TRAVATAN SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRAVOPROST

제공처:

ALCON CANADA INC

ATC 코드:

S01EE04

INN (국제 이름):

TRAVOPROST

복용량:

0.004%

약제 형태:

SOLUTION

구성:

TRAVOPROST 0.004%

관리 경로:

OPHTHALMIC

패키지 단위:

1.5/2.5/5ML

처방전 유형:

Prescription

치료 영역:

PROSTAGLANDIN ANALOGS

제품 요약:

Active ingredient group (AIG) number: 0145801001; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2010-11-16

제품 특성 요약

PRODUCT MONOGRAPH
TRAVATAN®
Travoprost Ophthalmic Solution, 0.004% w/v
(with benzalkonium chloride, 0.015%)
TRAVATAN® Z
Travoprost Ophthalmic Solution, 0.004% w/v
(without benzalkonium chloride)
THERAPEUTIC CLASSIFICATION:
Elevated Intraocular Pressure Therapy
Prostaglandin F
2
"
analogue
Alcon Canada Inc
Date of Revision:
2665 Meadowpine Blvd
June 4, 2009
Mississauga, Ontario
L5N 8C7
CONTROL NUMBER: 124861
®
Registered trademark of Alcon Inc.
1
PRODUCT MONOGRAPH
TRAVATAN ®
Travoprost Ophthalmic Solution, 0.004% w/v
(with benzalkonium chloride, 0.015%)
TRAVATAN
®
Z
Travoprost Ophthalmic Solution, 0.004% w/v
(without benzalkonium chloride)
THERAPEUTIC CLASSIFICATION:
Elevated Intraocular Pressure Therapy
Prostaglandin F
2
"
analogue
ACTIONS & CLINICAL PHARMACOLOGY
Mechanism of Action
Travoprost, an isopropyl ester prodrug, is rapidly hydrolyzed by
esterases in the cornea to the
biologically active free acid. Travoprost free acid is a highly
selective, potent agonist for the FP
prostanoid receptor. FP receptor agonists are thought to reduce
intraocular pressure (IOP) by
increasing the outflow of aqueous humor, primarily by increased
uveoscleral outflow.
Pharmacokinetics/ Pharmacodynamics
TRAVATAN® (travoprost) Ophthalmic Solution, when applied topically to
the eye, reduces
elevated as well as normal intraocular pressure, whether or not
accompanied by glaucoma.
Elevated intraocular pressure is a major risk factor in the
pathogenesis of glaucomatous visual
field loss. The higher the level of intraocular pressure, the greater
the likelihood of
glaucomatous visual field loss and optic nerve damage. The Advanced
Glaucoma Intervention
Study (AGIS) (1) established elevated intraocular pressure as a
positive risk factor for
glaucomatous visual field loss. Eyes with intraocular pressures below
18 mmHg at all visits were
found to have little to no visual field loss during the six-year
monitoring period.
Absorption: Travoprost is absorbed through the cornea. Studies in
rabbits have shown peak
concentrations in aqueous h