LOXALATE

What it is

LOXALATE is escitalopram oxalate, available in tablets of 5 mg, 10 mg or 20 mg. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). It is a potent inhibitor of serotonin reuptake, with antidepressant action presumably linked to potentiation of serotonergic activity in the central nervous system resulting from its inhibitory effect on the reuptake of serotonin from the synaptic cleft.

Approved indications

— Treatment of major depression. — Treatment of social anxiety disorder (social phobia). — Treatment of generalised anxiety disorder. — Treatment of obsessive-compulsive disorder.

Dosing overview

For elderly patients aged over 65 years, 10 mg is the recommended maximum maintenance dose. For patients with reduced hepatic function, an initial dose of 5 mg daily for the first two weeks of treatment is recommended, with a possible increase to 10 mg depending on individual patient response.

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 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. Patients and caregivers should be alerted about the need to monitor for any worsening of their condition and seek medical advice immediately if suicidal ideation or thoughts of harming themselves are present. The use of SSRIs has been associated with the development of akathisia, characterised by a subjectively unpleasant restlessness and need to move often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. Bleeding abnormalities of the skin and mucous membranes have been reported with SSRIs. SSRIs may increase the risk of postpartum haemorrhage. Hyponatraemia has been reported as a rare adverse reaction with SSRIs, probably due to inappropriate antidiuretic hormone secretion. Caution should be exercised in elderly patients, patients with cirrhosis, or if used in combination with other medications which may cause hyponatraemia. Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt. The risk may depend on the duration and dose of therapy and the rate of dose reduction. Dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea and vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions.

Contraindications

LOXALATE is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. Escitalopram should not be used in combination with monoamine oxidase inhibitors or the reversible MAOI moclobemide, or within 14 days of discontinuing treatment with a MAOI, and at least one day after discontinuing moclobemide. Cases of serious reactions such as potentially life-threatening serotonin syndrome have been reported in patients receiving an SSRI in combination with a MAOI or moclobemide. Concomitant use in patients taking pimozide is contraindicated.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

LOXALATE escitalopram oxalate 5 mg, 10 mg and 20 mg tablets in blister packs were first listed on the ARTG on 22 May 2008. Bulk pack formulations of 10 mg and 20 mg tablets were first listed on 28 March 2018.