WARNING: AVOID USE IN PREGNANCY: When pregnancy is detected, discontinue EXFORGE or EXFORGE HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus. [See Warnings and Precautions (5.1)]
Because of the hydrochlorothiazide component, EXFORGE HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Excessive hypotension was seen in 0.4% of patients treated with EXFORGE and in 1.7% of patients treated with EXFORGE HCT 10/320/25 mg. Correct volume- or salt-depletion before administering EXFORGE or EXFORGE HCT or symptomatic hypotension may occur. Caution should be observed when initiating therapy with EXFORGE in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis. Do not initiate treatment with EXFORGE HCT in patients with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy.
Rarely, increased frequency, duration, or severity of angina or acute myocardial infarction have developed in patients treated with calcium channel blockers; particularly patients with severe obstructive coronary artery disease.
EXFORGE should be used with caution in patients with severe hepatic impairment and should be used with care in patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, because of lower valsartan clearance.
Avoid use of EXFORGE HCT in patients with severe hepatic impairment. In patients with mild-to-moderate hepatic impairment, including patients with biliary obstructive disorders, monitor for worsening of hepati
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