Prestarium - instructions for use, analogs, reviews and release forms (tablets 2.5 mg, 5 mg, 10 mg A with arginine) drugs for the treatment of hypertension and heart failure in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Prestarium. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Prestarium in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Prestarium in the presence of existing structural analogues. Use for the treatment of hypertension and heart failure in adults, children, as well as in pregnancy and lactation.

Prestarium - ACE inhibitor.Reduces blood pressure, which is mainly due to a violation of the formation of angiotensin 2 and the elimination of its narrowing influence mainly on the arterial vessels, as well as the stimulating effect of angiotensin 2 on the secretion of aldosterone. With long-term use, Prestarium helps restore the elasticity of large arterial vessels, reduces left ventricular hypertrophy.

In patients with chronic heart failure Prestarium reduces myocardial hypertrophy, reduces excess amount of subendocardial collagen, normalizes the isoenzymatic profile of myosin, reduces the frequency of reperfusion arrhythmias. Prestarium normalizes the work of the heart, reducing preload and afterload. When applying the drug, the pressure of filling the left and right ventricles was noted, the decrease in the OPSS, and a moderate decrease in heart rate. In the course of treatment, there is a significant improvement in the clinical signs of heart failure, an increase in exercise tolerance (according to the bicycle ergometric test).

Composition

Perindopril tert-butylamine salt + auxiliary substances (Prestarium).

Perindopril arginine + auxiliary substances (Prestarium A).

Pharmacokinetics

After ingestion Prestarium is rapidly absorbed from the digestive tract. Approximately 27% of the total amount of absorbed Perindopril is converted to perindoprilat, the active metabolite. In addition to perindoprilata, 5 metabolites are formed in the metabolism process - all of them are inactive substances. The intake of the drug during meals is accompanied by a decrease in the conversion of perindopril to perindoprilat, thus decreasing the bioavailability of the drug. Perindoprilat is excreted by the kidneys.

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 by ischemic type;
• stable CHD: to reduce the risk of cardiovascular complications.

Forms of release

Tablets 2.5 mg, 5 mg and 10 mg.

Instructions for use and reception scheme

The drug is administered orally once a day in the morning, before eating.

Arterial hypertension

The recommended initial dose is 5 mg 1 time per day, in the morning. If the therapy is ineffective for a month, the dose can be increased to 10 mg once a day.

With the appointment of ACE inhibitors, patients with severe RAAS activation (with renal arterial hypertension, water-salt balance, diuretic therapy, severe arterial hypertension, cardiac decompensation) may experience an unpredictable sharp decrease in blood pressure, for the prevention of which it is recommended to stop diuretics for 2-3 days before the expected initiation of Prestarium therapy.

If it is not possible to cancel diuretics, the initial dose of Prestarium is 2.5 mg. In this case, it is necessary to monitor kidney function and potassium content in the blood serum. In the following, if necessary, the dose may be increased.

In elderly patients, treatment should begin with a dose of 2.5 mg per day, and then, if necessary, gradually increase it up to a maximum dose of 10 mg per day.

Heart failure

Treatment with Prestarium 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 once a day, in the morning.In the future, depending on the tolerability and response to therapy, after 2 weeks of treatment the dose of the drug can be increased to 5 mg once a day.

In patients with a high risk of developing symptomatic arterial hypotension, for example, with reduced salt content with or without hyponatremia, hypovolemia, or taking diuretics, before the administration of Prestarium, the listed conditions should be adjusted as far as possible. Such indicators as the magnitude of AD, kidney function and the content of potassium in the blood plasma should be monitored both before and during therapy.

Prevention of recurrent stroke

In patients with a history of cerebrovascular disease, Prestarium should be started at a dose of 2.5 mg during the first 2 weeks before the administration of indapamide.

Therapy should be started at any time (from 2 weeks to several years) after a stroke.

Reducing the risk of cardiovascular complications

With stable ischemic heart disease, Prestarium should be started at a dose of 5 mg once a day for 2 weeks. Then the daily dose should be increased to 10 mg once a day (depending on the kidney function).

