Indicated for:

Hypertension: (1 year of age and older)

• The treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. Diovan may be administered with other antihypertensive agents. 

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Heart Failure: (adult patients)

• To reduce the risk of hospitalization for heart failure in patients with heart failure (NYHA class II-IV). There is no evidence that Diovan provides added benefits when it is used with an adequate dose of an angiotensin converting enzyme (ACE) inhibitor.

Post-Myocardial Infarction: (adult patients)

• In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.

Diovan tablets and oral suspension are not substitutable on a milligram-per-milligram basis. Do not combine two dosage forms to achieve the total dose. The systemic exposure to valsartan (AUC) is 60% higher with the suspension compared to tablets.

Use of the oral suspension is recommended:

• in pediatric patients aged 1 to 5 years
• in patients >5 years of age who cannot swallow tablets and
• in pediatric patients for whom the calculated dose (mg/kg) does not correspond to the available tablet strengths of Diovan

Do not co-administer aliskiren with Diovan in patients with diabetes.

Avoid use of aliskiren with Diovan in patients with renal impairment (GFR <60 mL/min).

Safety and effectiveness of Diovan in patients with severe renal impairment (CrCl ≤30 mL/min) have not been established.

Excessive hypotension was rarely seen in patients with uncomplicated hypertension treated with Diovan alone.

Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment.

Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.

Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure.

The antihypertensive effect of angiotensin II receptor antagonists, including valsartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including Diovan.

When pregnancy is detected, discontinue Diovan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause  injury and death to the developing fetus.

There is no information regarding the presence of Diovan in human milk, the effects on the breastfed infant, or the effects on milk production. Diovan is present in rat milk. Because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with Diovan.

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• Use in patients under 1 year of age. GoToSource

• Diabetic nephropathy. GoToSource

• Sexual dysfunction in female patients. GoToSource

• Preventing type 2 diabetes in high-risk hypertensive patients. GoToSource

Angioedema (swelling in deep layers of skin). GoToSource

Pneumonitis (inflammation of lung tissue). GoToSource

Fetal and neonatal morbidity and death. GoToSource

Exanthematous drug reactions (hypersensitivity reaction). GoToSource

Acute kidney failure. GoToSource

Sprue-like enteropathy. GoToSource

Dry, persistent cough. GoToSource

Lawsuits filed for cancer.