• Hypertension

Edarbyclor Generic Name & Formulations

General Description

Azilsartan medoxomil, chlorthalidone; 40/12.5mg, 40/25mg; tabs.

Pharmacological Class

Angiotensin II receptor blocker (ARB) + thiazide-like diuretic.

How Supplied


Edarbyclor 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


≥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.


<18yrs: not established.

Edarbyclor Contraindications


Anuria. Concomitant aliskiren-containing products in patients with diabetes.

Edarbyclor Boxed Warnings

Boxed Warning

Fetal toxicity.

Edarbyclor 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


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