ESCITALOPRAM

Posology Safety of daily doses above 20 mg has not been demonstrated. Major depressive episodes Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily. Usually 2-4 weeks are necessary to obtain antidepressant response.

After the symptoms resolve, treatment for at least 6 months is required for consolidation of the response. Panic disorder with or without agoraphobia An initial dose of 5 mg is recommended for the first week before increasing the dose to 10 mg daily.

The dose may be further increased, up to a maximum of 20 mg daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. Social anxiety disorder Usual dosage is 10 mg once daily.

Usually 2-4 weeks are necessary to obtain symptom relief. The dose may subsequently, depending on individual patient response, be decreased to 5 mg or increased to a maximum of 20 mg daily. Social anxiety disorder is a disease with a chronic course, and treatment for 12 weeks is recommended to consolidate response.

Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse; treatment benefits should be re-evaluated at regular intervals. Social anxiety disorder is a well-defined diagnostic terminology of a specific disorder, which should not be confounded with excessive shyness.

Pharmacotherapy is only indicated if the disorder interferes significantly with professional and social activities. The place of this treatment compared to cognitive behavioural therapy has not been assessed. Pharmacotherapy is part of an overall therapeutic strategy.

Generalised anxiety disorder Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. Long-term treatment of responders has been studied for at least 6 months in patients receiving 20 mg/day.

1). Obsessive-compulsive disorder Initial dosage is 10 mg once daily. Depending on the individual patient response, the dose may be increased to a maximum of 20 mg daily. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free.

1). Elderly (>65 years of age) Initial dosage is 5 mg once daily. 2). The efficacy of escitalopram in social anxiety disorder has not been studied in elderly patients. 4). Renal impairment Dosage adjustment is not necessary in patients with mild or moderate renal impairment.

2). Hepatic impairment An initial dose of 5 mg daily for the first two weeks of treatment is recommended in patients with mild or moderate hepatic impairment. Depending on individual patient response, the dose may be increased to 10 mg daily.

2). Poor metabolisers of CYP2C19 For patients who are known to be poor metabolisers with respect to CYP2C19, an initial dose of 5 mg daily during the first two weeks of treatment is recommended. 2). Discontinuation symptoms seen when stopping treatment Abrupt discontinuation should be avoided.

8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Method of administration Escitalopram is administered as a single daily dose and may be taken with or without food.

Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment. Tabulated list of adverse reactions Adverse reactions known for SSRIs and also reported for escitalopram in either placebo-controlled clinical studies or as spontaneous post-marketing events are listed below by system organ class and frequency.

Frequencies are taken from clinical studies; they are not placebo-corrected.

Frequencies are defined as:

Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), or not known (cannot be estimated from the available data). System organ class Frequency Undesirable Effect Blood and lymphatic system disorders Not known Thrombocytopenia Immune system disorders Rare Anaphylactic reaction Endocrine disorders Not known Inappropriate ADH secretion, hyperprolactinaemia Common Decreased appetite, increased appetite, weight increased Uncommon Weight decreased Metabolism and nutrition disorders Not known Hyponatraemia, anorexia1 Common Anxiety, restlessness, abnormal dreams, libido decreased Female: anorgasmia Uncommon Bruxism, agitation, nervousness, panic attack, confusional state Rare Aggression, depersonalisation, hallucination Psychiatric disorders Not known Mania, suicidal ideation, suicidal behaviour2 Very common Headache Common Insomnia, somnolence, dizziness, paraesthesia, tremor Uncommon Taste disturbance, sleep disorder, syncope Rare Serotonin syndrome Nervous system disorders Not known Dyskinesia, movement disorder, convulsion, psychomotor restlessness/akathisia1 Eye disorders Uncommon Mydriasis, visual disturbance Ear and labyrinth disorders Uncommon Tinnitus Uncommon Tachycardia Rare Bradycardia Cardiac disorders Not known Electrocardiogram QT prolonged, ventricular arrhythmia including torsade de pointes Vascular disorders Not known Orthostatic hypotension Common Sinusitis, yawningRespiratory, thoracic and mediastinal disorders Uncommon Epistaxis Very common Nausea Common Diarrhoea, constipation, vomiting, dry mouth Gastrointestinal disorders Uncommon Gastrointestinal haemorrhages (including rectal haemorrhage) Hepatobiliary disorders Not known Hepatitis, liver function test abnormal Common Sweating increased Uncommon Urticaria, alopecia, rash, pruritus Skin and subcutaneous tissue disorders Not known Ecchymosis, angioedemas Musculoskeletal and connective tissue disorders Common Arthralgia, myalgia Renal and urinary disorders Not known Urinary retention Common Male: ejaculation disorder, impotence Uncommon Female: metrorrhagia, menorrhagia Reproductive system and breast disorders Not known Galactorrhoea, postpartum haemorrhage3 Male: priapism Common Fatigue, pyrexiaGeneral disorders and administration site conditions Uncommon Oedema 1 These events have been reported for the therapeutic class of SSRIs.

4). 6). 1). Class effects Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. The mechanism leading to this risk is unknown. Discontinuation symptoms seen when stopping treatment Discontinuation of SSRIs/SNRIs (particularly when abrupt) commonly leads to discontinuation symptoms.

Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), 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 events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The following special warnings and precautions apply to the therapeutic class of SSRIs (Selective Serotonin Re-uptake Inhibitors). Paediatric population Escitalopram should not be used in the treatment of paediatric population. Suicide related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among the paediatric population treated with antidepressants compared to those treated with placebo.

If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in the paediatric population concerning growth, maturation and cognitive and behavioural development are lacking.

Paradoxical anxiety Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants. This paradoxical reaction usually subsides within two weeks during continued treatment.

2). Seizures Escitalopram should be discontinued if a patient develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy). SSRIs should be avoided in patients with unstable epilepsy, and patients with controlled epilepsy should be closely monitored.

Mania 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. Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control (hypoglycaemia or hyperglycaemia).

Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs.

As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.

Other psychiatric conditions for which Escitalopram is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.

Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.

A meta-analysis of placebo controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Akathisia/psychomotor restlessness The use of SSRIs/SNRIs 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. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy.

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. Haemorrhage There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura, with SSRIs.

8). g. atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and non-steroidal anti- inflammatory medicinal products (NSAIDs), ticlopidine and dipyridamole) and in patients with known bleeding tendencies.

ECT (electroconvulsive therapy) There is limited clinical experience of concurrent administration of SSRIs and ECT, therefore caution is advisable. Serotonin syndrome Caution is advisable if escitalopram is used concomitantly with medicinal products with serotonergic effects such as triptans (including sumatriptan), opioids (including tramadol), and tryptophan.

In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia may indicate the development of this condition.

If this occurs treatment with the SSRI and the serotonergic medicinal product should be discontinued immediately and symptomatic treatment initiated. St. John´s Wort Concomitant use of SSRIs and herbal remedies containing St. 5). Discontinuation symptoms seen when […]

1. Concomitant treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO-inhibitors) is contraindicated due to the risk of serotonin syndrome with agitation, tremor, hyperthermia etc. 5). g. 5). Escitalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome.

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