Prestanz tablets 10 mg + 10 mg, 30 pcs. (3fromodiprinfromodiprind103 ryl)

Release form

Tablets.

Packing

30 pcs.

Pharmacological action

Prestanz tablets - a combined antihypertensive and antianginal drug. Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (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 effect, to an inactive heptapeptide. Since ACE inactivates bradykinin, ACE suppression is accompanied by an increase in the activity of both the circulating and tissue kallikrein-kinin systems, while the prostaglandin system is also activated. Perindopril has a therapeutic effect due to the active metabolite, perindoprilat. Other metabolites do not inhibit ACE in vitro. Perindopril is a drug for the treatment of hypertension of any severity. Against the background of its use, there is a decrease in both systolic and diastolic blood pressure in the supine and standing position. Perindopril reduces OPSS, which leads to a decrease in high blood pressure and an improvement in peripheral blood flow without a change in heart rate. As a rule, taking perindopril increases renal blood flow, the glomerular filtration rate does not change. The antihypertensive effect of the drug reaches a maximum 4-6 hours after a single oral administration and persists for 24 hours. The antihypertensive effect 24 hours after a single oral administration is about 87-100% of the maximum antihypertensive effect. Lowering blood pressure is achieved quite quickly. The therapeutic effect occurs less than 1 month after the start of therapy and is not accompanied by tachycardia. Discontinuation of treatment does not cause 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. The efficacy of perindopril in patients (12,218 patients over 18 years of age) with stable coronary artery disease without clinical symptoms of chronic heart failure was studied in a 4-year study (EUROPA). 90% of the study participants had previous acute myocardial infarction or coronary revascularization. Therapy with perindopril tertbutylamine at a dose of 8 mg / day (equivalent to 10 mg of perindopril arginine) led to a significant decrease in the absolute risk of complications by 1.9%, in patients who had previous myocardial infarction or coronary revascularization, the decrease in absolute risk was 2.2% compared with the placebo group. Amlodipine is a slow calcium channel blocker, a derivative of the dihydropyridine series. Amlodipine inhibits the transmembrane transition of calcium ions to cardiomyocytes and smooth muscle cells of the vascular wall. The antihypertensive effect of amlodipine is due to a direct effect on the smooth muscle cells of the vascular wall. It was established that amlodipine causes the expansion of peripheral arterioles, decreasing OPSS (afterload), since heart rate does not change, and myocardial oxygen demand decreases. It causes the expansion of coronary arteries and arterioles in both ischemic and intact zones. In patients with Prinzmetal angina, coronary blood flow improves. In patients with arterial hypertension, taking amlodipine 1 time / day provides a clinically significant decrease in blood pressure when standing and lying down for 24 hours. The antihypertensive effect develops slowly, and therefore the development of acute arterial hypotension is uncharacteristic. In patients with angina pectoris, taking amlodipine 1 time / day increases exercise tolerance, delays the onset of an attack of angina pectoris and ischemic depression of the ST segment, and also reduces the frequency of angina attacks and consumption of nitroglycerin (short-acting forms). Amlodipine does not affect the lipid profile and does not cause changes in lipid-lowering blood plasma parameters. The drug can be used in patients with concomitant bronchial asthma, diabetes mellitus and gout. The efficacy and safety of the use of amlodipine at a dose of 2.5-10 mg / day, an ACE inhibitor lisinopril at a dose of 10-40 mg / day and a thiazide diuretic chlortalidone at a dose of 12.5-25 mg / day as a first-line drug was studied in a 5-year ALLHAT study ( involving 33,357 patients aged 55 years and older) in patients with mild to moderate arterial hypertension and at least one of the additional risk factors for coronary complications, such as: myocardial infarction or stroke, more than 6 months before inclusion in the study, or other confirmed cardiovascular disease of atherosclerotic origin, diabetes mellitus HDL cholesterol less than 35 mg / dl left ventricular hypertrophy according to ECG or echocardiography smoking. The main criterion for assessing effectiveness is a combined indicator of the frequency of deaths from coronary heart disease and the frequency of non-fatal myocardial infarction. There were no significant differences between the groups of amlodipine and chlortalidone according to the main evaluation criterion. The frequency of heart failure in the amlodipine group was significantly higher than in the chlortalidone group - 10.2% and 7.7%, respectively, the overall frequency of deaths in the amlodipine and chlortalidone group did not differ significantly. Effectiveness with prolonged use of amlodipine in combination with perindopril and atenolol in combination with bendroflumethiazide in patients aged 40 to 79 years with arterial hypertension and at least 3 of the additional risk factors: left ventricular hypertrophy according to ECG or echocardiography diabetes mellitus 2 such as peripheral arterial atherosclerosis, a previous stroke or transient ischemic attack male sex 55 years of age and older with microalbuminuria or proteinuria smoking with total cholesterol / cholester Institute of HDL 6 early development of coronary heart disease in immediate families was studied in the ASCOT-BPLA study. The main criterion for assessing effectiveness is a combined indicator of the frequency of non-fatal myocardial infarction (incl. painless) and death of coronary heart disease. The frequency of complications stipulated by the main evaluation criterion was 10% lower in the amlodipine / perindopril group than in the atenolol / bendroflumethiazide group, but this difference was not statistically significant. In the amlodipine / perindopril group, there was a significant decrease in the frequency of complications provided for by additional performance criteria (except for fatal and non-fatal heart failure).

