Initial dose: 1 tablet (12.5 mg-160 mg) orally once a day
Maintenance dose: Titrate as necessary (every 1 to 2 weeks) up to a maximum of 25 mg-320 mg orally once a day
Comment:
Hydrochlorothiazide-valsartan may be substituted for the titrated components.
Renal Dose Adjustments
CrCl less than 30 mL/min: Hydrochlorothiazide-valsartan is not recommended because hydrochlorothiazide is not expected to be filtered into the renal tubule (its site of action) when the glomerular filtration rate is less than 30 mL/min.
Liver Dose Adjustments
Because valsartan is primarily eliminated by the liver, caution is recommended when advancing doses or giving maximum doses to a patient with liver disease. Theoretically, the risk of side effects is higher in this case, especially when higher doses are used.
Precautions
US BOXED WARNINGS:
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. The resulting oligohydramnios is associated with fetal lung hypoplasia and skeletal deformations. Adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
Discontinue hydrochlorothiazide-valsartan as soon as possible if pregnancy is detected.
Intrauterine exposure to thiazide diuretics is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Valsartan is not removed by hemodialysis.
Other Comments
Administration advice:
Hydrochlorothiazide-valsartan should be taken consistently either with or without food.
General:
The maximum antihypertensive effect is usually seen within 2 to 4 weeks; however, 4 to 8 weeks may be required in some patients.
The maximum antihypertensive effect is seen within 2 to 4 weeks.
Patient advice:
Advise women not to breastfeed during treatment with this drug.
