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INDICATIONS

EXFORGE® is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy (with an angiotensin receptor blocker or a dihydropyridine calcium channel blocker) and as initial therapy in patients likely to need multiple drugs to reach their blood pressure goals.

The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination product compared to monotherapy.

EXFORGE HCT® is indicated for the treatment of hypertension and is not indicated for the initial therapy of hypertension.

EXFORGE HCT may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

IMPORTANT SAFETY INFORMATION

WARNING: AVOID USE IN PREGNANCY
When pregnancy is detected, discontinue EXFORGE or EXFORGE HCT as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus. [See Warnings and Precautions: Fetal/Neonatal Morbidity and Mortality (5.1)]

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

Excessive hypotension was seen in 0.4% of patients treated with EXFORGE and in 1.7% of patients treated with EXFORGE HCT 10/320/25 mg. Correct volume- or salt-depletion before administering EXFORGE or EXFORGE HCT or symptomatic hypotension may occur. Caution should be observed when initiating therapy with EXFORGE in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis. Do not initiate treatment with EXFORGE HCT in patients with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy.

Rarely, increased frequency, duration, or severity of angina or acute myocardial infarction have developed in patients treated with calcium channel blockers, particularly patients with severe obstructive coronary artery disease.

EXFORGE should be used with caution in patients with severe hepatic impairment. Amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t-1/2) is 56 hours in these patients. EXFORGE should be used with care in patients with mild to moderate hepatic impairment, including patients with biliary obstructive disorders, because of lower valsartan clearance.

Avoid use of EXFORGE HCT in patients with severe hepatic impairment. In patients with impaired hepatic function or progressive liver disease, minor alterations of fluid and electrolyte balance, such as those resulting from diuretic use, may precipitate hepatic coma. In patients with mild to moderate hepatic impairment, including patients with biliary obstructive disorders, monitor for worsening of hepatic or renal function, including fluid status and electrolytes, and adverse reactions.

In patients with renal artery stenosis or severe renal impairment, care should be exercised with dosing of EXFORGE. Avoid use of EXFORGE HCT in severe renal disease (creatinine clearance ≤30 mL/min). The usual regimens of therapy with EXFORGE HCT may be followed if the patient's creatinine clearance is >30 mL/min. There has been no long-term use of valsartan in patients with unilateral or bilateral renal artery stenosis, but an effect similar to that seen with angiotensin-converting enzyme (ACE) inhibitors (increases in serum creatinine or blood urea nitrogen) should be anticipated.

In patients with severe heart failure, decline in renal function and, rarely, acute renal failure and/or death has been associated with inhibiting the renin-angiotensin system. Evaluation of patients with heart failure or post-myocardial infarction should always include assessment of renal function. Dosage reduction and/or discontinuation of the diuretic and/or valsartan may be required.

Concomitant use of EXFORGE or EXFORGE HCT with drugs that increase potassium (eg, potassium-sparing diuretics) or salt substitutes containing potassium may lead to increased serum potassium.

Monitor renal function periodically in patients receiving valsartan and non-steroidal anti-inflammatory drugs (NSAIDs) who are also 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.

Important considerations due to the hydrochlorothiazide component of EXFORGE 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. Lithium generally should not be given with thiazides.

Monitor serum electrolytes periodically based on EXFORGE HCT use and other factors such as renal function, other medications, or history of prior electrolyte imbalances.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in transient myopia and angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Discontinue hydrochlorothiazide as rapidly as possible in these patients. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

The most common adverse reactions that occurred more frequently with EXFORGE than placebo were peripheral edema (5% vs 3%), nasopharyngitis (4% vs 2%), upper respiratory tract infection (3% vs 2%), and dizziness (2% vs 1%).

The most frequent adverse events that occurred in ≥2% of patients treated with EXFORGE HCT were dizziness (8.2%), edema (6.5%), headache (5.2%), dyspepsia (2.2%), fatigue (2.2%), muscle spasms (2.2%), back pain (2.1%), nausea (2.1%) and nasopharyngitis (2.1%).

Please see accompanying full Prescribing Information, including Boxed WARNING, for EXFORGE and EXFORGE HCT.