Indications

- Arterial hypertension.

- CHD: stable angina pectoris in patients who require perindopril and amlodipine therapy.

Contraindications

- Renal failure (CC less than 60 ml / min).

- Age under 18 years of age (efficacy and safety not established).

- Hereditary lactose intolerance, lactase deficiency and glucose / galactose malabsorption syndrome.

- Hypersensitivity to excipients that make up the drug.

Precautions:

- Renal artery stenosis (including bilateral).

- The only functioning kidney.

- Liver failure.

- Renal failure.

- Systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma).

- Therapy with immunosuppressants, allopurinol, procainamide (risk of neutropenia, agranulocytosis).

- Reduced bcc (intake of diuretics, salt-free diet, vomiting, diarrhea).

- Atherosclerosis.

- Cerebrovascular disease.

- Renovascular hypertension.

- Diabetes mellitus.

- Chronic heart failure.

- Use of dantrolene, estramustine, potassium-sparing diuretics, potassium preparations, potassium-containing salt substitutes and lithium preparations.

- Hyperkalemia.

- Surgery / General Anesthesia.

- Old age.

- Hemodialysis using high flow membranes (e.g. AN69 В®).

- Desensitizing therapy.

- Apheresis LDL.

- Aortic stenosis / mitral stenosis / hypertrophic cardiomyopathy.

- Patients of the Negroid race.

Use during pregnancy and lactation

The drug is contraindicated in pregnancy. With the exception of cases when therapy with Prestance is necessary for health reasons, when planning pregnancy, the drug should be discontinued and other antihypertensive agents approved for use during pregnancy should be prescribed. When pregnancy occurs, you should immediately stop taking Prestans and, if necessary, prescribe another therapy. It is known that the effects of ACE inhibitors on the fetus in the second and third trimesters of pregnancy can lead to impaired development (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia). breastfeeding should be discontinued.

Special instructions

Precautions relating to perindopril and amlodipine, applicable to the drug Prestanz.

Perindopril: Hypersensitivity / Angioedema: when taking ACE inhibitors, including and perindopril, in rare cases, the development of angioedema of the face, limbs, lips, mucous membranes, tongue, vocal cords and / or larynx can be observed. When symptoms appear, the drug should be stopped immediately, and the patient should be observed until the signs of edema disappear completely. If edema affects only the face and lips, then its manifestations usually go away on their own, although antihistamines can be used to treat symptoms. Angioneurotic edema, accompanied by laryngeal edema, can be fatal. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction. When these symptoms appear, epinephrine (adrenaline) should be administered subcutaneously immediately and / or airway should be ensured. The patient should be under medical supervision until the symptoms disappear completely and persistently. In patients with a history of Quincke’s edema, not associated with ACE inhibitors, the risk of its development when taking drugs of this group may be increased. In rare cases, against the background of therapy with ACE inhibitors, angioedema of the intestine develops. In this case, patients have abdominal pain as an isolated symptom or in combination with nausea and vomiting, in some cases, without previous angioedema of the face and with a normal level of C1 esterase. The diagnosis is made using computed tomography of the abdominal region, ultrasound or at the time of surgery. Symptoms disappear after stopping ACE inhibitors. Therefore, in patients with pain in the abdomen receiving ACE inhibitors, when conducting differential diagnosis, it is necessary to take into account the possibility of developing angioedema of the intestine.

