DORZOLAMIDE-TIMOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Available from:

ALCON CANADA INC

ATC code:

S01ED51

INN (International Name):

TIMOLOL, COMBINATIONS

Dosage:

2.0%; 0.5%

Pharmaceutical form:

SOLUTION

Composition:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 2.0%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Administration route:

OPHTHALMIC

Units in package:

5ML/10ML

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC AGENTS

Product summary:

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

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2021-06-25

Summary of Product characteristics

_Product Monograph – _
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_Page 1 of 28_
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_DORZOLAMIDE-TIMOLOL _
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PRODUCT MONOGRAPH
PR
DORZOLAMIDE-TIMOLOL
Dorzolamide (as Dorzolamide Hydrochloride USP) 2.0% and
Timolol (as Timolol Maleate USP) 0.5% w/v
Sterile Ophthalmic Solution
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
Alcon Canada Inc.
2665 Meadowpine Blvd.
Mississauga, ON
L5N 8C7
Date of Preparation:
October 1, 2010
SUBMISSION CONTROL NO: 131041
_Product Monograph – _
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_Page 2 of 28_
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_DORZOLAMIDE-TIMOLOL _
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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......................................................................................................
8
DOSAGE AND ADMINISTRATION
...............................................................................
10
OVERDOSAGE
...................................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND
STABILITY............................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
...........................................................................
15
PHARMACEUTICAL
INFORMATIO