PDP-AMANTADINE HYDROCHLORIDE CAPSULES

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMANTADINE HYDROCHLORIDE

Available from:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC code:

N04BB01

INN (International Name):

AMANTADINE

Dosage:

100MG

Pharmaceutical form:

CAPSULE

Composition:

AMANTADINE HYDROCHLORIDE 100MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ADAMANTANES

Product summary:

Active ingredient group (AIG) number: 0109101001; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-03-13

Summary of Product characteristics

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pdp-AMANTADINE HYDROCHLORIDE
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_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PDP-AMANTADINE HYDROCHLORIDE CAPSULES
amantadine hydrochloride capsules
100 mg
House Standard
PR
PDP-AMANTADINE HYDROCHLORIDE SYRUP
amantadine hydrochloride oral solution
10 mg/mL
USP
Antiparkinsonian Agent
Antiviral Agent
PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Initial Authorization:
Jun 27, 1992
Date of Revision:
Jun 13, 2022
Submission Control Number: 261229
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_pdp-AMANTADINE HYDROCHLORIDE_
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_Page 2 of 42 _
RECENT MAJOR LABEL CHANGES
1 Indications
12/2021
2 Contraindications
06/2022
4 Dosage and Administration
12/2021
4.2 Recommended Dose and Dosage Adjustment
06/2022
7 Warnings and Precautions
12/2021
7 Warnings and Precautions, Cardiovascular
06/2022
7 Warnings and Precautions, Neurologic
06/2022
7 Warnings and Precautions, Ophthalmologic
06/2022
7 Warnings and Precautions, Psychiatric
06/2022
7 Warnings and Precautions, Renal
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
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5
4
DOSAGE AND
ADMINISTRATION