Aliskiren / Amlodipine Dosage

Applies to the following strengths: 150 mg-5 mg; 150 mg-10 mg; 300 mg-5 mg; 300 mg-10 mg

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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

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.