FAVERIN

What it is

FAVERIN contains fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) . It is chemically unrelated to tricyclic antidepressants and other serotonin reuptake inhibitors as it is a monocyclic compound . FAVERIN is available in 50 mg and 100 mg tablet strengths .

Approved indications

— Treatment of major depression in adults . — Treatment of Obsessive Compulsive Disorder (OCD) in children aged 8 years of age and older, adolescents, and adults .

Dosing overview

For depression, the recommended starting dose is 50 mg per day for one week, given as a single dose in the evening, with doses gradually increased by 50 mg per week until an effective dose is reached, with a maximum of 300 mg per day (usually effective dose is 100 mg/day) . Doses up to 150 mg can be given as a single dose; doses greater than 150 mg should be given in 2 or 3 divided doses . For Obsessive Compulsive Disorder in adults, the recommended starting dose is 50 mg per day for 3 to 4 days, with dosage increased gradually by 50 mg every 4 to 6 days until an effective dose is achieved, with a maximum of 300 mg per day . The usually effective dose is in the range of 100–300 mg/day . For children and adolescents aged 8–17 years with OCD, the recommended starting dose is 25 mg at bedtime, increased in 25 mg increments every 4 to 7 days as tolerated, with a maximum dose not exceeding 200 mg/day .

Key safety warnings

The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients with depression may experience worsening of depressive symptoms and/or emergence of suicidal ideation and behaviours whether or not taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at dose changes . Pooled analyses of placebo-controlled trials in children and adolescents revealed a greater risk of suicidal behaviour or thinking during the first few months of treatment in those receiving antidepressants, with an average risk of 4% compared with 2% for placebo . Fluvoxamine has been associated with development of akathisia, most likely within the first few weeks of treatment, and increasing the dose may be detrimental in patients who develop these symptoms . Serious skin reactions, some of them fatal, including Stevens–Johnson syndrome and toxic epidermal necrolysis, have been reported. Patients appear to be at highest risk early in the course of therapy. If skin reactions occur, fluvoxamine should be discontinued immediately . Abrupt discontinuation should be avoided. When stopping treatment, the dose should be gradually reduced over at least one or two weeks to reduce the risk of withdrawal reactions .

Contraindications

Fluvoxamine is contraindicated in combination with tizanidine . Fluvoxamine should not be used in combination with monoamine oxidase inhibitors (MAOIs) or reversible MAOIs (RIMAs), moclobemide or linezolid, or within 14 days of discontinuing treatment with a MAOI . Fluvoxamine immediate-release tablets should not be used in combination with pimozide and ramelteon . Fluvoxamine is contraindicated in combination with cisapride . Fluvoxamine should not be used by nursing mothers .

Regulatory history

FAVERIN 100 mg tablets were first listed on the Australian Register of Therapeutic Goods on 27 May 1998 . FAVERIN 50 mg tablets were first listed on 12 July 2002 .