ACULAR LS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

KETOROLAC TROMETHAMINE

Available from:

ABBVIE CORPORATION

ATC code:

S01BC05

INN (International Name):

KETOROLAC

Dosage:

0.4%

Pharmaceutical form:

SOLUTION

Composition:

KETOROLAC TROMETHAMINE 0.4%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

NONSTEROIDAL ANTI-INFLAMMATORY AGENTS

Product summary:

Active ingredient group (AIG) number: 0121995005; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-11-08

Summary of Product characteristics

_ACULAR / ACULAR LS (ketorolac tromethamine) _
_Page 1 of 20 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACULAR®
ketorolac tromethamine ophthalmic solution
Solution, 0.5% w/v, for ophthalmic use
with benzalkonium chloride 0.01% w/v as preservative
Pr
ACULAR LS®
ketorolac tromethamine ophthalmic solution
Solution, 0.4% w/v, for ophthalmic use
with benzalkonium chloride 0.006% w/v as preservative
Topical Non-Steroidal Anti-Inflammatory Agent
ATC code: S01BC05
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Submission Control Number: 268269
Date of Initial Authorization:
FEB 12, 1992
Date of Revision:
NOV
8, 2022
_ACULAR / ACULAR LS (ketorolac tromethamine) _
_Page 2 of 20 _
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
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 Dosa