Drug Detail:Amlodipine and valsartan (Amlodipine and valsartan [ am-loe-de-peen-val-sar-tan ])
Drug Class: Angiotensin II inhibitors with calcium channel blockers
Usual Adult Dose for Hypertension
Initial therapy: Amlodipine 5 mg-Valsartan 160 mg orally once a day
Add-on/Replacement therapy: Amlodipine 5 to 10 mg-Valsartan 160 to 320 mg orally once a day
Comments:
- May increase dose after 1 to 2 weeks of therapy.
- A patient who experiences dose-limiting adverse reactions on either component alone may be switched to this drug containing a lower dose of that component in combination with the other. If blood pressure remains uncontrolled after 3 to 4 weeks, may titrate up to a maximum of amlodipine 10 mg-valsartan 320 mg orally once a day.
Renal Dose Adjustments
Mild to moderate renal dysfunction (CrCl 30 to 90 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Data not available
Liver Dose Adjustments
Initial therapy not recommended
Precautions
US BOXED WARNING:
- FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) 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
Monitoring: Monitor renal function and serum electrolytes periodically.
Patient advice:
- Advise patients to immediately report any signs or symptoms of angioedema (breathing difficulty or swelling of face, eyes, lips, or tongue) and to stop taking this drug until consulting a physician.
- Advise patients that lightheadedness can occur, especially during the first days of treatment, and that it should be reported to their healthcare provider.
- Advise patients to discontinue this drug until a physician has been consulted if syncope occurs.
- Inform patients that inadequate fluid intake, excessive perspiration, diarrhea, or vomiting can lead to an excessive fall in blood pressure.
- Advise patients not to use salt substitutes without first consulting their healthcare provider.
- Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible.
- Advice women not to breastfeed during treatment with this drug.
