INDICATIONS FOR THERAPEUTIC USE:
- Hypertension: Treatment of hypertension in children and adolescents aged 6 to 18 years.
- Recent myocardial infarction: Treatment of symptomatic heart failure in clinically stable adult patients or asymptomatic left ventricular systolic dysfunction following a recent myocardial infarction (12 hours to 10 days).
- Heart failure: Treatment of symptomatic heart failure in adults who cannot tolerate ACE inhibitors or beta-blockers as add-on therapy to ACE inhibitors when mineralocorticoid receptor antagonists cannot be used.
DOSAGE AND ADMINISTRATION:
Usage:
The drug is taken orally. Absorption is not affected by food.
Choose another valsartan-containing product when a dose < 80 is required
Dosage:
- Adults:
+ Hypertension:
The recommended starting dose is 80 mg valsartan/day. The baseline antihypertensive effect occurs within 2 weeks, and the maximum effect is achieved within 4 weeks. The dose may be increased to 160 mg and to a maximum of 320 mg in patients not adequately controlled.
Valsartan can be combined with other antihypertensive drugs. The addition of a diuretic such as hydrochlorothiazide will further reduce blood pressure in these patients.
+ Recent myocardial infarction:
In clinically stable patients, treatment may be initiated 12 hours after the myocardial infarction. After an initial dose of 20 mg twice daily, titrate to 40 mg, 80 mg and 160 mg twice daily over the next few weeks.
The maximum dose is 160 mg twice daily. It is generally recommended that patients achieve a dose of 80 mg twice daily within 2 weeks of starting treatment and a maximum dose of 160 mg twice daily after 3 months, depending on the patient's tolerability. Consider reducing the dose if hypotension or renal dysfunction occurs.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, such as thrombolytics, acetylsalicylic acid, beta-blockers, statins and diuretics. Combination with angiotensin converting enzyme inhibitors is not recommended.
Evaluation of patients after myocardial infarction should always include assessment of renal function.
+ Heart failure
The recommended starting dose is 40 mg twice daily. Titration to 80 mg and 160 mg twice daily should be performed over a period of at least 2 weeks and to the highest dose, as tolerated by the patient. Consider reducing the dose of concomitant diuretics. The maximum daily dose in clinical trials was 320 mg.
Valsartan may be used with other heart failure therapies. However, the triple combination of angiotensin converting enzyme inhibitors, valsartan, beta-blockers or potassium-sparing diuretics is not recommended.
- Children:
+ Hypertension in children:
Children and adolescents aged 6 to 18 years:
The starting dose is 40 mg once daily for children weighing less than 35 kg and 80 mg once daily for children weighing 35 kg or more. Adjust the dose based on the patient's blood pressure response. The maximum doses used in clinical studies are listed in the following table.
Weight Maximum dose used in clinical studies
≥18 kg to <35 kg 80 mg
≥35 kg to <80 kg 160 mg
≥80 kg to ≤160 kg 320 mg
Higher doses have not been studied and are therefore not recommended.
Children under 6 years of age: Available data in this patient group are presented in Adverse Reactions, Pharmacokinetics. However, the safety and efficacy of valsartan have not been established in patients aged 1 to 6 years.
Patients aged 6 to 18 years with renal impairment: There have been no studies on the use of the drug in patients with creatinine clearance < 30 ml/min and patients on hemodialysis, therefore valsartan is not used in these patients. No dosage adjustment is necessary in patients with creatinine clearance > 30 ml/min. Careful monitoring of renal function and serum potassium levels is recommended.
Patients aged 6 to 18 years with hepatic impairment: As in adults, valsartan is contraindicated in paediatric patients with severe hepatic impairment, cirrhosis and cholestasis. Clinical experience with valsartan in pediatric patients with mild to moderate hepatic impairment is limited. The dose of valsartan should not exceed 80 mg/day in these patients.
+ Pediatric patients with heart failure and recent myocardial infarction
Due to the lack of data on the safety and efficacy of valsartan in the treatment of heart failure and recent myocardial infarction in children and adolescents under 18 years of age, the drug should not be used in this patient group.
CONTRAINDICATIONS:
Hypersensitivity to valsartan or to any of the excipients.
Severe hepatic impairment, cirrhosis and cholestasis.
Second and third trimesters of pregnancy.
Concomitant use of valsartan with aliskiren-containing products is contraindicated in patients with diabetes or renal impairment (GFR < 60 ml/min/1.73 m2).
