February 25, 2017
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Luvox

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Luvox




Indications
Dosage
How Supplied

INDICATIONS

Obsessive-Compulsive Disorder

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

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 efficacy of Fluvoxamine Maleate Tablets was established in four trials in outpatients with OCD: two 10week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults. [See Clinical Studies].

DOSAGE AND ADMINISTRATION

Adults

The recommended starting dose for Fluvoxamine Maleate Tablets in adult patients is 50 mg, administered as a single daily dose at bedtime. In the controlled clinical trials establishing the effectiveness of Fluvoxamine Maleate Tablets 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 to 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.

Pediatric Population (children and adolescents)

The recommended starting dose for Fluvoxamine Maleate Tablets in pediatric populations (ages 8-17 years) is 25 mg, administered as a single daily dose at bedtime. In a controlled clinical trial establishing the effectiveness of Fluvoxamine Maleate Tablets in OCD, pediatric patients (ages 8-17) were titrated within a dose range of 50 to 200 mg/day. Physicians should consider age and gender differences when dosing pediatric patients. The maximum dose in children up to age 11 should not exceed 200 mg/day. Therapeutic effect in female children may be achieved with lower doses. Dose adjustment in adolescents (up to the adult maximum dose of 300 mg) may be indicated to achieve therapeutic benefit. The dose should be increased in 25 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. It is advisable that a total daily dose of more than 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

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.

Pregnant Women During The Third Trimester

Neonates exposed to Fluvoxamine Maleate Tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding and may be at risk for persistent pulmonary hypertension of the newborn (PPHN). [See Use in Specific Populations]. When treating pregnant women with Fluvoxamine Maleate Tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Switching A Patient To Or From A Monoamine Oxidase Inhibitor (MAOI) Intended To Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Fluvoxamine Maleate Tablets. Conversely, at least 14 days should be allowed after stopping Fluvoxamine Maleate Tablets before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use Of Fluvoxamine Maleate Tablets With Other MAOIs Such As Linezolid Or Methylene Blue

Do not start Fluvoxamine Maleate Tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving Fluvoxamine Maleate Tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Fluvoxamine Maleate Tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Fluvoxamine Maleate Tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Fluvoxamine Maleate Tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

Maintenance/Continuation Extended Treatment

It is generally agreed that obsessive compulsive disorder requires several months or longer of sustained pharmacologic therapy. The benefit of maintaining patients with OCD on Fluvoxamine Maleate Tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial [see Clinical Trials]. The physician who elects to use Fluvoxamine Maleate Tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Discontinuation Of Treatment With Fluvoxamine Maleate Tablets

Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported. [See WARNINGS AND PRECAUTIONS]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

HOW SUPPLIED

Dosage Forms And Strengths

Fluvoxamine Maleate Tablets USP are available as:

Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side)

Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other)

Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other)

Storage And Handling

Fluvoxamine Maleate Tablets USP are available in the following strengths, colors, imprints, and presentations:

Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “1222” on one side)

Bottles of 100.............................NDC 62559-158-01

Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “1225” on one side and scored on the other)

Bottles of 100.............................NDC 62559-159-01

Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “1221” on one side and scored on the other)

Bottles of 100.............................NDC 62559-160-01

Storage

Keep out of reach of children.

Fluvoxamine Maleate Tablets should be protected from high humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in tight containers.

Manufactured by ANI Pharmaceuticals, Inc. Baudette, MN 56623. Revised: Jan 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/3/2017

Indications
Dosage
How Supplied

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