XANAX SL

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

ALPRAZOLAM

Saadav alates:

PFIZER INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

ALPRAZOLAM

Annus:

1 MG

Ravimvorm:

TABLET SUBLINGUAL

Ühikuid pakis:

DUS,2 BLISTER @ 15 TABLET SUBLINGUAL

Valmistatud:

PFIZER ITALIA S.R.L - Italy

Loa andmise kuupäev:

2019-12-05

Toote omadused

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