MINT-LATANOPROST SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LATANOPROST

Dostopno od:

MINT PHARMACEUTICALS INC

Koda artikla:

S01EE01

INN (mednarodno ime):

LATANOPROST

Odmerek:

50MCG

Farmacevtska oblika:

SOLUTION

Sestava:

LATANOPROST 50MCG

Pot uporabe:

OPHTHALMIC

Enote v paketu:

2.5ML

Tip zastaranja:

Prescription

Terapevtsko območje:

PROSTAGLANDIN ANALOGS

Povzetek izdelek:

Active ingredient group (AIG) number: 0132916002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2014-03-07

Lastnosti izdelka

PRODUCT
MONOGRAPH
Pr
MINT-LATANOPROST
(Latanoprost Ophthalmic
Solution)
50
mcg/mL
PROSTAGLANDIN F
2Α
ANALOGUE
Mint Pharmaceuticals Inc.,
Date of Preparation:
1093 Meyerside Drive, Unit 1,
February 14, 2014
Mississauga, Ontario
L5T 1J6
CONTROL NO. 161370
Page 2 of 32
PRODUCT
MONOGRAPH
Pr
MINT-LATANOPROST
(Latanoprost Ophthalmic
Solution)
50
mcg
/mL
Prostaglandin
F
2α
analogue
ACTION AND CLINICAL
PHARMACOLOGY
MINT-LATANOPROST (latanoprost), a prostaglandin F
2α
(13,14-dihydro-17-phenyl-18,19,20-
trinor-PGF
2α
isopropyl ester) analogue, is a selective prostanoid FP receptor
agonist which reduces
the intraocular pressure by increasing the outflow of aqueous humour.
Studies in animals and
man indicate that the main mechanism of action is increased
uveoscleral outflow.
Glaucoma is a disease with characteristic optic nerve damage and a
corresponding visual field
defect. Increased intraocular pressure (IOP) is one of the main risk
factors. However,
disturbances in blood flow may also play a role in some cases. In
ocular hypertension, patients
may have increased IOP but without changes in the visual field or
corresponding optic nerve
damage.
MINT-LATANOPROST is a sterile, isotonic, buffered aqueous solution
with a pH of
approximately 6.7.
Each mL contains 50 mcg of Latanoprost, a colourless to yellow oil.
Latanoprost is an isopropyl
ester prodrug which is well absorbed through the cornea and upon
entering the aqueous humour is
rapidly and completely hydrolysed to the biologically active acid.
Studies in humans indicate that
the peak concentration in the aqueous humour is reached about two
hours after topical
administration.
Following topical administration in monkeys, latanoprost is primarily
distributed in the anterior
segment, conjunctiva and eyelids with only minute quantities reaching
the posterior segment.
Reduction of IOP following a single dose in humans starts about 3 to 4
hours following topical
Page 3 of 32
administration, and the maximum effect is reached after 8 to 12 hours.
Pressure reduction is
maintaine