Anaphylactoid reactions during LDL apheresis: in rare cases, patients receiving ACE inhibitors may develop life-threatening anaphylactoid reactions when performing LDL apheresis using dextran. To prevent anaphylactoid reaction, ACE inhibitor therapy should be temporarily discontinued before each apheresis procedure.

Anaphylactoid reactions during desensitization: there are separate reports of the development of anaphylactoid reactions in patients receiving ACE inhibitors during desensitization therapy (e.g. Hymenoptera venom). In these same patients, the anaphylactoid reaction was avoided by temporarily disabling ACE inhibitors, and with an accidental administration of the drug, the anaphylactoid reaction occurred again.

Neutropenia, agranulocytosis, thrombocytopenia, anemia: neutropenia / agranulocytosis, thrombocytopenia, and anemia may occur with ACE inhibitors. In patients with normal renal function and in the absence of other aggravating factors, neutropenia develops rarely. With extreme caution, perindopril should be used in patients with diffuse diseases of the connective tissue, while taking immunosuppressants, allopurinol or procainamide, especially in patients with impaired renal function. Some patients experienced severe infectious lesions, in some cases resistant to intensive antibiotic therapy. When prescribing perindopril to such patients, it is recommended to periodically monitor the number of leukocytes in the blood. Patients should inform the doctor of any signs of an infectious disease.

Arterial hypotension: ACE inhibitors can cause a sharp decrease in blood pressure. Symptomatic arterial hypotension rarely develops in patients without concomitant diseases. The risk of an excessive decrease in blood pressure is increased in patients with reduced BCC, which can be observed during diuretic therapy, with a strict salt-free diet, hemodialysis, diarrhea and vomiting, as well as in patients with severe arterial hypertension with high renin activity. In patients with an increased risk of developing symptomatic arterial hypotension, it is necessary to carefully control blood pressure, renal function and serum potassium during treatment with Prestanz. A similar approach is also used in patients with angina pectoris and cerebrovascular diseases, in which severe arterial hypotension can lead to myocardial infarction or impaired cerebral circulation. In the event of the development of arterial hypotension, the patient should be transferred to the supine position with raised legs. If necessary, BCC should be replenished by iv injection of 0.9% sodium chloride solution. Transient arterial hypotension is not an obstacle to further administration of the drug. After the restoration of BCC and blood pressure, treatment can be continued.

Mitral stenosis, aortic stenosis, hypertrophic cardiomyopathy: Prestanz, like other ACE inhibitors, it should be used with caution in patients with left ventricular outlet tract obstruction (aortic stenosis, hypertrophic cardiomyopathy), as well as in patients with mitral stenosis.

Impaired renal function: patients with renal failure (CC less than 60 ml / min) are advised to individually select the doses of perindopril and amlodipine. Such patients need regular monitoring of serum potassium and creatinine. In patients with bilateral renal artery stenosis or stenosis of a single kidney artery during treatment with ACE inhibitors, an increase in the content of urea and creatinine in the blood serum, which usually occurs when therapy is canceled, is possible. More often this effect is observed in patients with renal failure. The additional presence of renovascular hypertension leads to an increased risk of developing severe arterial hypotension and renal failure in such patients. In some patients with arterial hypertension without signs of damage to the blood vessels of the kidneys, an increase in the concentration of urea and creatinine in the blood serum is possible, especially with the combined appointment of perindopril with a diuretic, usually insignificant and transient. More often this effect is observed in patients with previous impaired renal function.

Hepatic insufficiency: in rare cases, while taking ACE inhibitors, cholestatic jaundice occurs. With the progression of this syndrome, fulminant liver necrosis develops, sometimes with a fatal outcome. The mechanism of development of this syndrome is unclear. If jaundice or a significant increase in the activity of liver enzymes occurs while taking ACE inhibitors, you should stop taking the drug and consult a doctor.

