RX ITEM-Luvox CR 100Mg Cap 30 By Jazz Pharma

LUVOX CR- fluvoxamine maleate capsule, extended release
Jazz Pharmaceuticals, Inc.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of LUVOX CR (fluvoxamine maleate) Extended-Release Capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. (See WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [5.1] and USE IN SPECIFIC POPULATIONS-Pediatric Use [8.4].)

1 INDICATIONS AND USAGE

1.1 Obsessive Compulsive Disorder


LUVOX CR 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 LUVOX CR Capsules was demonstrated in one 12-week trial in adults with LUVOX CR Capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8-17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES [14.1, 14.3]).

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 Capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION [2.4]).

2 DOSAGE AND ADMINISTRATION

2.1 OCD (Obsessive Compulsive Disorder)
The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day.

Capsules should not be crushed or chewed.

2.2 Pediatric Patients Na�ve to Fluvoxamine Maleate
Physicians should consider that the lowest available dose of LUVOX CR Capsules may not be appropriate for pediatric patients na�ve to fluvoxamine maleate.

2.3 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 titrate slowly following the initial dose of 100 mg in these patient groups.

RX ITEM-Luvox CR 100Mg Cap 30 By Jazz Ph
NDC 68727-0600-01 UPC/GTIN No.3-68727-60001-2 Mfg.Part No.60001

Luvox CR 100Mg Cap 30 By Jazz Pharma
BRAND: LUVOX NDC: 68727-0600-01,68727060001 UPC: 3-68727-60001-2,368727600012 Jazz Pharma

FLUVOXAMINE MALEATE ORAL
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