APO-ESCITALOPRAM

What it is

APO-ESCITALOPRAM contains escitalopram oxalate in strengths of 5 mg, 10 mg or 20 mg. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). Escitalopram is a potent inhibitor of serotonin (5-HT)-uptake, with the antidepressant action presumably linked to the potentiation of serotonergic activity in the central nervous system (CNS) 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 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 is recommended, which may be increased to 10 mg depending on individual patient response. For patients who are known poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks is recommended, which may be increased to 10 mg depending on individual patient response. 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/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 with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. 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. In patients who develop these symptoms, increasing the dose may be detrimental. Bleeding abnormalities of the skin and mucous membranes have been reported with the use of SSRIs. APO-ESCITALOPRAM should be used with caution in patients concomitantly treated with oral anticoagulants, medicinal products known to affect platelet function, 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 (SIADH). 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. SSRIs should be discontinued if there is an increase in seizure frequency. 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. SSRIs should be used with caution in patients with a history of mania/hypomania. SSRIs should be discontinued in any patient entering a manic phase. Antidepressants including APO-ESCITALOPRAM may have an effect on pupil size resulting in mydriasis. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in pre-disposed patients. APO-ESCITALOPRAM should therefore be used with caution in patients with raised intraocular pressure and in those at risk of angle-closure glaucoma. 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/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. They usually occur within the first few days of discontinuing treatment, but generally these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged.

Contraindications

APO-ESCITALOPRAM is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. APO-ESCITALOPRAM 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 (RIMA), moclobemide. At least 14 days should be allowed after stopping escitalopram before starting a MAOI or RIMA. Cases of serious reactions, such as potentially life-threatening serotonin syndrome, have been reported in patients receiving an SSRI in combination with a MAOI or RIMA, and in patients who have recently discontinued an SSRI and have been started on a MAOI. Concomitant use in patients taking pimozide is contraindicated.

Regulatory history

APO-ESCITALOPRAM was first registered on the ARTG on 24 July 2008, with registrations for 5 mg, 15 mg and 20 mg tablets in both bottle pack and blister pack formats. Additional registrations for 10 mg and 20 mg tablets as escitalopram oxalate in blister packs were added on 6 November 2013.