Usual Adult Dose for Hypertension

Initial dose: 1 tablet orally daily
The dosage may be increased after 2 weeks of therapy.

Maximum dose: Aliskiren/amlodipine/hydrochlorothiazide 300/10/25 mg orally daily

Comments:

• The combination product may be substituted for patients receiving aliskiren, amlodipine, and hydrochlorothiazide 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).

Renal Dose Adjustments

CrCl less than 30 mL/min: Not recommended

CrCl greater than 30 mL/min: No adjustment 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/hydrochlorothiazide may be used for patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium channel blockers, and thiazide diuretics.
• A patient who experiences dose-limiting adverse reactions attributed to an individual component while on any dual combination of the components of aliskiren/amlodipine/hydrochlorothiazide may be switched to aliskiren/amlodipine/hydrochlorothiazide at a lower dose of that component to achieve similar blood pressure reductions.
• For patients receiving aliskiren, amlodipine, and hydrochlorothiazide from separate tablets, aliskiren/amlodipine/hydrochlorothiazide 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/hydrochlorothiazide, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.