LUVOX

What it is

Fluvoxamine is a member of a class of antidepressant agents known as selective serotonin reuptake inhibitors (SSRI). It is chemically unrelated to the tricyclic antidepressants, and to other serotonin reuptake inhibitors as it is a monocyclic compound. The mechanism of action of fluvoxamine is believed to be related to its ability to selectively inhibit presynaptic reuptake of serotonin, and thus increase the serotonin concentrations within the synaptic cleft, accompanied by minimal interference with the noradrenergic and dopaminergic processes. LUVOX is available as 50 mg or 100 mg tablets.

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

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 their depressive symptoms and/or the emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of a course of treatment, or at the time of dose changes. Pooled analyses of 24 short-term placebo-controlled trials of nine antidepressant medicines in 4400 children and adolescents have revealed a greater risk of adverse events representing suicidal behaviour or thinking during the first few months of treatment, with an average risk of 4% in patients treated with an antidepressant compared with 2% of patients given placebo. The use of fluvoxamine has been associated with the development of akathisia, most likely to occur within the first few weeks of treatment, and increasing the dose may be detrimental. Serious skin reactions, some of them fatal, including Stevens–Johnson syndrome and toxic epidermal necrolysis, have been reported in association with fluvoxamine. Patients appear to be at highest risk of these reactions early in the course of therapy. If skin reactions occur, fluvoxamine should be discontinued immediately. Development of serotonin syndrome may occur in association with treatment with SSRIs, particularly when given in combination with MAOIs or other serotonergic and/or neuroleptic agents or in combination with opiate/opioid drugs. Symptoms and signs of serotonin syndrome include rapid onset of neuromuscular excitation, altered mental status and autonomic dysfunction.

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. LUVOX tablets are contraindicated in patients with hypersensitivity to any component of the product. Fluvoxamine should not be used by nursing mothers.

PBS listing

LUVOX fluvoxamine maleate 50 mg tablets are listed on the PBS (2 items) with restricted access at an ex-manufacturer price of A$8.52. LUVOX fluvoxamine maleate 100 mg tablets are listed on the PBS (2 items) with restricted access at an ex-manufacturer price of A$11.23.

Regulatory history

LUVOX fluvoxamine maleate 50 mg and 100 mg tablets were first registered on the ARTG on 1 April 1997.