LEXAM

What it is

LEXAM contains escitalopram oxalate, available in 5 mg, 10 mg or 20 mg tablets. Escitalopram is a highly selective Serotonin Reuptake Inhibitor (SSRI). Escitalopram is a potent inhibitor of serotonin 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 serotonin 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, with a possible increase to 10 mg depending on individual response. Significant discontinuation symptoms may occur with abrupt discontinuation; tapered discontinuation over 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 depressive symptoms and/or emergence of suicidal ideation and behaviours whether or not they are taking antidepressant medications. Patients should be closely monitored for clinical worsening and suicidality, especially at the beginning of treatment or at the time of dose changes. The use of SSRIs has been associated with the development of akathisia, characterised by subjectively unpleasant or distressing restlessness and need to move, 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 SSRIs. LEXAM should be used with caution in patients concomitantly treated with oral anticoagulants, medicines affecting platelet function, or those with a history of abnormal bleeding. Pharmacological gastroprotection should be considered for high risk patients. Hyponatraemia has been reported as a rare adverse reaction with SSRIs, probably due to inappropriate antidiuretic hormone secretion. Caution should be exercised in patients at risk, such as the elderly, or those with cirrhosis, or if used with other medicines 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. Antidepressants including escitalopram may have an effect on pupil size resulting in mydriasis, which has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in pre-disposed patients. Escitalopram should be used with caution in patients with raised intraocular pressure and in those at risk of angle-closure glaucoma.

Contraindications

LEXAM is contraindicated in patients with hypersensitivity to citalopram, escitalopram or any excipients. LEXAM 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. Concomitant use in patients taking pimozide is contraindicated.

PBS listing

The documents provided do not contain information about PBS listing status, item numbers, restriction types, or ex-manufacturer pricing for LEXAM.

Regulatory history

LEXAM 10 mg and LEXAM 20 mg were first listed on the ARTG on 21 August 2020 as medicines sponsored by Arrotex Pharmaceuticals.