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

The efficacy of LUVOX Tablets was established in three 10-week trials with obsessive compulsive outpatients with the diagnosis of obsessive compulsive disorder as defined in DSM-III-R. (See Clinical Trials under CLINICAL PHARMACOLOGY.)

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 effectiveness of LUVOX Tablets 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 LUVOX Tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. (See DOSAGE AND ADMINISTRATION.)

Dosage for Adults

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

Dosage for Pediatric Population (children and adolescents)

The recommended starting dose for LUVOX 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 LUVOX 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 then 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.

Special Populations

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.

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to LUVOX Tablets and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. (See PRECAUTIONS.) When treating pregnant women with LUVOX Tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering LUVOX Tablets in the third trimester.

Maintenance/Continuation Extended Treatment

Although the efficacy of LUVOX Tablets 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.

Discontinuation of Treatment with LUVOX Tablets

Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported. (See 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.

Switching Patients To or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with LUVOX. Similarly, at least 14 days should be allowed after stopping LUVOX before starting an MAOI.

Tablets 25 mg: unscored, white, elliptical, film-coated (debossed “LT25” on one side)

Bottles of 100.......................................NDC 68727-500-01

Tablets 50 mg: scored, yellow, elliptical, film-coated (debossed “LT50” on one side and scored on the other)

Bottles of 100.......................................NDC 68727-501-01

Tablets 100 mg: scored, beige, elliptical, film-coated (debossed “LT100” on one side and scored on the other)

Bottles of 100.......... ............................NDC 68727-502-01

Storage

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

Dispense in tight containers.

Keep out of reach of children.

Lotronex™ is a trademark of GlaxoSmithKline. LUVOX® is a registered trade of Solvay Pharmaceuticals, Inc. Distributed by: Jazz Pharmaceuticals, Inc.Palo Alto, CA 94304. Rev 1207. FDA rev date: 12/20/2007

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