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Edarbi Generic Name & Formulations
Legal Class
Rx
General Description
Azilsartan medoxomil 40mg, 80mg; tabs.
Pharmacological Class
Angiotensin II receptor blocker (ARB).
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Mechanism of Action
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 AT1 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.
Edarbi Indications
Indications
Hypertension, alone or in combination with other antihypertensive agents.
Edarbi Dosage and Administration
Adult
≥18yrs: Monotherapy, not volume-depleted: 80mg once daily. Volume-depleted (eg, concomitant high-dose diuretics): initially 40mg once daily.
Children
<18yrs: not established.
Edarbi Contraindications
Contraindications
Concomitant aliskiren-containing products in patients with diabetes.
Edarbi Boxed Warnings
Boxed Warning
Fetal toxicity.
Edarbi Warnings/Precautions
Warnings/Precautions
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy, or reduce initial dose (see Adult); monitor for hypotension. Renal impairment: monitor for worsening renal function. Severe CHF. Renal artery stenosis. Severe hepatic impairment. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.
Edarbi Pharmacokinetics
Absorption
Absolute bioavailability: ~60%. Peak plasma concentrations: reached within 1.5–3 hours.
Distribution
Volume of distribution: ~16L. Plasma protein bound: >99%.
Elimination
Fecal (55%), renal (42%). Half-life: ~11 hours. Renal clearance: ~2.3 mL/min.
Edarbi Interactions
Interactions
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; avoid or monitor closely. Avoid concomitant aliskiren in renal impairment (CrCl <60mL/min). May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors (monitor renal function esp. in elderly and/or volume-depleted). May potentiate lithium; monitor.
Edarbi Adverse Reactions
Adverse Reactions
Diarrhea; orthostatic hypotension, elevated serum creatinine.
Edarbi Clinical Trials
See Literature
Edarbi Note
Not Applicable
Edarbi Patient Counseling
See Literature
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