Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESCITALOPRAM OXALATE
Ranbaxy Ireland Limited
20 Milligram
Film Coated Tablet
2010-09-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Escitalopram 20mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of escitalopram equivalent to 25.54 mg of escitalopram oxalate. Each tablet contains 100.00 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Escitalopram Ranbaxy 20 mg: White to off-white, oval biconvex film-coated tablets, debossed with "E” and “9" on either side of the eye breakline on one side and plain on the other side. The 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 obsessive-compulsive disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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 to 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 on Read the complete document