Exforge
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Uses
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.
 Figure 1: Probability of Achieving Systolic Blood Pressure <140 mmHg at Week 8 |
 Figure 2: Probability of Achieving Diastolic Blood Pressure <90 mmHg at Week 8 |
 Figure 3: Probability of Achieving Systolic Blood Pressure <130 mmHg at Week 8 |
 Figure 4: Probability of Achieving Diastolic Blood Pressure <80 mmHg at Week 8 |
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).
History
There is currently no drug history available for this drug.
Other Information
Exforge is a fixed combination of amlodipine and valsartan.
Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is
Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.
Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2’-(1H-tetrazol-5-yl) [1,1’-biphenyl]-4-yl]methyl]-L-valine; its structural formula is
Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.
Exforge tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc and titanium dioxide.
Sources
Exforge Manufacturers
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Physicians Total Care, Inc.
![Exforge (Amlodipine Besylate And Valsartan) Tablet, Film Coated [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Exforge | Physicians Total Care, Inc.
2.1 General ConsiderationsAmlodipine 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(5)] 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 (6)].
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 (14)].
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.
2.2 Add-on TherapyA 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.
2.3 Replacement TherapyFor convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Exforge containing the same component doses.
2.4 Initial TherapyA 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.
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Remedyrepack Inc.
Exforge | Remedyrepack Inc.
General Considerations:
Majority of effect attained within 2 weeks (2.1) May be administered with other antihypertensive agents (2.1)Hypertension:
May be used as add-on therapy for patients not controlled on monotherapy (2.2) Patients who experience dose-limiting adverse reactions on monotherapy may be switched to Exforge containing a lower dose of that component (2.2) May be substituted for titrated components (2.3) When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily (2.4)Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/320mg tablet once daily as needed to control blood pressure. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.
Exforge may be administered with or without food.
Exforge may be administered with other antihypertensive agents.
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.
For convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Exforge containing the same component doses.
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.
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Novartis Pharmaceuticals Corporation
Exforge | Novartis Pharmaceuticals Corporation
2.1 General ConsiderationsDose once daily. 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. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose.
Exforge may be administered with or without food.
Exforge may be administered with other antihypertensive agents.
2.2 Add-on TherapyA 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.
2.3 Replacement TherapyFor convenience, patients receiving amlodipine and valsartan from separate tablets may instead wish to receive tablets of Exforge containing the same component doses.
2.4 Initial TherapyA 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.
![Exforge (Amlodipine Besylate And Valsartan) Tablet, Film Coated [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=08b1aa59-7892-451a-ad74-0388632e8235&name=MM3.jpg)
![Exforge (Amlodipine Besylate And Valsartan) Tablet, Film Coated [Novartis Pharmaceuticals Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d0caec89-96ec-411d-a933-63eda74a6da7&name=exforge-07.jpg)
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