LUVOX CR® (fluvoxamine maleate) Extended-Release 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient
IMPORTANT SAFETY INFORMATION
- Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with LUVOX CR is contraindicated.
- The use of MAOIs intended to treat psychiatric disorders with LUVOX CR or within 14 days of stopping treatment with LUVOX CR is contraindicated because of an increased risk of serotonin syndrome. The use of LUVOX CR within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see Dosing and Administration and Warnings and Precautions).
- Starting LUVOX CR in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see Dosing and Administration and Warnings and Precautions).
WARNINGS AND PRECAUTIONS
- Monitor patients for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric disorders. These symptoms may represent precursors to emerging suicidality. Families and caregivers of patients being treated should be alerted about the need for close daily monitoring of patients.
- Prescriptions for LUVOX CR should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
- Prior to initiating treatment with an antidepressant, patients should be adequately screened to determine if they are at risk for bipolar disorder. Treatment with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.
- The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including LUVOX CR, alone but particularly with concomitant use of serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.
The concomitant use of LUVOX CR with MAOIs intended to treat psychiatric disorders is contraindicated. If concomitant use of LUVOX CR with certain other serotonergic drugs, treatment with LUVOX CR and any concomitant serotonergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
- Fluvoxamine inhibits several CYP isoenzymes. This may result in drug interactions when Luvox CR is prescribed concomitantly with agents that are metabolized by some isoenzymes (CYP1A2, CYP3A4, CYP2C9, CYP2C19, and CYP2D6).
A clinically significant fluvoxamine interaction is possible with drugs having a narrow therapeutic ratio such as pimozide, warfarin, theophylline, certain benzodiazepines, omeprazole, and phenytoin. Other potentially important drug interactions may result from coadministration of Luvox CR with the following drugs: benzodiazepines, alprazolam, diazepam, clozapine, methadone, mexiletine, theophylline, warfarin, carbamazepine, litium, tacrine, tricyclic antidepressants, tryptophan and beta-blockers.
As with other psychotropic medications, patients should be advised to avoid alcohol while taking LUVOX CR.
Please see Contraindications, Warnings and Precautions, and Drug Interactions in the full Prescribing Information for additional information regarding potential drug-drug interactions for Luvox CR.
- Symptoms associated with discontinuation have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.
- LUVOX CR, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.
- LUVOX CR should be used cautiously in patients with a history of mania.
- Caution is recommended when the drug is administered to patients with a history of convulsive disorders. Fluvoxamine should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be carefully monitored. Treatment with fluvoxamine should be discontinued if seizures occur or if seizure frequency increases.
- Hyponatremia may occur as a result of treatment with LUVOX CR. Discontinuation of LUVOX CR should be considered in patients with symptomatic hyponatremia.
- Caution is advised in administering LUVOX CR to patients with diseases or conditions that could affect hemodynamic responses, or metabolism.
- Patients with hepatic impairment should begin with a low dose of LUVOX CR and increase it slowly with careful monitoring.
- In clinical trials, the most commonly observed treatment-emergent adverse reactions associated with the use of LUVOX CR and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating, and tremor. In the 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, myalgia, pharyngitis, and vomiting. The following additional reactions occurred in another studied population: dyspepsia, dizziness, insomnia, and yawning.
- In a study evaluating immediate-release fluvoxamine maleate tablets in pediatric patients with OCD, the following additional reactions were identified: agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.
USE IN SPECIAL POPULATIONS
- Pregnancy: Consider both potential risks and benefits when treating a pregnant woman. Infants exposed to SSRIs in pregnancy have developed various complications and may be at risk for persistent pulmonary hypertension of the newborn (PPHN).
- Nursing mothers: Fluvoxamine is secreted in human breast milk.
- Geriatric: Use of a lower starting dose may be warranted. Titrate slowly during initiation of therapy.
Please see full Prescribing Information, including BOXED Warning and Medication Guide, for additional important safety information.
LUVOX CR is a registered trademark of Abbott Products, Inc.
SODAS® is a registered trademark of Elan Pharma International Ltd. (EPIL).
US Patent no 7,465,462.