Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM
H. Lundbeck A/S
10
Oral Drops Solution
2005-09-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lexapro 10mg/ml oral drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains: 10 mg escitalopram (as 12.78 mg escitalopram oxalate). Each drop contains 0.5 mg escitalopram. 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 (40 drops) has not been demonstrated. Lexapro is administered as a single daily dose and may be taken with or without food. A bottle with dropper applicator or an oral syringe may be used for administration. The oral syringe bears a graduation in mg referring to the escitalopram dose. Lexapro oral drops, solution can be mixed with water, orange juice or apple juice. Major depressive episodes Usual dosage is 10 mg (20 drops) once daily. Depending on individual patient response, the dose may be increased to a maximum of 20 mg (40 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 (10 drops) is recommended for the first week before increasing the dose to 10 mg (20 drops) daily. The dose may be further increased, up to a maximum of 20 mg (40 drops) daily, dependent on individual patient res Prečítajte si celý dokument