Initial dose: 150 mg-12.5 mg or 150 mg-25 mg once daily
Maximum dose: Aliskiren-hydrochlorothiazide 300/25 mg orally daily
Comments:
The combination product may be substituted for patients receiving aliskiren 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
No adjustment recommended
Precautions
US BOXED WARNING:
FETAL TOXICITY: If pregnancy is detected, discontinue aliskiren-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
Administration advice: Patients should establish a routine pattern for taking aliskiren-hydrochlorothiazide, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.
Patient advice: Instruct patients to protect skin from sun and undergo regular skin cancer screening.
