DORZOLAMIDE-TIMOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Available from:

JAMP PHARMA CORPORATION

ATC code:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosage:

20MG; 5MG

Pharmaceutical form:

SOLUTION

Composition:

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

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-11-04

Summary of Product characteristics

_Dorzolamide-Timolol_
_ _
_(Dorzolamide Hydrochloride and Timolol Maleate) _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
Solution, 20 mg / mL Dorzolamide (as Dorzolamide Hydrochloride) and 5
mg / mL Timolol
(as Timolol Maleate), Ophthalmic
Manufacturer’s Standard
Elevated Intraocular Pressure Therapy
Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 28, 2021
Date of Revision:
December 30, 2022
Submission Control Number: 266282
_Dorzolamide-Timolol_
_ _
_(Dorzolamide Hydrochloride and Timolol Maleate) _
_Page 2 of 35 _
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
..............................................................................4
4.1
Dosing Considerations
....................................................................................4
4.2
Recommended Dose and Dosage Adjustment
......