essure <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) or62% (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).
2DOSAGE AND ADMINISTRATION
2.1 General Considerations
Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg to10 mg while valsartan is effective in doses of 80 mg to320 mg. In clinical trials with once daily Exforge (amlodipine and valsartan) using amlodipine doses of 5 mg to10 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 [seeAdverse 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 [seeClinical 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 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 eva luated and if blood pressure remains uncontrolled after 3 to4 weeks of therapy, the dose may be titrated up to a maximum of 10/320 mg.
2.3 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.
2.4 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.
3DOSAGE 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 |
