1:01 AM | February 07, 2012
Metabolization and CYP InhibitionClinically Important Substrates and Concomitant Administration InformationInhibition Potential of Antidepressants at CYP450 Enzyme SystemsDrug Interactions Reference Tool: fluvoxamine maleateBrand Name Index

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 the risk with a clinical need. Short-term studies did not show an increase in this 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 and 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. (See WARNINGS AND PRECAUTIONS - Clinical Worsening and Suicide Risk and USE IN SPECIFIC POPULATIONS - Pediatric Use.)

Metabolization and CYP Inhibition

Fluvoxamine is extensively metabolized by the liver[1]

  • Metabolized at least in part by CYP450 isoenzyme 2D6
  • The metabolism of fluvoxamine has not been fully characterized
  • The effects of potent CYP450 inhibition has not been studied

Fluvoxamine appears to inhibit several CYP isoenzymes.* This may result in an interaction when fluvoxamine maleate extended-release capsules are prescribed concomitantly with an agent that is metabolized via these isoenzymes[1]

  • Potent inhibitor of CYP1A2; likely a potent inhibitor of CYP3A4
  • Inhibitor of CYP2C9 and CYP2C19
  • Weak inhibitor of CYP2D6

Stronger inhibition may suggest the greater likelihood of an interaction


No drug studied for interactions significantly affected the pharmacokinetics of fluvoxamine

*Classification of inhibition may vary depending on the study.

Please see full prescribing information, including BOXED WARNING

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Once-A-Day LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV.

Important Safety Information

CONTRAINDICATIONS

  • The use of thioridazine, tizanidine, pimozide, alosetron or ramelteon with LUVOX CR Capsules is contraindicated.
  • The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 2 weeks of discontinuing treatment with LUVOX CR Capsules is contraindicated. Also, LUVOX CR Capsules should not be administered within 14 days (2 weeks) after discontinuing treatment with an MAOI (See WARNINGS AND PRECAUTIONS).
  • Development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including LUVOX CR treatment, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs that impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine agonists.
  • See WARNINGS AND PRECAUTIONS for other important safety information, including information about drug interactions.

ADVERSE EVENTS

  • In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, abnormal ejaculation, tremor, sweating, and anorgasmia.
  • In one controlled trial in patients with OCD, the following additional reactions occurred at an incidence of 5% or greater and at least twice that for placebo: anxiety, decreased libido, vomiting, pharyngitis and myalgia.
  • In clinical trials, discontinuation rates due to an adverse reaction were 19% for the OCD population (N=124) and 26% in another studied population (N=279). [1]

DOSING CONSIDERATIONS

  • A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. There have been spontaneous reports of adverse reactions occurring upon discontinuation of SSRIs and SNRIs, particularly when abrupt. Patients should be monitored for these symptoms when discontinuing treatment with LUVOX CR Capsules.
  • SSRIs and SNRIs, including LUVOX CR may increase the risk of bleeding events. Concomitant use of fluvoxamine, NSAIDs, aspirin, warfarin, or other drugs that affect coagulation, should be cautioned.
  • LUVOX CR may impair judgment, thinking, or motor skills; patients should be cautioned until they have adapted to therapy.
  • Screen and monitor for depression, suicidality, and bi-polar disorder.

Please see full prescribing information, including BOXED WARNING, for LUVOX CR.

References:

  1. ^ LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA.

LUVOX CR is a registered trademark of Abbott Products, Inc.
CT STEPS is a registered trademark of Jazz Pharmaceuticals, Inc.
SODAS® is a registered trademark of Elan Pharma International Ltd. (EPIL). US Patent no 7,465,462.

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