Edarbi 40mg 28 tablets — Made in Ireland — Free Delivery
(Edarbi 40mg )
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Description Edarbi 40mg 28 tablets — Made in Ireland — Free Delivery
Indications
Treatment of essential hypertension in adults.
Application
Edarbi is intended for oral use, the tablets can be taken with or without food.
The recommended starting dose is 40 mg once daily.
For patients in whom this dose does not adequately control blood pressure, the dose may be increased to the maximum recommended dose of 80 mg once daily.
A stable antihypertensive effect is achieved within 2 weeks of treatment. The maximum effect is achieved after 4 weeks of taking the preparation.
If during monotherapy with Edarbi it is not possible to achieve adequate control of blood pressure levels, an additional decrease in blood pressure can be achieved through combined treatment with other antihypertensive preparations, including diuretics (for example, chlorthalidone and hydrochlorothiazide) and calcium channel blockers.
Elderly patients (over 65 years of age) do not need to adjust the initial dose of Edarbi. However, for patients over the age of 75 years with a risk of arterial hypotension, the possibility of using the preparation at a dose of 20 mg should be considered (see Pharmacokinetics).
Impaired kidney function. Edarbi should be used with caution in patients with hypertension and severely impaired renal function or end-stage renal disease, since there is no experience with the preparation in such patients. Azilsartan is not excreted from the systemic circulation during hemodialysis. Patients with mild or moderate renal insufficiency do not require dose adjustment.
Impaired liver function. Studies on the use of Edarbi in patients with severely impaired liver function have not been conducted, so the preparationis not recommended for use in patients of this group.
Since the experience of using Edarbi in patients with mild to moderate hepatic impairment is limited, it is recommended to carefully monitor the condition of such patients and consider using the preparation at an initial dose of 20 mg.
Deficit of intravascular volume. In patients with possible intravascular volume deficiency or salt depletion (for example, patients with vomiting, diarrhea, or patients who receive high doses of diuretics), Edarbi is prescribed under the supervision of a physician, and the possibility of using an initial dose of 20 mg should also be considered.
Negroid patients. There is no need for dose adjustment, although these patients have a less pronounced decrease in blood pressure compared to patients of other races. This usually applies to other angiotensin II receptor blockers and ACE inhibitors. This population may require more frequent dose escalation of Edarbi and concomitant medications.
Compound
active ingredient: azilsartan medoxomil
1 tablet of Edarbi 40 mg contains 42.68 mg of azilsartan medoxomil potassium, which is equivalent to 40 mg of azilsartan medoxomil
1 tablet of Edarbi 80 mg contains 85.36 mg of azilsartan medoxomil potassium, which is equivalent to 80 mg of azilsartan medoxomil.
excipients: mannitol (E 421) fumaric acid sodium hydroxide hydroxypropyl cellulose sodium croscarmellose cellulose microcrystalline magnesium stearate purified water.
Contraindications
Hypersensitivity to the active substance or other components of the preparation. pregnancy or women planning a pregnancy (see use during pregnancy and lactation). do not use edarbi with preparations containing aliskiren in patients with diabetes mellitus or impaired renal function (glomerular filtration rate 60 ml / min / 1.73 m2).
Side effects
Undesirable effects according to the frequency of occurrence are classified into the following categories: very often (≥1/10), often (≥1/100, 1/10), infrequently (≥1/1000, 1/100), rarely (≥1/10,000 and 1/1000), very rarely (1/10,000), including isolated cases.
In each system organ class, adverse reactions are listed in descending order of their clinical significance.
From the nervous system: often - dizziness.
From the vascular system: infrequently - hypotension.
From the digestive tract: often - diarrhea; infrequently - nausea.
From the skin and subcutaneous tissues: infrequently - rash, itching; rarely - angioedema.
From the musculoskeletal system and connective tissue: infrequently - muscle spasms.
General disorders: infrequently - fatigue, peripheral edema.
Laboratory studies: often - an increase in the level of CPK in the blood; infrequently - an increase in the level of creatinine in the blood, an increase in the level of uric acid in the blood / hyperuricemia.
