APO-NITRAZEPAM TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-03-2022
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Active ingredient:
NITRAZEPAM
Available from:
APOTEX INC
ATC code:
N05CD02
INN (International Name):
NITRAZEPAM
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
NITRAZEPAM 5MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Targeted (CDSA IV)
Therapeutic area:
BENZODIAZEPINES
Product summary:
Active ingredient group (AIG) number: 0114345001; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-01-21
Summary of Product characteristics
Page 1 of 27
PRODUCT MONOGRAPH
APO-NITRAZEPAM
Nitrazepam Tablets BP
5 mg and 10 mg
Hypnotic and Anticonvulsant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
March 24, 2022
Control No: 256493
Page 2 of 27
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND
PRECAUTIONS..................................................................................
4
ADVERSE REACTIONS
.................................................................................................10
POST-MARKET ADVERSE REACTIONS
......................................................................10
DRUG INTERACTIONS
..................................................................................................11
SERIOUS DRUG INTERACTIONS
.................................................................................11
DOSAGE AND ADMINISTRATION
...............................................................................11
DOSING CONSIDERATIONS
.........................................................................................11
OVERDOSAGE
...............................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
..............................................................13
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................15
PART II: SCIENTIFIC INFORMATION
.........................................................................
16
PHARMACEUTICAL INFORMATION
...........................
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