a significant decrease in blood pressure, the patient should be placed in a lying position and immediately replenished with bcc, if possible, infuse angiotensin II and / or inject iv catecholamines. With the development of persistent severe bradycardia, the use of an artificial pacemaker may be required. Constant monitoring of the vital functions of the body, serum electrolytes and QC is necessary. Perindopril can be removed from the systemic circulation by hemodialysis. During dialysis, the use of high-flow polyacrylonitrile membranes must be avoided.

Expiration

3 years.

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