EDARBI

Posology The recommended starting dose in adults is 40 mg once daily. The dose may be increased to a maximum of 80 mg once daily for patients whose blood pressure is not adequately controlled at the lower dose. Near-maximal antihypertensive effect is evident at 2 weeks, with maximal effects attained by 4 weeks.

1). 2), although consideration can be given to 20 mg as a starting dose in the very elderly (≥ 75 years), who may be at risk of hypotension. 2). Haemodialysis does not remove azilsartan from the systemic circulation. No dose adjustment is required in patients with mild or moderate renal impairment.

2). 2). g. 4). 1). This generally has been true for other angiotensin II receptor (AT1) antagonists and angiotensin-converting enzyme inhibitors. Consequently, uptitration of Edarbi and concomitant therapy may be needed more frequently for blood pressure control in black patients.

Paediatric population Edarbi is not indicated for use in children or adolescents under 18 years of age. 2 but no recommendation on a posology can be made. The safety and efficacy of Edarbi in children < 6 years of age have not yet been established.

No data are available. 2).

Summary of the safety profile Edarbi at doses of 20, 40 or 80 mg has been evaluated for safety in clinical studies in adult patients treated for up to 56 weeks. In these clinical studies, adverse reactions associated with treatment with Edarbi were mostly mild or moderate, with an overall incidence similar to placebo.

The most common adverse reaction was dizziness. The incidence of adverse reactions with this treatment was not affected by gender, age, or race. Adverse reactions were reported at a similar frequency for the Edarbi 20 mg dose as with the 40 and 80 mg doses in one placebo controlled study.

Tabulated list of adverse reactions Adverse reactions based on pooled data (40 and 80 mg doses) are listed below according to system organ class and preferred terms. These are ranked by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Adverse drug reactions from clinical trials and post marketing experience System organ class Frequency Adverse reaction Nervous system disorders Common Dizziness Vascular disorders Uncommon Hypotension Gastrointestinal disorders Common Uncommon Diarrhoea Nausea Skin and subcutaneous tissue disorders Uncommon Rare Rash, pruritus Angioedema Musculoskeletal and connective tissue disorders Not known Uncommon Arthralgia Muscle spasms General disorders and administration site conditions Uncommon Fatigue Peripheral oedema Investigations Common Uncommon Blood creatine phosphokinase increased Adverse drug reactions from clinical trials and post marketing experience System organ class Frequency Adverse reaction Blood creatinine increased Blood uric acid increased / Hyperuricemia Description of selected adverse reactions When Edarbi was coadministered with chlortalidone, the frequencies of blood creatinine increased and hypotension were increased from uncommon to common.

g. patients with congestive heart failure, severe renal impairment or renal artery stenosis), treatment with medicinal products that affect this system, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists, has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.

The possibility of similar effects cannot be excluded with Edarbi. 2). Excessive blood pressure decreases in patients with ischaemic cardiomyopathy or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.

Dual blockade of the RAAS There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure).

1). If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure. ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.

Kidney transplantation There is currently no experience on the use of Edarbi in patients who have recently undergone kidney transplantation. 2). g. patients with vomiting, diarrhoea or taking high doses of diuretics) symptomatic hypotension could occur after initiation of treatment with Edarbi.

Hypovolemia should be corrected prior to administration of Edarbi, or the treatment should start under close medical supervision, and consideration can be given to a starting dose of 20 mg. Primary hyperaldosteronism Patients with primary hyperaldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the RAAS.

Therefore, the use of Edarbi is not recommended in these patients. g. 5). In the elderly, in patients with renal insufficiency, in diabetic patients and/or in patients with other co-morbidities, the risk of hyperkalaemia, which may be fatal, is increased.

1. 6). 1).