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.Valsartan
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.
Treatment of hypertension.
Titrate slowly in patients with severe renal function impairment.Hepatic function impairment
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.Elderly
PO Initially, 2.5 mg of amlodipine once daily.
Store at 59° to 86°F; protect from moisture.
Amlodipine plasma concentrations may be elevated, increasing the pharmacologic effects and adverse reactions.Lithium
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.
None well documented.
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.
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.Dialysis
Use with caution.
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.
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.
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