Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland
Treatment of essential hypertension.
Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.
The recommended starting dose of olmesartan medoxomil is 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added.
The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient.
No adjustment of dosage is generally required in elderly people (see below for dose recommendations in patients with renal impairment). If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored.
The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20-60 ml/min) is 20 mg olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of olmesartan medoxomil in patients with severe renal impairment (creatinine clearance <20 ml/min) is not recommended, since there is only limited experience in this patient group (see sections 4.4 and 5.2).
No adjustment of dosage recommendations is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg olmesartan medoxomil once daily is recommended and the maximum dose should not exceed 20 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of olmesartan medoxomil in patients with severe hepatic impairment, therefore use is not recommended in this patient group (see sections 4.4 and 5.2). Olmesartan medoxomil should not be used in patients with biliary obstruction (see section 4.3).
The recommended starting dose of olmesartan medoxomil in children from 6 to less than 18 years of age is 10 mg olmesartan medoxomil once daily. In children whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily. If additional blood pressure reduction is required, in children who weigh >35 kg, the olmesartan medoxomil dose may be increased to a maximum of 40 mg. In children who weigh <35 kg, the daily dose should not exceed 20 mg.
The safety and efficacy of olmesartan medoxomil in children aged 1 to 5 years old have not yet been established. Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Olmesartan medoxomil should not be used in children below 1 years of age because of safety concerns and lack of data in this age group.
For oral use. In order to assist compliance, it is recommended that Olmesartan Tablets be taken at about the same time each day, with or without food, for example at breakfast time. The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should be swallowed whole and not chewed.
Only limited information is available regarding overdosage in humans. The most likely effect of overdosage is hypotension. In the event of overdosage, the patient should be carefully monitored and treatment should be symptomatic and supportive.
No information is available regarding the dialysability of olmesartan.
Shelf life: 2 years.
This medicinal product does not require any special storage conditions.
Aluminium/aluminium blister pack.
Packs of 7, 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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