JAMP ALPRAZOLAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-08-2021
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Active ingredient:
ALPRAZOLAM
Available from:
JAMP PHARMA CORPORATION
ATC code:
N05BA12
INN (International Name):
ALPRAZOLAM
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
ALPRAZOLAM 2MG
Administration route:
ORAL
Units in package:
100/500/1000
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0115008004; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-09-15
Summary of Product characteristics
JAMP-Alprazolam (alprazolam)-Product Monograph Page 1 of 43
PRODUCT MONOGRAPH JAMP ALPRAZOLAM
Alprazolam Tablets, USP
0.25 mg, 0.5 mg, 1 mg and 2 mg
ANXIOLYTIC
– ANTIPANIC
JAMP Pharma Corporation Date of Revision:
1310 rue Nobel August 12, 2021
Boucherville,
Quebec
J4B 5H3
Submission
Control No.: 253380
JAMP-Alprazolam (alprazolam)-Product Monograph Page 2 of 43
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
..............................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................
5
ADVERSE REACTIONS
.............................................................................................
13
DRUG INTERACTIONS
.............................................................................................
17
DOSAGE AND ADMINISTRATION
............................................................................
20
OVERDOSAGE
.........................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 23
STORAGE AND STABILITY
......................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
................................................................. 26
PHARMACEUTICAL INFORMATION
........................................................................
26
CLINICAL TRIALS
....................................................................................................
26
DETAILED PHARMACOLOGY
........................................
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