DORZOLAMIDE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE)

Available from:

JAMP PHARMA CORPORATION

ATC code:

S01EC03

INN (International Name):

DORZOLAMIDE

Dosage:

20MG

Pharmaceutical form:

SOLUTION

Composition:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE) 20MG

Administration route:

OPHTHALMIC

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

CARBONIC ANHYDRASE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-11-15

Summary of Product characteristics

_Dorzolamide_
_ _
_(dorzolamide hydrochloride) _Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DORZOLAMIDE
Dorzolamide Hydrochloride Ophthalmic Solution, USP
20 mg/mL Dorzolamide (as Dorzolamide Hydrochloride)
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 15, 2021
Date of Revision:
October 12, 2023
Submission Control Number: 275514
_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
............................................................... 4
4.4 Administration
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