Diovan

[Valsartan]

Some patients with heart failure have developed increases in blood urea nitrogen, serum creatinine, and potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of the diuretic and/or Diovan may be required. In the Valsartan Heart Failure Trial, in which 93% of patients were on concomitant ACE inhibitors, treatment was discontinued for elevations in creatinine or potassium (total of 1.0% on valsartan vs. 0.2% on placebo). Evaluation of patients with heart failure should always include assessment of renal function.

Concomitant Therapy in Patients with Heart Failure:

In patients with heart failure, concomitant use of Diovan, an ACE inhibitor, and a beta blocker is not recommended. In the Valsartan Heart Failure Trial, this triple combination was associated with an unfavorable heart failure outcome (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Heart Failure).

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Information for Patients

Pregnancy:

Female patients of childbearing age should be told about the consequences of second-and third-trimester exposure to drugs that act on the renin-angiotensin system, and they should also be told that these consequences do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. These patients should be asked to report pregnancies to their physicians as soon as possible.

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