MED-DORZOLAMIDE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Available from:

GENERIC MEDICAL PARTNERS INC

ATC code:

S01EC03

INN (International Name):

DORZOLAMIDE

Dosage:

2%

Pharmaceutical form:

SOLUTION

Composition:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2%

Administration route:

OPHTHALMIC

Units in package:

5ML FILL VOLUME

Prescription type:

Prescription

Therapeutic area:

CARBONIC ANHYDRASE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0128558001; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-08-31

Summary of Product characteristics

_MED-DORZOLAMIDE_
_ _
_(dorzolamide hydrochloride) _
_Page 1 of 28 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MED-DORZOLAMIDE
Dorzolamide Eye Drops
Solution, dorzolamide 2% weight/volume, Ophthalmic
B.P.
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
Generic Medical Partners Inc.
1500 Don Mills Road, Suite 711
Toronto, Ontario,
M3B 3K4
Date of Initial Authorization:
August 29, 2016
Date of Revision:
July 28, 2023
Submission Control Number: 272250
_MED-DORZOLAMIDE_
_ _
_(dorzolamide hydrochloride) _
_Page 2 of 28 _
RECENT MAJOR LABEL CHANGES
Not applicable.
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
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
...............................................................................................