Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ESCITALOPRAM
PYRIDAM FARMA TBK - Indonesia
ESCITALOPRAM
20 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
H. LUDBECK A/S - Denmark
2016-11-28
Cipralex 5mg, 10mg, 20mg Film-coated tablet escitalopram (as oxalate) 1. NAME OF THE MEDICINAL PRODUCT CIPRALEX 5 mg film-coated tablets CIPRALEX 10 mg film-coated tablets CIPRALEX 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cipralex 5 mg: Each tablet contains 5 mg escitalopram (as 6.39 mg escitalopram oxalate) Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg escitalopram oxalate) Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as 25.54 mg escitalopram oxalate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Cipralex 5 mg: Round, white, film-coated tablet marked with "EK" on one side. Cipralex 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. Cipralex 20 mg: Oval, white, scored, film-coated tablet marked with "E” and “N" on each side of the score on one side of the tablet. The 10 and 20 mg tablets can be divided into equal doses 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. Cipralex 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, DISETUJUI OLEH BPOM: 06/09/2021 ID: EREG10019312100130-32 EREG10019312100078-80 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 Baca dokumen lengkapnya