Amlodipine and Olmesartan

Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. 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.

Azor. Azor is a combination of two antihypertensive drugs: a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), amlodipine besylate, and an angiotensin II receptor blocker, olmesartan medoxomil. The amlodipine component of Azor inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, and the olmesartan medoxomil component of Azor blocks the vasoconstrictor effects of angiotensin II. Amlodipine. Experimental data suggests that amlodipine binds to both dihydropyridine and nonhydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [ s ee Clinical Studies ]. Recommended starting dose: 5/20 mg once daily. Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily.

Do not co-administer aliskiren with Azor in patients with diabetes.

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue Azor as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Anticipate hypotension in volume- or salt-depleted patients with treatment initiation. Start treatment under close supervision. Increased angina or myocardial infarction may occur upon dosage initiation or increase. Impaired renal function: changes in renal function may occur. Sprue-like enteropathy has been reported. Consider discontinuation of Azor in cases where no other etiology is found.

Most common adverse reaction (incidence ≥3%) is edema.

Amlodipine: If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. Increased exposure of amlodipine when coadministered with CYP3A inhibitors. Olmesartan medoxomil: Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Lithium: Increases in serum lithium concentrations and lithium toxicity.

Store at 25ºC (77ºF), excursions permitted to 15ºC-30ºC (59ºF-86ºF).