Side effect

• decreased renal function;
• cough;
• difficulty breathing;
• bronchospasm;
• angioedema;
• eosinophilic pneumonia;
• rhinitis;
• nausea, vomiting;
• abdominal pain;
• a taste disorder;
• diarrhea;
• constipation;
• decreased appetite;
• dry mouth;
• skin rash;
• itching;
• hives;
• headache;
• asthenia;
• dizziness;
• tinnitus;
• visual impairment;
• muscle cramps;
• paresthesia;
• decreased mood;
• sleep disorders;
• confusion of consciousness;
• sweating;
• violation of sexual function;
• excessive BP reduction and associated symptoms;
• arrhythmia;
• angina pectoris;
• myocardial infarction;
• stroke;
• reduction of hemoglobin and hematocrit;
• thrombocytopenia, leukopenia / neutropenia, single cases of agranulocytosis or pancytopenia.

Contraindications

• angioedema in the anamnesis (congenital / idiopathic or associated with previous treatment with ACE inhibitor reaction);
• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to the components of the drug;
• increased sensitivity to other ACE inhibitors;
• lactase insufficiency, galactosemia, glucose / galactose malabsorption syndrome (due to the fact that lactose monohydrate is included in the formulation of excipients).

Application in pregnancy and lactation

It is not recommended to use Prestarium in the first trimester of pregnancy. When planning or confirming pregnancy, you need to switch to alternative therapy. Adequate strictly controlled clinical studies on the effect of ACE inhibitors in the first trimester of pregnancy have not been conducted. In a limited number of cases of the use of ACE inhibitors in the first trimester of pregnancy, there were no developmental defects associated with fetotoxicity.

Perindopril is contraindicated in the 2nd and 3rd trimesters of pregnancy, there are data on the manifestation of fetotoxicity (decreased renal function, oligohydramnion (pronounced decrease in amniotic fluid volume), delay in formation of the skull bones) and neonatal toxicity (renal dysfunction, hypotension, hyperkalemia). If perindopril therapy was performed in the 2nd and / or 3rd trimester of pregnancy, ultrasound examination of the kidneys and skull of the fetus should be performed.

It is not known whether perindopril is excreted in breast milk in humans, so it is not recommended to use the drug during lactation (breastfeeding).

special instructions

In patients with stable coronary heart disease in the event of an episode of unstable angina (significant or not) during the first month of therapy with Prestarium A, the benefits and risks should be assessed before continuing treatment.

ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients without concomitant diseases. The risk of excessive reduction in blood pressure is increased in patients with reduced BCC, which can be observed against the background of diuretic therapy, while observing a strict salt-free diet, hemodialysis, and also with vomiting and diarrhea. In most cases, episodes of a marked decrease in blood pressure are observed in patients with severe heart failure both in the presence of concomitant renal failure and in the absence of it. Most often, this side effect is observed in patients receiving "loop" diuretics in high doses, as well as against hyponatremia or in renal dysfunction. In such patients, treatment should begin under careful medical supervision, preferably in a hospital setting. In this case, the drug is administered in small doses, followed by a thorough titration of the dose. If possible, diuretic therapy should be discontinued temporarily.This approach is also used in patients with angina pectoris or with cerebrovascular diseases in which severe arterial hypotension can lead to the development of myocardial infarction or cerebrovascular complications.

Before prescribing Prestarium, as well as other ACE inhibitors, and at the time of administration, blood pressure, renal function and potassium ion concentration in blood serum should be closely monitored.

In order to reduce the likelihood of developing symptomatic arterial hypotension in patients receiving high-dose diuretics, the dose of diuretics should be reduced, if possible, a few days before the use of Prestarium.

In the case of development of arterial hypotension the patient should be transferred in the supine position on the back. If necessary, BCC replacement should be performed by intravenous injection of physiological saline. The pronounced decrease in blood pressure at the first intake of the drug is not an obstacle to the further administration of the drug. After the recovery of bcc and blood pressure, treatment can be continued provided that the dose of the drug is carefully selected.

