Posology : מינונים

4.2   Posology and method of administration

Hypertension (only 80mg and 160 mg)
The recommended dose of Diovan is 80 mg once daily for most patients. The antihypertensive effect is substantially present within 2 weeks and maximal effects are seen after 4 weeks. In some patients whose blood pressure is not adequately controlled, the dose may be increased to 160 mg, or a greater decrease in BP may be achieved by adding in a thiazide diuretic.

Diovan may also be administered with other antihypertensive agents (see section 4.3, 4.4, 4.5 and 5.1).

Diovan is not indicated for children and adolescents under 18 years old.

Heart failure (40 mg, 80 mg and 160 mg)
The recommended starting dose of Diovan is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics.
The maximum daily dose administered in clinical trials is 320 mg in divided doses.

Post-myocardial infarction (40 mg, 80 mg and 160 mg)
Therapy may be initiated as early as 12 hours after a myocardial infarction. After an initial dose of 20 mg twice daily, valsartan therapy should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks. The starting dose is provided by the 40 mg divisible tablet.

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Achievement of the target dose of 160 mg twice daily should be based on the patient's tolerability to valsartan during titration. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dose reduction.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers, statins.

Additional information on special populations
Use in patients over 75 years:

A lower starting dose of 40 mg once daily is recommended.
Use in patients with renal impairment:
Hypertension- No initial dose adjustment is required in patients with mild renal impairment (i.e.creatinine clearance 20-50 ml/min). For patients with moderate to severe renal impairment or patients on dialysis, a lower starting dose of 40 mg once daily is recommended.

Heart Failure- Evaluation of patients with heart failure should always include assessment of renal function.

Post myocardial infarction- In the indication of current myocardial infarction no dosage adjustment is required for patients with mild renal impairment. There are currently no data available in post myocardial patients with severe renal impairment (serum creatinine ≥ 221 μmol/l). Diovan should therefore be used with caution in such patients, with appropriate assessment of renal function (see Section 4.4) 
Concomitant use of Diovan with Aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).

Patients with Hepatic impairment

Hypertension
Use in patients with mild to moderate hepatic impairment:
Treatment should commence at dose of 40 mg once daily. A daily dose of 80mg valsartan should not be exceed. Patients with severe hepatic impairment, cirrhosis or biliary obstruction should not use Diovan (see Section 4.3 Contraindications).

Post-myocardial infarction

Use in patients with mild to moderate hepatic impairment:

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Doses higher than 80mg twice daily should only be considered if the clinical benefit is likely to outweigh the possible risk associated with increased exposure of valsartan.
Patients with severe hepatic impairment, cirrhosis or biliary obstruction should not use Diovan (see Section 4.3 Contraindications).

Use in patients with intravascular volume depletion:

For those patients who have intravascular volume depletion (e.g. those treated with high dose diuretics who are unable to have their dose of diuretic reduced) a starting dose of 40 mg is recommended.

Paediatric population:
Diovan is not recommended for the treatment of heart failure or recent myocardial infarction in children and adolescents below the age of 18 years due to the lack of data on safety and efficacy.

Diovan is not indicated for children and adolescents under 18 years old.

Diovan must not be used in combination with Aliskiren in patients with diabetes mellitus (see section 4.3 )
Method of administration

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