Triplixam coated pills 5 mg + 2.5 mg + 10 mg N30
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Description
Triplixam is a combination drug that includes three antihypertensive components, each of which complements the action of others on controlling blood pressure in patients with arterial hypertension. Amlodipine is a blocker of “slow” calcium channels (BCCA), a derivative of dihydropyridine, indapamide is a sulfonamide diuretic, perindopril arginine is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (an ACE inhibitor).
Active ingredients
Amlodipine + Indapamide + Perindopril
Release form
Pills
Composition
Indapamide, amlodipine, perindopril arginine, calcium carbonate, pregelatinized corn starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, pregelatinized starch.
Pharmacological effect
The pharmacological properties of the drug Triplix combine the properties of each of its active ingredients. In addition, the combination of amlodipine, indapamide and perindopril arginine enhances the antihypertensive effect of each of the components. Amlodipine - BMCC, a dihydropyridine derivative. Amlodipine inhibits the transmembrane transition of calcium ions into cardiomyocytes and smooth muscle cells of the vascular wall. Indapamide is a derivative of a sulfonamide with an indole ring and, by its pharmacological properties, is close to thiazide diuretics, which inhibit the reabsorption of sodium ions in the cortical segment of the nephron loop. At the same time, kidneys excrete sodium, chlorine and, to a lesser extent, potassium and magnesium ions, which is accompanied by an increase in diuresis and an antihypertensive effect. Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (an inhibitor of the angiotensin-converting enzyme (ACE)). ACE, or kininase II, is an exopeptidase that converts angiotensin I into a vasoconstrictor angiotensin II. In addition, the enzyme stimulates the production of aldosterone by the adrenal cortex and the destruction of bradykinin, which has a vasodilating effect, to inactive heptapeptide. As a result, perindopril reduces the secretion of aldosterone and, by the principle of negative feedback, increases renin activity in the blood plasma.With long-term use, perindopril reduces total peripheral vascular resistance (OPSS), which is mainly due to the effect on the vessels in the muscles and kidneys. These effects are not accompanied by the retention of sodium ions or liquid or the development of reflex tachycardia with prolonged use.
Pharmacokinetics
The combined use of perindopril / indapamide and amlodipine does not change their pharmacokinetic characteristics compared with the separate administration of these agents. After oral administration, amlodipine is well absorbed from the gastrointestinal tract. The maximum concentration of amlodipine in the blood plasma is reached 6-12 hours after ingestion. Absolute bioavailability is about 64-80%, volume of distribution is about 21 l / kg. In vitro studies have shown that about 97.5% of circulating amlodipine is associated with plasma proteins. Simultaneous food intake does not affect the bioavailability of amlodipine. Amlodipine is metabolized in the liver with the formation of inactive metabolites, the kidneys excrete 10% of the accepted dose of amlodipine unchanged and 60% as metabolites. The final half-life of amlodipine from blood plasma is 35-50 hours, which allows you to take the drug 1 time per day. When ingestion of perindopril is rapidly absorbed in the gastrointestinal tract, the maximum concentration in the blood plasma is reached after 1 h (perindopril is the active metabolite of perindopril). The half-life of perindopril from blood plasma is 1 hour. Eating slows down the conversion of perindopril to perindoprilat, thus affecting bioavailability. Therefore, the drug should be taken 1 time per day, in the morning, before eating. Perindoprilat is excreted by the kidneys. The final half-life of the free fraction is about 17 hours, so an equilibrium state is reached within 4 days. There is a linear dependence of the concentration of perindopril in plasma from its dose.
Indications
As therapy in patients with arterial hypertension while reducing blood pressure while taking amlodipine, indapamide and perindopril in the same doses.
Contraindications
Hypersensitivity to the active and auxiliary substances that are part of the drug, a sulfonamide derivative, a dihydropyridine derivative,other ACE inhibitors, any other substances that are part of the drug, patients on hemodialysis, untreated heart failure in the decompensation stage, severe renal failure, moderate renal failure, angioedema (Quincke edema) in the background of taking ACE inhibitors in history, hereditary / idiopathic angioedema, pregnancy, breastfeeding, hepatic encephalopathy, severe liver failure, hypokalemia, severe arterial gi otension (systolic blood pressure less than 90 mm Hg), shock (including cardiogenic), obstruction of the outgoing tract of the left ventricle (for example, clinically significant stenosis of the aortic mouth), hemodynamically unstable heart failure after acute myocardial infarction, bilateral stenosis of the renal arteries, artery stenosis single kidney, age up to 18 years (efficacy and safety not established).
