Indicated for the treatment of hypertension, to lower blood pressure.

Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.

Diovan HCT is not recommended as initial therapy in patients with intravascular volume depletion.

Diovan HCT may be substituted for the titrated components.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

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

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

Hydrochlorothiazide can cause hypokalemia and hyponatremia.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hydrochlorothiazide may raise the serum uric acid level due to reduced clearance of uric acid and may cause or exacerbate hyperuricemia and precipitate gout in susceptible patients.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels in patients with hypercalcemia receiving Diovan HCT.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of valsartan or thiazide diuretics.

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. If co medication is considered necessary, monitoring of serum potassium is advisable.

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.

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. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on valsartan and other agents that affect the RAS.

Use with carbamazepine may lead to symptomatic hyponatremia.

Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.

When used with antidiabetic drugs (oral agents and insulin) dosage adjustment of the antidiabetic drug may be required.

Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of resins would potentially minimize the interaction.

Diovan HCT can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

There is limited information regarding the presence of Diovan HCT in human milk, the effects on the breastfed infant, or the effects on milk production. Valsartan is present in rat milk. Hydrochlorothiazide is  present in human breast milk. Because of the potential for serious adverse reactions in breastfed infants, advise a nursing woman that breastfeeding is not recommended during treatment with Diovan HCT.

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• Use in patients under the age of 18. GoToSource

• Diabetic nephropathy. GoToSource

• Sexual dysfunction in female patients. GoToSource

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

Lip and nonmelanoma skin cancer. GoToSource

Upper respiratory tract infection, back pain, myalgia (muscle pain), vertigo and hypotension (low blood pressure). GoToSource

Hypokalemia (low blood potassium level). GoToSource

Sprue-like enteropathy (intestinal condition involving chronic diarrhea and rapid weight loss). GoToSource

Subacute cutaneous lupus erythematosus (rash on sun-exposed areas of the body). GoToSource

Hyponatremia (low blood sodium level) and hypercalcemia (elevated blood calcium level). GoToSource

Bilateral myopia (nearsightedness) and ciliochoroidal effusion (fluid in the suprachoroidal space). GoToSource

Bilateral acute angle closure glaucoma. GoToSource

Impaired glucose tolerance and new-onset diabetes. GoToSource

Increased plasma triglycerides and total plasma cholesterol. GoToSource

Hyperuricemia (high blood uric acid level). GoToSource

Gout (joint inflammation caused by uric acid crystal deposits in the joint space). GoToSource

Cholecystitis (inflammation of the gallbladder) and hepatotoxicity (toxic damage to the liver). 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

Dry, persistent cough. GoToSource

Lawsuits filed for cancer and liver damage.