HIGHLIGHTS OF PRESCRIBING INFORMATION • Symptomatic hypotension with volume- or salt-depletion. Correct
volume-depletion prior to administration (5. 2)
These highlights do not include all the information needed to use Exforge
• Increased angina and/or myocardial infarction ( )
HCT safely and effectively. See full prescribing information for Exforge
• Avoid in patients with severely impaired hepatic (, ) or renal
HCT.
function (creatinine clearance ≤30 mL/min) (, )
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) • Observe for signs of fluid or electrolyte imbalance ()
Tablets • Thiazide diuretics may cause an exacerbation or activation of
Initial . Approval: 2009 systemic lupus erythematosus ()
WARNING: AVOID USE IN PREGNANCY
-------------------ADVERSE REACTIONS----------------------
When pregnancy is detected, discontinue Exforge HCT as soon as
possible. Drugs that act directly on the renin-angiotensin system can Most common adverse events (≥2% incidence) are dizziness, peripheral
cause injury or death to the developing fetus. () edema, headache, dyspepsia, fatigue, muscle spasms, back pain, nausea
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