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IMPORTANT SAFETY INFORMATIONU.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING and Medication Guide.
SAMSCA should be initiated and re-initiated in patients only in a hospital where serum sodium can be monitored closely. Too rapid correction of hyponatremia (e.g., >12 mEq/L/24 hours) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. SAFETY INFORMATION CONTINUED BELOW
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SAMSCA: Mechanism of Action
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Manufactured by Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.Distributed and marketed by Otsuka America Pharmaceutical, Inc., Rockville, MD 20850.SAMSCA is a registered trademark of Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.
©2014 Otsuka America Pharmaceutical, Inc. March 2014 07US14EBP0086