Precautionary measures
Care should be taken in case of diseases: the presence of only one functioning kidney, impaired water and electrolyte balance, systemic connective tissue diseases, therapy with immunosuppressants, allopurinol, procainamide (risk of developing neutropenia, agranulocytosis), acute myocardial infarction (and within 1 month after myocardial infarction ), sick sinus syndrome (marked tachy and bradycardia), with simultaneous appointment with inhibitors or inducers of the CYP3A4 isoenzyme, hepatic failure mild to moderate severity, inhibition of bone marrow hematopoiesis, reduced circulating blood volume (diuretic intake, diet with restricted salt, vomiting, diarrhea, hemodialysis), giperpericemia (especially accompanied by gout and urate nephrolithiasis), the simultaneous use of dantrolene, estramustine, laboratura, osteopathy, laboratura, ostrumterine, laboratura, ostrumstine, ostromstina, ostromstina, ostrovstina, ostromstriya, ostromstiny, apheresis of low density lipoprotein (LDL) using dextran sulfate, condition after kidney transplantation, Negroid patients, coronary heart disease, cerebrovas cural diseases, renovascular hypertension, diabetes mellitus, chronic heart failure (III and IV functional class according to the NYHA classification), simultaneous use of potassium-saving diuretics, potassium preparations,potassium-containing salt and lithium substitutes, surgery / general anesthesia, hemodialysis using high-flow membranes (for example, AN69), simultaneous desensitization therapy with allergens (eg, hymenoptera), aortic stenosis / mitral stenosis / hypertrophic obstructive cardiomyo-myopathology.
Use during pregnancy and lactation
The use of the drug Triplixam during pregnancy is contraindicated. When planning a pregnancy or when it occurs while taking the drug, Triplix should immediately stop taking it and prescribe an alternative anti-hypertensive therapy with a proven safety profile. Triplixam is contraindicated during breastfeeding. It is necessary to assess the significance of therapy for the mother and decide whether to stop breastfeeding or to stop taking the drug.
Dosage and administration
Inside, on 1 tablet once a day, preferably in the morning before meals. The dose of the drug Triplixam is selected after the previous titration of doses of individual components. The maximum daily dose is 1 tablet at a dosage of 10.0 mg + 2.5 mg + 10.0 mg.
Side effects
The most frequent adverse reactions reported in the treatment of perindopril, indapamide and amlodipine as monotherapy were: dizziness, headache, paresthesias, vertigo, drowsiness, visual disturbances, tinnitus, palpitations, flushes of blood to the skin of the face, decreased blood pressure (and effects associated with hypotension), cough, shortness of breath, gastrointestinal disorders (abdominal pain, constipation, diarrhea, taste perversion, nausea, dyspepsia, vomiting), pruritus, rash, maculopapular rash, muscle spasms, swelling in the area ankles, ac eniya, swelling and fatigue.
Overdose
For the combination of perindopril / indapamide, the most likely symptom of an overdose is arterial hypotension, sometimes in combination with nausea, vomiting, seizures, dizziness, drowsiness, confusion and oliguria, which can turn into anuria (as a result of hypovolemia). Electrolyte disturbances may also occur (hyponatremia, hypokalemia). Emergency measures are reduced to the removal of the drug from the body: gastric lavage and / or reception of activated carbon, followed by the restoration of water-electrolyte balance.With a significant decrease in blood pressure, the patient should be placed in the "lying" position on the back with raised legs, if necessary, correction of hypovolemia (for example, intravenous infusion of a 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed from the body through dialysis.
Interaction with other drugs
Some drugs may increase the risk of developing hyperkalemia: aliskiren, potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists (ARA II), nonsteroidal anti-inflammatory drugs (NSAIDs), heparin, immunosuppressants such as cyclosporin or trimetre, trimetre, trimetrome, or trimest, The simultaneous use of the drug Triplix with these agents increases the risk of hyperkalemia. In patients with diabetes mellitus or renal insufficiency (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2 of body surface area), the risk of hyperkalemia, deterioration of renal function, increase in the incidence of adverse cardiovascular events and mortality from cardiovascular diseases.
special instructions
When using amlodipine in patients with chronic heart failure III and IV functional class according to the NYHA classification, pulmonary edema may develop. Slow calcium channel blockers, including amlodipine, should be used with caution in patients with chronic heart failure, due to the possible increase in the risk of adverse events from the cardiovascular system and mortality. In patients with severe chronic heart failure (NYHA classification IV), treatment should begin with lower doses and under close medical supervision. Patients with arterial hypertension and ischemic heart disease should not stop taking beta-blockers: an ACE inhibitor should be used in conjunction with beta-blockers. In patients with an increased concentration of uric acid in the blood plasma during therapy, the incidence of gout attacks may increase.