Edarbi Clos pills 40 mg + 25 mg 28 pieces
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Description
Edarbi Clos pills in film coating - a combined antihypertensive drug. The Edarbi Clo drug contains the angiotensin II receptor antagonist (azilsartan medoxomil) and the thiazide-like diuretic (chlorthalidone). The simultaneous use of two active substances leads to a more pronounced decrease in blood pressure compared to taking each of them in monotherapy. When taking the drug 1 time / day, an effective decrease in blood pressure is achieved within 24 hours. Azilsartan medoxomil is a specific antagonist of angiotensin II type 1 receptors (AT1). Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the main vasoconstrictor factor of the RAAS, its action includes vasoconstriction, stimulation of the synthesis and secretion of aldosterone, increased heart rate and reabsorption of sodium by the kidneys. Azilsartan medoxomil is a prodrug for oral administration. It quickly turns into an active azilsartan molecule, which selectively prevents the development of effects of angiotensin II by blocking its binding to the AT1 receptor in various tissues, for example, in vascular smooth muscle and adrenal glands. Therefore, its action is not related to the biosynthesis of angiotensin II. The AT2 receptor is also found in many tissues, but it does not participate in the regulation of the cardiovascular system. The affinity of azilsartan for the AT1 receptor is 10,000 times higher than that for the AT2 receptor. Inhibiting the activity of RAAS by means of ACE inhibitors that suppress the formation of angiotensin II from angiotensin I is widely used in the treatment of arterial hypertension. ACE inhibitors also inhibit the breakdown of bradykinin, which is catalyzed by ACE. Since azilsartan does not suppress ACE (kininase II), it should not affect the activity of bradykinin. Azilsartan does not bind to other receptors or ion channels that play an important role in the regulation of the cardiovascular system, and does not block them. Azilsartan inhibits the vasoconstrictor effects of angiotensin II in a dose-dependent manner. A single dose of azilsartan at a dose equivalent to 32 mg of azilsartan medoxomil inhibited the maximum vasoconstrictor effect of angiotensin II by about 90% at the time of greatest concentration, and about 60% 24 hours after administration.In healthy volunteers, angiotensin I and angiotensin II concentrations and renin activity in plasma increased, and aldosterone concentrations decreased after a single dose and after repeated doses of azilsartan medoxomil, there was no clinically significant effect on serum potassium or sodium. In general, the pharmacodynamic properties of azilsartan medoxomil are consistent with the blocking of AT1 receptors. The antihypertensive effect of azilsartan medoxomil develops during the first 2 weeks of use, with the maximum therapeutic effect being achieved after 4 weeks. A decrease in blood pressure after ingestion of a single dose is usually achieved within a few hours and lasts for 24 hours. Chlorthalidone, a thiazide-like diuretic, suppresses the active reabsorption of sodium ions in the renal tubules (the initial part of the distal convoluted nephron tubule), increasing the excretion of sodium ions and chlorine and strengthening diuresis. In addition, chlorthalidone increases the excretion of potassium, magnesium and bicarbonate ions, retains calcium ions and uric acid. The antihypertensive effect of chlorthalidone is associated with the removal of fluid and sodium from the body. The diuretic effect develops 2-3 hours after taking chlorthalidone orally and lasts for 2-3 days. The antihypertensive effect of chlorthalidone develops gradually with the achievement of the maximum therapeutic effect 2-4 weeks after the start of therapy. In clinical studies, the combination of azilsartan medoxomil / chlorothalidone was more effective than the combination of azylsartan medoxomil with hydrochlorothiazide or the combination of olmesartan medoxomil / hydrochlorothiazide, despite the fact that a higher proportion of participants use The study in the comparison group required an increase in dose due to insufficient blood pressure control. During a double-blind study with a planned increase in dose of 12 weeks, the combination of azilsartan medoxomil / chlorthalidone 40 mg / 25 mg was significantly higher than the combination of olmesartan medoxomil / hydrochlorothiazide 40 mg / 25 mg decrease in systolic blood pressure with moderate and severe arterial hypertension. Similar results were obtained in all subgroups of patients, regardless of age, gender or race.The combination of azilsartan medoxomil / chlorthalidone reduced blood pressure more effectively than the combination of olmesartan medoxomil / hydrochlorothiazide in each hour of the 24-hour interval between doses of drugs, according to the data of BPMD (daily monitoring of blood pressure).
