Edarby - instructions for use, analogs, reviews and release forms (tablets 20 mg, 40 mg and 80 mg, clo with a diuretic 40 mg + 12.5 mg, 40 mg + 25 mg) of the drug for the treatment of hypertension and pressure reduction in adults, children and during pregnancy. Composition

In this article, you can read the instructions for using the drug Edarby. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of experts on the use of Edarby in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogies of Edarby in the presence of existing structural analogues. Use to treat hypertension and reduce blood pressure in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Edarby - specific antagonist of angiotensin 2 receptor type 1 (AT1). Azilsartan medoxomil (the active substance of the Edarby preparation) is a prodrug. Rapidly turns into an active molecule of azilsartan, which selectively inhibits the development of the effects of angiotensin 2 by blocking its binding to the AT1 receptors in various tissues. Angiotensin 2 is the primary vasoactive hormone RAAS with effects including vasoconstriction, cardiac stimulation, synthesis stimulation and aldosterone release, and as a consequence, renal sodium reabsorption.

The blockade of AT1 receptors inhibits the negative regulatory response of angiotensin 2 to renin secretion, but the total increase in plasma activity of renin and the level of circulating angiotensin 2 does not suppress the antihypertensive effect of azilsartan.

The antihypertensive effect of Edarby develops during the first 2 weeks of use with the maximum therapeutic effect achieved after 4 weeks. Reduction of blood pressure after ingestion of a single dose is usually achieved within a few hours and persists for 24 hours.

The withdrawal syndrome after a sudden discontinuation of treatment with prolonged therapy (for 6 months) with Edarby was not observed.

The safety and effectiveness of the drug do not depend on the age of the patients, but a greater sensitivity to lowering blood pressure in some elderly patients can not be ruled out. As with the use of other antagonists of angiotensin 2 receptors and ACE inhibitors, the antihypertensive effect is less pronounced in patients of the Negroid race (usually a population with low renin activity in the blood plasma). Simultaneous use of Edarby 40 mg and 80 mg with dihydropyridine blockers of slow calcium channels (amlodipine) or thiazide diuretics (chlorthalidone) leads to an additional reduction in blood pressure as compared with antihypertensive therapy used in monotherapy.

Edarby Clos is a combined preparation that contains an angiotensin 2 receptor antagonist (azilsartan medoxomil) and a thiazide-like diuretic (chlorthalidone). Simultaneous use of two active substances leads to a more pronounced decrease in blood pressure as compared with the reception of each of them in monotherapy.When taking the drug 1 time per day, an effective BP reduction is achieved within 24 hours.

Composition

Azilsartan medoxomil potassium + auxiliary substances (Edarby).

Azilsartan medoxomil potassium + Chlortalidone + excipients (Edarby Clos).

Pharmacokinetics

Azilsartan medoxomil

The pharmacokinetic parameters (Tmax, Cmax, AUC value) of azilsartan are similar both when it is co-administered with chlorthalidone and without it. After taking the drug inside Cmax, the azilsartan in the blood plasma, on average, is reached within 3 hours. Azilsartan is metabolized to two primary metabolites mainly in the liver. Azilsartan and its metabolites are excreted from the body both through the intestine and by the kidneys. Studies have shown that after ingestion of azilsartan medoxomil, about 55% (predominantly in the form of metabolite M-1) is found in the feces and about 42% (15% in the form of azilsartan, 19% in the metabolite M-2) - in the urine.

The pharmacokinetics of azilsartan in young (18-45 years) and elderly (65-85 years) patients is not significantly different.

The pharmacokinetics of azilsartan in men and women is not significantly different. Correction of dose depending on sex is not required.

