País: Indonésia
Língua: indonésio
Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AGOMELATINE
DARYA-VARIA LABORATORIA TBK - Indonesia
AGOMELATINE
25 MG
TABLET SALUT SELAPUT
DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT
LES LABORATOIRES SERVIER INDUSTRIE - France
2022-02-16
VALDOXAN COMPOSITION Each film-coated tablet contains 25 mg of agomelatine. Excipient with known effect Each film-coated tablet contains 61.8 mg lactose (as monohydrate) PHARMACEUTICAL FORM Film-coated tablet (tablet) Orange-yellow, oblong, film-coated tablet with blue imprint of company logo on one side. THERAPEUTIC INDICATIONS Valdoxan is indicated for the treatment of major depressive episodes in adults. POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 25 mg once daily taken orally at bedtime. After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime. Decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of Liver Function Test monitoring. Liver function tests should be performed in all patients before starting treatment. Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see “Contraindication” and “Special warnings and precautions for use”). During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see “Special warnings and precautions for use”). Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see “Contraindication” and “Special warnings and precautions for use”). When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment. _Treatment duration _ Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms. _Switching therapy from SSRI/SNRI antidepressant to agomelatine _ Patients may experience discontinuation symptoms after cessation from an SSRI/ SNR Leia o documento completo