Amlodipine / Valsartan Dosage
Applies to the following strength(s): 5 mg-160 mg ; 10 mg-160 mg ; 5 mg-320 mg ; 10 mg-320 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hypertension
Initial dose: Individualize based on the effectiveness and tolerance for each individual component. In clinical trials, the dose for each component is amlodipine 5 mg to 10 mg orally once daily and valsartan 160 mg to 320 mg orally once daily.
In general, the antihypertensive effectiveness increases with increasing doses.
Renal Dose Adjustments
No dose adjustment is required in patients with mild to moderate renal dysfunction.
Caution is advised when amlodipine-valsartan is used in patients with severe renal dysfunction (CrCl less than 10 mL/min). There is insufficient information to make a dosage recommendation.
Liver Dose Adjustments
Use of a lower initial dose has been suggested for patients with liver dysfunction because of decreased clearance of amlodipine in this patient population; however, a specific dose has not been recommended. No dosage adjustment based on valsartan is required in patients with mild to moderate liver dysfunction; however, caution is advised when used in patients with liver disease.
Use of a lower initial dose has been suggested for elderly patients because of decreased clearance of amlodipine in this patient population; however, a specific dose has not been recommended. No dosage adjustment based on valsartan is required.
Use of amlodipine-valsartan during pregnancy is considered contraindicated. Drugs (i.e., valsartan) acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected or expected, amlodipine-valsartan should be discontinued as soon as possible.
Excessive hypotension has been reported in patients with uncomplicated hypertension treated with amlodipine-valsartan. Symptomatic hypotension can occur in volume- or salt-depleted patients with an activated renin-angiotensin system; therefore, such conditions should be corrected prior to administration or therapy should be initiated under close medical supervision.
Caution is advised when starting therapy in postmyocardial infarction patients, patients with heart failure, and in patients undergoing surgery or dialysis. Such patients often have some reduction in blood pressure when given valsartan, although discontinuation is usually not necessary when dosing instructions are followed. If excessive hypotension occurs, the patient should be placed in the supine position and given an intravenous infusion of normal saline if necessary. Transient hypotension is not a contraindication to further treatment, and therapy usually can be continued without difficulty once the blood pressure has stabilized.
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration and/or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated. Since the vasodilation induced by amlodipine is gradual in onset, acute hypotension has rarely been reported after oral administration of amlodipine. Nonetheless, caution should be exercised when administering amlodipine as with any other peripheral vasodilator particularly in patients with severe aortic stenosis.
Caution is advised when administering amlodipine-valsartan to patients with severe hepatic dysfunction. In patients with liver dysfunction, the half-life of amlodipine is increased since it is extensively metabolized in the liver and the clearance of valsartan is reduced in these patients.
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may occur particularly in volume depleted patients. In some patients whose renal function is dependent upon the renin-angiotensin-aldosterone (RAA) system, such as patients with severe congestive heart failure, use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. In addition, as with ACE inhibitors, use of angiotensin II receptor inhibitors can lead to increases in BUN and serum creatinine in patients with unilateral or bilateral renal artery stenosis.
In general, calcium channel blockers should be used with caution in patients with heart failure. Amlodipine (5 to 10 mg per day) has been studied in a placebo-controlled trial of 1153 patients with New York heart association (NYHA) Class III or IV heart failure on stable doses of ACE inhibitor, digoxin, and diuretics. Follow-up was at least 6 months, with a mean of about 14 months. There was no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure). Amlodipine has been compared to placebo in four 8 to 12 week studies of patients with NYHA class II/III heart failure, involving a total of 697 patients. In these studies, there was no evidence of worsened heart failure based on measures of exercise tolerance, NYHA classification, symptoms, or left ventricular ejection fraction.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Limited data suggest that only a very small amount of amlodipine is removed by hemodialysis. Valsartan is not removed by hemodialysis.
A specific dose has not been recommended in patients who undergo hemodialysis.
A patient whose blood pressure is inadequately controlled by either agent alone may be switched to the combination of amlodipine-valsartan.
A patient who experiences a dose-limiting adverse reaction on either component alone may be switched to the combination of amlodipine-valsartan at a lower dose of that component along with the other agent to achieve similar blood pressure reductions.
Following initiation of therapy or a dose increase, efficacy should be reevaluated after 3 to 4 weeks of therapy.
Periodic monitoring of blood pressure has been suggested.
More about amlodipine/valsartan
- Other brands: Exforge