Active Ingredient: Valsartan
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, between 80 milligrams valsartan and 320 milligrams valsartan, once daily. The maximum allowed total dose is 320 milligrams valsartan daily.
The recommended starting dose of valsartan is 80 mg once daily. The antihypertensive effect is substantially present within 2 weeks, and maximal effects are attained within 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose can be increased to 160 mg and to a maximum of 320 mg.
Valsartan may also be administered with other antihypertensive agents. The addition of a diuretic such as hydrochlorothiazide will decrease blood pressure even further in these patients.
Valsartan may be taken independently of a meal and should be administered with water.
For:
Regimen A: In case that patient age in years is ≥ 18 and patient weight is ≤ 35 kg, oral, between 40 milligrams valsartan and 80 milligrams valsartan, once daily. The maximum allowed total dose is 80 milligrams valsartan daily.
Regimen B: In case that patient age in years is ≥ 35 and patient weight is ≤ 80 kg, oral, between 80 milligrams valsartan and 160 milligrams valsartan, once daily. The maximum allowed total dose is 160 milligrams valsartan daily.
Regimen C: In case that patient age in years is ≥ 80 and patient weight is ≤ 160 kg, oral, between 40 milligrams valsartan and 320 milligrams valsartan, once daily. The maximum allowed total dose is 320 milligrams valsartan daily.
For children and adolescents who are unable to swallow tablets, the use of the valsartan oral solution is recommended. The systemic exposure and peak plasma concentration of valsartan is about 1.7-fold and 2.2-fold higher with the solution compared to the tablets.
Children and adolescents 6 to less than 18 years of age:
For valsartan tablets, the initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more. The dose should be adjusted based on blood pressure response and tolerability. For maximum doses studied in clinical trials please refer to the table below.
Doses higher than those listed have not been studied and are therefore not recommended.
Weight | Maximum dose studied in clinical trials |
---|---|
≥18 kg to <35 kg | 80 mg |
≥35 kg to <80 kg | 160 mg |
≥80 kg to ≤160 kg | 320 mg |
Valsartan may be taken independently of a meal and should be administered with water.
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