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Black Box Warning: Should be initiated and re-initiated in a hospital where serum Na can be monitored

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TOLVAPTAN - RESTRICTED

TOLVAPTAN - RESTRICTED
Drug Name Form Strength Non-Formulary Notes
SAMSCA TABLET 15 mg  

View Other Therapeutic Options: Vasopressin Antagonists: 402828

Comments:

Restricted:  Must be prescribed by Nephrology, Cardiology or Pulmonology

Indications:
- Hypervolemic hyponatremia (including patients with heart failure (HF))
- Euvolemic hyponatremia (including patients with SIADH)
- Patient admitted from home on Tolvaptan

Contraindications:
- Urgent need to raise serum sodium acutely
- Inability of the patient to sense or appropriately respond to thirst
- Hypovolemic hyponatremia or dehydration
- Concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole,
ketonazole, nefazodone, nelfinavir, saquinavir, telithromycin )
- Anuric patient or patients with CrCl < 10ml/min (because drug effects on serum sodium
levels are likely lost at very low levels of renal function)


Last updated: Oct. 27, 2021


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