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Prestanz: Instructions for use

Prestanz: Indications for use

- arterial hypertension;
- IHD: stable exertional angina in patients requiring Perindopril and Amlodipine.

Prestanz: Contraindications

Perindopril
- angioedema (angioedema) in history (including against the background of taking other ACE inhibitors);
- hereditary / idiopathic angioedema;
- age up to 18 years (efficiency and safety have not been established);
- Hypersensitivity to perindopril or other ACE inhibitors.
Amlodipine
- severe arterial hypotension (systolic blood pressure less than 90 mm Hg);
- obstruction of the output tract of the left ventricle (for example, severe aortic stenosis);
- unstable angina (with the exception of Prinzmetal stenocardia);
- age up to 18 years (efficiency and safety have not been established);
- Hypersensitivity to amlodipine or other dihydropyridine derivatives.
Prestants
- renal failure (CC less than 60 ml / min);
- age up to 18 years (efficiency and safety have not been established);
- hereditary lactose intolerance, lactase deficiency and glucose / galactose malabsorption syndrome;
- Hypersensitivity to excipients that are part of the drug.
Carefully
Renal artery stenosis (including bilateral), the only functioning kidney, liver failure, renal failure, systemic diseases of the connective tissue (including systemic lupus erythematosus, scleroderma), immunosuppressant therapy, Allopurinol, procainamide (risk of developing neutropenia, agranulocytosis), reduced bcc (diuretic intake, salt-free diet, vomiting, diarrhea), atherosclerosis, cerebrovascular diseases, renovascular hypertension, diabetes mellitus, chronic heart failure, enenie dantrolene, estramustine, potassium-sparing diuretics, potassium preparations, potassium-based salt substitutes food and drugs lithium, hyperkalemia, surgery / anesthesia general, elderly, hemodialysis using vysokoprotochnyh membranes (e.g., AN69®), desensitizing therapy, LDL aphaeresis, aortic stenosis / mitral stenosis / hypertrophic cardiomyopathy, Negroid patients.

Storage conditions

Under normal conditions.

Prestanz: Pharmacological action

Combined antihypertensive and antianginal drug.
Perindopril
Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (ACE inhibitor). ACE, or kininase II, is exopeptidase, which carries out both the conversion of angiotensin I into a vasoconstrictor substance angiotensin II, and the destruction of bradykinin, which has a vasodilator, 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 system, and the prostaglandin system is also activated.
Perindopril has a therapeutic effect due to its active metabolite, perindoprilat. Other metabolites have no inhibitory effect on ACE in vitro.
Arterial hypertension
Perindopril is a drug for treating hypertension of any severity. Against the background of its use, a decrease in both systolic and diastolic blood pressure in the prone and standing position is noted. Perindopril reduces OPSS, which leads to a decrease in elevated blood pressure and improvement of peripheral blood flow without changing heart rate.
As a rule, perindopril increases renal blood flow, while the glomerular filtration rate does not change.
The antihypertensive effect of the drug reaches a maximum after 4-6 hours after a single dose and remains for 24 hours.
The antihypertensive effect 24 hours after a single dose is about 87-100% of the maximum antihypertensive effect. Reduced blood pressure is achieved quite quickly.
The therapeutic effect occurs less than 1 month from 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.
Stable ischemic heart disease
The efficacy of perindopril in patients (12,218 patients over 18 years old) with stable coronary artery disease without the clinical symptoms of chronic heart failure was studied during a 4-year study (EUROPA). 90% of study participants previously had acute myocardial infarction or coronary revascularization. Therapy with perindopril tertbutylamine at a dose of 8 mg / (equivalent to 10 mg of perindopril arginine) resulted in a significant reduction in the absolute risk of complications by 1.9%, in patients who had previous myocardial infarction or coronary revascularization, the absolute risk was 2.2% compared to the placebo group.
Amlodipine
Amlodipine is a blocker of slow Calcium channels, a derivative of the dihydropyridine series. Amlodipine inhibits the transmembrane transition of calcium ions into 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 is established that amlodipine causes expansion of peripheral arterioles, reducing OPSS (afterload), since the heart rate does not change, and the need of myocardium for oxygen decreases. It causes the expansion of coronary arteries and arterioles in both ischemic and intact areas. In patients with Prinzmetal angina, coronary blood flow is improved.
In patients with arterial hypertension, amlodipine is administered 1 time / provides a clinically significant reduction in blood pressure while standing and lying down for 24 hours. The antihypertensive effect develops slowly, and therefore the development of acute arterial hypotension is not typical.
In patients with angina, taking amlodipine 1 time / increases exercise tolerance, delaying the onset of an attack of angina and "ischemic" depression of the ST segment, and also reduces the frequency of attacks of angina and Nitroglycerin (short-acting form).
Amlodipine does not affect the lipid profile and does not cause changes in the hypolipidemic parameters of blood plasma.
The drug can be used in patients with concomitant bronchial asthma, diabetes mellitus and gout.
The efficacy and safety of using amlodipine at a dose of 2.5-10 mg /, an ACE inhibitor lisinopril at a dose of 10-40 mg / and thiazide diuretic chlortalidone at a dose of 12.5-25 mg / as a first-line drug was studied in a 5-year study ALLHAT (involving 33 357 patients aged 55 years and older) in patients with mild or moderate arterial hypertension and at least one of the additional risk factors for coronary complications, such as: myocardial infarction or stroke, suffered more than 6 months before being included in the study and and other evidence of cardiovascular disease of atherosclerotic; diabetes; HDL cholesterol levels of less than 35 mg / dL; left ventricular hypertrophy according to ECG or echocardiography; smoking.
The main criterion for evaluating the effectiveness is a combined indicator of the frequency of deaths from IHD and the frequency of nonfatal myocardial infarction.There were no significant differences between the amlodipine and chlorthalidone groups in the main evaluation criteria. The incidence of heart failure in the amlodipine group was significantly higher than in the chlorthalidone group — 10.2% and 7.7%, respectively; the overall incidence of deaths in the amlodipine and chlorthalidone groups did not differ significantly.
Perindopril and Amlodipine
Effectiveness with long-term 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; type 2 diabetes; peripheral artery atherosclerosis; previous stroke or transient ischemic attack; male; age 55 years and older; microalbuminuria or proteinuria; smoking; total cholesterol / HDL cholesterol ≥ 6; The early development of coronary artery disease in next of kin was studied in an ASCOT-BPLA study.
The main criterion for evaluating the effectiveness is a combined indicator of the frequency of nonfatal myocardial infarction (including painless) and deaths of IHD. The incidence of complications provided for by the main evaluation criteria in the amlodipine / perindopril group was 10% lower 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 incidence of complications,envisaged by additional criteria of effectiveness (except for fatal and non-fatal heart failure).

