Xalatan

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Latanoprost 50 µg/mL;  ;  ;  

Commercializzato da:

Upjohn New Zealand ULC

INN (Nome Internazionale):

Latanoprost 50 µg/mL

Dosaggio:

50 mcg/mL

Forma farmaceutica:

Eye drops, solution

Composizione:

Active: Latanoprost 50 µg/mL       Excipient: Benzalkonium chloride Dibasic sodium phosphate Monobasic sodium phosphate monohydrate Sodium chloride Water for injection

Confezione:

Bottle, dropper, 1x2.5ml, 2.5 mL

Classe:

Prescription

Tipo di ricetta:

Prescription

Prodotto da:

Pfizer Pharmaceuticals LLC

Indicazioni terapeutiche:

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dettagli prodotto:

Package - Contents - Shelf Life: Bottle, dropper, - 2.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 weeks opened stored at or below 25°C protect from light

Data dell'autorizzazione:

1996-11-27

Scheda tecnica

DATA SHEET
XALATAN
®
EYE DROPS (LATANOPROST 50 MICROGRAMS/ML)
NAME OF THE MEDICINE
The
chemical
name
of
latanoprost
is
Isopropyl-(Z)-7[(1R,2R,3R,5S)
3,5-dihydroxy-2-[(3R)-3-
hydroxy-5-phenyl-1-pentyl]cyclopentyl]-5-heptenoate, according to
IUPAC. Its molecular formula
is C
26
H
40
O
5
and its molecular weight is 432.58. The CAS number for latanoprost is
130209-82-4.
The structural formula is as follows:
OH
OH
OH
COOCH(CH
3
)
2
DESCRIPTION
The active ingredient in XALATAN is latanoprost, a prostaglandin F
2
α
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 XALATAN
it is purified as a single
isomer.
XALATAN Eye Drops is a sterile, isotonic solution containing 50
micrograms/mL of latanoprost in
an aqueous buffer solution of pH 6.7. The excipients in XALATAN are
sodium chloride, sodium
phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous,
Water for Injections and
benzalkonium chloride (0.20 mg/mL) as a preservative agent.
The solution is a clear and colourless liquid, filled in a
polyethylene container.
PHARMACOLOGY
PHARMACODYNAMICS
Latanoprost, a selective prostaglandin F
2
α
analogue, is a selective prostanoid FP receptor agonist
which reduces the intraocular pressure (IOP) by increasing the outflow
of aqueous humour.
Reduction of the IOP 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 in outflow
resistance) has been reported in
man.
Clinical trials have shown that latanoprost has no significant effect
on the production of aqueous
humour. Latanoprost has not been found to have any effect on the
blood-aqueous barrier.