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American Journal of Medicine Publishes Hypertension Study Comparing the Fixed-Dose Combination of Azilsartan Medoxomil and Chlorthalidone versus Azilsartan Medoxomil Co-administered with Hydrochlorothiazide
Date:9/5/2012

t of hypertension to lower blood pressure in adults and may be used in patients not adequately controlled with monotherapy and as an initial therapy if a patient is likely to need multiple drugs to help achieve blood pressure goals. The recommended starting dose in adults is 40/12.5 mg taken orally once daily. The maximum recommended dose is 40/25 mg.

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. There are no controlled trials demonstrating risk reduction with Edarbyclor, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits. For example, ALLHAT and SHEP were landmark clinical trials that have shown that long-term use of chlorthalidone at doses of 12.5 mg to 25 mg was associated with reductions in risk of serious cardiovascular events, such as heart attack and stroke.

Important Safety Information
WARNING: FETAL TOXICITY See full Prescribing Information for complete boxed warning.
When pregnancy is detected, discontinue Edarbyclor as soon as possible.
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Edarbyclor is contraindicated in patients with anuria.

Fetal Toxicity: 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, discontinue Edarbyclor as soon as possible. Thiazides cross the placental barrier and appear in cord blood and may be associated with adverse reactions, including fetal or neonatal jaundice and thrombocytopenia.

In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients, Edarbyclor can cause excessive hypotension. Correct volume or salt depletion prior to adminis
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SOURCE Takeda Pharmaceuticals U.S.A., Inc.
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