Name Prestans tablets 1010 mg in bottles No. 30 in package No. 1 Main active ingredient Amlodipine + perindopril Release form tablets Dosage 1010 mg Special instructions The excretion of perindopril is slowed down in the elderly and in patients with renal and heart failure, so they need to regularly check the concentration of potassium and creatinine in blood plasma. Due to the possible strong decrease in blood pressure, the development of drowsiness, dizziness and other side effects, you should be careful when driving, especially at the beginning of therapy and when increasing the dose used. Pharmacological action The drug has a hypotensive effect, and also inhibits angiotensin-converting enzyme and calcium channels. Pharmacodynamics: Perindopril inhibits the enzyme that converts angiotensin I to angiotensin II. Kininase II, or angiotensin-converting enzyme, carries out both the transformation of angiotensin I into the vasoconstrictor angiotensin II and the inactivation of bradykinin, which has a vasodilating effect. Perindopril has a therapeutic effect due to its metabolite, perindoprilat. Other derivatives have no effect. Perindopril is a drug for the treatment of arterial hypertension of any form and severity. It reduces systolic and diastolic blood pressure in the upright and horizontal positions. The drug lowers peripheral vascular resistance, which leads to a decrease in increased blood pressure and an increase in peripheral blood supply without increasing heart rate. The effect of the drug becomes maximum 5-6 hours after ingestion and persists for a day. The pressure drop is achieved quickly. The therapeutic effect occurs 1 month after the start of therapy. After cessation of treatment, withdrawal syndrome does not develop. Perindopril also helps to increase the elasticity of large vessels, restore the structure of the wall of smaller arteries and reduce left ventricular hypertrophy. Amlodipine is a calcium channel blocker. Suppresses the transmembrane movement of calcium ions in myocardial tissue and vascular smooth muscle cells. It is known that amlodipine: dilates arterioles, reducing peripheral resistance, while heart rate remains at the same level, and myocardial oxygen demand decreases; dilates the heart arteries and arterioles. In individuals with Prinzmetal’s angina, coronary blood flow increases in this case. Amlodipine does not affect the lipid profile and hypolipidemic blood parameters. The drug can be used in people with diabetes, asthma and gout. Pharmacokinetics When taken orally, perindopril is rapidly adsorbed, the maximum concentration in the blood appears after 1 hour. The elimination half-life from the blood is also 1 hour. Perindopril is pharmacologically inactive. 27% of the substance enters the vascular bed in the form of perindoprilat (active metabolite). In addition to perindoprilat, 5 more metabolites are known that are not pharmacologically active. The maximum concentration of perindoprilat in the blood appears 3 hours after ingestion. Food intake inhibits the conversion to perindoprilat, affecting bioavailability. Therefore, the drug should be used once a day, before breakfast. The binding of perindoprilat to blood proteins is approximately 20% and is dose-dependent. Perindoprilat is excreted from the body through the kidneys. The terminal half-life is 17 hours, so the equilibrium concentration is reached within four days. After administration, amlodipine is absorbed from the digestive tract more slowly than perindapril. Eating does not change the bioavailability of this substance. The maximum concentration of amlodipine in the blood occurs after 7-11 hours. Bioavailability ranges from 64-80%. About 97% of amlodipine circulating in the blood is in the blood in a bound state. The final half-life of amlodipine from the blood is 37-50 hours. This allows you to take the drug once a day. It is metabolized in the liver, with 10% of the dose excreted in its original form and 60% excreted in the urine as metabolites. Not excreted by dialysis. Indications for use Stable exertional angina in persons requiring treatment with amlodipine and perindopril. Arterial hypertension. Dosage and administration Instructions for use Prestanza recommends taking the tablets orally, once a day before breakfast. The dose of the drug is selected individually based on four possible dose ratios of perindopril and amlodipine in the preparation: Prestans 5 mg + 5 mg, Prestans 5 mg + 10 mg, Prestans 10 mg + 5 mg, Prestans 10 mg + 10 mg. In elderly patients and patients with kidney damage, constant monitoring of creatinine and potassium in the blood should be carried out, since the excretion of perindoprilat is slowed down in this group of people. In persons with hepatic insufficiency, dose selection should be carried out with caution. It is better to start using the drug with small doses. Use during pregnancy and lactation It is forbidden to take Prestanz during pregnancy and during breastfeeding due to lack of clinical experience with the use of amlodipine and perindopril. Interaction with other drugs Interaction with Perindopril When taken together with potassium and lithium preparations, potassium-sparing diuretics, some individuals may develop hyperkalemia and an increase in lithium levels in the blood. Simultaneous administration of ACE inhibitors with non-steroidal anti-inflammatory drugs leads to a weakening of the