Samsca

Samsca

tolvaptan

Manufacturer:

Otsuka
Concise Prescribing Info
Contents
Tolvaptan
Indications/Uses
Adult patients w/ hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH). Clinically significant hypervolemic hyponatremia that has resisted correction w/ fluid restriction (serum Na <125 mEq/L or less-marked hyponatremia that is symptomatic in patients w/ heart failure).
Dosage/Direction for Use
Adult patients should be in a hospital for initiation & re-initiation of therapy to evaluate the therapeutic response. Initially 15 mg once daily, may be increased to 30 mg once daily after at least 24 hr. Max: 60 mg once daily.
Administration
May be taken with or without food: Avoid grapefruit juice.
Contraindications
Urgent need to raise serum Na acutely; inability to sense or appropriately respond to thirst; hypovolemic hyponatremia; strong CYP3A inhibitors (eg, clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone & telithromycin); anuric patients.
Special Precautions
Patients should be monitored to assess serum Na conc & neurologic status especially during initiation & after titration. Avoid fluid restriction during the 1st 24 hr of therapy. Patients receiving Samsca should be advised that they can continue ingestion of fluid in response to thirst. Discontinue or interrupt treatment if patients develop too rapid arise in serum Na; significant signs & symptoms of dehydration & hypovolemia. Monitor serum K levels during concomitant therapy. Pregnancy & lactation. Childn.
Adverse Reactions
Thirst, dry mouth, pollakiuria or polyuria, asthenia, constipation, hyperglycemia.
Drug Interactions
Strong CYP3A inhibitors (eg, ketoconazole, clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir & nefazodone). Moderate CYP3A inhibitors (eg, erythromycin, fluconazole, aprepitant, diltiazem & verapamil). CYP3A inducers (eg, rifampin, rifabutin, rifapentin, barbiturates, phenytoin, carbamazepine, St. John's wort); P-gp inhibitors (eg, cyclosporine). Grapefruit juice. Digoxin.
MIMS Class
ATC Classification
C03XA01 - tolvaptan ; Belongs to the class of vasopressin antagonists. Used as diuretics.
Presentation/Packing
Form
Samsca tab 15 mg
Packing/Price
1 × 10's
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