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Healthcare
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Get important information
and facts about LUVOX CR.
Safety Information
Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).
Warning
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.)
Important Safety Information
Adverse Events
In clinical trials, nausea was the most common adverse event, although typically mild to moderate in severity and transient in nature.[1]
Important Drug-Drug Interaction Information
- While in vitro data suggest that fluvoxamine is a weak inhibitor of cytochrome P450 2D6, there is potential for interactions with drugs inhibited or metabolized by cytochrome P450
- LUVOX CR should not be used in combination with ramelteon, alosetron, tizanidine, thioridazine, or pimozide. Monoamine oxidase inhibitors (MAOIs) should not be used in combination with or within 14 days of discontinuing LUVOX CR*
- A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio, such as warfarin or theophylline, certain benzodiazepines, and phenytoin
- If LUVOX CR Capsules are to be administered together with a drug that is eliminated via oxidative metabolism and has a narrow therapeutic window, plasma levels and/or pharmacodynamic effects of the latter drug should be monitored closely, at least until steady-state conditions are reached*
* Please see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS in full prescribing information.
Please see full prescribing information, including boxed warning for LUVOX CR.
LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.
© 2008 Jazz Pharmaceuticals, Inc.
References:
- ^ Data on file. Jazz Pharmaceuticals, Inc., Palo Alto, CA.
