Active Ingredient: Olmesartan medoxomil
Treatment of hypertension in children and adolescents from 6 to less than 18 years of age.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: In case that patient weight is ≤ 35 kg, oral, 10 milligrams olmesartan medoxomil, once daily. Afterwards, in case that patient weight is ≤ 35 kg, oral, between 10 milligrams olmesartan medoxomil and 20 milligrams olmesartan medoxomil, once daily. The maximum allowed total dose is 20 milligrams olmesartan medoxomil daily.
Regimen B: In case that patient weight is ≥ 35 kg, oral, 10 milligrams olmesartan medoxomil, once daily. Afterwards, in case that patient weight is ≥ 35 kg, oral, between 10 milligrams olmesartan medoxomil and 40 milligrams olmesartan medoxomil, once daily. The maximum allowed total dose is 40 milligrams olmesartan medoxomil daily.
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.
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.
In order to assist compliance, it is recommended that olmesartan be taken at about the same time each day, with or without food, for example at breakfast time.
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