SAMSCA
These highlights do not include all the information needed to use SAMSCA safely and effectively. See full prescribing information for SAMSCA. SAMSCA (tolvaptan) tablets, for oral use Initial U.S. Approval: 2009
5526617c-c7b9-4556-886d-729bbabbc566
HUMAN PRESCRIPTION DRUG LABEL
Nov 9, 2022
Otsuka America Pharmaceutical, Inc.
DUNS: 008314390
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tolvaptan
PRODUCT DETAILS
INGREDIENTS (8)
tolvaptan
PRODUCT DETAILS
INGREDIENTS (8)
Drug Labeling Information
BOXED WARNING SECTION
WARNING: (A) INITIATE AND RE-INITIATE IN A HOSPITAL AND MONITOR SERUM SODIUM
(B) NOT FOR USE FOR AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE (ADPKD)
See full prescribing information for complete boxed warning.
(A) 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.
(B) Not for use for autosomal dominant polycystic kidney disease (ADPKD)
Because of the risk of hepatotoxicity, tolvaptan should not be used for ADPKD outside of the FDA-approved REMS*(4)**