Pharmacy & Therapeutics - May 2008 - (Page 291) For social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) Introducing New Once-A-Day Available in 100 mg and 150 mg capsules Important Safety Information CONTRAINDICATIONS The use of alosetron, tizanidine, thioridazine, or pimozide with Luvox CR Capsules is contraindicated. The use of MAO inhibitors in combination with Luvox CR Capsules, or within 14 days of discontinuing treatment with Luvox CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). Luvox CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients. Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. LUVOX CR Capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.) www.LuvoxCR.com ©2008 Jazz Pharmaceuticals, Inc. Printed in U.S.A. LCR-NAA-01 Luvox is a registered trademark of Solvay Pharmaceuticals, Inc. Please see brief summary for Luvox CR. http://www.LuvoxCR.com http://www.LuvoxCR.com
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