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FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Date:12/20/2011

single tablet. Chlorthalidone reduces the amount of water in the body by increasing the flow of urine, which helps lower blood pressure. EDARBYCLOR is indicated for the treatment of hypertension to lower blood pressure and may be used as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure control. The recommended starting dose of EDARBYCLOR in adults is 40/12.5 mg taken orally once daily. The maximum recommended dose is 40/25 mg.

Important Safety Information
Boxed Warning for FETAL TOXICITY

When pregnancy is detected, patients should discontinue EDARBI or EDARBYCLOR as soon as possible. Drugs that act directly on the reninangiotensin system can cause injury and death to the developing fetus.

EDARBYCLOR is contraindicated in patients with anuria.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, patients should discontinue EDARBI or EDARBYCLOR as soon as possible. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, EDARBI can cause symptomatic hypotension. EDARBYCLOR can cause excessive hypotension. Correct volume or salt depletion prior to administration of EDARBI or EDARBYCLOR.

Patients with renal impairment should be monitored for worsening renal function. In patients whose renal function may depend on the activity of the renin-angiotensin system, treatment with ACE inhibitors and ARBs has been associated with oliguria and azotemia and rarely with acute renal failure and death. In patients with renal artery stenosis, EDARBI and EDARBYCLOR may cause renal failure. In p
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SOURCE Takeda Pharmaceuticals North America, Inc.
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