Generic Name and Formulations:
Azilsartan medoxomil 40mg, 80mg; tabs.
Arbor Pharmaceuticals, LLC
Indications for EDARBI:
Hypertension, alone or in combination with other antihypertensive agents.
≥18yrs: Monotherapy, not volume-depleted: 80mg once daily. Volume-depleted (eg, concomitant high-dose diuretics): initially 40mg once daily.
<18yrs: not established.
Concomitant aliskiren-containing products in patients with diabetes.
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 (Cat.D); avoid. Nursing mothers: not recommended.
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.
Angiotensin II receptor blocker (ARB).
Diarrhea; orthostatic hypotension, elevated serum creatinine.
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