Generic Name and Formulations:
Azilsartan medoxomil 40mg, 80mg; tabs.

Company:
Arbor Pharmaceuticals, Inc

Indications for EDARBI:
Hypertension. May be used alone or in combination with other antihypertensive agents.

Adult:
≥18yrs: Monotherapy, not volume-depleted: 80mg once daily. Volume-depleted (eg, concomitant high-dose diuretics): initially 40mg once daily.

Children:
<18yrs: not established.

Pharmacological Class:
Angiotensin II receptor blocker.

Contraindications:
Concomitant aliskiren in patients with diabetes.

Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy, or reduce initial dose; monitor for hypotension. Severe CHF. Renal artery stenosis. Renal impairment: monitor for worsening renal function. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.

Interactions:
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; 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 periodically in elderly and/or volume-depleted). May increase lithium levels; monitor.

Adverse Reactions:
Diarrhea; rare: orthostatic hypotension, dizziness, nausea, asthenia, fatigue, muscle spasm, cough.

How Supplied:
Tabs—30