Fluvoxamine (Fluvoxamine Maleate) Full Prescribing Information
Brand Name: Luvox
Generic Name: Fluvoxamine Meleate
Outside U.S., Brand Names also known as: Dumirox; Dumyrox; Faverin; Favoxil; Fevarin; Floxyfral; Maveral
Luvox patient information (plain English)
Fluvoxamine (Luvox) is a selective serotonin reuptake inhibitor (SSRI) used to treat obsessive-compulsive disorder (OCD). It may also be used to treat depression and other conditions as determined by your doctor.
The mechanism of action of fluvoxamine maleate in Obsessive Compulsive Disorder is presumed to be linked to its specific serotonin reuptake inhibition in brain neurons. In preclinical studies, it was found that fluvoxamine inhibited neuronal uptake of serotonin.
Following a single 100 mg oral dose, peak plasma levels of 31 to 87 ng/mL were attained 1.5 to 8 hours post-dose.
Indications and Usage
Luvox (Fluvoxamine Maleate) is indicated for the treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD).
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.
For the symptomatic relief of depressive illness.
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The effectiveness of fluvoxamine maleate for long-term use, i.e., for more than 10 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use fluvoxamine maleate for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Co-administration of terfenadine (Seldane), astemizole (Hismanal), or cisapride with fluvoxamine maleate is contraindicated.
Fluvoxamine maleate is contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate.
Potential for Interaction with Monoamine Oxidase Inhibitors
In patients receiving another serotonin reuptake inhibitor drug in combination with monoamine oxidase inhibitors (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have discontinued that drug and have been started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore, it is recommended that fluvoxamine maleate not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. After stopping fluvoxamine maleate, at least 2 weeks should be allowed before starting a MAOI.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes astemizole, cyproheptadine, terfenadine, cisapride, clozapine, fenfluramine, dexfenfluramine, monoamine oxidase inhibitors (MAOIs), tramadol, or tricyclic antidepressants. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.
Lithium, and possibly tryptophan, may enhance the serotonergic effects of fluvoxamine; these combinations should therefore be used with caution.
Activation of Mania/Hypomania: During premarketing studies involving primarily depressed patients, hypomania or mania occurred in approximately 1% of patients treated with fluvoxamine. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, fluvoxamine maleate should be used cautiously in patients with a history of mania.
Seizures: During premarketing studies, seizures were reported in 0.2% of fluvoxamine-treated patients. Fluvoxamine maleate should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures.
Suicide: The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as OCD. Close supervision of high risk patients should accompany initial drug therapy. Prescriptions for fluvoxamine maleate should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Use in Patients with Concomitant Illness: Closely monitored clinical experience with fluvoxamine maleate in patients with concomitant systemic illness is limited. Caution is advised in administering fluvoxamine maleate to patients who diseases or conditions that could affect hemodynamic responses or metabolism.
Interference with Cognitive or Motor Performance: Since any psychoactive drug may impair judgement, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain that fluvoxamine maleate therapy does not adversely affect their ability to engage in such activities.
Combined use of fluvoxamine and MAO inhibitors is contraindicated. (See Warnings)
DO NOT TAKE THIS MEDICINE with terfenadine (Seldane), astemizole (Hismanal), or cisapride.
In clinical trials, the most commonly observed adverse events associated with fluvoxamine administration, and not seen at an equivalent incidence among placebo-treated patients, were gastrointestinal complaints, including nausea (sometimes accompanied by vomiting), constipation, anorexia, diarrhea and dyspepsia; CNS complaints, including somnolence, dry mouth, nervousness, insomnia, dizziness, tremor and agitation; and asthenia. Abnormal (mostly delayed) ejaculation was frequently reported by patients with obsessive compulsive disorder, primarily at doses over 150 mg/day.
In a pool of two studies involving only patients with OCD, the following additional events were identified: dry mouth, decreased libido, urinary frequency, anorgasmia, rhinitis and taste perversion.
The potential for abuse, tolerance and physical dependence with fluvoxamine maleate has been studied in a nonhuman primate model. No evidence of dependency phenomena was found.
Generally, it is not possible to predict on the basis of preclinical or premarketing clinical experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of fluvoxamine maleate misuse or abuse (i.e., development of tolerance, incrementation of dose, drug-seeking behavior).
Signs and Symptoms
Symptoms of overdose may include drowsiness, vomiting, diarrhea, and dizziness. Cardiac disturbances, liver function disturbances, convulsions and coma have also been reported.
Of the 354 cases of deliberate or accidental overdose involving fluvoxamine maleate reported, there were 19 deaths. Of the 19 deaths, 2 were in patients taking fluvoxamine maleate alone and the remaining 17 were in patients taking fluvoxamine maleate along with other drugs.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
There are no specific antidotes for fluvoxamine maleate.
An unobstructed airway should be established with maintenance of respiration as required. Vital signs and ECG should be monitored. Administration of activated charcoal may be as effective as emesis or lavage and should be considered in treating overdose. Since absorption with overdose may be delayed, measures to minimize absorption may be necessary for up to 24 hours post-ingestion.
In managing overdosage, consider the possibility of multiple drug involvement.
Several weeks (up to 8 weeks) may pass before you feel the full effect of this medicine.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- Continue to take this medicine even if you feel better.
- If you miss a dose of this medicine and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. If you miss a dose of this medicine and you are taking more than 1 dose a day, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
The recommended starting dose for fluvoxamine maleate is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of fluvoxamine maleate in OCD, patients were titrated within a dose range of 100 to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved, not exceed 300 mg per day. It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.
Dosage for Elderly or Hepatically Impaired Patients: Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to modify the initial dose and the subsequent dose titration for these patient groups.
Maintenance/Continuation Extended Treatment: Although the efficacy of fluvoxamine maleate beyond 10 weeks of dosing for OCD has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.
Tablets:: 50 mg and 100 mg
Luvox Patient Information Sheet (plain English)
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.
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- Created: 04 January 2009
- Last Updated: 01 September 2014
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