ARTG Entry

MOVOX

ARTG entry for MOVOX (fluvoxamine maleate), ARTG 90058 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

MOVOX contains fluvoxamine, 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. MOVOX is available as a 50 mg and 100 mg tablet.

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 treatment or at the time of dose changes. A major depressive episode may be the initial presentation of bipolar disorder. Treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk of bipolar disorder. Patients should be adequately screened prior to initiating treatment with an antidepressant. Use of MOVOX has been associated with the development of akathisia, which is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, 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 MOVOX. Patients appear to be at highest risk of these reactions early in the course of therapy. If skin reactions occur, MOVOX should be discontinued immediately. Although MOVOX has no pro-convulsive properties in animal studies, caution is recommended when administered to patients with a history of convulsive disorders. MOVOX should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Treatment should be discontinued if seizures occur or if seizure frequency increases.

Contraindications

MOVOX is contraindicated in combination with tizanidine. MOVOX 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. At least one week should be allowed after stopping MOVOX before starting a MAOI. MOVOX should not be used in combination with pimozide and ramelteon. MOVOX is contraindicated in combination with cisapride. MOVOX is contraindicated in patients with hypersensitivity to any component of the product. MOVOX should not be used by nursing mothers.

Regulatory history

MOVOX 50 mg and 100 mg tablet formulations were first listed on the Australian Register of Therapeutic Goods on 29 July 2002.

TGA Public Summary — ARTG 90058