Chlorthalidone

After taking the drug inside chlortalidone is absorbed from the digestive tract by 60%. The value of AUC of chlorthalidone is similar to that when it is co-administered with azilsartan medoxomil, and without it. However, Cmax is 47% higher when it is co-administered with azilsartan medoxomil in the formulation of Edarby Clos. Eating does not have a clinically significant effect on the bioavailability of the drug. In whole blood chlortalidone is associated, mainly, with the carbonic anhydrase of erythrocytes. In blood plasma, approximately 75% of chlorthalidone is associated with blood plasma proteins, with 58% with albumin. Chlortalidone is mainly excreted unchanged. There are no data on the comparative amounts of chlorthalidone, which is excreted unchanged and in the form of metabolites. Chlortalidone is mainly excreted by the kidneys unchanged. As a thiazide-like diuretic, chlorthalidone is excreted in breast milk.

In elderly patients, chlorthalidone is excreted more slowly than in young patients, which is presumably associated with age-related changes in renal function and leads to an increase in the half-life. Reduction of elimination is not clinically significant.

With renal failure, it is possible to accumulate chlorthalidone.

Indications

• Essential (primary) hypertension (pressure reduction).

Forms of release

Tablets of 20 mg, 40 mg and 80 mg (Edarby).

Tablets coated with 40 mg + 12.5 mg, 40 mg + 25 mg (Edarby Clos).

Instructions for use and dosage

Edarby

The drug is taken orally 1 time per day, regardless of food intake.

The recommended initial dose is 40 mg once a day. If it is necessary to further reduce blood pressure, the dose of the drug can be increased to a maximum of 80 mg once a day. The maximum daily dose is 80 mg.

In case of inadequate control of blood pressure in the use of Edarbi as a monotherapy, its simultaneous use with other antihypertensive drugs, including diuretics (chlorthalidone and hydrochlorothiazide) and dihydropyridine blockers of slow calcium channels (amlodipine), is possible.

The drug Edarby should be taken daily, without interruption. If the treatment is discontinued, the patient should be informed about this by the doctor.

If you miss a dose, the patient should take the next dose at the usual time. Do not take a double dose of Edarby.

It is not necessary to correct the initial dose of Edarbi in elderly patients.However, in patients older than 75 years, a dose of 20 mg can be considered as an initial (increases the risk of developing arterial hypotension).

There is no need for correction of the dosing regimen in patients with impaired renal function of mild and moderate severity. There is no clinical experience with the use of Edarby in patients with impaired renal function and severe end-stage renal disease, so use the drug in this category of patients should be cautious.

Because of the limited experience with the use of Edarbi in patients with impaired liver function of mild and moderate severity, it is recommended to start treatment at a dose of 20 mg 1 time per day and to conduct it under close supervision. It is not recommended to use the drug in patients with impaired hepatic function due to lack of clinical experience.

Edarby should be given to patients with reduced BCC and / or hyponatremia (for example, patients with prolonged vomiting, diarrhea, or taking diuretics in high doses) only under strict medical supervision. It is recommended to start treatment with a dosage of 20 mg once a day.

Due to the lack of clinical experience, the Edarbie drug should be used with caution in patients with severe chronic heart failure (NYHA 4 functional class).

Edarby Claw

The drug Edarby Clos is taken orally 1 time per day, regardless of the time of ingestion.

The recommended initial dose of Edarby Claw is 40 mg of azilsartan medoxomil + 12.5 mg of chlorthalidone once a day.

If it is necessary to further reduce blood pressure, the dose of Edarby Clos can be increased to a maximum of 40 mg of azilsartan medoxomil plus 25 mg of chlorthalidone once a day.

The drug Edarby Clos should be taken daily, without interruption. In the event of discontinuation of treatment, the patient should inform the physician about this.

If you miss a dose, the patient should take the next dose at the usual time. Do not take a double dose of Edarby Claw.

The withdrawal syndrome with a sudden discontinuation of azilsartan medoxomil after prolonged therapy (for 6 months) was not observed. However, the elimination of Edarby Claw after long-term treatment should be carried out, if possible, gradually.

Older patients do not need to adjust the initial dose of the drug.

