Edarbi pills 80mg №28

Indications

- essential hypertension.

Dosage and administration

The drug is taken orally 1 time / day, regardless of the meal.

The recommended initial dose is 40 mg 1 time / day. If necessary, an additional reduction in blood pressure can be increased to the maximum dose - 80 mg 1 time / day. The maximum daily dose is 80 mg.

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

Drug edarbi^® should be taken daily, without interruption. In case of termination of treatment, the patient should inform the doctor.

In case of skipping the next dose, the next dose should be taken at the usual time. Do not take a double dose of Edarbi^®.

Correction of the initial dose of the drug Edarbi is not required.^® at elderly patients. However, in patients over the age of 75, a dose of 20 mg can be considered as the initial dose (the risk of arterial hypotension increases).

Correction of dosing regimen is not required. patients with impaired renal mild and moderate severity. No clinical experience with Edarbi^® at patients with severe renal impairment and end-stage renal diseasetherefore, it is necessary to use the drug in this category of patients with caution.

Due to limited experience with the use of the drug Edarbi^® at patients with impaired liver function mild and moderate severity It is recommended to begin treatment with a dose of 20 mg 1 time / day and carry it out under close observation. It is not recommended to use the drug in patients with severe hepatic impairment due to lack of clinical experience.

Drug edarbi^® It should be prescribed to patients with reduced BCC and / or hyponatremia (for example, patients with prolonged vomiting, diarrhea, or taking diuretics in large doses) only under strict medical supervision. It is recommended to begin treatment with a dosage of 20 mg 1 time / day.

Due to the lack of clinical experience, Edarbi should be used with caution.^® in patients with severe chronic heart failure (functional class IV by NYHA classification).

Dose adjustment is not required in patients of the Negroid race. As with other angiotensin II receptor antagonists (AT₁) and ACE inhibitors, in patients of the Negroid race there is a lesser decrease in blood pressure compared with the rest of the population. In this regard, in order to adequately control blood pressure in Negroid patients, it may be necessary to increase the dose of the Edarbi drug.^® and complex therapy more often than in other patients.

Adverse effects

The frequency of adverse reactions was determined in accordance with the WHO recommendations: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100; rarely (> 1/10 000, <1/1000); very rarely (<1/10 000), including individual messages; unspecified frequency (the frequency cannot be calculated by the available data).

Nervous system: often dizziness.

Cardiovascular: infrequently - pronounced decrease in blood pressure.

Gastrointestinal: often - diarrhea; infrequently - nausea.

Dermatological: infrequently - rash, itching; rarely - angioedema.

Musculoskeletal system: infrequently - muscle spasms.

From the laboratory and instrumental studies: often - increased activity of CPK; infrequently - an increase in the concentration of creatinine, hyperuricemia.

Other: infrequently - increased fatigue, peripheral edema.

Description of individual adverse reactions

With the simultaneous use of the drug Edarbi^® with chlorthalidone, the frequency of adverse reactions — a pronounced decrease in blood pressure and an increase in creatinine concentration — increases in frequency from “infrequently” to “often”.

With the simultaneous use of the drug Edarbi^® with Amlodipine, the incidence of adverse reactions — peripheral edema — increases from infrequent to frequent, but is less common than with amlodipine monotherapy.

Rarely observed angioedema, swelling of the face, lips and periorbital edema.

As with the use of other angiotensin II receptor antagonists and ACE inhibitors, the simultaneous use of Edarbi^® with diuretics (for example, chlorthalidone) leads to an increase in the increase in creatinine concentration. Increasing the concentration of creatinine while using the drug Edarbi^® with diuretics is associated with a more pronounced decrease in blood pressure compared with monotherapy with Edarbi^®. Most of these effects were short-term or not progressive, while patients continued therapy. After discontinuation of the drug, most cases of an increase in the concentration of creatinine that were not treated during treatment were reversible. The concentration of creatinine in most patients returned to values ​​at baseline, or values ​​close to baseline.

When treated with Edarbi^® there was a slight increase in serum uric acid concentration (10.8 mcmol / L) compared with placebo (4.3 mcmol / L).

As with the use of other RAAS inhibitors, when using the drug Edarbi^® as a monotherapy, a slight decrease in hemoglobin and hematocrit was observed (on average, decreased by about 3 g / l and 1% by volume, respectively).

If any of the side effects indicated in the instructions are aggravated, or the patient notes other side effects that are not indicated in the instructions, you should inform your doctor.

Contraindications

- severe violations of the liver (more than 9 points on the Child-Pugh scale) (no experience with the application);

- pregnancy;

- simultaneous use of aliskiren in patients with diabetes mellitus;

- age up to 18 years (efficiency and safety have not been established);

- hypersensitivity to the active substance and other components of the drug.

Carefully the drug should be used for severe chronic heart failure (NYHA functional class IV); severe renal failure (CC <30 ml / min); bilateral stenosis of the renal arteries and arterial stenosis of the only functioning kidney; ischemic cardiomyopathy; ischemic cerebrovascular diseases; condition after kidney transplantation; conditions accompanied by a decrease in the BCC (including vomiting, diarrhea), as well as in patients who follow a diet with the restriction of table salt; with simultaneous use with diuretics in high doses; primary hyperaldosteronism; hyperkalemia; stenosis of the aortic and mitral valves; hypertrophic obstructive cardiomyopathy (GOKMP); in patients over the age of 75 years.

Use during pregnancy and lactation

Pregnancy

In animal studies, it was found that azilsartan and M-II penetrate the placental barrier.

Patients planning a pregnancy should begin therapy with alternative antihypertensive drugs with an established safety profile for pregnant women.Immediately after confirmation of pregnancy should stop taking the drug Edarbi^® and, if necessary, begin treatment with drugs approved for use in pregnancy.

