nts (see BOXED WARNING). The efficacy of fluvoxamine maleate administered as immediate-release tablets for the treatment of OCD was demonstrated in a 10-week multicenter placebo-controlled study with 120 outpatients ages 8-17. In addition, 99 of these outpatients continued open-label fluvoxamine maleate treatment for up to another one to three years, equivalent to 94 patient years. The adverse reaction profile observed in that study was generally similar to that observed in adult studies with immediate-release fluvoxamine maleate tablets (see ADVERSE REACTIONS [6.3]).
Decreased appetite and weight loss have been observed in association with the use of fluvoxamine as well as other SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as LUVOX CR Capsules.
The risks, if any, that may be associated with fluvoxamine's extended use in children and adolescents with OCD have not been systematically assessed. The prescriber should be mindful that the evidence relied upon to conclude that fluvoxamine is safe for use in children and adolescents derives from relatively short-term clinical studies and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly eva luate the effects of long-term fluvoxamine use on the growth, cognitive behavioral development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that fluvoxamine possesses a capacity to adversely affect growth, development, or maturation, the absence of such findings is not compelling evidence of the absence of the potential of fluvoxamine to have adverse effects in chronic use (see WARNINGS AND PRECAUTIONS -Clinical Worsening and Suicide Risk [5.1]).
Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established (see BOXED WARNING and WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [5.1]). Anyone considering the use of LUVOX CR Capsules in a child or adolescent must balance the potential risks with the clinical need.
8.5 Geriatric Use
Approximately 230 patients and 5 patients participating in controlled premarketing studies with immediate-release fluvoxamine maleate tablets and LUVOX CR Capsules, respectively, were 65-years of age or over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients. However, SSRIs and SNRIs, including fluvoxamine, have been associated with several cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction (see WARNINGS AND PRECAUTIONS [5.14]). Furthermore, the clearance of fluvoxamine is decreased by about 50% in elderly compared to younger patients (see CLINICAL PHARMACOLOGY-Elderly [12.3]), and greater sensitivity of some older individuals also cannot be ruled out. Consequently, a lower starting dose should be considered in elderly patients, and LUVOX CR Capsules should be slowly titrated during initiation of therapy.
9 DRUG ABUSE AND DEPENDENCE
9.1 Controlled Substance
LUVOX CR is not a controlled substance.
9.2 Physical and Psychological Dependence The potential for abuse, tolerance, and phy |
