Usual Adult Dose for Hypertension

Initial or add-on therapy: 150 mg/5 mg orally once a day. Titrate as needed up to a maximum of 300 mg/10 mg.

The blood pressure lowering effect is largely attained within 1 to 2 weeks.

Maximum dose: 300 mg/10 mg

Comments:

• The combination product may be substituted for patients receiving aliskiren and amlodipine from separate tablets.
• Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).

Usual Geriatric Dose for Hypertension

Exposure to aliskiren and amlodipine is increased in elderly patients. Lower initial doses of aliskiren-amlodipine should be considered.

Renal Dose Adjustments

CrCl less than 30 mL/min: Not recommended

Liver Dose Adjustments

Exposure to amlodipine is increased in patients with hepatic insufficiency. Lower doses should be considered in these patients.

Dose Adjustments

• Aliskiren-amlodipine may be used for patients not adequately controlled with aliskiren alone or amlodipine (or another dihydropyridine calcium channel blocker) alone.
• A patient who experiences dose-limiting adverse reactions attributed to an individual component while on any dual combination of the components of aliskiren-amlodipine may be switched to aliskiren-amlodipine at a lower dose of that component to achieve similar blood pressure reductions.
• For patients receiving aliskiren and amlodipine from separate tablets, aliskiren-amlodipine may be substituted containing the same component doses.

Precautions

US BOXED WARNING:

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

Dialysis

Data not available

Other Comments

Patients should establish a routine pattern for taking aliskiren-amlodipine, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.