Hypertension:
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.
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.
Contraindications:
Anuria. Concomitant aliskiren-containing products in patients with diabetes.
Boxed Warning:
Fetal toxicity.
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 (Cat.D); avoid. Nursing mothers: not recommended.
Pharmacologic Class:
Angiotensin II receptor blocker (ARB) + thiazide-like diuretic.
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.
Adverse Reactions:
Dizziness, fatigue, hypotension, elevated serum creatinine; hypokalemia, hyponatremia, hyperuricemia.
How Supplied:
Tabs—30