Side effect

• anemia;
• dizziness;
• postural dizziness;
• paresthesia;
• excessive decrease in blood pressure;
• diarrhea;
• nausea, vomiting;
• rash;
• itching;
• muscle spasms;
• hypokalemia, hyperkalemia, hyponatremia;
• exacerbation of gout;
• increasing the concentration of creatinine;
• increased urea concentration;
• increase in glucose concentration;
• angioedema;
• increased fatigue;
• peripheral edema.

Azilsartan medoxomil (monotherapy)

• dizziness;
• headache;
• excessive decrease in blood pressure;
• diarrhea, nausea;
• rash;
• itching;
• muscle spasms;
• increased creatinine concentration, hyperuricemia;
• angioedema;
• increased fatigue;
• peripheral edema.

Chlortalidone (monotherapy)

• Thrombocytopenia, leukopenia, agranulocytosis, eosinophilia;
• headache;
• excessive decrease in blood pressure;
• arrhythmia;
• allergic pulmonary edema;
• loss of appetite;
• gastrointestinal disorders;
• constipation;
• stomach ache;
• intrahepatic cholestasis or jaundice;
• pancreatitis;
• allergic interstitial nephritis;
• photosensitization;
• cutaneous vasculitis;
• hyperlipidemia, hypokalemia, hypomagnesemia, hypercalcemia;
• decompensation of existing diabetes mellitus;
• hives;
• decreased potency.

With the simultaneous use of azilsartan medoxomil with chlorthalidone, the incidence of hypokalemia is reduced.

If any of the side effects listed in the manual are aggravated or any other side effects not indicated in the instructions appear, the patient should be informed of this to the doctor.

Contraindications

• refractory hypokalemia;
• anuria;
• simultaneous administration of aliskiren and aliskiren-containing drugs in patients with diabetes mellitus or moderate or severe renal dysfunction (GFR less than 60 ml / min / 1.73 m2);
• severe forms of diabetes mellitus;
• violations of liver function severe (more than 9 points on the scale Child-Pugh), tk. no experience of use;
• renal failure of severe degree (QC less than 30 ml / min), because no experience of use;
• age under 18 years (effectiveness and safety not established);
• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to the components of the drug.

Carefully:

• severe chronic heart failure (NYHA 4 functional class);
• impaired renal function (QC more than 30 ml / min);
• impaired liver function of mild and moderate degree (5-9 points on the Child-Pugh scale);
• bilateral stenosis of the renal arteries and stenosis of the artery of a single functioning kidney;
• ischemic cardiomyopathy;
• ischemic cerebrovascular disease;
• condition after kidney transplantation;
• conditions accompanied by a decrease in BCC (including vomiting, diarrhea, the use of diuretics in high doses), as well as in patients who follow a diet with restriction of table salt;
• primary hyperaldosteronism;
• hyperuricemia, gout;
• bronchial asthma;
• systemic lupus erythematosus;
• stenosis of the aortic and mitral valve;
• hypertrophic obstructive cardiomyopathy (GOKMP);
• age over 75 years;
• hypokalemia.

Application in pregnancy and lactation

The experience of using the drug Edarby in pregnant women is absent. The use of the drug during pregnancy and during breastfeeding is not recommended.

In newborns, whose mothers received the medication of azilsartan medoxomil, hypotension may develop, and newborns should be under careful medical supervision.

Chlortalidone penetrates the placental barrier into the umbilical cord blood and can cause jaundice of the fetus or newborn, thrombocytopenia and also other unwanted reactions noted in adults.

Immediately after confirmation of pregnancy, you should stop using the drug Edarby Clo and, if necessary, switch to the use of drugs with proven safety during pregnancy.

There is no information on a person about the ability of azilsartan and / or its metabolites to excrete with breast milk. In experimental animal studies, it was found that the azilsartan and its metabolite M-2 are secreted with the milk of lactating rats.

Chlortalidone is excreted in breast milk.

If you need to use the drug Edarby Clos during lactation, you must stop breastfeeding, or stop taking the drug. Preferably use drugs with a proven safety profile.

