These highlights do not include all the information needed to use   Exforge safely and effectively . See full prescribing information for Exforge . Exforge (amlodipine and valsartan) Tablets

When pregnancy is detected, discontinue Exforge as soon as possible . Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus . [ See   W arnings   and P recautions   (5.1) ]

Exforge (amlodipine and valsartan) is indicated for the treatment of hypertension.

Exforge may be used in patients whose blood pressure is not adequately controlled on either monotherapy.

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

The choice of Exforge as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of Exforge.

Patients with stage 2 hypertension (moderate or severe) are at a relatively higher risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure and vision problems, so prompt treatment is clinically relevant. 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 compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.

Data from the high-dose multifactorial study [see Clinical Studies (14)] provide estimates of the probability of reaching a blood pressure goal with Exforge compared to amlodipine or valsartan monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Exforge 10/320 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 67% likelihood of achieving a goal of <140 mmHg (systolic) and 80% likelihood of achieving <90 mmHg (diastolic) on amlodipine alone, and the likelihood of achieving these goals on valsartan alone is about 47% (systolic) or 62% (diastolic). The likelihood of achieving these goals on Exforge rises to about 80% (systolic) or 85% (diastolic). The likelihood of achieving these goals on placebo is about 28% (systolic) or 37% (diastolic).

Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg to 10 mg while valsartan is effective in doses of 80 mg to 320 mg. In clinical trials with once daily Exforge (amlodipine and valsartan) using amlodipine doses of 5 mg to 10 mg and