<p><strong>Pediatric Use</strong>: Clinical studies on the use of Levomilnacipran in pediatric patients have not been conducted; therefore, the safety and effectiveness of Levomilnacipran in the pediatric population have not been established. Levomilnacipran is not approved for use in pediatric patients.<br />
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<strong>Geriatric Use</strong>: No dose adjustment is recommended on the basis of age. In a multiple-dose clinical pharmacokinetic study, elderly subjects (&gt; 65 years) had a slightly higher exposure (C max by 24% and AUC by 26%) of levomilnacipran than younger subjects (18-45 years). Of the total number of subjects in the 8-week clinical studies of Levomilnacipran, 2.8% of patients were age 65 or older. Because levomilnacipran is predominately excreted by the kidney, renal clearance of levomilnacipran should be considered when determining the dose. SSRIs and SNRIs, including Levomilnacipran, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event.<br />
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<strong>Hepatic Impairment</strong>: Hepatic elimination of levomilnacipran is low. Dose adjustment is not recommended in subjects with mild (Child-Pugh score of 1-6), moderate (Child-Pugh score of 7-9), or severe (Child-Pugh score of 10-13) hepatic impairment.<br />
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<strong>Renal Impairment</strong>: Renal excretion plays a predominant role in the elimination of levomilnacipran. Dose adjustment is not recommended for patients with mild (creatinine clearance of 60-89 ml/min) renal impairment. Dosing adjustment is recommended for patients with moderate (creatinine clearance of 30-59 ml/min) or severe (creatinine clearance of 15-29 ml/min) renal impairment. Levomilnacipran is not recommended for patients with end stage renal disease.</p>