Escitalopram-TIH

What it is

Escitalopram-TIH contains escitalopram oxalate as the active ingredient, available in 5 mg, 10 mg and 20 mg tablet strengths. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). Escitalopram is a potent inhibitor of serotonin (5-HT) uptake, and its antidepressant action 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

For elderly patients over 65 years of age, 10 mg is the recommended maximum maintenance dose. In patients with hepatic impairment, an initial dose of 5 mg daily for the first two weeks is recommended, with potential increase to 10 mg depending on individual response. For patients who are known to be poor metabolisers of CYP2C19, an initial dose of 5 mg daily during the first two weeks is recommended, with potential increase to 10 mg depending on individual 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/or the emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. As improvement may not occur during the first few weeks or more of treatment, 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/or the emergence of suicidal ideation or behaviour 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, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment, and increasing the dose may be detrimental in patients who develop these symptoms. Bleeding abnormalities of the skin and mucous membranes have been reported with SSRIs. Escitalopram-TIH should therefore be used with caution in patients concomitantly treated with oral anticoagulants and medicines known to affect platelet function, as well as in patients with a past history of abnormal bleeding or those with predisposing conditions. Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion, has been reported as a rare adverse reaction with SSRIs. Caution should be exercised in patients at risk, such as the elderly, or 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 be dependent on several factors including 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

Escitalopram-TIH is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. Escitalopram-TIH should not be used in combination with monoamine oxidase inhibitors (MAOI) or the reversible MAOI moclobemide, or within 14 days of discontinuing treatment with a MAOI, and at least one day after discontinuing treatment with moclobemide. 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

Information regarding PBS listing for Escitalopram-TIH is not available in the provided source documents.

Regulatory history

Escitalopram-TIH was first registered on the ARTG on 5 July 2013 in two strengths: 10 mg and 20 mg tablet blister packs.