Aliskiren / Amlodipine / Hydrochlorothiazide Dosage

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.

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/hydrochlorothiazide, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer