PMS-DORZOLAMIDE-TIMOLOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DORZOLAMIDE (DORZOLAMIDE HYDROCHLORIDE); TIMOLOL (TIMOLOL MALEATE)

Available from:

PHARMASCIENCE 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:

APPROVED

Authorization date:

2015-06-05

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
PMS-DORZOLAMIDE-TIMOLOL
Dorzolamide and Timolol Eye Drops, BP
20 mg/mL dorzolamide (as dorzolamide hydrochloride) and 5 mg/mL
timolol (as timolol
maleate)
Elevated Intraocular Pressure Therapy
(Topical Carbonic Anhydrase Inhibitor and Topical Beta-Adrenergic
Blocking Agent)
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Preparation:
June 5, 2015
Submission Control No: 175713
_ _
_pms-DORZOLAMIDE-TIMOLOL Product Monograph _
_Page 2 of 27_
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
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
.......................................................