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Drugs reference index «Amlodipine/Valsartan»


Amlodipine / Valsartan

Pronunciation: (am-LOE-di-PEEN/val-SAR-tan)Class: Antihypertensive combination

Trade Names:Exforge- Tablets amlodipine 5 mg/valsartan 160 mg- Tablets amlodipine 10 mg/valsartan 160 mg- Tablets amlodipine 5 mg/valsartan 320 mg- Tablets amlodipine 10 mg/valsartan 320 mg



Inhibits movement of calcium ions across cell membranes in systemic and coronary vascular smooth muscle.


Antagonizes the effect of angiotensin II (vasoconstriction and aldosterone secretion) by blocking the angiotensin II receptor (AT 1 receptor) in vascular smooth muscle and the adrenal gland, producing decreased blood pressure.

Indications and Usage

Treatment of hypertension.


Standard considerations.

Dosage and Administration

Renal function impairment

Titrate slowly in patients with severe renal function impairment.

Hepatic function impairment

Titrate slowly.


PO 5 mg/160 mg once daily in patients who are not volume-depleted is the usual starting dose. Increase after 1 to 2 wk to a max of 10 mg/320 mg once daily.


PO Initially, 2.5 mg of amlodipine once daily.

General Advice

  • May be taken with or without food.
  • May be administered with other antihypertensive agents.
  • Patients not adequately controlled on amlodipine (or another dihydropyridine calcium channel blocker) alone or valsartan (or another angiotensin II receptor blocker) alone may be switched to amlodipine/valsartan tablets.
  • May be substituted for individually titrated components.


Store at 59° to 86°F; protect from moisture.

Drug Interactions

Conivaptan, diltiazem, protease inhibitors (eg, ritonavir)

Amlodipine plasma concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.


Plasma concentrations may be elevated by valsartan, increasing the pharmacologic and toxic effects of lithium.

Potassium-sparing diuretics (eg, spironolactone), potassium supplements

Coadministration with valsartan may cause elevated potassium concentrations and, in heart failure patients, increased serum creatinine. Amlodipine plasma concentrations may be elevated.

Laboratory Test Interactions

None well documented.

Adverse Reactions




Dizziness (2%); syncope.




Nasopharyngitis (4%); tinnitus, visual disturbance.


Peripheral edema (5%); increased potassium (3%).


Upper respiratory tract infection (3%).


Increased BUN (6%); increased creatinine (4%); elevated liver function tests, hypersensitivity.



When used in pregnancy, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, discontinue therapy as soon as possible.


Monitor BP at regular intervals during therapy. Assess renal function in heart failure and post-MI patients.


Category D .




Safety and efficacy not established.

Renal Function

In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (eg, patients with severe CHF), valsartan treatment may be associated with oliguria and/or progressive azotemia, which may rarely result in acute renal failure and death.


Use with caution.

Hepatic Function

Use with caution.


Increased frequency, duration, or severity of angina or acute MI may occur. Use with caution in patients with heart failure or severe aortic stenosis.

Hypotension/Volume-depleted patients

Symptomatic hypotension may occur after initiation of valsartan in patients who are intravascularly volume-depleted (eg, those treated with diuretics). Correct these conditions prior to administration of valsartan or start treatment under close medical supervision.


Use with caution in patients undergoing surgery.



Bradycardia, circulatory shock, depressed consciousness, hypotension, peripheral vasodilation, shock, tachycardia.

Patient Information

  • Advise patient to take once daily as prescribed without regard to meals, but to take with food if GI upset occurs.
  • Advise patient to try to take each dose at about the same time each day.
  • Inform patient that drug controls, but does not cure, hypertension and to continue taking drug as prescribed even when BP is not elevated.
  • Instruct patient to avoid the use of supplements or salt substitutes containing potassium without first consulting health care provider.
  • Advise patient to monitor and record BP and pulse at home and to inform health care provider if abnormal measurements are noted.
  • Caution patient to avoid sudden position changes to prevent orthostatic hypotension.
  • Inform women of childbearing age to report pregnancy to health care provider as soon as possible.
  • Advise women not to breast-feed while taking this medication.

Copyright © 2009 Wolters Kluwer Health.

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