Essential hypertension

Active Ingredient: Valsartan

Indication for Valsartan

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Curative procedure

For this indication, competent medicine agencies globally authorize below treatments:

80-320 mg once daily

For:

Dosage regimens

Oral, between 80 milligrams valsartan and 320 milligrams valsartan, once daily. The maximum allowed total dose is 320 milligrams valsartan daily.

Detailed description

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.

Dosage considerations

Valsartan may be taken independently of a meal and should be administered with water.

For children weighing <35 kg 40-80 mg once daily, for ≥35 kg to <80 kg 80-160 mg once daily and for ≥80 kg to ≤160 kg 80-320 mg once daily

For:

Dosage regimens

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.

Detailed description

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.

WeightMaximum dose studied in clinical trials
≥18 kg to <35 kg80 mg
≥35 kg to <80 kg160 mg
≥80 kg to ≤160 kg320 mg

Dosage considerations

Valsartan may be taken independently of a meal and should be administered with water.

Active ingredient

Valsartan

Valsartan is an orally active, potent, and specific angiotensin II (Ang II) receptor antagonist. It acts selectively on the AT1-receptor subtype, which is responsible for the known actions of angiotensin II.

Read more about Valsartan

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