Maa: Indonesia
Kieli: indonesia
Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
ALPRAZOLAM
PFIZER INDONESIA - Indonesia
ALPRAZOLAM
1 MG
TABLET SUBLINGUAL
DUS,2 BLISTER @ 15 TABLET SUBLINGUAL
PFIZER ITALIA S.R.L - Italy
2019-12-05
Generic Name: Alprazolam Trade Name: XANAX SL CDS Effective Date: November 20, 2018 Supersedes: December 12, 2013 Approved by BPOM: 2017-0032200, 2017-0024955, 2018-0040716, 2017-0030807 Page 1 of 10 PT PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Alprazolam Trade Name: XANAX SL CDS Effective Date: November 20, 2018 Supersedes: December 12, 2013 1. NAME OF THE MEDICINAL PRODUCT XANAX SL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual (SL) tablet contains 0.5 mg or 1 mg of alprazolam. 3. PHARMACEUTICAL FORM Sublingual tablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS XANAX SL is indicated for the treatment of: • Anxiety – including anxiety neurosis, anxiety disorders, symptoms of anxiety, etc. • Mixed anxiety-depression – including anxiety associated with depression. • Panic disorders – including panic disorder with or without agoraphobia. The essential feature of panic disorder is the unexpected panic attack, a sudden onset of intense apprehension, fear or terror. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The optimum dose should be individualized based upon the severity of the symptoms and individual patient response. The daily dosage (see Table) will meet the needs of most patients. In the few patients who require higher doses, dosage should be increased cautiously to avoid adverse effects. When higher dosage is required, the evening dose should be increased before the daytime doses. In general, patients who have not previously received psychotropic medications will require lower doses than those previously treated with minor tranquilizers, antidepressants, or hypnotics or those with a history of chronic alcoholism. Patients should be periodically reassessed and dosage adjustments made, as appropriate. DISETUJUI OLEH BPOM: 3/12/2020 EREG10024112000514 EREG10024112000515 Generic Name: Alprazolam Trade Name: XANAX SL CDS Effective Date: November 20, 2018 Supersedes: December 12, 2013 Approved by BPOM: 2017-0032200, 2017-0024955, 2018-0040716, 2017-0030807 Page 2 of 10 Lue koko asiakirja