The drug is prescribed by mouth, 1 tablet 1 time / day. preferably in the morning before eating. The dose of the drug Prestants is selected after a previously performed titration of doses of individual components of the drug: perindopril and amlodipine in patients with arterial hypertension and stable angina pectoris.
When therapeutic, the dose of Prestans can be changed, based on individual selection of doses of individual components: 5 mg perindopril + 5 mg amlodipine or 5 mg perindopril + 10 mg amlodipine or 10 mg perindopril + 5 mg amlodipine or 10 mg perindopril + 10 mg amlodipine.
Prestans in doses of 10 mg of perindopril + 10 mg of amlodipine is the maximum daily dose of the drug, which is not recommended to exceed.
The elimination of perindoprilat in elderly patients and patients with renal insufficiency is slow. Therefore, in such patients, it is necessary to regularly monitor the concentration of creatinine and potassium in the blood plasma. Prestans may be administered to patients with a CC ≥ 60 mL / min. Prestanc is contraindicated in patients with CC <60 ml / min. Such patients are recommended individual selection of doses of perindopril and amlodipine. Changes in the concentration of amlodipine in the blood plasma do not correlate with the severity of renal failure.
Caution should be exercised in the appointment of the drug Prestan in patients with hepatic insufficiency due to the lack of recommendations on the dosing of the drug in these patients.
Prestanza should not be prescribed to children and adolescents under 18 years of age due to the lack of data on the efficacy and safety of perindopril and amlodipine in these groups of patients, both as monotherapy and as combination therapy.

Prestanz: Side Effects

On the part of the hematopoietic system: very rarely - leukopenia, neutropenia, agranulocytosis, pancytopenia, thrombocytopenia, hemolytic anemia in patients with congenital glucose-6-phosphate dehydrogenase deficiency, a decrease in hemoglobin and hematocrit.
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, mood lability, sleep disturbance, tremor, hypoesthesia; very rarely - peripheral neuropathy, confusion.
On the part of the organ of vision: often - visual disturbances.
From the organ of hearing: often - tinnitus.
Since the cardiovascular system: often - heartbeat, flushing of blood to the skin of the face, pronounced 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 high-risk patients, arrhythmias (includingbradycardia, ventricular tachycardia and atrial fibrillation), stroke, possibly due to an excessive decrease in blood pressure in high-risk patients, vasculitis.
On the part of the respiratory system: often - shortness of breath, cough; infrequently - rhinitis, bronchospasm; very rarely - eosinophilic pneumonia.
On the part of the digestive system: often - abdominal pain, nausea, vomiting, dyspepsia, a violation of taste perception, diarrhea, constipation; infrequently - constipation, dryness of the oral mucosa; rarely, increased bilirubin levels; very rarely - pancreatitis, gum hyperplasia, gastritis, hepatitis, cholestatic jaundice, cytolytic or cholestatic hepatitis, increased activity of liver enzymes ACT, ALT (most often in combination with cholestasis).
On the part of the skin: often - itching, rash; infrequently - angioedema of the face, extremities, lips, mucous membranes, tongue, glottis and / or larynx, alopecia, hemorrhagic rash, photosensitization, increased sweating; very rarely - angioedema, erythema multiforme, Stevens-Johnson syndrome.
From the musculoskeletal system: often - muscle spasms; infrequently - arthralgia, myalgia, back pain.
On the part of the kidneys and urinary tract: infrequently - a violation of urination, nocturia, frequent urination, renal failure; very rarely - severe renal failure.
On the part of 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 concentration of urea and serum creatinine, hyperkalemia.

Combined antihypertensive and antianginal drug