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Lexapro

Escitalopram (as oxalate)

 

1. NAME OF THE MEDICINAL PRODUCT

LEXAPRO 5 mg film-coated tablets

LEXAPRO 10 mg film-coated tablets

LEXAPRO 15 mg film-coated tablets

LEXAPRO 20 mg film-coated tablets

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Lexapro 5 mg : Each tablet contains 5 mg escitalopram (as 6.39 mg escitalopram oxalate)

Lexapro 10 mg : Each tablet contains 10 mg escitalopram (as 12.77 mg escitalopram oxalate)

Lexapro 15 mg : Each tablet contains 15 mg escitalopram (as 19.16 mg escitalopram oxalate)

Lexapro 20 mg : Each tablet contains 20 mg escitalopram (as 25.54 mg escitalopram oxalate)

For a full list of excipients, see section 6.1.

 

3. PHARMACEUTICAL FORM

Lexapro 5 mg : Round, white, film-coated tablet marked with "EK" on one side.

Lexapro 10 mg : Oval, white, scored, film-coated tablet marked with "E" and "L" on each side of the score on one side of the tablet.

Lexapro 15 mg : Oval, white, scored, film-coated tablet marked with "E" and "M" on each side of the score on one side of the tablet.

Lexapro 20 mg : Oval, white, scored, film-coated tablet marked with "E" ad "N" on each side of the score on one side of the tablet.

The 10, 15 and 20 mg tablets can be divided into equal halves

 

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of major depressive episodes.

Treatment of panic disorder with or without agoraphobia.

Treatment of social anxiety disorder (social phobia).

Treatment of generalised anxiety disorder.

Treatment of obsessive-compulsive disorder.

 

4.2 Posology and method of administration

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

Lexapro 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 to10 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. 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 symptom relief. Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals.

 

Generalised anxiety disorder

Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.

 

Treatment for 3 months is recommended to consolidate response. Long-term treatment of responders for 6 months has been shown to prevent relapse and can be considered on an individual basis; treatment benefits should be re-evaluated at regular intervals.

 

Obsessive-compulsive disorder (OCD)

Usual dosage is 10 mg once daily. Depending on individual patient response, the dose may be increased to 20 mg daily.

 

Long-term treatment of patients responding to a 16-week open treatment phase has been studied for at least 24 weeks in patients receiving 10 or 20 mg/ day. As OCD is a chronic disease, patients should be treated for a sufficient period to ensure that they are symptom free. This period may be several months or even longer.

 

Elderly patients ( >65 years of age )

Initial treatment with half the usually recommended dose and a lower maximum dose should be considered (see section 5.2).

 

Children and adolescents ( <18 years )

Lexapro should not be used in the treatment of children and adolescents under the age of 18 years. (see section 4.4).

 

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 5.2).

 

Reduced hepatic function

An initial dose of 5 mg daily for the first two weeks of treatment is recommended. Depending on individual patient response, the dose may be increased to 10 mg daily (see section 5.2).

 

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. Depending on individual patient response, the dose may be increased to1 0 mg daily (see section 5.2).

 

Discontinuation symptoms

When stopping treatment with Lexapro the dose should be gradually reduced over a period of at least one to two weeks in order to avoid possible discontinuations symptoms ( see section 4.4 and 4.8).

 

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