Description of individual adverse reactions. During the combined use of Edarbi and chlorthalidone, the frequency of increased blood creatinine and hypotension increased from infrequently to often.
During the combined use of Edarbi and amlodipine, the incidence of peripheral edema increased from infrequently to often, but was lower than that characteristic of amlodipine in monotherapy.
special instructions
Raas activation. in patients whose vascular tone and renal function are predominantly dependent on RAAS activity (eg, patients with congestive heart failure, severe renal failure, or renal artery stenosis), treatment with preparations that affect the RAAS (eg, ACE inhibitors and angiotensin II receptor blockers) has been associated with the occurrence of acute arterial hypotension, azotemia, oliguria, or, in rare cases, acute renal failure. it is impossible to exclude the occurrence of such phenomena when using edarbi.
Edarbi should be used with caution in the treatment of patients with hypertension and severe renal impairment, congestive heart failure or renal artery stenosis, since there is no experience with the preparation in the treatment of such patients.
An excessive decrease in blood pressure in patients with coronary artery disease or ischemic cerebrovascular accident can lead to myocardial infarction or stroke.
Double blockade of the RAAS. The combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of arterial hypotension, hyperkalemia and deterioration of renal function (including acute renal failure). Therefore, dual blockade of the RAAS due to the combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is not recommended (see Interactions). If dual blockade therapy is necessary, it should be carried out under the supervision of a physician and monitoring of renal function, electrolyte levels and blood pressure. Patients with diabetic nephropathy should not take ACE inhibitors together with angiotensin II receptor blockers.
Kidney transplant. To date, there is no experience with the use of Edarbi in patients who have recently undergone kidney transplantation.
Liver dysfunction. The use of Edarbi for the treatment of patients with severe hepatic impairment has not been studied, therefore this preparation is not recommended for patients in this group.
Arterial hypotension in patients with BCC deficiency and/or salt depletion. In patients with severe BCC deficiency and / or salt depletion (for example, patients with diarrhea, vomiting, or patients taking high doses of diuretics), symptomatic hypotension may occur after the start of treatment with Edarbi. Before starting treatment, measures should be taken to compensate for hypovolemia or treatment should be started under close medical supervision. An initial dose of 20 mg should also be considered.
Primary hyperaldosteronism. Patients with primary aldosteronism usually do not respond to treatment with antihypertensive preparations, the mechanism of action of which is to suppress the renin-angiotensin-aldosterone system. Thus, the use of Edarbi in such patients is not recommended.
Hyperkalemia. Based on the experience with other preparations that affect the RAAS, the simultaneous use of Edarbi with potassium-sparing diuretics, potassium-containing supplements, potassium-containing salt substitutes, or other preparations that can increase the level of potassium in the blood (for example, heparin), may lead to an increase in the level potassium in the blood of patients with hypertension. In elderly patients, with renal insufficiency, with diabetes mellitus and / or with other concomitant diseases, the risk of hyperkalemia (which can be fatal) is increased. If necessary, the level of potassium should be monitored.
Stenosis of the aortic and mitral valves, obstructive hypertrophic cardiomyopathy. Treatment of patients with aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy requires special care.
Lithium. As with other angiotensin II receptor blockers, Edarbi should not be administered concomitantly with lithium preparations.
Use during pregnancy and lactation
Pregnancy. The preparation should not be used in pregnant women or women who are planning a pregnancy. If pregnancy is confirmed during treatment, the use of the preparation should be stopped immediately and another preparation approved for use in pregnant women should be prescribed.
There are no data on the use of Edarbi in pregnant women. Animal studies have shown reproductive toxicity.
Epidemiological data do not indicate a risk of teratogenicity as a result of exposure to ACE inhibitors during the first trimester of pregnancy, but a slight increase in risk cannot be ruled out. Due to the lack of controlled epidemiological data on the risk associated with angiotensin II receptor blockers, this risk cannot be excluded for preparations in this class. Patients planning pregnancy should switch to an alternative antihypertensive therapy that has a more well-researched safety profile for use in pregnant women.
