Servier #Circulatory_system #Decrease_in_pressure #HEALTH_CARE
Product description
Tablets "Prestarium® 5 mg" in this dosage are used for the following indications:
- arterial hypertension;
- heart failure;
- prevention of recurrent stroke in patients with cerebrovascular diseases;
- prevention of cardiovascular complications in patients with documented stable ischemic heart disease (long-term treatment reduces the risk of myocardial infarction and heart failure (according to the EUROPA study)).
Compound
The active substance is perindopril arginine (one tablet contains perindopril arginine 5 mg, which corresponds to 3.395 mg of perindopril).
Excipients: lactose monohydrate, magnesium stearate, maltodextrin, colloidal hydrophobic silicon, sodium starch glycolate (type A), glycerin (E 422a), hypromellose (E 464), macrogol 6000, titanium dioxide (E 171), copper chlorophyllin (E 141іi) .
Contraindications
- hypersensitivity to perindopril or to any of the excipients, or to any other ACE inhibitor;
- history of angioedema associated with previous treatment with an ACE inhibitor;
- idiopathic or hereditary angioedema;
- pregnant women or women who plan to become pregnant;
- simultaneous use with preparations containing the active substance aliskiren in patients with diabetes mellitus or impaired renal function (glomerular filtration rate < 60 ml / minute / 1.73 m2);
- simultaneous use with sacubitril / valsartan;
- extracorporeal therapies that bring the blood into contact with negatively charged surfaces;
- significant bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney.
Mode of application
For oral use.
Tablets of 5 mg are to be divided into two equal parts.
Tablets are recommended to be taken 1 time per day in the morning before meals.
The dose should be selected individually, depending on the patient's profile, blood pressure indicators and response to treatment.
Arterial hypertension
Perindopril arginine can be given alone or in combination with other classes of antihypertensive preparations.
The recommended starting dose is 5 mg once daily in the morning.
Patients with high activity of the renin-angiotensin-aldosterone system (especially patients with renovascular hypertension, fluid and electrolyte imbalance, cardiac decompensation or severe hypertension) may experience an excessive decrease in blood pressure after taking the first dose. It is recommended that such patients start treatment with a dose of 2.5 mg and start therapy under the supervision of a physician.
The dose can be increased to 10 mg 1 time per day after 1 month of treatment.
At the beginning of the use of perindopril arginine, symptomatic arterial hypotension may occur; this is more likely in patients who are taking diuretics concomitantly. In such patients, treatment with perindopril should be initiated with caution, as they may be deficient in water and/or salt.
If possible, diuretics should be discontinued 2-3 days before the start of perindopril arginine therapy.
In patients with arterial hypertension who cannot be discontinued from diuretics, treatment should be started with a dose of 2.5 mg. In such patients, renal function and serum potassium levels should be monitored. Further increase in the dose of perindopril arginine should be carried out depending on the indicators of blood pressure. If necessary, diuretic therapy can be restored.
Elderly patients should begin treatment with a dose of 2.5 mg, which can be increased to 5 mg after 1 month of treatment, and then, if necessary, up to 10 mg, taking into account renal function.
Symptomatic heart failure
Patients with heart failure in whom perindopril arginine should usually be given concomitantly with a potassium-wasting diuretic and/or digoxin and/or a β-blocker are advised to start treatment under close supervision and with an initial dose of 2.5 mg taken in the morning. After two weeks, subject to good tolerance, increase the dose to 5 mg 1 time per day. In the future, the dose should be selected individually, depending on the clinical response of the patient to treatment.
Patients with severe heart failure and other high-risk patients (patients with impaired renal function and a tendency to electrolyte disturbances, patients receiving concomitant therapy with diuretics and / or vasodilators) should begin treatment under close supervision.
In patients at high risk of symptomatic arterial hypotension, namely, patients with electrolyte deficiency with or without hyponatremia, patients with hypovolemia or those who received intensive diuretic therapy, the above conditions should be corrected, if possible, before prescribing the preparation. Blood pressure, kidney function and serum potassium levels should be carefully monitored both before and during treatment.
Prevention of recurrent stroke in patients with cerebrovascular disease
The recommended starting dose is 2.5 mg once daily in the morning. After 2 weeks of treatment, increase the dose to 5 mg 1 time per day in the morning. If, after 2 weeks of treatment with Prestarium® 5 mg, the patient needs additional control of blood pressure, indapamide can be prescribed at a dose of one tablet per day. Treatment can be started at any time from 2 weeks to several years after the initial stroke.
Prevention of cardiovascular complications in patients with documented stable ischemic heart disease
Long-term treatment with Prestarium® 10 mg (one tablet per day) reduces the risk of myocardial infarction and heart failure (according to the results of the 4-year EUROPA study). Treatment should begin with the preparation "Prestarium® 5 mg" (one tablet per day in the morning). After two weeks, subject to good tolerance, increase the dose to 10 mg for long-term use of the preparation "Prestarium® 10 mg" one tablet per day in the morning.
Elderly patients with documented coronary heart disease should start treatment with a dose of 2.5 mg once daily in the morning, increasing to 5 mg a week later; after 2 weeks, subject to good tolerance and depending on kidney function, increase the dose to 10 mg and start long-term treatment.
Application features
Children
The efficacy and safety of use in children under 18 years of age has not been established. Perindopril arginine is not recommended for children.
Drivers
Perindopril arginine does not directly affect the ability to drive and use machines. But some patients may experience individual reactions associated with a decrease in blood pressure, especially at the beginning of treatment or when used simultaneously with other antihypertensive preparations. As a result, the ability to drive or use machines may be impaired.
Overdose
There is not enough information on overdose of perindopril. Symptoms associated with an overdose of ACE inhibitors may be as follows: arterial hypotension, circulatory shock, electrolyte imbalance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough, and the like.
In case of an overdose, the introduction of a 0.9% sodium chloride solution (9 mg / ml) is recommended. In the event of arterial hypotension, the patient must be given a horizontal position with a low headboard. If possible, the patient should be given angiotensin II infusion and/or catecholamine administration. Perindopril can be removed from the systemic circulation by hemodialysis. In the event of treatment-resistant bradycardia, the use of an artificial pacemaker is indicated. It is necessary to establish constant monitoring of the main vital signs, the concentration of electrolytes and creatinine in the blood plasma.
Side effects
The safety profile of perindopril is consistent with that of ACE inhibitors. The most common adverse reactions reported during clinical trials with perindopril are: dizziness, headache, paresthesia, vertigo, blurred vision, tinnitus, hypotension, cough, shortness of breath, abdominal pain, constipation, diarrhea, taste perversion (dysgeusia ), dyspepsia, nausea, vomiting, pruritus, rash, maculopapular rash, muscle cramps and asthenia.
Storage conditions
Store tablets in a tightly closed container and out of the reach of children.
Shelf life - 3 years.
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