Azilsartan

Azilsartan medoxomil is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 azilsartan medoxomil. 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.

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Azilsartan medoxomil is an orally administered prodrug that is rapidly converted by esterases during absorption to the active moiety, azilsartan. Azilsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is, therefore, independent of the pathway for angiotensin II synthesis.

The recommended dose in adults is 80 mg taken once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. Azilsartan medoxomil may be administered with or without food. Azilsartan medoxomil may be administered with other antihypertensive agents.

Do not coadminister aliskiren-containing products with azilsartan medoxomil in patients with diabetes.

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue azilsartan medoxomil as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Correct volume or salt depletion prior to administration of azilsartan medoxomil. Monitor for worsening renal function in patients with renal impairment.

The most common adverse reaction in adults was diarrhea (2%).

Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Lithium: Increases in serum lithium concentrations and lithium toxicity.

Storage Store at 25°C (77°F), excursions permitted to 15°-30°C (59°-86°F). Protect from moisture and light. Do not repackage, dispense and store in original container.