LATANOPROST SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LATANOPROST

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

S01EE01

INN (Nama Internasional):

LATANOPROST

Dosis:

50MCG

Bentuk farmasi:

SOLUTION

Komposisi:

LATANOPROST 50MCG

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

2.5ML

Jenis Resep:

Prescription

Area terapi:

PROSTAGLANDIN ANALOGS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2016-06-13

Karakteristik produk

PRODUCT MONOGRAPH
PR
LATANOPROST
(LATANOPROST OPHTHALMIC SOLUTION)
50 ΜG/ML PROSTAGLANDIN F
2
α
ANALOGUE
LABORATOIRE RIVA INC. DATE OF PREPARATION:
660 Boul. Industriel
January 25, 2012
Blainville, Québec, CANADA
J7C 3V4
www.labriva.com
CONTROL NO. 150903
2
PRODUCT MONOGRAPH
Pr
LATANOPROST
(Latanoprost Ophthalmic Solution)
50 µg/mL
Prostaglandin F
2
α
analogue
ACTION AND CLINICAL PHARMACOLOGY
LATANOPROST (latanoprost), a prostaglandin F
2
α
(13,14-dihydro-17-phenyl-18,19,20-trinor-
PGF
2
α
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.
Latanoprost is a sterile, isotonic, buffered aqueous solution with a
pH of approximately 6.7.
Each mL contains 50 µg of latanoprost, a colourless to slightly
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.
3
Reduction of IOP following a single dose in humans starts about 3 to 4
hours following topical
administration, and the maximum effect is reached after 8 to 12 hours.
Pressure reduction is
maintained for at least 24 hour