Duoval/Duoval Max Special Precautions

Serum Electrolytes: Valsartan-Hydrochlorothiazide: In controlled trials of various doses of the combination of valsartan and hydrochlorothiazide the incidence of hypertensive patients who developed hypokalemia (serum potassium >3.5 mEq/L) was 0.3%.
Hydrochlorothiazide: All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determination are particularly important when the patients is vomiting excessively or receiving parenteral fluids.
Impaired Hepatic Function: Valsartan: As the majority of valsartan is eliminated in the bile, patients with mild to moderate hepatic impairment, including patients with biliary obstructive disorders, showed lower valsartan clearance (higher AUCs). Care should be exercised in administering (Valsartan + hydrochlorothiazide) Duoval to these patients.
Impaired Renal Function - Heart Failure: Valsartan: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure). Treatments with Angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists have been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. (Valsartan + hydrochlorothiazide) Duoval would be expected to behave similarly.
Hydrochlorothiazide: Thiazides should be used with caution in severe renal disease. In patients with renal disease, thiazides may be precipitate azotemia. Cumulative effects of the drug may develop in a patient with impaired renal function.
INFORMATION FOR THE PATIENT: Pregnancy: Female patients of childbearing age should be told about the consequences of second and third trimester exposure to drug that act on the renin-angiotensin system and they should be told that these consequences do not appears 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 physician as soon as possible.