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Fluvoxamine (Fluvoxamine Maleate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Obsessive-Compulsive Disorder

Fluvoxamine Maleate Tablets, USP 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, USP was established in three trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17). (See CLINICAL STUDIES [ 14 ].)

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 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.

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 [ 8.1 ].) When treating pregnant women with Fluvoxamine Maleate Tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Fluvoxamine Maleate Tablets in the third trimester.

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 Fluvoxamine Maleate Tablets. Similarly, at least 14 days should be allowed after stopping Fluvoxamine Maleate Tablets before starting an MAOI.

Discontinuation of Treatment with Fluvoxamine Maleate Tablets

Symptoms associated with discontinuation of other SSRIs or SNRIs have been reported. (See WARNINGS AND PRECAUTIONS [ 5.9 ].) 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.

DOSAGE FORMS AND STRENGTHS

Fluvoxamine Maleate Tablets, USP are available as:

Tablets 25 mg: oval, beige, biconvex film-coated tablets with “357” debossed on one side and plain on the other side

Tablets 50 mg: oval, yellow, biconvex film-coated tablets with “361” debossed on one side and scored on the other side

Tablets 100 mg: oval, red, biconvex film-coated tablets with “362” debossed on one side and scored on the other side

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Fluvoxamine maleate tablets, USP, 25 mg are oval, beige, biconvex film-coated tablets with “357” debossed on one side and plain on the other side are available as follows:


Bottles of 100               NDC 57664-357-88
Bottles of 500               NDC 57664-357-13
Bottles of 1000             NDC 57664-357-18

Fluvoxamine maleate tablets, USP, 50 mg are oval, yellow, biconvex film-coated tablets with “361” debossed on one side and scored on the other side are available as follows:


Bottles of 100               NDC 57664-361-88
Bottles of 500               NDC 57664-361-13
Bottles of 1000             NDC 57664-361-18

Fluvoxamine maleate tablets, USP, 100 mg are oval, red, biconvex film-coated tablets with “362” debossed on one side and scored on the other side are available as follows:


Bottles of 100                NDC 57664-362-88
Bottles of 500                NDC 57664-362-13
Bottles of 1000              NDC 57664-362-18

Storage

Keep out of reach of children.

Fluvoxamine Maleate Tablets, USP should be protected from high humidity and stored at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP. KEEP TIGHTLY CLOSED.

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