antihypertensive effect, and can also lead to impaired renal function, an increase in the concentration of potassium in the blood. Hypoglycemic agents, interacting with ACE inhibitors, increase the hypoglycemic effect of insulin and sulfonylurea metabolites in people with diabetes mellitus. In patients using diuretics at the beginning of therapy with ACE inhibitors, a strong decrease in blood pressure is likely. Sympathomimetics weaken the hypotensive effect of ACE inhibitors. The combined use of ACE inhibitors and drugs for general anesthesia leads to the activation of the antihypertensive effect. Interaction with amlodipine. The simultaneous use of inducers of the CYP3A4 isoenzyme (rifampicin, St. John’s wort) leads to a decrease in the concentration of amlodipine in the blood. Amlodipine activates the hypotensive effect of other pressure tablets. In studies, Prestanz tablets did not affect the pharmacokinetics of digoxin, atorvastatin, warfarin and cyclosporine. The use of grapefruit juice or grapefruits increases the bioavailability of amlodipine in some patients, which can lead to a strong decrease in blood pressure. Tricyclic antidepressants, neuroleptics, Amifostine, Baclofen, antihypertensives, vasodilators enhance the antihypertensive effect of perindopril and amlodipine. Contraindications Contraindications to taking perindopril: Quincke’s edema; allergy to perindopril or other drugs from the group of ACE inhibitors; age less than 18 years. Contraindications to taking amlodipine: allergy to amlodipine; shock, including cardiogenic; severe arterial hypotension; obstruction of the outflow tract of the left ventricle; heart failure with unstable hemodynamics after myocardial infarction; age less than 18 years. Contraindications to taking Prestanza: allergy to any of the components of the drug; kidney failure; age less than 18 years; lactose intolerance, lactase deficiency and glucose-galactose malabsorption. Use with caution in: solitary kidney, renal artery stenosis, hepatic or renal failure, allopurinol therapy, immunosuppressants, procainamide, systemic connective tissue diseases, cerebrovascular disorders, atherosclerosis, diabetes mellitus, renovascular hypertension, heart failure, concomitant use of estramustine, potassium-sparing diuretics, dantrolene, potassium preparations, lithium preparations, hyperkalemia, surgery, old age, desensitizing therapy, aortic or mitral stenosis. Prestans is available in 4 different ratios of active ingredients: perindopril arginine – 5 mg / 10 mg (which is equal to 3.395 mg / 6.79 mg of perindopril), amlodipine besylate – 6.935 mg / 13.87 mg (which is equal to 5 mg / 10 mg of amlodipine). Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide. Overdose There are no data on overdose with Prestans. An overdose of amlodipine causes: a strong decrease in blood pressure with the possible development of tachycardia and peripheral vasodilation. Treatment: it is necessary to perform a gastric lavage, take activated charcoal, maintain indicators of the cardiac and respiratory systems, control the volume of circulating blood and diuresis, symptomatic therapy, intravenous administration of calcium gluconate and dopamine. Symptoms of an overdose of perindopril: a pronounced decrease in blood pressure, electrolyte disturbances, shock, renal failure, tachycardia, dizziness, anxiety. Treatment: gastric lavage and activated charcoal, correction of hypovolemia, intravenous catecholamines, hemodialysis. Side effects On the part of the blood: leukopenia, agranulocytosis, pancytopenia, neutropenia, thrombocytopenia, decreased hematocrit and hemoglobin. From the side of metabolism: hyperglycemia, hypoglycemia. From the side of immunity: allergic reactions. From the ENT organs: visual impairment, tinnitus. From the nervous system: headache, dizziness, mood lability, drowsiness, insomnia, tremor, depression, peripheral neuropathy. From the side of the cardiovascular system: a strong decrease in pressure, heart attack, angina pectoris, stroke, vasculitis. From the respiratory system: cough, eosinophilic pneumonia, bronchospasm. From the digestive system: abdominal pain, nausea, diarrhea, dyspepsia, constipation, dry mouth. From the hepatobiliary system: jaundice, hepatitis, increased concentration of liver enzymes. From the skin: itching, exanthema, Quincke’s edema, hemorrhagic rash, alopecia, discoloration of the skin, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis. From the musculoskeletal system: swelling of the legs, muscle spasms, myalgia, arthralgia. From the genitourinary system: nocturia, impaired renal function, impaired urination, impotence, gynecomastia. General disorders: asthenia, edema, fatigue, chest pain, change in body weight. Episodic cases of extrapyramidal syndrome have also been reported. Storage conditions The drug does not require special storage conditions. The bottle must be kept closed in the original packaging. Keep away from children. Buy Prestans tablets 10/10mg No. 30 No. 1 Price for Prestans tablets 10/10 mg No. 30 No. 1
INN | PERINDOPRIL |
---|---|
The code | 50 036 |
Barcode | 5 391 189 230 469 |
Dosage | 10/10 |
Active substance | perindopril, amlodipine |
Manufacturer | Servier (Ireland) Ind. Ltd., Ireland |
Importer | IOOO Interfarmaks 223028 Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Star, 19a-5, room. 5-2 |
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