APX-ESCITALOPRAM

What it is

APX-ESCITALOPRAM contains escitalopram oxalate as the active ingredient, supplied in tablets of 5 mg, 10 mg or 20 mg strength. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). The antidepressant action of escitalopram is presumably linked to the potentiation of serotonergic activity in the central nervous system resulting from its inhibitory effect on the reuptake of 5-HT 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

APX-ESCITALOPRAM tablets are intended for oral administration as a single oral dose and may be taken with or without food. For elderly patients over 65 years of age, 10 mg is the recommended maximum maintenance dose. For patients with hepatic impairment, an initial dose of 5 mg daily for the first two weeks of treatment is recommended, which may be increased to 10 mg depending on individual patient response. Significant numbers of discontinuation symptoms may occur with abrupt discontinuation of escitalopram, and tapered discontinuation over a period of at least one to two weeks is recommended to minimise discontinuation reactions.

Key safety warnings

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, and 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. Patients and caregivers should be alerted about the need to monitor for any worsening of their condition and/or the emergence of suicidal ideation or thoughts of harming themselves and to seek medical advice immediately if these symptoms are present. The use of SSRIs has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, most likely to occur within the first few weeks of treatment. Bleeding abnormalities of the skin and mucous membranes have been reported with the use of SSRIs, and APX-ESCITALOPRAM should be used with caution in patients concomitantly treated with oral anticoagulants or medicinal products known to affect platelet function. Hyponatraemia has been reported as a rare adverse reaction with the use of SSRIs, probably due to inappropriate antidiuretic hormone secretion, and caution should be exercised in elderly patients or those with cirrhosis. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored, with discontinuation if there is an increase in seizure frequency. A major depressive episode may be the initial presentation of bipolar disorder, and treating such an episode with an antidepressant alone can increase the likelihood of precipitation of a mixed or manic episode in patients at risk of bipolar disorder. Antidepressants including APX-ESCITALOPRAM may have an effect on pupil size resulting in mydriasis, which has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, and APX-ESCITALOPRAM should be used with caution in patients at risk. Discontinuation symptoms commonly reported when stopping treatment include dizziness, sensory disturbances, sleep disturbances, agitation, nausea, tremor, confusion, sweating, headache, diarrhoea and visual disturbances; these are generally mild to moderate and self-limiting, usually resolving within 2 weeks, though in some individuals they may be prolonged.

Contraindications

APX-ESCITALOPRAM is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. APX-ESCITALOPRAM should not be used in combination with monoamine oxidase inhibitors (MAOI) or reversible MAOI (RIMA) moclobemide, or within 14 days of discontinuing treatment with a MAOI, and at least one day after discontinuing treatment with moclobemide; similarly, at least 14 days should be allowed after stopping escitalopram before starting a MAOI or RIMA. Concomitant use in patients taking pimozide is contraindicated.

PBS listing

No information is available in the source documents regarding PBS listing status or pricing for APX-ESCITALOPRAM.

Regulatory history

APX-ESCITALOPRAM 10 mg and 20 mg film-coated tablets were first listed on the ARTG (Australian Register of Therapeutic Goods) on 21 August 2020.