Each coated tablet contains escitaloprame oxalate equivalent to 10 mg escitalopram.

For the full list of excipients, see section List of excipients.

Safety of daily doses above 20 mg has not been demonstrated.

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

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 daily. Treatment benefits and dose should be re-evaluated at regular intervals (see Section Pharmacodynamic properties).

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.

Treatment benefits and dose should be re-evaluated at regular intervals (see section Pharmacodynamic properties).

Elderly patients (> 65 years of age)

Initial dosage is 5 mg once daily. Depending on individual patient response the dose may be increased to 10 mg daily (see section Pharmacokinetic properties).

The efficacy of Escitalopram in social anxiety disorder has not been studied in elderly patients.

Children and adolescents (<18 years)

Escitalopram should not be used in the treatment of children and adolescents under the age of 18 years (see section Special warnings and precautions for use).

Reduced renal function

Dosage adjustment is not necessary in patients with mild or moderate renal impairment. Caution is advised in patients with severely reduced renal function (CLCR less than 30 ml/min.) (see section Pharmacokinetic properties).

Reduced hepatic function

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. Caution and extra careful dose titration is advised in patients with severely reduced hepatic function (see section Pharmacokinetic properties).

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. Depending on individual patient response, the dose may be increased to 10 mg daily (see section Pharmacokinetic properties).

Discontinuation symptoms seen when stopping treatment

Abrupt discontinuation should be avoided. When stopping treatment with escitalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of discontinuation symptoms (see sections Special warnings and precautions for use and Undesirable effects). 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.

Pharmacotherapeutic group: antidepressants, selective serotonin reuptake inhibitors

ATC code: N06AB10

List of excipients

Tablet core:

Microcrystalline cellulose,

Lactose monohydrate

Povidone K30

Corn starch

Magnesium stearate

Sodium starch glycolate

Coating:

Titanium dioxide

Hypromellose

Talc purified

Propylene glycol

Color red (E124)

For more detailed information about the drug, click: http://pharm.cals.am/pharm/data/drug_134482/1734095746965.pdf