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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
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 (Cat.D); avoid. Nursing mothers: not recommended.
Edarbi Pharmacokinetics
See Literature
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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