Prestarium A, pills 10mg, 30pcs

Composition

>

of 1 tab. contains:

Active ingredient:

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, colloidal hydrophobic silicon dioxide-0.54 mg, sodium carboxymethyl starch-5.4 mg.

Shell composition:  premix for film sheath green 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 (E 141(ii)) – 0.29%) – 4.828 mg, macrogol 6000 – 0.172 mg.

Pharmacological action

PRESTARIUM A is an antihypertensive drug, an ACE inhibitor. ACE, or kininase, is an exopeptidase that performs both the conversion of angiotensin I to the vasoconstrictor angiotensin II, and the destruction of bradykinin, which has a vasodilating effect, to an inactive heptapeptide. ACE inhibition leads to a decrease in the content of angiotensin II in blood plasma, as a result, plasma renin activity increases (due to inhibition of negative feedback, which prevents the release of renin) and aldosterone secretion decreases. Since ACE inhibits bradykinin, ACE inhibition is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin systems, while the prostaglandin system is activated. Perindopril reduces OPSS, which leads to a decrease in blood pressure. In this case, the peripheral blood flow accelerates, but the heart rate does not increase. Perindopril has a therapeutic effect due to its active metabolite, perindoprilat. Other metabolites of the drug do not have an ACE inhibitory effect in vitro. Arterial hypertension In case of arterial hypertension against the background of its use, the drug shows a decrease in both systolic and diastolic blood pressure in the supine and standing positions. Blood pressure reduction is achieved fairly quickly. In patients with a positive response to treatment, blood pressure normalizes within a month. At the same time, 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 restore the elasticity of large arteries and the structure of the vascular wall of small arteries, and also reduces left ventricular hypertrophy. Concomitant use of thiazide diuretics increases the hypotensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of hypokalemia when taking diuretics. Heart failure Perindopril normalizes heart function by reducing preload and afterload. In patients with chronic heart failure treated with perindopril, there was a decrease in filling pressure in the left and right ventricles of the heart; a decrease in OPSS; an increase in cardiac output and an increase in the cardiac index. A study of the drug compared with placebo showed that changes in blood pressure after the first use 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. The international multicenter study (PROGRESS) evaluated the effect of active therapy with perindopril (monotherapy or in combination with indapamide) for 4 years on the risk of recurrent stroke in patients with a history of cerebrovascular diseases. After an introductory period of 2 mg perindopril tretbutylamine (equivalent to 2.5 mg perindopril arginine) once daily for 2 weeks and then 4 mg (equivalent to 5 mg perindopril arginine) once daily for the next two weeks,6105 patients were randomly assigned to two groups: placebo (n = 3054) and 4 mg perindopril tretbutylamine (equivalent 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 the standard therapy for stroke and / or arterial hypertension or other pathological conditions. All randomized patients had a history of cerebrovascular diseases (stroke or transient ischemic attack) within the last 5 years. The BP value was not a criterion for inclusion: 2916 patients had arterial hypertension and 3189 had normal BP. After 3.9 years of therapy, 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) of the order of 28% (95% CI (17; 38), pAdditionally, there was a significant reduction in the risk of fatal or disabling strokes; major cardiovascular events, including fatal myocardial infarction; stroke-related dementia; and severe cognitive impairment. These therapeutic benefits are observed both in patients with arterial hypertension and in patients with normal blood pressure, regardless of age, gender, the presence or absence of diabetes mellitus and the type of stroke. Stable CHD In a 4-year, multicenter, randomized, double-blind, placebo-controlled trial EUROPA, the efficacy of perindopril in patients with stable CHD was evaluated. A total of 12,218 patients over 18 years of age participated in the clinical trial: 6110 patients received perindopril tretbutylamine 8 mg (equivalent to 10 mg of perindopril arginine) and 6108 patients received placebo. The main evaluation criteria were cardiovascular mortality, non-fatal myocardial infarction and / or cardiac arrest followed by successful resuscitation. To participate in the study, we selected patients with CHD who had an established myocardial infarction at least 3 months prior to screening, who had undergone coronary revascularization at least 6 months prior to screening, angiographically detected stenosis (at least 70% narrowing of one or more major coronary arteries), or a positive stress test with 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 received antiplatelet agents, lipid-lowering agents, 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, treatment with perindopril tretbutylamine 8 mg once daily resulted in a significant 20% (95% CI ) reduction in the relative risk of pre-defined complications: 488 (8%) patients in the perindopril tretbutylamine group and 603 (9.9%) patients in the placebo group (p = 0.0003). The result did not depend on gender, age, blood pressure, or a history of myocardial infarction.

