Sodium- and/or Volume-Depleted Patients: In severely sodium- and/or volume-depleted patients eg, those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with Diovan. Sodium and/or volume depletion should be corrected before starting treatment with Diovan eg, by reducing the diuretic dose.
If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an IV infusion of normal saline. Treatment can be continued once the blood pressure has stabilized.
Renal Artery Stenosis: Short-term administration of Diovan to 12 patients with renovascular hypertension secondary to unilateral renal artery stenosis did not induce any significant changes in renal haemodynamics, serum creatinine or blood urea nitrogen (BUN). However, since other drugs that affect the renin-angiotensin-aldosterone system may increase blood urea and serum creatinine in patients with bilateral or unilateral renal artery stenosis, monitoring is recommended as a safety measure.
Impaired Renal Function: No dosage adjustment is required for patients with renal impairment. However, in severe cases (creatinine clearance <10 mL/min), no data are available, and therefore caution is advised.
Hepatic Impairment: No dosage adjustment is required for patients with hepatic insufficiency. Valsartan is mostly eliminated unchanged in the bile, and patients with biliary obstructive disorders showed lower valsartan clearance (see Pharmacokinetics under Actions). Particular caution should be exercised when administering valsartan to these patients.
Heart Failure: Patients with heart failure given Diovan commonly have some reduction in blood pressure, but discontinuation therapy because of continuing symptomatic hypotension usually is not necessary when dosing instructions are followed. Caution should be observed when initiating therapy in patients with heart failure (see Dosage & Administration).
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Evaluation of patients with heart failure should always include assessment of renal function.
In patients with heart failure, the triple combination of an ACE inhibitor, a β-blocker and an ARB (angiotensin II receptor blocker), valsartan is not recommended (see Pharmacology under Actions).
Effects on the Ability to Drive or Operate Machinery: As with other antihypertensive agents, it is advisable to exercise caution when driving or operating machinery.
Use in children: The safety and efficacy of Diovan have not been established in children.