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Edarbyclor Generic Name & Formulations
Legal Class
Rx
General Description
Azilsartan medoxomil, chlorthalidone; 40/12.5mg, 40/25mg; tabs.
Pharmacological Class
Angiotensin II receptor blocker (ARB) + thiazide-like diuretic.
How Supplied
Tabs—30
Manufacturer
Edarbyclor Indications
Indications
Hypertension in patients not adequately controlled with monotherapy. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Edarbyclor Dosage and Administration
Adult
≥18yrs: initially 40/12.5mg once daily; may increase to 40/25mg after 2–4 weeks as needed. Max: 40/25mg. Patients titrated to the individual components: may give corresponding dose of Edarbyclor. See full labeling.
Children
<18yrs: not established.
Edarbyclor Contraindications
Contraindications
Anuria. Concomitant aliskiren-containing products in patients with diabetes.
Edarbyclor Boxed Warnings
Boxed Warning
Fetal toxicity.
Edarbyclor Warnings/Precautions
Warnings/Precautions
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy; monitor for hypotension. Renal impairment: monitor; consider discontinuing if impairment progresses. Severe CHF. Renal artery stenosis. Severe hepatic impairment. Monitor serum electrolytes periodically. Gout. Neonates. Pregnancy (esp. during 2nd & 3rd trimester), nursing mothers: not recommended.
Edarbyclor Pharmacokinetics
See Literature
Edarbyclor 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. Concomitant digitalis may exacerbate hypokalemia.
Edarbyclor Adverse Reactions
Adverse Reactions
Dizziness, fatigue, hypotension, elevated serum creatinine; hypokalemia, hyponatremia, hyperuricemia.
Edarbyclor Clinical Trials
See Literature
Edarbyclor Note
Not Applicable
Edarbyclor Patient Counseling
See Literature
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