LATANOPROST SANDOZ latanoprost 50 micrograms/mL eye drop solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

latanoprost

Available from:

Sandoz Pty Ltd

INN (International Name):

Latanoprost

Authorization status:

Registered

Summary of Product characteristics

_Product Information Page _
_Latanoprost Sandoz 50 micrograms/mL Eye Drops Solution _
_09/2017_
_Sandoz Pty Ltd _
_ _
_Version 04 _
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_1 _
PRODUCT INFORMATION
LATANOPROST SANDOZ
®
50MICROGRAM/ML EYE DROPS SOLUTION
NAME OF THE MEDICINE
Latanoprost
_Chemical Name_
Isopropyl-(Z)-7[(1R,2R,3R,5S) 3,5-dihydroxy-2-[(3R)-3-hydroxy-5-
phenyl-1-pentyl]cyclopentyl]-5-heptenoate.
_Chemical structure _
_ _
_ _
CAS [130209-82-4]
Empirical formula: C
26
H
40
O
5
MW: 432.593
DESCRIPTION
Latanoprost
Sandoz
Eye
Drops
is
a
sterile,
isotonic
solution
containing
50micrograms/mL of latanoprost in an aqueous solution of pH 6.7.
The active ingredient latanoprost is a prostaglandin F
2α
analogue. Latanoprost is a
viscous oil which is practically insoluble in water, freely soluble in
ethanol, ethyl
acetate, isopropanol, methanol, acetone and octanol, and very soluble
in acetonitrile.
Sixty four isomers of latanoprost are possible, however, for
Latanoprost Sandoz it is
purified as a single isomer.
Latanoprost
Sandoz
Eye
Drops
also
contain
the
following
inactive
ingredients:
sodium
chloride,
monobasic
sodium
phosphate
monohydrate,
dibasic
sodium
phosphate,
water
for
injections
and
benzalkonium
chloride
(0.20mg/mL)
as
a
preservative agent.
_ _
The solution is a clear and colourless liquid, filled in a
polyethylene container.
_ _
_ _
_Product Information Page _
_Latanoprost Sandoz 50 micrograms/mL Eye Drops Solution _
_09/2017_
_Sandoz Pty Ltd _
_ _
_Version 04 _
_ _
_2 _
PHARMACOLOGY
Pharmacodynamics
Latanoprost, a selective prostaglandin F
2α
analogue, is a selective prostanoid FP
receptor agonist which reduces the intraocular pressure by increasing
the outflow of
aqueous humour. Reduction of the intraocular pressure in man starts
about three to
four hours after administration and maximum effect is reached after 8
to 12 hours.
Pressure reduction is maintained for at least 24 hours. Studies in
animals and man
indicate that the main mechanism of action is increased uveoscleral
outflow, although
some increase in outflow facility (decrease