Valsartan is used in the management of hypertension, to reduce mortality in patients with left ventricular dysfunction following myocardial infarction, and in the management of heart failure.
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 once daily and to a maximum of 320 mg.
- Recent myocardial infarction
In clinically stable patients, therapy may be initiated as early as 12 hours after a myocardial infarction.
After an initial dose of 20 mg twice daily, valsartan should be titrated to 40 mg, 80 mg, and 160 mg twice daily over the next few weeks.
The target maximum dose is 160 mg twice daily. In general, it is recommended that patients achieve a dose level of 80 mg twice daily by two weeks after treatment initiation and that the target maximum dose, 160 mg twice daily, be achieved by three months, based on the patient’s tolerability. 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 and diuretics. The combination with ACE inhibitors is not recommended.
- In heart failure
The recommended starting dose of valsartan is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks 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.
Valsartan may be administered with other heart failure therapies. However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended.
- Patients with renal impairment
No dose adjustment is required for these patients with a creatinine clearance ≥ 10 ml/min. Valsartan should be used with caution in patients with a creatinine clearance < 10 ml/min.
- No dose adjustment is required in elderly patients.
Children and adolescents 6 to 18 years of age: 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.
For maximum doses:
18 – 35 kg: Maximum 80 mg
35 – 80 kg: Maximum 160 mg
80 – 160 kg: Maximum 320 mg
Children less than 6 years of age: Safety and efficacy of valsartan in children aged 1 to 6 years have not been established.
Valsartan 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.
- Renal impairment
Valsartan is not recommended in these patients with a creatinine clearance < 30 ml/min.
No dose adjustment is required for these patients with a creatinine clearance > 30 ml/min.
Renal function and serum potassium should be closely monitored.
- Hepatic impairment
Valsartan should be used with caution in patients with hepatic impairment.
In patients with mild to moderate hepatic impairment without cholestasis, the dose of valsartan should not exceed 80 mg.
Valsartan is contraindicated in patients with severe hepatic impairment, billiary cirrhosis and cholestasis.
Valsartan STELLA 80 mg is taken orally, independently of a meal and should be administered with water.