Dosage and Administration
Hypertension:
The recommended dose of Vasotec 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.
Vasotec 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.
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, Vasotec 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. 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 occur, consideration should be given to a dosage reduction.
Vasotec 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.
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
Heart failure:
The recommended starting dose of Vasotec 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.
Vasotec may be administered with other heart failure therapies. However, the triple combination of an ACE inhibitor, a beta blocker and Vasotec is not recommended.
Evaluation of patients with heart failure should always include assessment of renal function.
Additional information on special populations:
Elderly:
No dose adjustment is required in elderly patients.
Renal impairment:
No dosage adjustment is required for patients with a creatinine clearance >10 ml/min.
Hepatic impairment:
Vasotec is contraindicated in patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis. In patients with mild to moderate hepatic impairment without cholestasis, the dose of Vasotec should not exceed 80 mg.
Paediatric population:
Paediatric hypertension:
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 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
Children less than 6 years of age:
Safety and efficacy of valsartan in children aged 1 to 6 years have not been established.
Use in paediatric patients aged 6 to 18 years with renal impairment:
Use in paediatric patients with a creatinine clearance < 30 ml/min and paediatric patients undergoing dialysis has not been studied, therefore valsartan is not recommended in these patients. No dose adjustment is required for paediatric patients with a creatinine clearance > 30 ml/min. Renal function and serum potassium should be closely monitored.
Use in paediatric patients aged 6 to 18 years with hepatic impairment:
As in adults, Vasotec is contraindicated in paediatric patients with severe hepatic impairment, biliary cirrhosis and in patients with cholestasis. There is limited clinical experience with valsartan in paediatric patients with mild to moderate hepatic impairment. The dose of Vasotec should not exceed 80 mg in these patients.
Paediatric heart failure and recent myocardial infarction:
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.
Vasotec may be taken independently of a meal and should be administered with water