MIDODRINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
30-11-2022
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Active ingredient:
MIDODRINE HYDROCHLORIDE
Available from:
SANIS HEALTH INC
ATC code:
C01CA17
INN (International Name):
MIDODRINE
Dosage:
2.5MG
Pharmaceutical form:
TABLET
Composition:
MIDODRINE HYDROCHLORIDE 2.5MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0123066001; AHFS:
Authorization status:
APPROVED
Authorization date:
2022-12-01
Summary of Product characteristics
Page 1 of 23
PRODUCT MONOGRAPH
Pr
MIDODRINE
MIDODRINE HYDROCHLORIDE TABLETS
2.5 MG AND 5 MG
MANUFACTURER’S STANDARD
VASOPRESSOR
Sanis Health Inc.
Date of Preparation:
1 President’s Choice Circle
NOV 30, 2022
Brampton, Ontario
L6Y 5S5
Submission Control No.:
269308
Page 2 of 23
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
................................................................................................................
6
DRUG INTERACTIONS
...............................................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................................
12
OVERDOSAGE
.............................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
14
STORAGE AND STABILITY
......................................................................................................
15
PART II: SCIENTIFIC INFORMATION
........................................................................................
12
PHARMACEUTICAL INFORMATION
......................................................................................
12
CLINICAL TRIALS
......................................................................................................................
18
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