IOPIDINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE)

Available from:

ESSENTIAL PHARMA SWITZERLAND GMBH

ATC code:

S01EA03

INN (International Name):

APRACLONIDINE

Dosage:

1%

Pharmaceutical form:

SOLUTION

Composition:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE) 1%

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

EENT DRUGS, MISCELLANEOUS

Product summary:

Active ingredient group (AIG) number: 0122471001; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-05-19

Summary of Product characteristics

_IOPIDINE Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IOPIDINE
®
Apraclonidine Ophthalmic Solution, USP
0.5% w/v and 1% w/v (as apraclonidine hydrochloride)
S01EA03 Ophthalmologicals: Antiglaucoma Preparations and Miotics
Essential Pharma Switzerland GmbH
Landis + Gyr-Strasse 1 c/o LacMont AG,
6300 Zug, Switzerland
www.essentialpharmagroup.com
Date of Preparation:
MAY 19, 2023
Imported / Distributed by:
McKesson Specialized Distribution Inc.
8449 Lawson Road, Unit 102
Milton, ON
L9T 9L1
Canada
Submission Control No.: 273954
IOPIDINE is a registered trademark
_ _
_IOPIDINE Product Monograph _
_Page 2 of 29_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSIT