Rx Item-Fluvoxamine 100MG 30 Cap by Par Pharma USA

FLUVOXAMINE MALEATE- fluvoxamine maleate tablet
Apotex Corp

25mg-100btl.jpg50mg-100btl.jpg100mg-100btl.jpg
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 fluvoxamine maleate tablets 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. Fluvoxamine maleate tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) [see WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk (5.1)].

1 INDICATIONS AND USAGE

1.1 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 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults [ see CLINICAL STUDIES (14)].

2 DOSAGE AND ADMINISTRATION

2.1 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.

Rx Item-Fluvoxamine 100MG 30 Cap by Par
Item No. RX213074, 213074, NDC No.: 10370-0175-11, 10370-175-11, 1037017511, 10370017511, 0175-11, 017511 UPC No. 3-10370-17511-7, 310370-175117, 310370175117

Rx Item-Fluvoxamine 100MG 30 Cap by Par
Item No. RX213074, 213074, NDC No.: 10370-0175-11, 10370-175-11, 1037017511, 10370017511, 0175-11, 017511 UPC No. 3-10370-17511-7, 310370-175117, 310370175117

Rx Item-Fluvoxamine 100MG 30 Cap by Par
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica