Azor- One tablet combines two antihypertensives

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Product:

Azor

Company:

Daiichi-Sankyo

Pharmacologic class:

Antihypertensive (calcium channel blocker + angiotensin II receptor blocker)

Active ingredients:

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

Also:

Azor 5/40

Active ingredients:

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

Also:

Azor 10/20

Active ingredients:

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

Also:

Azor 10/40

Active ingredients:

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

Indication:

Hypertension.

Pharmacology:

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 BP.

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.

Clinical trials:

Azor was compared to monotherapy with its components in an 8-week, double-blind, multicenter, parallel group study involving 1,940 patients with mild to severe hypertension to determine if treatment with the combination drug product would result in significant reductions in BP.

Patients were randomized to receive either placebo, amlodipine 5 or 10 mg, olmesartan medoxomil 10 mg, 20 mg, or 40 mg, or combination therapy with amlodipine/olmesartan medoxomil 5/10 mg, 5/20 mg, 5/40 mg, 10/10 mg, 10/20 mg, or 10/40 mg.

Patients given the combination therapy experienced significant reductions in diastolic and systolic BP compared with those given the respective monotherapies. These reductions were dose-related for both amlodipine and olmesartan medoxomil. For combination treatment with Azor, the BP lowering effect was maintained throughout the 24-hour dosing interval.

Adults:

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

Children:

Not recommended.

Precautions:

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 first trimester, Cat. D in second and third trimesters). Nursing mothers: not recommended.

Adverse reactions:

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

How supplied:

Tabs—30, 90, 100, 1000.

For more information, call 877.437.7763 or visit www.Azor.com

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