Clinically significant hypervolemic & euvolemic hyponatremia including patients w/ heart failure, & syndrome of inappropriate antidiuretic hormone (SIADH). Adjunct treatment of vol overload in heart failure. Should be used in combination w/ other diuretics eg, loop diuretics, thiazides & aldosterone antagonists.
AdultHyponatremia Initially 15 mg once daily, may be increased to 30 mg once daily after at least 24 hr. Max: 60 mg once daily. Adjunct treatment of vol overload in heart failure 15 mg once daily in the morning but recommended to start from 7.5 mg/day for serum Na <125 mEq/L or when rapid vol decrease is inappropriate.
View Samsca overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Avoid grapefruit juice.
Contraindications
History of hypersensitivity to tolvaptan or benzazepine derivatives. Urgent need to raise serum Na acutely; inability to sense or appropriately respond to thirst; hypovolemic hyponatremia; concomitant use w/ strong CYP3A inhibitors eg, clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone & telithromycin; anuric patients; hypernatremia.
Patients should be monitored to assess serum Na conc & neurologic status especially during initiation & after titration. Fluid intake, urine vol, serum Na level & occurrence of clinical symptoms eg, thirst & dehydration should be carefully monitored during treatment. Blood testing for hepatic transaminases & bilirubin is required prior to initiation of therapy (& continuing mthly for 18 mth & at regular intervals, thereafter, in prolonged use); perform liver function test prior to initiation & frequently at least for the 1st 2 wk during treatment; promptly discontinue if liver injury is suspected. Concomitant use w/ hypertonic saline; strong CYP3A inhibitors; CYP3A inducers; P-gp inhibitors. Monitor serum K levels after initiation of therapy in patients w/ a serum K >5 mEq/L & receiving drugs known to increase serum K levels. CrCl <10 mL/min or in patients undergoing dialysis. Pregnancy & lactation. Childn.
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