Hypotension/volume- or salt-depleted patients: In patients who are intravascularly volume depleted (e.g., those treated with diuretics), symptomatic hypotension may occur. Correct these conditions prior to administration or start treatment under close medical supervision with a reduced dose.
Hyperkalemia: Hyperkalemia may occur in patients receiving valsartan, especially in those with heart failure and preexisting renal impairment. Dosage reduction or discontinuance of valsartan therapy may be required. Risk factors include renal dysfunction, diabetes mellitus, or concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium containing salts.
Surgery: Hypotension may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists due to blockade of the renin-angiotensin system.
Aortic/mitral stenosis: Use caution in patients with significant aortic/mitral stenosis.
ACE inhibitors and renin inhibitors: Concomitant use of an ACE inhibitor or renin inhibitor (e.g., Aliskiren) is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction. Concomitant use with aliskiren should be avoided in patients with glomerular filtration rate (GFR) less than 60 mL/minute and is contraindicated in patients with diabetes mellitus (regardless of GFR).
Renal effects: As a consequence of inhibiting the renin-angiotensin system, changes in renal function, including acute renal failure, may occur. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function.
Renal artery stenosis: Use with caution in patients with unstented unilateral/bilateral renal artery stenosis.
Renal function impairment: Use caution with preexisting renal insufficiency.
Hepatic function impairment: Valsartan should be used with caution in patients with obstructive biliary disease or hepatic impairment since the drug is eliminated primarily by biliary excretion and clearance of the drug may be reduced.
Sensitivity reactions: Sensitivity reactions, including various anaphylactoid reactions and/or angioedema, have been reported in patients receiving angiotensin II receptor antagonists, including valsartan. These drugs should be used with extreme caution in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy. Valsartan should not be readministered to patients with a history of angioedema. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved. Discontinue therapy immediately if angioedema occurs.
Effect on ability to drive and use machine: Data is not available.
Use in Pregnancy: Fetal toxicity: Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue valsartan as soon as possible.
Use in Children: Valsartan is not recommended for pediatric patients younger than 6 years.