ESCICOR

What it is

Escicor contains escitalopram oxalate, the S-enantiomer of citalopram. Escicor 10 and 20 are white to off-white, oval, biconvex, film-coated tablets. Escitalopram is a potent inhibitor of serotonin reuptake, and its antidepressant action is linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of serotonin reuptake from the synaptic cleft. It is a highly selective serotonin reuptake inhibitor (SSRI).

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

Escitalopram is administered as a single oral dose and may be taken with or without food. The recommended maximum maintenance dose in elderly patients over 65 years of age is 10 mg. For patients with reduced hepatic function, an initial dose of 5 mg daily for the first two weeks is recommended, with possible increase to 10 mg depending on response. 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.

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. 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 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. Bleeding abnormalities of the skin and mucous membranes have been reported with the use of SSRIs. Escicor should therefore be used with caution in patients concomitantly treated with oral anticoagulants or medicines known to affect platelet function, as well as in patients with a past history of abnormal bleeding. Hyponatraemia has been reported as a rare adverse reaction with the use of SSRIs, probably due to inappropriate antidiuretic hormone secretion. Especially elderly patients seem to be a risk group. 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. SSRIs should be discontinued if there is an increase in seizure frequency.

Contraindications

Escicor is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. 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. 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 pharmaceutical benefits scheme listing information was available in the source documents.

Regulatory history

Escicor 10 and 20 were first listed on the Australian Register of Therapeutic Goods on 16 February 2011.