ESCITALOPRAM-WGR

What it is

ESCITALOPRAM-WGR contains escitalopram oxalate as the active ingredient, available in 5 mg, 10 mg and 20 mg tablet strengths. The 5 mg tablets are white to off-white circular film-coated tablets, whilst the 10 mg and 20 mg tablets are white to off-white oval film-coated tablets. Escitalopram is a highly selective serotonin reuptake inhibitor (SSRI). It is a potent inhibitor of serotonin reuptake, 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.

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

In elderly patients aged over 65 years, 10 mg is the recommended maximum maintenance dose. In 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 patient response. For patients who are known 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 patient response. Significant numbers of discontinuation symptoms may occur with abrupt discontinuation; tapered discontinuation over 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 this risk may persist until significant remission occurs. 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/behaviour 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 often accompanied by an inability to sit or stand still, most likely occurring within the first few weeks of treatment. Bleeding abnormalities of the skin and mucous membranes have been reported with the use of SSRIs. ESCITALOPRAM-WGR should therefore be used with caution in patients concomitantly treated with oral anticoagulants, medicinal products known to affect platelet function such as atypical antipsychotics, 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, probably due to inappropriate antidiuretic hormone secretion, has been reported as a rare adverse reaction with the use of 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. The drug should be discontinued in any patient who develops seizures. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed that treating such an episode with an antidepressant alone can increase the likelihood of precipitation of a mixed/manic episode in patients at risk of bipolar disorder. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI. Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt. The risk of discontinuation symptoms 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/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally these symptoms are mild to moderate, however, in some patients they may be severe in intensity.

Contraindications

Hypersensitivity to citalopram, escitalopram and any excipients in ESCITALOPRAM-WGR. ESCITALOPRAM-WGR 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 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.

Regulatory history

ESCITALOPRAM-WGR was registered on the Australian Register of Therapeutic Goods (ARTG) with three strengths first listed on 25 September 2012: ARTG 191870 (20 mg tablets), ARTG 191845 (10 mg tablets), and ARTG 191879 (5 mg tablets).