Ethnic differences: patients of the Negroid race are more likely than representatives of other races to develop angioedema while taking ACE inhibitors. Perindopril, like other ACE inhibitors, may have a less pronounced hypotensive effect in patients of the Negroid race compared with representatives of other races. Perhaps this difference is due to the fact that patients with arterial hypertension of the Negroid race are more likely to have low renin activity.

Cough: Dry cough may occur during treatment with an ACE inhibitor. The cough persists for a long time while taking drugs of this group and disappears after they are canceled. If a patient develops a dry cough, one should remember the possible iatrogenic nature of this symptom.

Surgical intervention / general anesthesia: the use of ACE inhibitors in patients undergoing extensive surgery and / or general anesthesia can lead to a marked decrease in blood pressure if agents for general anesthesia with a hypotensive effect are used. This is due to the blocking of the formation of angiotensin II against the background of a compensatory increase in renin activity. If the development of arterial hypotension is associated with the described mechanism, the volume of circulating plasma should be increased. It is recommended to stop taking the drug 24 hours before surgery.

Hyperkalemia may develop during treatment with ACE inhibitors, including and perindopril. Risk factors for hyperkalemia are renal failure, advanced age (over 70 years), diabetes mellitus, certain concomitant conditions (dehydration, acute decompensation of chronic heart failure, metabolic acidosis), the simultaneous use of potassium-sparing diuretics (such as spironolactone and its derivative eplerenone, triamterene, amiloride), as well as potassium or potassium-containing substitutes for edible salt, as well as the use of other drugs that increase the potassium content in blood plasma (for example, heparin). The use of potassium preparations, potassium-sparing diuretics, potassium-containing substitutes for edible salt can lead to a significant increase in the level of potassium in the blood, especially in patients with reduced renal function. Hyperkalemia can lead to serious, sometimes fatal heart rhythm disturbances. If simultaneous administration of perindopril and the above drugs is necessary, treatment should be carried out with caution against the background of regular monitoring of potassium in the blood serum.

Patients with diabetes mellitus: when prescribing the drug to patients with diabetes mellitus receiving hypoglycemic agents for oral administration or insulin, it is necessary to carefully monitor the concentration of glucose in the blood during the first month of therapy.

Amlodipine: Liver failure: in patients with impaired liver function, T 1/2 of amlodipine increases. When prescribing the drug to such patients, caution should be exercised and regular monitoring of the activity of liver enzymes.

Chronic heart failure: Caution should be exercised when prescribing amlodipine to patients with chronic heart failure.

Prestanz: due to the presence of lactose in the composition of the drug, the drug should not be prescribed to patients with hereditary lactose intolerance, lactase deficiency and glucose / galactose malabsorption syndrome.

Due to the possible development of weakness and dizziness, caution should be exercised when driving vehicles and engaging in certain activities that require increased concentration of attention and rapid motor response.

Composition of

1 tablet contains: perindopril 10 mg and amlodipine 10 mg.

Dosage and administration

The drug is administered orally, 1 tablet 1 time / day, preferably in the morning before meals. The dose of Prestanz is selected after a previous titration of doses of the individual components of the drug: perindopril and amlodipine in patients with arterial hypertension and stable angina pectoris. With therapeutic need, the dose of Prestanz may be changed based on individual selection of doses of the individual components: 5 mg of perindopril + 5 mg of amlodipine or 5 mg of perindopril + 10 mg of amlodipine or 10 mg of perindopril + 5 mg of amlodipine or 10 mg of perindopril + 10 mg of amlodipine . Prestanz in doses of 10 mg perindopril + 10 mg amlodipine is the maximum daily dose that should not be exceeded. Excretion of perindoprilat in elderly patients and patients with renal failure is slowed down. Therefore, in such patients, it is necessary to regularly monitor the concentration of creatinine and potassium in the blood plasma. Prestanz may be prescribed to patients with CC> 60 ml / min. Prestanz is contraindicated in patients with CC <60 ml / min. Such patients are recommended an individual selection of doses of perindopril and amlodipine. A change in the concentration of amlodipine in blood plasma does not correlate with the severity of renal failure. Prestanz should not be prescribed to children and adolescents under 18 years of age due to a lack of data on the efficacy and safety of perindopril and amlodipine in these patient groups, both as monotherapy and as combination therapy.

