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Initiate and re-initiate in a hospital and monitor serum sodium: 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.
For volume overload in heart failure, administration of SAMSCA should be
initiated or re-initiated only under hospitalization, as occurrence of consciousness disturbance has been reported as a result of dehydration and
hypernatremia associated with rapid water diuresis and rapid increase in
serum sodium concentration may induce osmotic demyelination syndrome
(ODS). On the first day of treatment initiation or re-initiation, serum sodium
concentration should be frequently monitored.
Not for use for autosomal dominant polycystic kidney disease (ADPKD): Because of the risk of hepatotoxicity, SAMSCA should not be used for
ADPKD [see Use in patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) under Contraindications].
