IMPORTANT SAFETY INFORMATION
WARNING: FETAL TOXICITY
-
When pregnancy is detected, discontinue DIOVAN or DIOVAN HCT as soon as possible. (5.1)
-
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
Contraindications: Do not use in patients with known hypersensitivity to any component.
Do not coadminister aliskiren with DIOVAN or DIOVAN HCT in patients with diabetes.
Because of the hydrochlorothiazide (HCTZ) component, DIOVAN HCT is contraindicated in patients with anuria or hypersensitivity
to other
sulfonamide-derived drugs.
Hypotension: Excessive hypotension was seen in 0.1 % of patients treated with DIOVAN and 0.7% of patients treated with DIOVAN HCT in controlled trials.
In patients with an activated renin-angiotensin system (RAS), such as volume- and/or salt-depleted patients receiving high doses of diuretics,
symptomatic hypotension may occur. Correct this condition before administering DIOVAN or DIOVAN HCT.
Impaired Renal Function: Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the RAS and by diuretics.
Patients whose renal function may depend in part on the activity of the RAS (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure,
or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or
discontinuing therapy in patients who develop a clinically significant decrease in renal function.
Evaluation of patients with HF or post-Ml should always include assessment
of renal function. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.
Impaired Renal Function: Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the RAS and by diuretics.
Patients whose renal function may depend in part on the activity of the RAS (eg, patients with renal artery stenosis,chronic kidney disease, severe congestive heart failure,
or volume depletion) may be at particular risk of developing acute renal failure on valsartan. Monitor renal function periodically in these patients. Consider withholding or
discontinuing therapy in patients who develop a clinically significant decrease in renal function.
Evaluation of patients with HF or post-Ml should always include assessment
of renal function. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.
INDICATION
DIOVAN
DIOVAN is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control,
diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
DIOVAN may be used alone or in combination with other antihypertensive agents.
DIOVAN HCT
DIOVAN HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control,
diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Add-On Therapy: DIOVAN HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Replacement Therapy: DIOVAN HCT may be substituted for the titrated components.
Initial Therapy: DIOVAN HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.
The choice of DIOVAN HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
Patients taking DIOVAN HCT should be observed for clinical signs of fluid or electrolyte imbalance. Hydrochlorothiazide can cause hypokalemia and hyponatremia.
Monitor serum electrolytes periodically based on factors such as renal function, other medications, or history of prior electrolyte imbalances.
Hyperkalemia: With DIOVAN, 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. Dosage reduction and/or
discontinuation of DIOVAN may be required.
Important Considerations Due to the HCTZ Component in DIOVAN HCT: Hypersensitivity reactions may occur in patients with or without a
history of allergy or bronchial asthma, but are more likely in patients with such a history. Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus.
HCTZ, a sulfonamide, can cause an idiosyncratic reaction resulting in transient myopia and angle-closure glaucoma, which left untreated, can lead to permanent vision loss.
Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Discontinue HCTZ as rapidly as possible in these patients.
Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Potassium Increasing Agents: Concomitant use of valsartan with other agents that block the renin angiotensin system, potassium-sparing diuretics,
potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (eg, heparin) may lead to increases in serum potassium and in heart
failure patients to increases in serum creatinine. During concomitant use, monitoring of serum potassium is advisable.
Non-Steroidal Anti-Inflammatory Agents Including COX-2 Inhibitors: Monitor renal function periodically in patients receiving valsartan and NSAIDs who are elderly,
volume-depleted (including those on diuretics), or who have compromised renal function due to potential reversible deterioration of renal function, including acute renal failure.
Dual Blockade of the RAS: Dual blockade of the RAS with angiotensin receptor blockers, ACEls, 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.
Lithium: Monitor lithium levels in patients receiving DIOVAN or DIOVAN HCT and lithium,
as increases in serum lithium concentrations and lithium toxicity have been reported.
The Following Drugs May Interact With Thiazide Diuretics: Antidiabetic drugs, non-steroidal anti-inflammatory drugs (NSAIDs and COX-2 selective inhibitors), carbamazepine,
ion exchange resins, and cyclosporine.
Lactation Risk: Breastfeeding is not recommended during treatment with DIOVAN or DIOVAN HCT.
Hepatic Impairment With HCTZ (DIOVAN HCT): Minor alterations of fluid and electrolyte balance may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
Common Adverse Reactions: The most common adverse reactions that occurred more frequently with DIOVAN than placebo in hypertension patients were viral infection (3% vs 2%), fatigue (2% vs 1 %),
and abdominal pain (2% vs 1 %).
The most common adverse reaction that occurred more frequently with DIOVAN HCT than placebo was nasopharyngitis (2.4% vs 1.9%).
Non-Melanoma Skin Cancer With HCTZ
(DIOVAN HCT): Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer.
Instruct patients to protect skin from the sun and undergo regular skin cancer screening.
INDICATION
DIOVAN
DIOVAN is indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients six years of age and older.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control,
diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
DIOVAN may be used alone or in combination with other antihypertensive agents.
DIOVAN HCT
DIOVAN HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control,
diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Add-On Therapy: DIOVAN HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.
Replacement Therapy: DIOVAN HCT may be substituted for the titrated components.
Initial Therapy: DIOVAN HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.
The choice of DIOVAN HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
or call 1-800-FDA-1088.
Please see Full Prescribing Information,
including IMPORTANT WARNING, for DIOVAN
Please see Full Prescribing Information,
including IMPORTANT WARNING, for DIOVAN HCT
