Important 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).

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.

PRECAUTIONS/DRUG-DRUG INTERACTIONS

LUVOX CR is a known potential inhibitor of:

  • CYP1A2
  • CYP3A4
  • CYP2C9
  • CYP2C19

In vitro data suggest fluvoxamine is a relatively weak inhibitor of CYP2D6

LUVOX CR interacts with:

Other drug interactions of note:

  • Drugs that interfere with hemostasis
  • Smoking
    • 25% increase in metabolism of fluvoxamine compared to non-smokers
  • Electroconvulsive therapy (ECT)
    • No clinical studies establishing the risks/benefits of ECT and fluvoxamine

For more information on LUVOX CR or drug-drug interactions, please see Drug Interactions Reference Tool and full prescribing information including boxed warning for LUVOX CR.

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.)

Please see full prescribing information, including boxed warning for LUVOX CR.

LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.

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The product information provided in this site is intended for residents of the United States only.
Jazz Pharmaceuticals