देश: इंडोनेशिया
भाषा: इंडोनेशियाई
स्रोत: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
QUETIAPINE FUMARATE
ASTRAZENECA INDONESIA - Indonesia
QUETIAPINE FUMARATE
400 MG
TABLET PELEPASAN LAMBAT
DUS, 1 BLISTER @ 10 TABLET PELEPASAN LAMBAT
ASTRAZENECA PHARMACEUTICAL COMPANY LTD.
2018-08-01
1 SEROQUEL XR ™ 50 MG, 150 MG, 200 MG, 300 MG AND 400 MG _quetiapine fumarate _ EXTENDED-RELEASE TABLETS QUALITATIVE AND QUANTITATIVE COMPOSITION SEROQUEL XR 50 mg contains 50 mg quetiapine (as quetiapine fumarate). SEROQUEL XR 150 mg contains 150 mg quetiapine (as quetiapine fumarate). SEROQUEL XR 200 mg contains 200 mg quetiapine (as quetiapine fumarate). SEROQUEL XR 300 mg contains 300 mg quetiapine (as quetiapine fumarate). SEROQUEL XR 400 mg contains 400 mg quetiapine (as quetiapine fumarate). For excipients, see _List of excipients._ PHARMACEUTICAL FORM Extended-release tablet. SEROQUEL XR 50 mg tablets are peach-coloured and engraved with “ XR 50 ” on one side. SEROQUEL XR 150 mg tablets are white and engraved with “XR 150” on one side. SEROQUEL XR 200 mg tablets are yellow and engraved with “ XR 200 ” on one side. SEROQUEL XR 300 mg tablets are pale yellow and engraved with “ XR 300 ” on one side. SEROQUEL XR 400 mg tablets are white and engraved with “ XR 400 ” on one side. THERAPEUTIC INDICATION SEROQUEL XR is indicated for: • The acute and maintenance treatment of schizophrenia • Bipolar Disorder including: o manic episodes associated with bipolar I disorder o depressive episodes associated with bipolar disorder • Add-on treatment of major depressive episodes in patients with Major Depressive Disorder (MDD) who have had inadequate response after 6 weeks treatment of antidepressant monotherapy. POSOLOGY AND METHOD OF ADMINISTRATION Different dosing schedules exist for each indication. It must therefore be ensured that patients receive clear information on the appropriate dosage for their condition. SEROQUEL XR should be administered once daily, with or without food. The tablets should be swallowed whole and not split, chewed or crushed. ADULTS: FOR THE TREATMENT OF SCHIZOPHRENIA The daily dose at the start of therapy is 300 mg on Day 1, 600 mg on Day 2 and up to 800 mg after Day 2. The dose should be adjusted within the effective dose range of 400 mg to 800 mg per day, depend पूरा दस्तावेज़ पढ़ें