Active ingredients
Azilsartan medoxomil + hlortalidone
Release form
Pills
Composition
Azilsartan medoxomil potassium 42.68 mg, which corresponds to the content of azilsartan medoxomil 40 mg, chlorthalidone 12.5 mg. Excipients: mannitol - 211.23 mg, microcrystalline cellulose - 54 mg, fumaric acid - 2 mg, sodium hydroxide - 0.69 mg, hyprolosis - 10.8 mg, crospovidone - 22.5 mg, magnesium stearate - 3.6 mg. The composition of the film coating: hypromellose 2910 - 7.8 mg, talc - 1.2 mg, titanium dioxide - 0.99 mg, iron dye red oxide - 0.01 mg, macrogol 8000 - 0.18 mg, gray ink F1 purified for labeling - trace amounts.
Indications
Essential hypertension (for patients who are recommended combination therapy).
Precautionary measures
With care: severe chronic heart failure (NYHA classification 4), kidney dysfunction (CC more than 30 ml / min), mild to moderate liver function dysfunction (5-9 points on the Child-Pugh scale), bilateral renal stenosis arteries and stenosis of the artery of a single functioning kidney, ischemic cardiomyopathy, ischemic cerebrovascular diseases, a condition after kidney transplantation, conditions accompanied by a decrease in BCC (including vomiting, diarrhea, use of diuretics in high doses), and also in patients on a diet with restricted salt, primary hyper aldosteronism, hyperuricemia, gout, bronchial asthma, systemic lupus erythematosus, aortic and mitral stenosis, hypertrophic obstructive cardiomyopathy (GOKMP), age over 75 years, hypokalemia.
Use during pregnancy and lactation
Experience with the use of the drug Edarbi Clo in pregnant women is missing. The use of the drug during pregnancy and during breastfeeding is not recommended. Newborns whose mothers received azilsartan medoxomil therapy can develop arterial hypotension, and therefore newborns should be carefully monitored. Chloridalidone penetrates the placental barrier into umbilical cord blood and can cause fetal or newborn jaundice, thrombocytopenia and other undesirable reactions,marked in adults. Immediately after confirmation of pregnancy, the use of the drug Edarbi Clo should be discontinued and, if necessary, switch to the use of drugs with proven safety of use in pregnancy. There is no information in relation to a person about the ability of azilsartan and / or its metabolites to pass into breast milk. In experimental animal studies, it was found that azilsartan and its metabolite M-II are excreted into the milk of lactating rats. Chloridalidone penetrates the placental barrier and is detected in cord blood, fetal blood and breast milk. If you need to use Edarbi Clough during lactation, you must stop feeding or stop taking the drug. Preferably the use of drugs with a proven safety profile.
Dosage and administration
Edarbi Clough is taken orally once a day, regardless of the time of the meal. The recommended initial dose of Edarbi Clough is 40 mg of azilsartan medoxomil + 12.5 mg of chlorthalidone once a day. medoxomil + 25 mg of chlorthalidone 1 time / day. Edarbi Clo should be taken daily, without interruption. In case of discontinuation of treatment, the patient should inform the physician about it. In case of skipping the next dose, the patient should take the next dose at the usual time. You should not take a double dose of the drug Edarbi Clo. Cancellation syndrome with a sudden discontinuation of azilsartan medoxomil after prolonged therapy (for 6 months) was not observed. However, the elimination of the drug Edarbi Claw after prolonged treatment should be carried out, if possible, gradually. Elderly patients (65 years and older) do not need to adjust the initial dose of the drug. There is no clinical experience with the use of Edarbi Clo in patients with hypertension with a violation severe renal function (CC less than 30 ml / min), therefore, it is not recommended to use the drug in this category of patients. In patients with impaired renal function of mild to moderate severity (CC more than 30 ml / min), no correction of the dosage regimen is required. The use of the drug in patients with severe hepatic impairment is not recommended, since there is no clinical experience of use (see the section Contraindications).Due to limited experience, Edarbi Clough should be used with caution in patients with mild and moderately impaired liver function (less than 9 on the Child-Pugh scale), since even small violations of water-electrolyte balance when taking diuretics can provoke a hepatic coma. It is recommended to actively monitor the condition of such patients. In patients with reduced BCC, before starting the use of Edarbi Clos, it is necessary to compensate for fluid and electrolyte losses. In patients with arterial hypertension with severe chronic heart failure (NYHA FC, NYHA classification) should be used with caution. lack of clinical experience. In patients of the Negroid race, dose adjustment is not required, because The antihypertensive effect of Edarbi Clos in this category of patients is similar to its effect in patients of other races.