Therapy with angiotensin II receptor blockers in women in the II and III trimester of pregnancy can lead to fetotoxicity (decreased renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, arterial hypotension, hyperkalemia).
If it is necessary to use angiotensin II receptor blockers in the second trimester of pregnancy, ultrasound is recommended to determine kidney function and ossification of the skull bones in the fetus.
Infants whose mothers have used angiotensin II receptor blockers should be carefully monitored for the development of hypotension (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS).
Breastfeeding. The preparation is not recommended for use during lactation due to the lack of relevant data. During breastfeeding, it is advisable to initiate an alternative treatment with a more researched safety profile, especially during breastfeeding of a newborn or premature infant.
Fertility. Data on the effect of azilsartan medoxomil on human reproductive function are not available. According to the results of preclinical studies, azilsartan did not affect the reproductive function of female and male rats.
Children. There are no data on the use of the preparation in children (under 18 years of age).
The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Given the pharmacodynamic characteristics of the preparation, azilsartan medoxomil may have a slight effect on the reaction rate when driving vehicles or working with other mechanisms. However, while taking any antihypertensive preparation, you need to be aware of the possible occurrence of dizziness or fatigue.
Interactions
Combinations that are not recommended
Lithium. With the simultaneous use of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and a reversible increase in the severity of manifestations of toxicity were noted. A similar effect is possible with angiotensin II receptor blockers. Due to the lack of experience with the simultaneous use of azilsartan medoxomil and lithium preparations, this combination of preparations is not recommended. If necessary, the simultaneous appointment of these preparations should carefully monitor the level of lithium in the blood serum.
Combinations to be used with caution
NSAIDs, including selective COX-2 inhibitors, acetylsalicylic acid at a dose of 3 g / day and non-selective NSAIDs. With the simultaneous use of NSAIDs (that is, selective COX-2 inhibitors, for example, acetylsalicylic acid at a dose of 3 g / day and non-selective NSAIDs) and angiotensin II receptor blockers, it is possible to weaken the severity of the hypotensive effect of the latter. In addition, the simultaneous use of angiotensin II receptor blockers and NSAIDs may lead to an increased risk of deterioration in kidney function and blood potassium levels. Thus, it is recommended to ensure adequate hydration of the patient and control of renal function at the beginning of treatment.
Potassium-sparing diuretics, potassium-containing supplements, potassium-containing salt substitutes, and other substances that can increase blood potassium levels. Potassium-sparing diuretics, potassium-containing supplements, potassium-containing salt substitutes, and other preparations (such as heparin) may increase blood potassium levels when taken concomitantly. If necessary, the level of potassium in the blood serum should be monitored.
Additional Information. Data from clinical studies have shown that dual blockade of the RAAS with the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of arterial hypotension, hyperkalemia, deterioration of renal function (including acute renal failure) compared with monotherapy with an active RAAS agent (see CONTRAINDICATIONS, SPECIAL INSTRUCTIONS).
In studies of the use of azilsartan medoxomil or azilsartan in combination with amlodipine, antacids, chlorthalidone, digoxin, fluconazole, glyburide, ketoconazole, metformin and warfarin, no clinically significant preparation interactions were registered.
Azilsartan medoxomil is rapidly hydrolyzed by esterases in the digestive tract and/or during absorption to the active substance azilsartan. In vitro studies indicate a low likelihood of interactions based on esterase inhibition.
Overdose
Symptoms. Based on the pharmacological properties, it can be expected that the main manifestations of overdose will be symptomatic hypotension and dizziness. in controlled clinical trials in healthy individuals, participants received edarbi at a dose of up to 320 mg once daily for 7 days. these doses were well tolerated by study participants.
Treatment. With the development of symptomatic hypotension, replacement therapy should be initiated and vital signs should be monitored. Azilsartan is not excreted by hemodialysis.
Storage conditions
Does not require special storage conditions. store in original packaging.
Tags: Edarbi
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