Usual Adult Dose for Hypertension

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Comments:

• The antihypertensive effect is substantially attained by 2 weeks.
• Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).

Aliskiren may be used alone or in combination with other antihypertensive agents.

Usual Pediatric Dose for Hypertension

6 TO 17 YEARS:
Less than 20 kg: Not recommended
20 to 50 kg (not approved for use due to the lack of an appropriate dosage form): 75 mg orally once a day; if blood pressure remains inadequately controlled, the daily dose may be increased to 150 mg
50 kg or greater: 150 mg orally once a day; if blood pressure remains inadequately controlled, the daily dose may be increased to 300 mg

Comments: The antihypertensive effect of a given dose is 85% to 90% attained by 2 weeks.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
Severe renal dysfunction (CrCl 30 mL/min or less): Not recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

No dosage adjustment is recommended based on gender, age, body weight, or race..

Precautions

US BOXED WARNING:

• FETAL TOXICITY: If pregnancy is detected, discontinue aliskiren as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 6 years and patients less than 20 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice: Oral pellets: The manufacturer product information should be consulted.

General: This drug is effective alone and in combination with other antihypertensive agents.

Monitoring:

• Metabolic: Periodic monitoring of serum electrolytes is recommended, particularly in patients with diabetes mellitus, renal dysfunction, or heart failure.
• Renal: Periodic monitoring of renal function is recommended, particularly in patients with diabetes mellitus, renal dysfunction, or heart failure.

Patient advice: Patients should establish a routine pattern for taking this drug either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.