ESCITALOPRAM GH

What it is

Escitalopram GH contains escitalopram oxalate as the active ingredient, available in tablets of 5 mg, 10 mg or 20 mg strength. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). It is a potent inhibitor of serotonin (5-HT) uptake, with antidepressant action 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. Escitalopram is the S-enantiomer of the racemate (citalopram) and is the enantiomer to which the therapeutic activity is attributed.

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 of treatment is recommended, with dose increase to 10 mg depending on individual patient response.

Key safety warnings

The risk of suicide attempt is inherent in depression. 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 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. Bleeding abnormalities of the skin and mucous membranes have been reported with the use of SSRIs. Escitalopram GH should be used with caution in patients concomitantly treated with oral anticoagulants, medicinal products known to affect platelet function (such as atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti-inflammatory medicinal products, ticlopidine and dipyridamole) as well as in patients with a past history of abnormal bleeding or those with predisposing conditions. Hyponatraemia has been reported as a rare adverse reaction with the use of SSRIs, probably due to inappropriate antidiuretic hormone secretion. 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. Significant numbers of discontinuation symptoms may occur with abrupt discontinuation of escitalopram. To minimise discontinuation reactions, tapered discontinuation over a period of at least one to two weeks is recommended.

Contraindications

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

Regulatory history

Escitalopram GH 10 mg and 20 mg tablets were first listed on the ARTG on 23 February 2018.