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Exforge

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Exforge

Exforge

INDICATIONS

Hypertension

Exforge (amlodipine and valsartan) 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge.

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. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

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.

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] 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.

Figure 1: Probability of Achieving Systolic Blood Pressure < 140 mmHg at Week 8

Probability of Achieving Systolic Blood Pressure < 140 mmHg at Week 8 - Illustration

Figure 2: Probability of Achieving Diastolic Blood Pressure < 90 mmHg at Week 8

Probability of Achieving Diastolic Blood Pressure < 90 mmHg at Week 8 - Illustration

Figure 3: Probability of Achieving Systolic Blood Pressure < 130 mmHg at Week 8

Probability of Achieving Systolic Blood Pressure < 130 mmHg at Week 8 - Illustration

Figure 4: Probability of Achieving Diastolic Blood Pressure < 80 mmHg at Week 8

Probability of Achieving Diastolic Blood Pressure < 80 mmHg at Week 8 - Illustration

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).

DOSAGE AND ADMINISTRATION

General Considerations

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 valsartan doses of 160 mg to 320 mg, the antihypertensive effects increased with increasing doses.

The hazards [see WARNINGS AND PRECAUTIONS] of valsartan are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter [see ADVERSE REACTIONS].

The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320 mg tablet once daily as needed to control blood pressure [see Clinical Studies].

Exforge may be administered with or without food.

Exforge may be administered with other antihypertensive agents.

Elderly patients

Because of decreased clearance of amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment

No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment

No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Add-on Therapy

A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine calcium-channel blocker) alone or with valsartan (or another angiotensin II receptor blocker) alone may be switched to combination therapy with Exforge.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Exforge containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Exforge should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.

Replacement Therapy

For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Exforge containing the same component doses.

Initial Therapy

A patient may be initiated on Exforge if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Exforge 5/160 mg once daily in patients who are not volume-depleted.

HOW SUPPLIED

Dosage Forms And Strengths

5/160 mg tablets, debossed with NVR/ECE (side 1/side 2)
10/160 mg tablets, debossed with NVR/UIC
5/320 mg tablets, debossed with NVR/CSF
10/320 mg tablets, debossed with NVR/LUF

Storage And Handling

Exforge is available as non-scored tablets containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg and 10/320 mg.

All strengths are packaged in bottles of 30 and 90 count.

5/160 mg Tablets - dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “ECE” on the other side.

Bottles of 30 NDC # 0078-0488-15
Bottles of 90 NDC # 0078-0488-34

10/160 mg Tablets - light yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and vUIC” on the other side.

Bottles of 30 NDC # 0078-0489-15
Bottles of 90 NDC # 0078-0489-34

5/320 mg Tablets - very dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “CSF” on the other side.

Bottles of 30 NDC # 0078-0490-15
Bottles of 90 NDC # 0078-0490-34

10/320 mg Tablets - dark yellow, ovaloid shaped, film coated tablet with beveled edge, debossed with “NVR” on one side and “LUF” on the other side.

Bottles of 30 NDC # 0078-0491-15
Bottles of 90 NDC # 0078-0491-34

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Revised: 12/2011

Last reviewed on RxList: 1/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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Hypertension

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