Advertisement
Advertisement
Samsca

Samsca

tolvaptan

Manufacturer:

Otsuka

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Tolvaptan
Indications/Uses
Clinically significant hypervolemic & euvolemic hyponatremia (serum Na <125 mEq/L or symptomatic hyponatremia & resisted correction w/ fluid restriction), including patients w/ heart failure & SIADH. Adjunct treatment of vol overload in heart failure.
Dosage/Direction for Use
Adult Hyponatremia Initially 15 mg once daily, may be increased to 30 mg once daily after at least 24 hr. Max: 60 mg once daily. Adjunct treatment of vol overload in heart failure 15 mg once daily in combination w/ other diuretics eg, loop diuretics, thiazides, aldosterone antagonists. Elderly, patient w/ serum Na <125 mEq/L, undesirable rapid plasma vol decrease or serum Na conc >140 mEq/L Initially 7.5 mg daily.
Administration
May be taken with or without food: Take in the morning. Swallow whole w/ water.
Contraindications
Hypersensitivity. Autosomal dominant polycystic kidney disease. Urgent need to raise serum Na acutely. Inability to sense or appropriately respond to thirst. Hypovolemic hyponatremia. Hypernatremia. Anuria. Concomitant use w/ strong CYP3A inhibitors.
Special Precautions
Initiate & re-initiate therapy in hospital to evaluate therapeutic response. Discontinue use if serum Na rises too rapidly (>12 mEq/L/24 hr); serum Na level increases above normal range; patients w/ symptoms indicating liver injury; osmotic demyelination syndrome; dehydration & hypovolemia. Secure urinary output for patients w/ partial urinary outflow obstruction. May induce thromboembolism for patients w/ serious CAD or cerebrovascular disease & elderly patients. Monitor serum Na level after initiation & when co-administered w/ diuretics. Assess serum Na conc & neurologic status during & after titration. Monitor serum K level after initiation in patients w/ serum K >5 mEq/L & patients receiving drugs increasing serum K level. Monitor fluid intake, urine vol, occurrence of thirst & dehydration. Limit duration of therapy to 30 days for hyponatremia treatment. Perform LFTs prior to initiation & frequently at least for 1st 2 wk of treatment for vol overload in heart failure. Perform blood testing for hepatic transaminases & bilirubin prior to initiation & continuing mthly for 18 mth at regular intervals thereafter for long-term use >30 days. Avoid fluid restriction during 1st 24 hr of treatment. Not to be used w/ strong CYP3A inhibitors. Avoid use w/ moderate CYP3A inhibitors. Not recommended in concomitant use w/ hypertonic saline. May need to increase dose if co-administered w/ CYP3A inducers & reduce dose in concomitant use w/ P-gp inhibitors. May affect ability to drive & use machines. Avoid use in patients w/ underlying hepatic disease. Not recommended in patients w/ CrCl <10 mL/min. Pregnancy & lactation. Ped. Elderly.
Adverse Reactions
Constipation; thirst. Pollakiuria. Hyponatremia: Dry mouth; asthenia, pyrexia; hyperglycemia, anorexia; polyuria. Vol overload in heart failure: Increased blood creatinine, urea & uric acid. Diarrhea; malaise; increased blood glucose & K, decreased BP, present blood urine; dizziness, headache.
Drug Interactions
Increased exposure w/ ketoconazole & other strong CYP3A inhibitors eg, clarithromycin, itraconazole, telithromycin, saquinavir, nelfinavir, ritonavir, nefazodone; moderate CYP3A inhibitors eg, erythromycin, fluconazole, aprepitant, diltiazem, verapamil; grapefruit juice. Reduced exposure w/ rifampin & other CYP3A inducers eg, rifabutin, rifapentine, barbiturates, phenytoin, carbamazepine, St. John's wort. Increased digoxin AUC & Cmax. Increased hyperkalemia w/ ARBs, ACE inhibitors, K-sparing diuretics. Interfered w/ V2 agonist activity of desmopressin. Required dose reduction in concomitant use w/ P-gp inhibitors eg, cyclosporine.
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
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement