APO-FLUVOXAMINE

What it is

APO-FLUVOXAMINE is a selective serotonin reuptake inhibitor (SSRI), a class of antidepressant agents that is chemically unrelated to tricyclic antidepressants and other serotonin reuptake inhibitors as it is a monocyclic compound. Each tablet contains 50 mg or 100 mg of fluvoxamine maleate. The mechanism of action is related to its ability to selectively inhibit presynaptic reuptake of serotonin, thus increasing serotonin concentrations within the synaptic cleft, with minimal interference with noradrenergic and dopaminergic processes.

Approved indications

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

Dosing overview

Doses up to 150 mg can be given as a single dose, and total daily doses greater than 150 mg should be given in 2 or 3 divided doses. When stopping treatment, the dose should be gradually reduced over at least one or two weeks to reduce the risk of withdrawal reactions.

Key safety warnings

A major depressive episode may be the initial presentation of bipolar disorder, and treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed or manic episode in patients at risk. Prior to initiating treatment, patients should be adequately screened for bipolar disorder risk, including detailed psychiatric history and family history of suicide, bipolar disorder and depression. The risk of suicide attempt is inherent in depression and may persist until significant remission occurs. Patients may experience worsening of depressive symptoms and emergence of suicidal ideation and behaviour whether or not taking antidepressants. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at times of dose changes. Pooled analysis of 24 short-term placebo-controlled trials in 4400 children and adolescents revealed a greater risk of suicidality during the first few months of treatment, with an average risk of 4% in those receiving antidepressants compared with 2% on placebo. Fluvoxamine use has been associated with development of akathisia, most likely occurring within the first few weeks of treatment, and increasing the dose may be detrimental in patients who develop these symptoms. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with fluvoxamine, with patients at highest risk early in the course of therapy. If skin reactions occur, fluvoxamine should be discontinued immediately and the patient closely monitored. Serotonin syndrome or neuroleptic malignant syndrome-like events may occur with SSRIs, particularly when given with monoamine oxidase inhibitors or other serotonergic agents, characterised by neuromuscular excitation, altered mental status and autonomic dysfunction.

Contraindications

Fluvoxamine is contraindicated in combination with tizanidine and should not be used with monoamine oxidase inhibitors (MAOIs), reversible MAOIs (RIMAs), moclobemide or linezolid, or within 14 days of discontinuing treatment with a MAOI. Fluvoxamine should not be used in combination with pimozide, ramelteon or cisapride. APO-FLUVOXAMINE is contraindicated in patients with hypersensitivity to any component of the product. Fluvoxamine should not be used by nursing mothers.

PBS listing

Information on Pharmaceutical Benefits Scheme listing is not provided in the available source documents.

Regulatory history

APO-FLUVOXAMINE was first approved on 11 July 2002. ARTG registrations for APO-FLUVOXAMINE include the 50 mg tablet blister pack (ARTG 147380) and the 100 mg tablet blister pack (ARTG 147389), both first listed on 14 January 2009 under licence category RE.