Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM
H. Lundbeck A/S
20
Oral Drops Solution
2007-09-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro 20 mg/ml oral drops, solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: 20 mg escitalopram (as 25.551 mg escitalopram oxalate). Each drop contains 1 mg escitalopram. Excipients: each drop contains 4.7 mg ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution Clear, nearly colourless to yellowish solution with a bitter taste. 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 (20 drops) has not been demonstrated. Lexapro is administered as a single daily dose and may be taken with or without food. Lexapro oral drops, solution can be mixed with water, orange juice or apple juice. Major depressive episodes Usual dosage is 10 mg (10 drops) once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg (20 drops) 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 (5 drops) is recommended for the first week before increasing the dose to 10 mg (10 drops) daily. The dose may be further increased, up to a maximum of 20 mg (20 drops) daily, dependent on individual patient response. Maximum effectiveness is reached after about 3 months. The treatment lasts several months. IRISH MEDICINES BOARD __ Read the complete document