tolvaptan
tolvaptan is listed in the FDA National Drug Code directory with 11 NDC codes, marketed under brand names including Jynarque, JYNARQUE, tolvaptan. Available dosage forms: kit, tablet.
Drug Details
- Generic Name
- tolvaptan
- Brand Names
- Jynarque, JYNARQUE, tolvaptan, SAMSCA
- Application Number
- NDA204441
- Sponsor
- Otsuka America Pharmaceutical, Inc.
- NDC Codes
- 11
- Dosage Forms
- KIT, TABLET
- Routes
- ORAL
- Active Ingredients
- TOLVAPTAN
Indications and Usage
1 INDICATIONS AND USAGE Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients. Tolvaptan tablets is a selective vasopressin V2-receptor antagonist indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH) ( 1 ) Limitations of Use: Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets ( 1 ) It has not been established that tolvaptan tablets provides a symptomatic benefit to patients ( 1 )