PENDO-AMIODARONE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2016
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Active ingredient:
AMIODARONE HYDROCHLORIDE
Available from:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC code:
C01BD01
INN (International Name):
AMIODARONE
Dosage:
200MG
Pharmaceutical form:
TABLET
Composition:
AMIODARONE HYDROCHLORIDE 200MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
CLASS III ANTIARRYTHMICS
Product summary:
Active ingredient group (AIG) number: 0118593001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-07-31
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr
pendo-AMIODARONE
Amiodarone Tablets, BP
200 mg amiodarone hydrochloride
Antiarrhythmic Agent
PENDOPHARM DIVISION OF/DE PHARMASCIENCE INC.
DATE OF PREPARATION:
6111 Royalmount Ave, Suite #100
July 28, 2014
Montreal, Quebec
H4P 2T4
www.pendopharm.com
Control No. : 175774
_pendo-AMIODARONE Product Monograph _
_Page 2 of 68 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
18
DRUG INTERACTIONS
.......................................................................................................
21
DOSAGE AND ADMINISTRATION
..................................................................................
26
OVERDOSAGE
......................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 29
STORAGE AND
STABILITY...............................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
................................................................................33
PHARMACEUTICAL INFORMATION
.................................................................................
33
CLINICAL TRIALS
..............................................................
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