Indications

• arterial hypertension;
• chronic heart failure;
• prevention of recurrent stroke (combined therapy with indapamide) in patients who have had a stroke or transient ischemic cerebral circulation disorder;
• stable coronary heart disease: to reduce the risk of cardiovascular complications.

Contraindications

• a history of angioedema (congenital/idiopathic or associated with previous treatment with ACE inhibitor response);
• pregnancy;
• lactation (breastfeeding);
• hypersensitivity to the components of the drug;
• hypersensitivity to other ACE inhibitors;
• lactase insufficiency, galactosemia, a syndrome glucose/galactose malabsorption (due to the fact that the composition of the excipients of the drug includes lactose monohydrate).

Side effects

Common side effects >1/100, >< 1/10 Rare Side effects > 1/1000, < 1/10 Rare Side effects >< 1/100 Extremely rare Side effects < 1 / 10,000

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

Respiratory system: often-Cough, difficulty breathing, rarely-Bronchospasm, angioedema, extremely rare-Eosinophilic pneumonia, rhinitis

Digestive system: often – Nausea, vomiting, abdominal pain, taste disorders diarrhea, constipation, decreased appetite, rarely-Dry mouth, extremely rarely-Cholestatic or cytolytic jaundice, pancreatitis

Allergic reactions: often – Skin rash, pruritus, rarely-Urticaria, extremely rarely-Erythema multiforme

Nervous system: often – Headache, asthenia, dizziness, ringing in the ears, visual disturbances, muscle cramps, paresthesia, rarely-Decreased mood, sleep disorders, extremely rarely-Confusion

Other: rarely-Sweating. Sexual dysfunction

Cardiovascular disorders: excessive lowering of blood pressure and associated symptoms. Extremely rare: arrhythmia, angina pectoris, myocardial infarction and stroke, may develop secondary severe arterial hypotension in patients at risk.

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

Interaction

In the initial period of treatment, some patients with diuretic therapy, especially with excessive excretion of fluids and/or salts, may experience an excessive decrease in blood pressure, the risk of which can be reduced by discontinuing the diuretic, introducing an increased amount of water and/or sodium chloride, as well as prescribing an ACE inhibitor in lower doses. Further increase in the dose of perindopril should be carried out with caution. During therapy with ACE inhibitors, as a rule, the content of potassium in the blood serum remains within normal limits, but sometimes hyperkalemia may develop. The combined use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene and amiloride) and potassium preparations, potassium-containing products and food additives can lead to a significant increase in the concentration of potassium in the blood serum. In this regard, their co-use with ACE inhibitors is not recommended. These combinations should be used only in the case of hypokalemia, taking precautions and constantly monitoring the potassium content in the blood serum. Co-use of ACE inhibitors and lithium preparations may lead to a reversible increase in serum lithium concentrations 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 – use of ACE inhibitors and lithium is not recommended. If this combination cannot be avoided, then regular monitoring of the lithium content in the blood serum is necessary. The use of NSAIDs may be accompanied by a weakening of the antihypertensive effect of ACE inhibitors. Moreover, NSAIDs and ACE inhibitors have been found to have an additive effect on increasing serum potassium levels, while possibly also impairing renal function. As a rule, these effects are reversible. In rare cases, acute renal failure may develop, which usually occurs with pre-existing renal dysfunction in elderly patients or against the background of dehydration. The antihypertensive effect of these drugs may be enhanced by concomitant use with ACE inhibitors. The use of nitroglycerin and / or other vasodilators may lead to an additional hypotensive effect. Concomitant use with ACE inhibitors allopurinol, immunosuppressants, including cytostatic agents and systemic corticosteroids, procainamide may increase the risk of leukopenia. The use of ACE inhibitors may increase 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 combined use of these drugs and in patients with renal insufficiency. Concomitant use of tricyclic antidepressants, antipsychotics (neuroleptics), and general anesthesia with ACE inhibitors may lead to an increased hypotensive effect. Sympathomimetics may weaken the antihypertensive effect of ACE inhibitors. When prescribing such a combination, the effectiveness of ACE inhibitors should be regularly evaluated. Antacids reduce the bioavailability of ACE inhibitors. Perindopril can be administered together with acetylsalicylic acid (as a thrombolytic), thrombolytic agents, beta-blockers and / or nitrates. Ethanol enhances the antihypertensive effect of ACE inhibitors.

