.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
14.1 Obsessive Compulsive Disorder (OCD) 14.2 Adult OCD Maintenance Study with Immediate-Release Fluvoxamine Maleate Tablets 14.3 Pediatric OCD Study 16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION
17.1 Clinical Worsening and Suicide Risk 17.2 Contraindicated Medications 17.3 Other Potentially Hazardous Drug Interactions 17.4 Abnormal Bleeding 17.5 Angle Closure Glaucoma 17.6 Interference with Cognitive or Motor Performance 17.7 Pregnancy 17.8 Nursing 17.9 Alcohol 17.10 Allergic Reactions * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
1.1 Obsessive Compulsive Disorder
LUVOX CR Capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.
The efficacy of LUVOX CR Capsules was demonstrated in one 12-week trial in adults with LUVOX CR Capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8-17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES [14.1, 14.3]).
The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see CLINICAL STUDIES [14.2]). The health care provider who elects to prescribe LUVOX CR Capsules for extended periods should periodically re-eva luate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION [2.4]).
2 DOSAGE AND ADMINISTRATION
2.1 OCD (Obsessive Compulsive Disorder)
The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day.
Capsules should not be crushed or chewed.
2.2 Pediatric Patients Naïve to Fluvoxamine Maleate Physicians should consider that the lowest available dose of LUVOX CR Capsules may not be appropriate for pediatric patients naïve to fluvoxamine maleate.
2.3 Dosage for Elderly or Hepatically Impaired Patients Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg in these patient groups.
2.4 Maintenance/Continuation of Extended Treatment
Although the efficacy of LUVOX CR Capsules beyond 12 weeks of dosing has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. The benefit of maintaining patients with OCD on immediate-release fluvoxamine maleate ta |
