her to continuation of immediate-release fluvoxamine maleate tablets (N=56) or to placebo (N=58) in a double-blind phase for observation of relapse. Relapse during the double-blind phase was defined as an increase in the Y-BOCS score of at least 30% over the baseline for that phase or patient refusal to continue treatment due to a substantial increase in OCD symptoms. In the double-blind phase, patients receiving continued immediate-release fluvoxamine maleate tablets treatment experienced, on average, a significantly lower relapse rate than those receiving placebo.
An examination of population subgroups from this trial did not reveal any clear evidence of a differential maintenance effect on the basis of age or gender.
14.3 Pediatric OCD Study LUVOX CR Capsules have not been eva luated in pediatric patients. However, the effectiveness of immediate-release fluvoxamine maleate tablets for the treatment of OCD was demonstrated in a 10-week multicenter, parallel group study in a pediatric outpatient population (children and adolescents, ages 8-17 years). Patients in this study were titrated to a total daily fluvoxamine dose of approximately 100 mg/day over the first two weeks of the trial, following which the dose was adjusted within a range of 50-200 mg/day (given in two doses per day) on the basis of response and tolerance. All patients had moderate-to-severe OCD (DSM-III-R) with mean baseline ratings on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) total score of 24.
Post hoc exploratory analyses for gender effects on outcomes did not suggest any differential responsiveness on the basis of gender. Further exploratory analyses revealed a prominent treatment effect in the 8 year to 11 year age group and essentially no effect in the 12 year to 17 year age group. While the significance of these results is not clear, the 2-3 fold higher steady-state plasma fluvoxamine concentrations in children compared to adolescents (see CLINICAL PHARMACOLOGY-Pediatric Subjects [12.3]) is suggestive that decreased exposure in adolescents may have been a factor, and dose adjustment in adolescents (up to the adult maximum dose of 300 mg/day) may be indicated to achieve therapeutic benefit.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied LUVOX CR Capsules are available in the following strengths, colors, imprints, and presentations:
100 mg Extended-Release Capsules: Available in a two-piece gelatin capsule (dark blue opaque cap/white opaque body) imprinted with on one side of the cap and LCR 100 on the other side of the cap.
Bottles of 30....................NDC 68727-600-01
150 mg Extended-Release Capsules: Available in a two-piece gelatin capsule (dark blue opaque cap/powder blue opaque body) imprinted with on one side of the cap and LCR 150 on the other side of the cap.
Bottles of 30....................NDC 68727-601-01
16.2 Storage Keep out of reach of children.
LUVOX CR Capsules should be protected from high humidity and stored at 25°C (77°F); excursions permitted to
15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Avoid exposure to temperatures above 30°C (86°F).
Dispense in tight containers.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Medication Guide (17.11