How to take, course of use and dosage

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

Overdose

Symptoms: marked decrease in blood pressure, shock, electrolyte disturbances (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 supine position and immediately replenish the BCC, if possible, conduct an infusion of angiotensin II and/or introduce intravenous catecholamines. With the development of persistent pronounced bradycardia, it may be necessary to use an artificial pacemaker.

Constant monitoring of vital body functions, serum electrolytes and creatinine clearance is required. Perindopril can be removed from the systemic circulation by hemodialysis. High-flow polyacrylonitrile membranes should be avoided during dialysis.

Special instructions

Diuretics In the initial period of treatment, some patients with diuretic therapy, especially with excessive fluid and/or salt excretion, may experience an excessive decrease in blood pressure at the very beginning of perindopril therapy, the risk of which can be reduced by discontinuing the diuretic, introducing an increased amount of water and/or sodium chloride, as well as prescribing an ACE inhibitor in lower doses. Further increase in the dose of perindopril should be carried out with caution. Potassium-sparing diuretics or potassium preparations, potassium-containing products and dietary supplements during therapy with ACE inhibitors, as a rule, the content of potassium in the blood serum remains within normal limits, but sometimes hyperkalemia may develop. The combined use of ACE inhibitors and potassium-sparing diuretics (spironolactone, triamterene and amiloride) and potassium preparations, potassium-containing products and food additives can lead to a significant increase in the concentration of potassium in the blood serum. In this regard, their co-use with ACE inhibitors is not recommended. Prescribe these combinations only in the case of hypokalemia, taking precautions and constantly monitoring the content of potassium in the blood serum. Lithium-couse of ACE inhibitors and lithium preparations can lead to a reversible increase in serum lithium concentrations and the development of lithium toxicity. The additional use of thiazide diuretics in combination with lithium and ACE inhibitors increases the already existing risk of lithium toxicity. Co – use of ACE inhibitors and lithium is not recommended. If it is impossible to avoid this combination, it is necessary to conduct regular monitoring of the lithium content in the blood serum. Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid (aspirin) ≥ 3 g / day. The use of NSAIDs may be accompanied by a weakening of the antihypertensive effect of ACE inhibitors. Moreover, NSAIDs and ACE inhibitors have been found to have an additive effect on increasing serum potassium levels, while possibly also impairing renal function. As a rule, these effects are reversible. In rare cases, acute renal failure may develop, which usually occurs with pre-existing renal dysfunction in elderly patients or against the background of dehydration. Antihypertensive and vasodilating agents The antihypertensive effect of drugs may be enhanced by combined use with ACE inhibitors. The use of nitroglycerin and / or other vasodilators may lead to an additional hypotensive effect. Allopurinol, immunosuppressants, including cytostatic agents and systemic glucocorticosteroids, Procainamide co-use with ACE inhibitors may increase the risk of leukopenia. Hypoglycemic agents use of ACE inhibitors may increase 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 combined use of these drugs and in patients with renal insufficiency. Tricyclic Antidepressants/ Antipsychotics (neuroleptics)/ General anaesthetic agents Co-administered with ACE inhibitors may lead to an increased hypotensive effect. Sympathomimetics may weaken the antihypertensive effect of ACE inhibitors. When prescribing such a combination, the effectiveness of ACE inhibitors should be regularly evaluated. Antacids reduce the bioavailability of ACE inhibitors. Acetylsalicylic acid, thrombolytic agents, beta-blockers, nitraty Perindopril can be prescribed together with acetylsalicylic acid (as a thrombolytic), thrombolytic agents, beta-blockers and / or nitrates. Alcohol increases the hypotensive effect of ACE inhibitors.

Storage conditions

No special storage conditions are required

Shelf life

3 years

Active ingredient

Perindopril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart failure, Hypertension, Angina, Prevention of heart attacks and strokes