Use in children

Contraindicated use of the drug in children and adolescents under the age of 18 years (efficacy and safety not established).

Application in elderly patients

Older patients do not need to adjust the initial dose of the drug.

Caution should be given to patients aged over 75 years.

special instructions

Patients in whom vascular tone and renal function depend to a large extent on the activity of RAAS (for example, in patients with severe chronic heart failure (NYHA functional class 4), severe renal failure or stenosis of the renal arteries), treatment with drugs acting on RAAS, such as ACE inhibitors and angiotensin 2 receptor antagonists, is associated with the possibility of developing acute arterial hypotension, azotemia, oliguria, or, rarely, acute renal failure. The possibility of developing these effects can not be ruled out when using Edarby.

A sharp decrease in blood pressure in patients with ischemic cardiomyopathy or ischemic cerebrovascular disease can lead to the development of myocardial infarction or stroke.

Data on the use of Edarbi in patients who have recently undergone kidney transplantation are not available.

Data on the clinical experience of using Edarbi in patients with severe liver function impairment are absent, therefore, the use of the drug in this category of patients is not recommended.

In patients with reduced bcc and / or hyponatremia (as a result of vomiting, diarrhea, high-dose diuretics, or a diet with restricted intake of salt), clinically significant hypotension may develop after initiation of therapy with Edarby. Hypovolemia should be adjusted before starting treatment with Edarby or starting treatment with a dosage of 20 mg.

Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect RAAS. In connection with this, it is not recommended to administer Edarby to such patients.

Clinical experience with other drugs that affect RAAS shows that the simultaneous administration of Edarbis with potassium-sparing diuretics, potassium preparations or salt substitutes containing potassium, or other drugs that may increase the potassium content of the blood (eg heparin) can lead to Hyperkalemia in patients with arterial hypertension.In elderly patients, patients with renal insufficiency, diabetes mellitus and / or patients with other concomitant diseases, the risk of developing hyperkalemia increases, which can be fatal. In such patients it is recommended to monitor the potassium content in the blood serum.

Care should be taken when using Edarbi in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.

As with the use of other antagonists of angiotensin 2 receptors, simultaneous use of lithium preparations and Edarbi preparation is not recommended.

When chlorthalidone is used, hypokalemia may develop. It is necessary to regularly monitor the potassium content in the blood serum. In patients taking cardiac glycosides, hypokalemia may predispose to arrhythmia.

Care should be taken when administering Edarby Claw to patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.

Impact on the ability to drive vehicles and manage mechanisms

Based on pharmacodynamic properties, it is expected that the azilsartan medoxomil will have little effect on the ability to drive vehicles and control mechanisms. Care should be taken, as with any antihypertensive drug (risk of dizziness and increased fatigue).

Drug Interactions

There was a reversible increase in serum lithium concentration and toxicity with simultaneous use of lithium preparations and ACE inhibitors and lithium preparations with angiotensin II receptor antagonists. Therefore, concomitant use of azilsartan medoxomil in combination with lithium preparations is not recommended. If this combination is necessary, regular monitoring of the lithium content in serum is recommended.

With simultaneous use of angiotensin 2 antagonists and non-steroidal anti-inflammatory drugs (NSAIDs) (for example, selective inhibitors of COX-2, Acetylsalicylic acid (more than 3 g per day) and nonselective NSAIDs), the antihypertensive effect may be attenuated.With the simultaneous use of angiotensin 2 antagonists and NSAIDs, the risk of renal dysfunction and increased serum potassium levels may increase. Therefore, at the beginning of treatment, patients are advised to take a regular intake of a sufficient amount of fluid and monitor the function of the kidneys.

Simultaneous use of potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium and other medicines (eg, heparin) with Edarby can lead to an increase in potassium in the serum. Patients should be monitored for serum potassium during combined therapy.

Double blockade of RAAS with angiotensin 2 receptor antagonists, ACE inhibitors or aliskiren is associated with an increased risk of arterial hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy.

