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Video: FDA approves Exforge HCT(R) - the Only High Blood Pressure Treatment to Combine Three Medications in a Single Pill
Date:4/30/2009

c or renal function, including fluid status and electrolytes, and adverse reactions.

In patients with renal artery stenosis or severe renal impairment, care should be exercised with dosing of EXFORGE. Avoid use of EXFORGE HCT in severe renal disease (creatinine clearance less than or equal to 30 mL/min). The usual regimens of therapy with EXFORGE HCT may be followed if the patient's creatinine clearance is >30 mL/min.

In patients with severe heart failure, decline in renal function and rarely, acute renal failure and/or death has been associated with inhibiting the renin-angiotensin system. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.

Important considerations due to the hydrochlorothiazide component of EXFORGE HCT: Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus. Lithium generally should not be given with thiazides.

Monitor serum electrolytes periodically based on EXFORGE HCT use and other factors such as renal function, other medications, or history of prior electrolyte imbalances.

The most common adverse reactions that occurred more frequently with EXFORGE than placebo were peripheral edema (5% vs 3%), nasopharyngitis (4% vs 2%), upper respiratory tract infection (3% vs 2%), and dizziness (2% vs 1%).

The most frequent adverse events that occurred in greater than or equal to 2% of patients treated with EXFORGE HCT were dizziness (8.2%), edema (6.5%), headache (5.2%), dyspepsia (2.2%), fatigue (2.2%), muscle spasms (2.2%), back pain (2.1%), nausea (2.1%) and nasopharyngitis (2.1%).

Please see accompanying full Prescribing Information.

Disclaimer

The foregoing release contains forward-lookin
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SOURCE Novartis
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