Generic Name and Formulations:
Azilsartan medoxomil, chlorthalidone; 40/12.5mg, 40/25mg; tabs.
Arbor Pharmaceuticals, LLC
Indications for EDARBYCLOR:
Hypertension in patients not adequately controlled with monotherapy. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
≥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.
Anuria. Concomitant aliskiren-containing products in patients with diabetes.
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 (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. Concomitant digitalis may exacerbate hypokalemia.
Angiotensin II receptor blocker (ARB) + thiazide-like diuretic.
Dizziness, fatigue, hypotension, elevated serum creatinine; hypokalemia, hyponatremia, hyperuricemia.
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