Samsca伸舒康

Samsca

tolvaptan

Manufacturer:

Otsuka

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Tolvaptan
Indications/Uses
Clinically significant hypervolemic & euvolemic hyponatremia including patients w/ heart failure & syndrome of inappropriate antidiuretic hormone (SIADH).
Dosage/Direction for Use
Adult Initially 15 mg once daily, may be increased to 30 mg once daily after at least 24 hr. Max: 60 mg once daily. Max duration of therapy: Not >30 days.
Administration
May be taken with or without food: Avoid grapefruit juice.
Contraindications
Hypersensitivity (eg, anaphylactic shock, generalized rash); patients w/ autosomal dominant polycystic kidney disease (ADPKD) outside of FDA-approved risk evaluation & mitigation strategy (local risk management plan); 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. Discontinue or interrupt treatment if patients develop too rapid arise in serum Na. Risk of serious liver injury; dehydration & hypovolemia; hyperkalemia. Discontinue in case of symptoms that may indicate liver injury; or significant signs & symptoms of dehydration & hypovolemia. Avoid use in patients w/ underlying liver disease including cirrhosis. Monitor serum K levels after initiation of therapy in patients w/ K >5 mEq/L or on drugs known to increase K. Concomitant use w/ hypertonic saline is not recommended. Avoid concomitant use w/ CYP3A inducers or moderate CYP34 inhibitors. Dose reduction when co-administered w/ P-gp inhibitors. Not recommended in patients w/ CrCl <10 mL/min. Pregnancy & lactation.
Adverse Reactions
Thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, & hyperglycemia.
Drug Interactions
Increased tolvaptan exposure w/ strong CYP3A inhibitors (eg, ketoconazole, clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir & nefazodone); moderate CYP3A inhibitors (eg, erythromycin, fluconazole, aprepitant, diltiazem & verapamil); grapefruit juice; P-gp inhibitors (eg, cyclosporine). Reduced tolvaptan exposure w/ CYP3A inducers (eg, rifampin, rifabutin, rifapentin, barbiturates, phenytoin, carbamazepine, St. John's wort). Increased digoxin AUC & Cmax. May interfere w/ V2-agonist activity of desmopressin.
MIMS Class
Diuretics
ATC Classification
C03XA01 - tolvaptan ; Belongs to the class of vasopressin antagonists. Used as diuretics.
Presentation/Packing
Form
Samsca tab 15 mg
Packing/Price
10's
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