Saptan 15 Special Precautions

Concomitant use: Avoid use of CYP3A inducers and moderate CYP3A inhibitors.
Not recommended for use with hypertonic saline.
Endocrine and metabolic: Too rapid serum sodium correction can cause serious neurologic sequelae.
Dehydration may occur, particularly in volume-depleted patients receiving diuretics or fluid-restricted patients; interrupt or discontinue use if suspected. Monitoring recommended.
Hyperkalemia, pre-existing, or drugs that increase serum potassium may further increase serum potassium; monitoring recommended.
Hypovolemia may occur, particularly in volume-depleted patients receiving diuretics or fluid-restricted patients; monitoring recommended; interrupt or discontinue use if suspected.
Hypernatremia may occur; monitoring recommended.
Neurologic: Serious neurologic conditions and osmotic demyelination syndrome may occur; increased risk in very low baseline sodium levels, concomitant use of diuretics, and conditions such as severe malnutrition, alcoholism, or advanced liver disease; avoid use if patient is fluid restricted during first 24 hours of therapy; monitoring recommended, especially during initiation and dose titration; interrupt or discontinue use if occurs.
Hepatic: Avoid use in liver disease (eg, cirrhosis); may impair liver injury recovery.
Serious and potentially fatal liver injury has been reported; limit Tolvaptan therapy to 30 days to minimize liver injury risk; liver function tests recommended if symptomatic; discontinue use if suspected; reinstitute therapy only if liver injury is unrelated to Tolvaptan.
Renal: Use not recommended if CrCl is less than 10 mL/min.