In patients with symptomatic heart failure, arterial hypotension, which develops during the initial period of therapy with ACE inhibitors, can lead to impaired renal function. Sometimes the developing acute renal failure is, as a rule, reversible.

In patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney (especially in the presence of renal insufficiency), the concentration of urea and creatinine in the blood serum can increase with the therapy with ACE inhibitors.

The use of ACE inhibitors in patients with reninvascular hypertension is accompanied by an increased risk of severe arterial hypotension and renal failure. Treatment of such patients begins under careful medical supervision with prescription of the drug in small doses and further adequate dose selection. During the first few weeks of therapy, it is necessary to temporarily stop treatment with diuretics and monitor kidney function.

In some patients with arterial hypertension, in the presence of previously unidentified renal failure, especially with the concomitant administration of diuretics,may increase the concentration of urea and creatinine in the serum. These changes are usually not very pronounced and are reversible. In this case, a reduction in the dose of Prestarium and / or removal of the diuretic is recommended.

In patients on hemodialysis using high-permeability membranes, several cases of persistent, life-threatening anaphylactic reactions were noted. The use of ACE inhibitors should be avoided when using this type of membrane.

There are no data on the use of Prestarium in kidney transplantation.

Angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx can develop in patients receiving ACE inhibitors, especially during the first few weeks of therapy. In rare cases, severe angioedema may occur with prolonged use of an ACE inhibitor. In such cases, treatment with an ACE inhibitor should be discontinued immediately, as a substitute, preparations of another pharmacotherapeutic group should be prescribed.

Angioedema, swelling of the tongue, glottis or larynx can lead to death.In its development, emergency therapy includes, in addition to other prescriptions, immediate subcutaneous injection of an epinephrine (adrenaline) 1: 1000 (1 mg / ml) solution of 0.3-0.5 ml or slow intravenous administration (according to the instructions for preparing an infusion solution) for ECG and blood pressure monitoring. The patient should be hospitalized for treatment and observation for at least 12-24 hours and until the symptoms of this reaction disappear completely.

When performing the procedure of apheresis of LDL with the help of dextran-sulphate absorption, in the appointment of ACE inhibitors in patients can develop anaphylactic reactions.

There are separate reports on the development of life-threatening anaphylactic reactions in patients receiving ACE inhibitors during desensitizing therapy with bee venom (bees, wasps). ACE inhibitors should be used with caution in patients with a predisposition to allergic reactions undergoing desensitization procedures. It is necessary to avoid the appointment of ACE inhibitors to patients receiving immunotherapy with bee venom. However, this reaction can be avoided by temporarily lifting the ACE inhibitor before the procedure begins.

Acceptance of ACE inhibitors is sometimes associated with a syndrome that begins with the development of cholestatic jaundice, progressing to fulminant liver necrosis, and (sometimes) fatal. The mechanism of development of this syndrome is not clear. When symptoms of jaundice appear or the activity of liver enzymes increases in patients taking ACE inhibitors, discontinue drug therapy and conduct an appropriate examination.

Neutropenia, agranulocytosis, thrombocytopenia, anemia can develop on the background of therapy with ACE inhibitors. With normal kidney function and no other complications, neutropenia occurs rarely. ACE inhibitors are prescribed only in emergency cases in the presence of systemic vasculitis, immunosuppressive therapy, reception of Allopurinol or procainamide, as well as when combining all of these factors, especially against the background of previous renal failure. There is a risk of developing severe infectious diseases resistant to intensive antibiotic therapy. When carrying out perindopril therapy in patients with the above factors, it is necessary to regularly monitorthe number of white blood cells and warn the patient about the need to inform the attending physician about the appearance of any symptoms of infection.

Against the background of therapy with an ACE inhibitor, a dry, unproductive cough may occur, which stops after the drug is discontinued.

