<p><strong>Pediatric Use</strong>: Safety and effectiveness of Tolvaptan in pediatric patients have not been established.<br />
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<strong>Geriatric Use</strong>: Of the total number of hyponatremic subjects treated with Tolvaptan in clinical studies, 42% were 65 and over, while 19% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Increasing age has no effect on Tolvaptan plasma concentrations.<br />
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<strong>Use in Patients with Hepatic Impairment</strong>: Moderate and severe hepatic impairment do not affect exposure to Tolvaptan to a clinically relevant extent. Avoid use of Tolvaptan in patients with underlying liver disease.<br />
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<strong>Use in Patients with Renal Impairment</strong>: No dose adjustment is necessary based on renal function. There are no clinical trial data in patients with CrCl&lt;10 ml/min, and, because drug effects on serum sodium levels are likely lost at very low levels of renal function, use in patients with a CrCl&lt;10 ml/min is not recommended. No benefit can be expected in patients who are anuric.<br />
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<strong>Use in Patients with Congestive Heart Failure</strong>: The exposure to Tolvaptan in patients with congestive heart failure is not clinically relevantly increased. No dose adjustment is necessary.</p>