LEXAPRO

What it is

LEXAPRO contains escitalopram oxalate and is available as film-coated tablets of 10 mg and 20 mg, and as an oral solution of 20 mg/mL.

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 major depression, the recommended dose is 10 mg once daily, with a maximum of 20 mg daily depending on individual patient response. For social anxiety disorder, the recommended dose is 10 mg once daily, with a possible increase to a maximum of 20 mg daily. For generalised anxiety disorder, the recommended starting dose is 10 mg once daily, with a maximum of 20 mg daily depending on individual patient response. For obsessive-compulsive disorder, the recommended starting dose is 10 mg once daily, with a possible increase to 20 mg daily. For elderly patients aged over 65 years, 10 mg is the recommended maximum maintenance dose. Patients with reduced hepatic function should receive an initial dose of 5 mg daily for the first two weeks, with possible increase to 10 mg depending on individual response.

Key safety warnings

The risk of suicide attempt is inherent in depression. Patients with depression may experience worsening of depressive symptoms or emergence of suicidal ideation whether or not taking antidepressants, 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 times of dose changes. Patients and caregivers should be alerted to monitor for any worsening of condition and emergence of suicidal ideation or thoughts of self-harm and to seek medical advice immediately if these symptoms are present. Use of LEXAPRO has been associated with 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, and SSRIs may increase the risk of postpartum haemorrhage. LEXAPRO should be used with caution in patients taking oral anticoagulants or medicines affecting platelet function, and in patients with a history of abnormal bleeding. 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. Discontinuation symptoms when stopping treatment are common, particularly if discontinuation is abrupt. The risk may depend on duration and dose of therapy and rate of dose reduction. Dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability and visual disturbances are commonly reported. Generally these symptoms are mild to moderate, however in some patients they may be severe.

Contraindications

LEXAPRO is contraindicated in patients with hypersensitivity to citalopram, escitalopram and any excipients. LEXAPRO should not be used in combination with monoamine oxidase inhibitors or moclobemide, or within 14 days of discontinuing a MAOI, and at least one day after discontinuing moclobemide. At least 14 days should be allowed after stopping escitalopram before starting a MAOI or reversible MAOI. Concomitant use in patients taking pimozide is contraindicated.

PBS listing

No information regarding PBS listing is available in the provided sources.

Regulatory history

LEXAPRO 10 mg tablets were first listed on the ARTG on 16 September 2003 (ARTG 92051), and 20 mg tablets were listed on the same date (ARTG 92053). The 20 mg/mL oral solution was first listed on 27 March 2014 (ARTG 209721).