Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Takeda Pharma A/S, Delta Park 45, 2665 Vallensbaek Strand, Denmark
Edarbi is indicated for the treatment of essential hypertension in adults.
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.
If blood pressure is not adequately controlled with Edarbi alone, additional blood pressure reduction can be achieved when this treatment is coadministered with other antihypertensive medicinal products, including diuretics (such as chlortalidone and hydrochlorothiazide) and calcium channel blockers (see sections 4.3, 4.4, 4.5 and 5.1).
No initial dose adjustment with Edarbi is necessary in elderly patients (see section 5.2), 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.
Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Edarbi in these patients (see sections 4.4 and 5.2). Hemodialysis does not remove azilsartan from the systemic circulation. No dose adjustment is required in patients with mild or moderate renal impairment.
Edarbi has not been studied in patients with severe hepatic impairment and therefore its use is not recommended in this patient group (see sections 4.4 and 5.2).
As there is limited experience of use of Edarbi in patients with mild to moderate hepatic impairment close monitoring is recommended and consideration should be given to 20 mg as a starting dose (see section 5.2).
For patients with possible depletion of intravascular volume or salt depletion (e.g. patients with vomiting, diarrhoea or taking high doses of diuretics), Edarbi should be initiated under close medical supervision and consideration can be given to 20 mg as a starting dose (see section 4.4).
No dose adjustment is required in the black population, although smaller reductions in blood pressure are observed compared with a non-black population (see section 5.1). 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.
Edarbi is not indicated for use in children or adolescents under 18 years of age. Currently available data in children or adolescents 6 to <18 years of age are described in sections 4.8, 5.1, and 5.2 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.
Edarbi is for oral use and may be taken with or without food (see section 5.2).
Based on pharmacological considerations, the main manifestation of an overdose is likely to be symptomatic hypotension and dizziness. During controlled clinical studies in healthy adult subjects, once daily doses up to 320 mg of azilsartan medoxomil were administered for 7 days and were well tolerated.
If symptomatic hypotension should occur, supportive treatment should be instituted and vital signs monitored.
Azilsartan is not removed by dialysis.
3 years.
Store in the original package in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.
Aluminum blisters
Pack sizes: 14, 28, 56 or 98 tablets; or
Aluminum blisters integrated with desiccant.
Pack sizes: 14, 28, 30, 56, 90 or 98 tablets.
Not all pack sizes may be marketed.
No special requirements.
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