DORZOLAMIDE-TIMOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TIMOLOL (TIMOLOL MALEATE); DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Available from:

MICRO LABS LIMITED

ATC code:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosage:

5MG; 20MG

Pharmaceutical form:

SOLUTION

Composition:

TIMOLOL (TIMOLOL MALEATE) 5MG; DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG

Administration route:

OPHTHALMIC

Units in package:

100

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0237301001; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-06-23

Summary of Product characteristics

_Page 1 of 37_
_DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide
Hydrochloride and Timolol Maleate Ophthalmic Solution
Ophthalmic Solution, 20 mg / mL dorzolamide (as dorzolamide
hydrochloride) and 5 mg / mL
timolol (as timolol maleate)
USP
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
Manufactured by:
Date of Initial Approval:
Micro Labs Limited
June 16, 2022
Bangalore– 560001
INDIA
Canadian Importer/Distributor:
13187811
Canada Inc.
Mississauga, ON L4Z 1S1
Submission Control Number: 250138
_Page 2 of 37_
_DORZOLAMIDE-TIMOLOL (Dorzolamide Hydrochloride and Timolol Maleate
Ophthalmic Solution)_
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
.............