In newborns whose mothers received therapy with Edarbi^®, hypotension may develop, and therefore, newborns must be under close medical supervision.

Lactation period

There is no information about the ability of azilsartan and / or its metabolites to penetrate into breast milk. In animal studies, it has been found that azilsartan and M-II are excreted in milk of activating rats.

Due to lack of experience with the use of the drug Edarbi^® in women during breastfeeding, its use in this category of patients is not recommended. Preferably the use of drugs with the most studied safety profile, especially during the care of a newborn or premature baby.

Fertility

Data on the effects of the drug Edarbi^® on fertility in humans are absent. Preclinical studies have shown no effect on male or female fertility in rats.

Application for violations of the liver

Due to limited experience with the use of the drug Edarbi^® at patients with impaired liver function mild and moderate severity It is recommended to begin treatment with a dose of 20 mg 1 time / day and carry it out under close observation. It is not recommended to use the drug in patients with severe hepatic impairment due to lack of clinical experience.

Application for violations of kidney function

Correction of dosing regimen is not required. patients with impaired renal mild and moderate severity. No clinical experience with Edarbi^® at patients with severe renal impairment and end-stage renal diseasetherefore, it is necessary to use the drug in this category of patients with caution.

Use in children

The drug is contraindicated in children and adolescents under the age of 18 years (efficacy and safety have not been established).

Use in elderly patients

Correction of the initial dose of the drug Edarbi is not required.^® at elderly patients. However, in patients over the age of 75, a dose of 20 mg can be considered as the initial dose (the risk of arterial hypotension increases).

special instructions

Patients whose vascular tone and kidney function depend to a large extent on the activity of the RAAS (for example, in patients with severe chronic heart failure (class IVHA functional class IV), severe renal failure or renal artery stenosis). on RAAS, such as ACE inhibitors and angiotensin II receptor antagonists, is associated with the possibility of developing acute arterial hypotension, azotemia, oliguria, or, rarely, acute renal failure . The possibility of the development of these effects can not be excluded when using Edarbi^®.

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

Data on the use of the drug Edarbi^® in patients who have recently had a kidney transplant, are absent.

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

Patients with reduced BCC and / or hyponatremia (as a result of vomiting, diarrhea, taking high doses of diuretics, or following a diet with restricted salt intake) may develop clinically significant hypotension after starting treatment with Edarbi^®. Hypovolemia should be adjusted before starting treatment with Edarbi.^® or start treatment with a dosage of 20 mg.

Patients with primary hyperaldosteronism are usually resistant to treatment with antihypertensive drugs that affect the RAAS. In this regard, the drug Edarbi^® It is not recommended to appoint such patients.

Clinical experience with other drugs that affect the RAAS, shows that the simultaneous appointment of the drug Edarbi^® with potassium-sparing diuretics, potassium preparations or potassium-containing salt substitutes, or other drugs that may increase the level of potassium in the blood (for example, heparin), can lead to hyperkalemia in patients with arterial hypertension.Elderly patients, patients with renal insufficiency, diabetes mellitus and / or patients with other concomitant diseases increase the risk of developing hyperkalemia, which can be fatal. In such patients, it is recommended to monitor the content of potassium in the serum.

When using the drug Edarbi^® Patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy should be careful.

As with the use of other angiotensin II receptor antagonists, the simultaneous use of lithium preparations and Edarbi is not recommended.^®.

Influence on ability to drive motor transport and control mechanisms

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

Overdose

Experience the use of the drug Edarbi^® in adults in doses up to 320 mg / day for 7 days, it shows that the drug is well tolerated.

Symptoms: pronounced decrease in blood pressure, dizziness.

Treatment: with a marked decrease in blood pressure should transfer the patient to a horizontal position with a low head; It is recommended that measures to increase the BCC and symptomatic therapy. Hemodialysis is not effective.

Drug interaction

A reversible increase in serum lithium concentration and manifestation of toxicity were observed with simultaneous use of lithium preparations and ACE inhibitors and lithium preparations with angiotensin II receptor antagonists. Therefore, the simultaneous use of azilsartan medoxomil in combination with lithium preparations is not recommended. If necessary, the use of this combination is recommended to regularly monitor the content of lithium in the serum.

With simultaneous use of antagonists of angiotensin II and NSAIDs (for example, selective COX-2 inhibitors, Acetylsalicylic acid (more than 3 g / day) and non-selective NSAIDs, the antihypertensive effect may be weakened. With simultaneous use of antagonists of angiotensin II and NSAIDs may increase the risk of impaired renal function and an increase in the content of potassium in the blood serum. Therefore, at the beginning of treatment, patients are recommended to regularly take a sufficient amount of fluid and monitor renal function.

The simultaneous use of potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium and other medicines (for example, heparin) with azilsartan medoxomil can lead to an increase in serum potassium. Patients during combination therapy should monitor the content of potassium in the serum.

RAAS double blockade with angiotensin II receptor antagonists,ACE inhibitors or aliskiren are associated with an increased risk of arterial hypotension, hyperkalemia, and impaired renal function (including acute renal failure) compared with monotherapy.

Pharmacokinetic interactions were not observed with the 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 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 enzyme inhibition are unlikely.

The antihypertensive effect of azilsartan medoxomil therapy can be enhanced when combined with other antihypertensive drugs, including diuretics (chlorthalidone and hydrochlorothiazide) and dihydropyridine blockers of slow calcium channels (amlodipine).

Terms and conditions of storage

The drug should be stored in its original packaging to protect from light and moisture, out of the reach of children at a temperature not exceeding 25 ° C.