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Samsca
tolvaptan
Black Box Warnings .
Appropriate Use
initiate and re-initiate tx only in hospital w/ serum Na monitoring; not for autosomal dominant polycystic kidney dz use outside of FDA-approved REMS due to hepatotoxicity risk
Monitor Serum Sodium
osmotic demyelination may occur w/ rapid correction of hyponatremia (>12 mEq/L/24h), resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, and death; slower rates of correction advised in pts w/ severe malnutrition, alcoholism or advanced liver dz
Adult Dosing .
Dosage forms: TAB: 15 mg, 30 mg
hyponatremia, euvolemic
- [15-60 mg PO qd]
- Start: 15 mg PO qd, may incr. dose no more frequently than q24h to 30 mg PO qd, then to 60 mg PO qd; Max: 60 mg/day; 30 days; Info: avoid fluid restriction during first 24h of tx
hyponatremia, hypervolemic
- [15-60 mg PO qd]
- Start: 15 mg PO qd, may incr. dose no more frequently than q24h to 30 mg PO qd, then to 60 mg PO qd; Max: 60 mg/day; 30 days; Info: avoid fluid restriction during first 24h of tx
renal dosing
- [see below]
- CrCl <10: avoid use; anuria: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic dz: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.