Side effects of the

From the hemopoietic system: very rarely - leukopenia, neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, hemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase, decreased hemoglobin and hematogen levels.

Allergic reactions: infrequently - urticaria.

Metabolic disorders: infrequently - weight gain, weight loss. Very rarely - hyperglycemia.

From the side of the central nervous system: often - drowsiness, dizziness, headache, paresthesia infrequently - insomnia, lability of mood, sleep disturbance, tremor, hypesthesia very rarely - peripheral neuropathy, confusion.

From the side of the organ of vision: often - visual disturbances.

On the part of the hearing organ: often - tinnitus.

From the cardiovascular system: often - palpitations, flushing of the face, a marked decrease in blood pressure. Infrequently - fainting. Rarely - pain behind the sternum. Very rarely - angina pectoris, myocardial infarction, possibly due to an excessive decrease in blood pressure in patients at high risk, arrhythmias (including bradycardia, ventricular tachycardia and atrial fibrillation), stroke, possibly due to an excessive decrease in blood pressure in patients from high risk, vasculitis.

From the respiratory system: often - shortness of breath, cough infrequently - rhinitis, bronchospasm very rarely - eosinophilic pneumonia.

From the digestive system: often - abdominal pain, nausea, vomiting, dyspepsia, taste disturbance, diarrhea, constipation infrequently - constipation, dry oral mucosa rarely - elevated bilirubin levels are very rare - pancreatitis, gingival hyperplasia, gastritis, hepatitis, cholestatic jaundice, cytolytic or cholestatic hepatitis, increased activity of liver enzymes ACT, ALT (most often in combination with cholestasis).

From the skin: often - itching, rash infrequently - angioedema of the face, limbs, lips, mucous membranes, tongue, glottis and / or larynx, alopecia, hemorrhagic rash, photosensitivity, increased sweating very rarely - Quincke's edema, multiform erythema, Stevens-Johnson syndrome.

From the musculoskeletal system: often - muscle spasms infrequently - arthralgia, myalgia, back pain.

From the kidneys and urinary tract: infrequently - impaired urination, nocturia, rapid urination, renal failure is very rare - severe renal failure.

From the reproductive system: infrequently - impotence, gynecomastia.

On the part of the body as a whole: often - peripheral edema, asthenia, increased fatigue. Infrequently - chest pain, malaise.

Laboratory indicators: unspecified frequency - increased serum urea and creatinine, hyperkalemia.

Overdose

There is no information on an overdose of Prestance.

Amlodipine

Information on overdose on amlodipine is limited.

Symptoms: pronounced decrease in blood pressure with possible development of reflex tachycardia and excessive peripheral vasodilation (risk of developing severe and persistent arterial hypotension, including with the development of shock and death).

Treatment: gastric lavage, appointment of activated charcoal (especially in the first 2 hours after overdose), maintenance of function of cardiovascular system, elevated position of extremities, control of BCC and diuresis, symptomatic and supportive therapy, in / in introduction of calcium of gluconate and dopamine. Dialysis is ineffective. With a significant decrease in blood pressure, the patient should be monitored under cardiac OIT. In the absence of contraindications, vasoconstrictors can be used to restore vascular tone and blood pressure.

Perindopril

Perindopril overdose is limited.

Symptoms: significant decrease in blood pressure, shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.

Treatment: With a significant decrease in blood pressure, the patient should be placed in a supine position with his / her feet raised, if necessary, correct for hypovolemia (eg, infusion of 0.9% sodium chloride solution). It is also possible to administer angiotensin II and / or catecholamines. With hemodialysis, perindopril can be removed from the systemic circulation. For therapy-resistant bradycardia, an artificial rhythm driver may be required. Dynamic control of the physical state, concentration of creatinine and blood plasma electrolytes is required.

Emergency measures are to eliminate the drug from the body: washing the stomach and / or the appointment of activated carbon, followed by the restoration of water-electrolyte balance.

Storage Conditions

No special storage conditions required. Keep vial tightly closed.

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