LEVODOPA-CARBIDOPA CR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LEVODOPA; CARBIDOPA

Available from:

PHARMASCIENCE INC

ATC code:

N04BA02

INN (International Name):

LEVODOPA AND DECARBOXYLASE INHIBITOR

Dosage:

200MG; 50MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

LEVODOPA 200MG; CARBIDOPA 50MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

DOPAMINE PRECURSORS

Product summary:

Active ingredient group (AIG) number: 0210315004; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-02-27

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
LEVODOPA-CARBIDOPA CR
Levodopa and Carbidopa Controlled Release Tablets
100 mg/25 mg
100 mg levodopa and 25 mg carbidopa
200 mg/50 mg
200 mg levodopa and 50 mg carbidopa
Antiparkinson Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Quebec
H4P 2T4
www.pharmascience.com
Date of revision:
November 18, 2020
Submission Control No.: 246046
_ _
_LEVODOPA-CARBIDOPA CR - Product Monograph _
_Page 2 of 34_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
CLINICAL TRIALS
..............................................