No pharmacokinetic interactions were observed with simultaneous use of azilsartan medoxomil or azilsartan with amlodipine, antacid preparations (magnesium and aluminum hydroxide), chlorthalidone, digoxin, fluconazole, glibenclamide, ketoconazole, Metformin and warfarin.

Azilsartan medoxomil is converted into the pharmacologically active metabolite azilsartan during absorption from the digestive tract by the action of the enzyme carboxymethylenebutenolidase in the intestine and liver. Studies have shown that interactions based on inhibition of enzymes are unlikely.

The antihypertensive effect of Edarby therapy can be strengthened when combined with other antihypertensive agents, including diuretics (chlorthalidone and hydrochlorothiazide) and dihydropyridine blockers of slow calcium channels (amlodipine).

Chlortalidone enhances the action of curare-like muscle relaxants and antihypertensive agents (including guanethidine, methyldopa, beta-adrenoblockers, vasodilating agents, slow calcium channel blockers), MAO inhibitors.

The simultaneous use of chlorthalidone with Allopurinol may lead to an increase in the frequency of development of hypersensitivity reactions to allopurinol.

Chlortalidone may increase the risk of adverse reactions caused by amantadine.

Anticholinergic drugs (eg, atropine, biperiden) can increase the bioavailability of chlorthalidone, reducing the motility of the gastrointestinal tract and evacuating the contents of the stomach.

The hypokalemic effect of chlorthalidone is enhanced with simultaneous use with corticosteroids, adrenocorticotropic hormone, amphotericin, beta2-adrenoblockers, carbenoxolone. Patients should be monitored for serum potassium during combined therapy.

It may be necessary to correct (decrease or increase) the dose of hypoglycemic agents for ingestion and insulin.

The pharmacological effects of calcium and vitamin D salts can increase to a clinically significant level when used simultaneously with chlorthalidone.

Simultaneous use with cyclosporine may increase the risk of hyperuricemia and complications such as gout.

Kolestyramin breaks the absorption of chlorthalidone. It is possible to reduce the pharmacological effect of chlorthalidone.

The simultaneous use of chlorthalidone with Methotrexate and cyclophosphamide may lead to potentiation of the pharmacological effect of antitumor drugs.

Analogues of Edarby's drug

Structural analogs for the active substance:

• Edarby Claw.

Analogues on the curative effect (means for treating arterialhypertension and pressure reduction):

• Amlodipine;
• Anaprilin;
• Andipal;
• Atacand;
• Atenolol;
• Berlipril;
• Betalk;
• Bisoprolol;
• Vasotensis;
• Wales;
• Walsakor;
• Vylloset;
• Verapamil;
• Veroshpiron;
• Hypothiazide;
• Dibazol;
• Diltiazem;
• Diroton;
• Diver;
• Doxazosin;
• Indapamide;
• Kalchek;
• Camyrin;
• Kapoten;
• Captopril;
• Carvedilol;
• Cardura;
• Concor;
• Corvalol Forte;
• Corvitol;
• Korgard;
• Cordaflex;
• Cordipine;
• Corinfar;
• Cristepin;
• Kudevita;
• Qudesan;
• Lasix;
• Lysinopril;
• Lodose;
• Lozap;
• Lozarel;
• Lorist;
• Magnesium sulfate;
• Metoprolol;
• Moxonidine;
• Niperten;
• Nifedipine;
• Noliprel;
• Obsidan;
• Prestan;
• Prestarium;
• Propranolol;
• Raunatin;
• Renitek;
• Spironolactone;
• Stamlo;
• Teveten;
• Felodipine;
• Felotenz retard;
• Physiotherapy;
• Fozinap;
• Furosemide;
• Hartil;
• Egilok;
• Equator;
• Exforge;
• Enalapril;
• Enam;
• Enap;
• Enarenal;
• Enziks;
• Enziks duo forte;
• Estecor.

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