tolvaptan 30 MG Oral Tablet
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). Tolvaptan tablets are selective vasopressin V 2 -receptor antagonists 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 provide a symptomatic benefit to patients ( 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. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.
apotex corp.
ROUND BLUE OTSUKA 30
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16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tolvaptan tablets are available in the following strengths and packages. Tolvaptan 15 mg tablets are non-scored, blue, triangular, shallow-convex, debossed with "OTSUKA" and "15" on one side. Blister of 10 NDC 60505-4704-0 Tolvaptan 30 mg tablets are non-scored, blue, round, shallow-convex, debossed with "OTSUKA" and "30" on one side. Blister of 10 NDC 60505-4705-0 Storage and Handling Store at 25°C (77°F), excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP controlled Room Temperature]. Keep out of reach of children.
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