ACULAR OPHTHALMIC SOLUTION 0.5%

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

KETOROLAC TROMETHAMINE

Saatavilla:

ABBVIE PTE. LTD.

ATC-koodi:

S01BC05

Annos:

0.5% w/v

Lääkemuoto:

SOLUTION

Koostumus:

KETOROLAC TROMETHAMINE 0.5% w/v

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

Prescription Only

Valmistaja:

ALLERGAN PHARMACEUTICALS IRELAND

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1999-10-11

Pakkausseloste

ACULAR
®
ketorolac tromethamine 0.5%
sterile ophthalmic solution
DESCRIPTION
EACH ML CONTAINS:
 ketorolac tromethamine 5 mg with: benzalkonium chloride 0.1 mg,
edetate disodium 1 mg, 
octoxynol 40, sodium chloride and purified water
.
ANIMAL PHARMACOLOGY
Ketorolac tromethamine prevented the development of increased
intraocular pressure induce
d in rabbits with 
topically applied arachidonic acid. Ketorolac did not inhibit rabbit
lens aldose reductase 
_in vitro_
.
Ketorolac tromethamine ophthalmic solution did not enhance the spread
of ocular infections induced in ra
bbits 
with 
_Candida albicans, Herpes simplex_
 virus type one or 
_Pseudomonas aeruginosa_
.
CLINICAL PHARMACOLOGY
Ketorolac tromethamine is a nonsteroidal anti-inflammator
y drug which, when administered systemically
, has 
demonstrated analgesic, anti-inflammator
y and anti-pyretic activity
. The mechanism of its action is thought to 
be
 due,
 in
 part,
 to
 its
 ability
 to
 inhibit
 prostaglandin
 biosynthesis.
 Ocular
 administration
 of
 ketorolac

tromethamine reduces prostaglandin E
2
 levels in aqueous humor
. The mean concentration of PGE
2
 was 80 
pg/mL in the aqueous humor of eyes receiving vehicle and 28 pg/mL in
the eyes receiving 0.5% ACULAR
®

ophthalmic solution.
Ketorolac tromethamine given systemically does not cause pupil
constriction.
Results from clinical studies indicate that ACULAR
®
 ophthalmic solution has no significant effect upon 
intraocular pressure.
Tw
o controlled clinical studies showed that ACULAR
®
 ophthalmic solution was significantly more effective 
than its vehicle in relieving ocular itching caused by seasonal
allergic conjunctivitis.
Tw
o controlled clinical studies showed that patients treated for two 
weeks with ACULAR
®
 ophthalmic solution 
were less likely to have measurable signs of inflammation (cell and
flare) than patients treated with its vehicle. 
Tw
o drops (0.1 mL) of 0.5% ACULAR
®
 ophthalmic solution instilled into the eyes of patients 12 hours

Valmisteyhteenveto

ACULAR
®
ketorolac tromethamine
0.5% sterile ophthalmic
solution
DESCRIPTION
EACH ML CONTAINS:
ketorolac tromethamine 5 mg with: benzalkonium chloride 0.1 mg,
edetate
disodium 1 mg, octoxynol 40, sodium chloride and purified water.
ANIMAL PHARMACOLOGY
Ketorolac tromethamine prevented the development of increased
intraocular pressure induced in rabbits
with topically applied arachidonic acid. Ketorolac did not inhibit
rabbit lens aldose reductase
_in vitro_
.
Ketorolac tromethamine ophthalmic solution did not enhance the spread
of ocular infections induced in
rabbits with
_Candida albicans, Herpes simplex _
virus type one or
_Pseudomonas aeruginosa_
.
CLINICAL PHARMACOLOGY
Ketorolac
tromethamine
is
a
nonsteroidal
anti-inflammatory
drug
which,
when
administered
systemically, has demonstrated analgesic, anti-inflammatory and
anti-pyretic activity. The mechanism
of its action is thought to be due, in part, to its ability to inhibit
prostaglandin biosynthesis. Ocular
administration of ketorolac tromethamine reduces prostaglandin E
2
levels in aqueous humor. The mean
concentration of PGE
2
was 80 pg/mL in the aqueous humor of eyes receiving vehicle and 28
pg/mL in
the eyes receiving 0.5% ACULAR
®
ophthalmic solution.
Ketorolac tromethamine given systemically does not cause pupil
constriction.
Results from clinical studies indicate that ACULAR
®
ophthalmic solution has no significant effect upon
intraocular pressure.
Two controlled clinical studies showed that ACULAR
®
ophthalmic solution was significantly more
effective than its vehicle in relieving ocular itching caused by
seasonal allergic conjunctivitis.
Two controlled clinical studies showed that patients treated for two
weeks with ACULAR
®
ophthalmic
solution were less likely to have measurable signs of inflammation
(cell and flare) than patients treated
with its vehicle. Two drops (0.1 mL) of 0.5% ACULAR
®
ophthalmic solution instilled into the eyes of
patients 12 hours and 1 hour prior to cataract extraction achieved
measurable levels in 8 of 9 patients’