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Urgent Need to Raise Serum Sodium Acutely: Samsca has not been studied in a setting of urgent need to raise serum sodium acutely.
Inability of the Patient to Sense or Appropriately Respond to Thirst: Patients who are unable to auto-regulate fluid balance are at substantially increased risk of incurring an overly rapid correction of serum sodium, hypernatremia and hypovolemia.
Hypovolemic Hyponatremia: Risks associated with worsening hypovolemia, including complications eg, hypotension and renal failure, outweigh possible benefits.
Concomitant Use of Strong CYP3A Inhibitors: Ketoconazole 200 mg administered with tolvaptan increased tolvaptan exposure by 5-fold. Larger doses would be expected to produce larger increases in tolvaptan exposure. There is no adequate experience to define the dose adjustment that would be needed to allow safe use of tolvaptan with strong CYP3A inhibitors eg, clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone and telithromycin.
Anuric Patients: In patients unable to make urine, no clinical benefit can be expected.
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