Company:

Daiichi-Sankyo

Antihypertensive (calcium channel blocker + angiotensin II receptor blocker)

Amlodipine (as besylate) 5mg, olmesartan medoxomil 20mg; tabs.

Amlodipine (as besylate) 5mg, olmesartan medoxomil 40mg; tabs.

Amlodipine (as besylate) 10mg, olmesartan medoxomil 20mg; tabs.

Amlodipine (as besylate) 10mg, olmesartan medoxomil 40mg; tabs.

Hypertension.

Amlodipine is a calcium channel blocker in the dihydropyridine class. It works by inhibiting the influx of calcium ions into vascular smooth muscle and cardiac muscle, causing a reduction in peripheral vascular resistance and a reduction in blood pressure. Olmesartan medoxomil is a prodrug of olmesartan, an angiotensin II receptor blocking agent. It blocks the vasoconstrictor effects of angiotensin II by interfering with its interaction with the AT1 receptors in vascular smooth muscle. Azor may be used as add-on therapy for patients inadequately controlled on either amlodipine or olmesartan. This combination product may be taken with other antihypertensive medications.

Azor was compared to monotherapy with its components in an 8-week, double-blind, multicenter, parallel group study involving 1940 patients with mild to severe hypertension to determine if treatment with the combination drug product would result in significant reductions in blood pressure. Patients were randomized to receive either placebo, amlodipine 5 or 10mg, olmesartan medoxomil 10mg, 20mg, or 40mg, or combination therapy with amlodipine/olmesartan medoxomil 5/10mg, 5/20mg, 5/40mg, 10/10mg, 10/20mg, or 10/40mg. Patients given the combination therapy experienced significant reductions in diastolic and systolic blood pressure compared to those given the respective monotherapies. These reductions were dose-related for both amlodipine and olmesartan medoxomil. For combination treatment with Azor, the blood pressure lowering effect was maintained throughout the 24-hour dosing interval.

Not for initial therapy. May be substituted for titrated components. Individualize; titrate at 2-week intervals; may increase dose of one or both components if BP not controlled on prior therapy. Max one 10/40 tab daily.

Not recommended.

Correct hypovolemia before starting (may need to reduce diuretic) or monitor closely for hypotension. Severe heart failure (if renal function depends on renin-angiotensin-aldosterone system). Severe obstructive coronary disease. Severe aortic stenosis. Severe hepatic or renal impairment. Renal artery stenosis. Elderly (may need lower initial dose of amlodipine). Pregnancy (Cat. C in 1st trimester, Cat. D in 2nd and 3rd trimesters). Nursing mothers: not recommended.

Edema, dizziness; headache, hypotension, rash, pruritus, palpitation, urinary frequency, nocturia, hepatic or renal dysfunction, decreased hematocrit, decreased hemoglobin, hyperkalemia (rare).

Tabs—30, 90, 100, 1000

For more information call (877) 437-7763 or visit www.Azor.com.

11/1/07