Saptan 15

Hypervolemic & euvolemic hyponatremia (serum Na <125 mEq/L or less marked hyponatremia that is symptomatic & resistant to fluid restriction) including patients w/ heart failure & SIADH. Adjunct treatment of vol overload in heart failure when adequate response is not obtained w/ other diuretics (eg, loop diuretics).

Adult Hypervolemic or euvolemic hyponatremia Initially 15 mg once daily. May be increased to 30 mg once daily after at least 24 hr to max of 60 mg once daily. Adjunct treatment of vol overload in heart failure 15 mg once daily. Patient w/ serum Na <125 mEq/L or rapid vol decrease is considered inappropriate Starting dose: 7.5 mg daily.

May be taken with or without food: Take in the morning to avoid nocturnal urination.

Hypersensitivity (eg, anaphylactic shock or generalized rash). Anuria. Inability to autoregulate fluid balance; hypovolemic hyponatremia (eg, risk of hypotension & renal failure). Urgent need to raise serum Na acutely. Uncorrected urinary outflow obstruction; abnormal blood Na conc. Unable to sense or respond to thirst. Concomitant use w/ strong CYP3A inhibitors (eg, clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, telithromycin). History, signs or symptoms of significant liver impairment or injury, excluding uncomplicated polycystic liver disease.

Discontinue treatment if serum Na increase above normal range; if serious & potentially fatal liver injury is suspected. Interrupt or discontinue treatment if dehydration or hypovolemia is suspected; if serious neurologic conditions & osmotic demyelination syndrome occur. Not indicated for urgent treatment of hyponatremia to prevent or treat serious neurological symptoms. Avoid use in patients w/ fluid-restriction during 1st 24 hr of therapy; liver disease eg, cirrhosis. Too rapid correction of hyponatremia (eg, >12 mEq/L/24 hr) can cause osmotic demyelination resulting in dysarthria, mutism, dysphagia, lethargy, affective changes, spastic quadriparesis, seizures, coma, & serious neurologic sequelae; hypernatremia leading to disturbed consciousness. Dehydration & hypovolemia in vol-depleted or fluid-restricted patients. Pre-existing hyperkalemia; severe malnutrition, alcoholism or advanced liver disease. Monitor for dehydration; hypovolemia; hypernatremia; hepatotoxicity during use. Limit therapy to 30 days to minimize liver injury risk. Perform LFTs in symptomatic patients. Avoid concomitant use w/ CYP3A inducers & moderate CYP3A inhibitors. Not recommended to be used w/ hypertonic saline. Concomitant use w/ drugs increasing serum K; diuretics. Not recommended in renal impairment (CrCl <10 mL/min). May cause fetal harm during pregnancy. Avoid lactation during therapy.

Hypernatremia; diarrhea, increased thirst, nausea, xerostomia; raised ALT/SGPT & serum bilirubin; asthenia; dizziness; increased urination frequency, polyuria; fatigue. Hypovolemia; GI hemorrhage; acute hepatic failure, liver injury; osmotic demyelination syndrome.

Avoid concomitant use w/ moderate CYP3A inhibitors eg, aprepitant, erythromycin, fluconazole, verapamil; strong CYP3A inducers eg, rifampin, barbiturates, phenytoin, carbamazepine, St. John's wort. Concomitant use w/ strong CYP3A inhibitors eg, ketoconazole, clarithromycin, ritonavir, saquinavir; P-gp inhibitors eg, cyclosporine, quinidine.

Diuretics

C03XA01 - tolvaptan ; Belongs to the class of vasopressin antagonists. Used as diuretics.

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