Azilsartan and Chlorthalidone

Edarbyclor is indicated for the treatment of hypertension, to lower blood pressure. Edarbyclor may be used in patients whose blood pressure is not adequately controlled on monotherapy. Edarbyclor may be used as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. 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 thiazide-like diuretics such as chlorthalidone and ARBs such as azilsartan medoxomil. There are no controlled trials demonstrating risk reduction with Edarbyclor.

The active ingredients of Edarbyclor target two separate mechanisms involved in blood pressure regulation. Azilsartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). Angiotensin II is the principle 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.

Starting dose is 40/12.5 mg once daily. Edarbyclor may be used to provide additional blood pressure lowering for patients not adequately controlled on azilsartan medoxomil 80 mg or chlorthalidone 25 mg. Dose may be increased to 40/25 mg after 2 to 4 weeks as needed to achieve blood pressure goals. Maximal dose is 40/25 mg. May be administered with other antihypertensive agents. Edarbyclor may be administered with or without food. Replace volume in volume-depleted patients prior to use

Edarbyclor is contraindicated in patients with anuria. Do not coadminister aliskiren-containing products with Edarbyclor in patients with diabetes. Anuria.

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue Edarbyclor as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, Edarbyclor can cause excessive hypotension. Correct volume or salt depletion prior to administration of Edarbyclor. In patients with renal artery stenosis, Edarbyclor may cause renal failure. Monitor renal function in patients with renal impairment. Consider discontinuing Edarbyclor with progressive renal impairment. Monitor serum electrolytes periodically

The following potential adverse reactions with Edarbyclor, azilsartan medoxomil, or chlorthalidone and similar agents are included in more detail in the Warnings and Precautions section of the label: Fetal toxicity Hypotension in Volume- or Salt-Depleted Patients Impaired Renal Function Hypokalemia Hyperuricemia Most common adverse reactions (incidence ≥2%) are dizziness and fatigue

Renal clearance of lithium is reduced by diuretics, such as chlorthalidone increasing the risk of lithium toxicity. NSAIDS increase risk of renal dysfunction and interfere with antihypertensive effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Lithium: Increases in serum lithium concentrations and lithium toxicity

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.