Samsca

Samsca

tolvaptan

Manufacturer:

Otsuka (Philippines)

Distributor:

Zuellig
Concise Prescribing Info
Contents
Tolvaptan
Indications/Uses
Adjunct treatment of vol overload in heart failure when adequate response is not obtained w/ other diuretics (loop diuretics). Treatment of clinically significant hypervolemic & euvolemic hyponatremia (serum Na <125 mEq/L or less marked hyponatremia that is symptomatic & has resisted correction w/ fluid restriction) including patients w/ syndrome of inappropriate antidiuretic hormone secretion & heart failure.
Dosage/Direction for Use
All doses to be taken once daily. Adult Adjunct treatment of vol overload in heart failure 15 mg. Patient w/ serum Na <125 mEq/L or for whom rapid vol decrease is considered inappropriate Initiate 7.5 mg/day. Take in the morning to avoid nocturnal urination. Treatment should be initiated in hospital & patients should be frequently monitored for serum Na especially during the 1st day of treatment. Hyponatremia Initially 15 mg, may be increased to 30 mg after at least 24 hr. Max: 60 mg.
Administration
May be taken with or without food: Avoid grapefruit juice.
Contraindications
Hypersensitivity to tolvaptan or benzazepine derivatives. Urgent need to raise serum Na acutely; inability to autoregulate fluid balance, hypernatremia; risks associated w/ worsening hypovolemia including complications eg, hypotension & renal failure; concomitant use of strong CYP3A inhibitors (eg, clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone & telithromycin); anuric patients.
Special Precautions
Risk of osmotic demyelination syndrome; hypernatremia; liver injury; GI bleeding (in patients w/ cirrhosis); dehydration & hypovolemia; hyperkalemia. Monitor/assess serum Na conc & K levels; neurologic status; fluid intake, urine vol & occurrence of clinical symptoms eg, thirst & dehydration. Perform blood testing for hepatic transaminases & bilirubin; liver function test prior to initiation for short-term use (frequently at least for the 1st 2 wk) & long-term use [continuing 18 mth & at regular (eg, 3-6 mth) intervals thereafter]. Concomitant use w/ hypertonic saline. Pregnancy & lactation. Childn.
Adverse Reactions
Hyponatremia; thirst, dry mouth, asthenia, constipation, pollakiuria or polyuria, hyperglycemia.
Drug Interactions
Increased exposure w/ strong (eg, ketoconazole, clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir & nefazodone) & moderate (eg, erythromycin, fluconazole, aprepitant, diltiazem & verapamil) inhibitors of CYP3A; grapefruit juice. Reduced exposure w/ CYP3A inducers (eg, rifampin, rifabutin, rifapentin, barbiturates, phenytoin, carbamazepine, St. John's wort). P-gp inhibitors eg, cyclosporine. Increased digoxin AUC & Cmax; exposure to lovastatin. Increased risk of hyperkalemia w/ angiotensin receptor blockers, ACE inhibitors & K-sparing diuretics.
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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