The use of ACE inhibitors in patients whose condition requires surgical intervention and / or, if necessary, general anesthesia, can lead to the development of arterial hypotension or collapse, which is due to a sharp increase in antihypertensive action. Admission perindoprila should be discontinued one day before surgery. With the development of arterial hypotension, it is necessary to maintain blood pressure by replenishing the BCC.

Against the background of therapy with ACE inhibitors, hyperkalemia may develop, especially if the patient has renal and / or heart failure, uncontrolled diabetes mellitus. It is usually not recommended to prescribe potassium preparations, potassium-sparing diuretics and other drugs associated with the risk of increasing the potassium content (eg, heparin) because of the possibility of pronounced hyperkalemia.If joint intake of these drugs is necessary, then therapy should be accompanied by regular monitoring of potassium in the blood serum.

In patients taking hypoglycemic agents for ingestion or insulin, during the first month of therapy with ACE inhibitors, the blood glucose level must be carefully monitored.

It is not recommended to use simultaneously with perindopril lithium preparations, potassium-sparing diuretics, potassium preparations, potassium-containing foods and nutritional supplements.

Due to the fact that in the preparation excipients include lactose monohydrate, Prestarium contraindicated in patients with lactase deficiency galactosemia or syndrome glucose / galactose malabsorption. Prestanium tablets of 2.5 mg, 5 mg and 10 mg contain 36.29 mg, 72.58 mg and 145.16 mg of lactose monohydrate, respectively.

Impact on the ability to drive vehicles and manage mechanisms

ACE inhibitors should be used with caution in patients who drive vehicles and engaged in activities that require high concentration and speed of psychomotor reactions, because of the risk of arterial hypotension and dizziness.

Drug Interactions

In the initial treatment period, in some patients with diuretic therapy, especially with excess fluid and / or salt removal, there may be an excessive decrease in blood pressure, the risk of which can be reduced by eliminating the diuretic, introducing increased amounts of water and / or sodium chloride, ACE inhibitor at lower doses. A further increase in the dose of perindopril should be carried out with caution.

Against the background of therapy with ACE inhibitors, as a rule, the content of potassium in the 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 preparations of potassium, potassium-containing products and nutritional supplements can lead to a significant increase in potassium concentration in the blood serum. In this regard, their joint appointment with ACE inhibitors is not recommended. These combinations should be used only in the case of hypokalemia, observing the precautionary measures and constantly monitoring the potassium content in the blood serum.

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

The administration of NSAIDs may be accompanied by a weakening of the antihypertensive effect of ACE inhibitors. Moreover, it has been established that NSAIDs and ACE inhibitors have an additive effect on the increase in serum potassium content, and kidney function may also worsen. As a rule, these effects are reversible. In rare cases, acute renal failure may occur, usually as a result of an existing impairment of renal function in elderly patients or with dehydration of the body.

The antihypertensive effect of the drugs can be intensified against the background of combined use with ACE inhibitors.The use of Nitroglycerin and / or other vasodilators can lead to an additional hypotensive effect.

With simultaneous use with ACE inhibitors allopurinol, immunosuppressants, incl. cytostatic agents and systemic SCS, procainamide, an increased risk of developing leukopenia.

The appointment of ACE inhibitors can enhance the hypoglycemic effect of insulin and oral hypoglycemic agents right 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.

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

Sympathomimetics can weaken the antihypertensive effect of ACE inhibitors. When this combination is prescribed, the effectiveness of ACE inhibitors should be evaluated regularly.

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 (alcohol) enhances the hypotensive effect of ACE inhibitors.

Analogues of the drug Prestarium

Structural analogs for the active substance:

• Arentopress;
• Hypernica;
• Cooverex;
• Parnavell;
• Perindopril;
• Perindopril Pfizer;
• Perindopril-Richter;
• Perindopril arginine;
• Perindopril tert-butylamine;
• Perindopril erbumine;
• Perineva;
• Perinpress;
• Prestarium A;
• Stoppress.

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