MINT-DORZOLAMIDE/TIMOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Available from:

MINT PHARMACEUTICALS INC

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:

10ML

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-05-23

Summary of Product characteristics

_Page 1 of 26_
PRODUCT MONOGRAPH
PR
MINT-DORZOLAMIDE/TIMOLOL
Dorzolamide and timolol eye drops
BP
2
0 mg/ml, 5
m
g/ml
(as dorzolamide hydrochloride and timolol maleate)
Elevated Intraocular Pressure
Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical
Beta-Adrenergic
Blocking
Agent)
MINT PHARMACEUTICALS INC.
1093 Meyerside Drive, Unit #1
Mississauga, Ontario
L5T 1J6
DATE OF PREPARATION:
15 JULY 2015 SUBMISSION CONTROL NO: 185392
_Page 2 of 26_
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
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND
STABILITY..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
.................................................................................14
PHARMACEUTICAL
INFORMATION...........................................................................14
CLINICAL TRIALS
................................