Side effects
Anemia, dizziness, postural dizziness, paresthesia, excessive reduction of blood pressure, diarrhea, nausea, vomiting, rash, pruritus, muscle spasms, hypokalemia, hyperkalemia, hyponatremia, exacerbation of the gout, increased concentration of creatinine, increased concentration of urea, increased glucose glucose, glucose, glucose, glucose, glucose, glucose, glucose, glucose, glucose, glucose, glucose, oxygen, glucose, excretion, glucose, glucose, glucose, glucose, glucose, glucose, glucose, glucose, oxygen,, , fatigue, peripheral edema. Azilsartan medoxomil (monotherapy) dizziness, headache, excessive decrease in blood pressure, diarrhea, nausea, rash, itching, muscle spasms, increased creatinine concentration, hyperuricemia, angioedema, fatigue, peripheral edema. Chlorthalidone (monotherapy), thrombocytopenia, leukopenia, agranulocytosis, eosinophilia, headache, excessive reduction of blood pressure, arrhythmia, allergic pulmonary edema, loss of appetite, gastrointestinal disorders, constipation, abdominal pain, intrahepatic cholestasis or jaundice, pancrethyre, photosensitization, cutaneous vasculitis, hyperlipidemia, hypokalemia, hypomagnesemia, hypercalcemia, decompensation of existing diabetes, urticaria, reduced potency. With the simultaneous use of azilsartan medoxomil with chlorthalidone, the incidence of hypokalemia decreases.
Overdose
Symptoms: pronounced decrease in blood pressure, dizziness. Treatment: when a pronounced decrease in blood pressure should transfer the patient to a horizontal position with a low headboard, it is recommended that measures to increase the BCC and symptomatic therapy. Azilsartan is not derived from systemic blood flow through dialysis. Chlorthalidone (monotherapy) Symptoms: nausea, weakness, dizziness, disturbances of water and electrolyte balance. Treatment: there is no specific antidote. In case of a pronounced decrease in blood pressure, the stomach should be flushed, measures are recommended to normalize water and electrolyte balance (infusion therapy), symptomatic therapy.
Interaction with other drugs
There was a reversible increase in serum lithium concentration and toxicity during simultaneous use of lithium preparations and diuretics and lithium preparations with angiotensin II receptor antagonists (APA II). Therefore, the simultaneous use of the drug Edarbi Clo in combination with lithium preparations is not recommended (see section "Special instructions"). If necessary, the use of appropriate combination therapy is recommended to regularly monitor the concentration of lithium in the blood serum. In elderly patients and patients with reduced BCC (including receiving diuretics) or with impaired renal function, simultaneous use of ARA II and NSAIDs can lead to deterioration of renal function until the development of acute renal failure. Therefore, at the beginning of treatment, patients are recommended to regularly take a sufficient amount of fluid and monitor renal function. With simultaneous use of ARA II and NSAIDs, including selective COX-2 inhibitors, acetylsalicylic acid (more than 3 g / day), and non-selective NSAIDs, the antihypertensive effect may be weakened. hypotension, hyperkalemia and deterioration of kidney function (including acute renal failure) compared with monotherapy. Simultaneous use of cardiac glycosides and a diuretic may aggravate consequences of hypokalemia, such as heart rhythm disordersglibenclamide, ketoconazole, metformin and warfarin. Azilsartan medoxomil is converted to the pharmacologically active metabolite azilsartan during absorption from the gastrointestinal tract under the action of the enzyme carboxymethylene butenolidase in the intestine and liver. In vitro studies have shown that interactions based on the inhibition of enzymes are unlikely. Additional information on the interaction of chlorothalidone , MAO inhibitors. Simultaneous use of chlorthalidone with allopurinol may lead to an increase in the frequency of hypersensitivity reactions to all Purinol. Chlorthalidone may increase the risk of side reactions caused by amantadine. Local anti-cholinergics (for example, atropine, biperiden) may increase the bioavailability of chlorthalidone, reducing gastrointestinal motility and evacuation of the stomach contents. -adrenergic blockers, carbenoxolone. Patients during combination therapy should monitor the content of potassium in the blood serum. May require correction (decrease or increase) of the dose of hypoglycemic agents for oral administration and insulin. The pharmacological effects of calcium and vitamin D salts may increase to a clinically significant level while being used with chlorthalidone. Simultaneous use with cyclosporine may increase the risk of hyperuricemia and complications such as gout. Colestyramine interferes with the absorption of chlorthalidone. Perhaps a decrease in the pharmacological effect of chlorthalidone. Simultaneous use of chlorthalidone with methotrexate and cyclophosphamide can lead to a potentiation of the pharmacological effect of anticancer drugs.