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FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
Date:10/22/2008

tory arrest, catastrophic brain damage and death.

In the treatment of hyponatremia associated with congestive heart failure, Vaprisol is indicated only for those patients for whom the expected benefit of raising serum sodium outweighs the increased risk of adverse events. Vaprisol is contraindicated in patients with hypovolemic hyponatremia.

About Hyponatremia

Hyponatremia, a condition of low serum sodium concentration, often results from elevated levels of the hormone arginine vasopressin (AVP), which regulates water and salt balance in the body. It is the most common electrolyte disorder in clinical medicine and one of the most difficult to treat. Syndrome of inappropriate antidiuretic hormone (SIADH), advanced kidney failure, hypothyroidism and cancer are common causes of hyponatremia. Dilutional hyponatremia, which includes euvolemic and hypervolemic hyponatremia, is the most common form of the condition, and occurs when retained water dilutes serum sodium content. Patients with hyponatremia are classified as hypervolemic if swelling of body tissues (edema) is present or euvolemic if there is an increase in total body water content without edema.

About Vaprisol

Discovered and developed by Astellas Pharma Inc. headquartered in Tokyo, Japan, Vaprisol is a drug that blocks the activity of AVP, resulting in increased urine output without loss of valuable electrolytes such as sodium and potassium. This effect, known as "aquaresis," helps to increase serum sodium levels in patients with hyponatremia. Vaprisol is the first AVP receptor antagonist with a demonstrated safety profile and that effectively promotes aquaresis in order to help restore salt and water balance in patients with euvolemic and hypervolemic hyponatremia.

Vaprisol is indicated for the treatment of euvolemic and hypervolemic hyponatremia in hospitalized patients. Vaprisol is not indicated for the treatment of congestive heart failure. It should only be used fo
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SOURCE Astellas Pharma US, Inc.
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