ACULAR OPHTHALMIC SOLUTION 0.5%

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

KETOROLAC TROMETHAMINE

Boleh didapati daripada:

Allergan Malaysia Sdn Bhd

INN (Nama Antarabangsa):

KETOROLAC TROMETHAMINE

Unit dalam pakej:

3ml mL; 5ml mL; 10ml mL

Dikeluarkan oleh:

ALLERGAN PHARMACEUTICALS IRELAND

Risalah maklumat

ACULAR
®
OPHTHALMIC SOLUTION
Ketorolac tromethamine (0.5% w/v)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What
ACULAR
®
is used for
2. How
ACULAR
®
works
3. Before you use
ACULAR
®
4. How to use
ACULAR
®
5. While you are using it
6. Side effects
7. Storage and Disposal of
ACULAR
®
8. Product Description
9. Manufacturer and Product
Registration
Holder
10. Date of revision
WHAT ACULAR
®
IS USED FOR
ACULAR
®
ophthalmic
solution
is
indicated for the short-term relief of itchy
eyes due to seasonal eye allergy and for
the
prevention
and
relief
of
eye
inflammation following eye surgery.
HOW ACULAR
®
WORKS
ACULAR
®
belongs
to
a
group
of
medicines known as
non-steroidal anti-
inflammatory drugs
(NSAIDs). The
active
ingredient
in
ACULAR
®
is
ketorolac tromethamine.
The
eye
solution
of
Ketorolac
tromethamine
works
by
decreasing
prostaglandin E2 levels in the eye.
Prostaglandins are normally produced by
the body, but in the eye they are thought
to be associated with pain, itching and
inflammation.
BEFORE YOU USE ACULAR
®
-
_ When you must not use it_
swelling of the face, lips, tongue, throat
or other parts of the body; rash, itching
or hives on the skin; fainting; or hay
fever-like symptoms.
-
_ Pregnancy and lactation_
Ask
your
doctor
or
pharmacist
for
advice before using any medicine.
ACULAR
®
should not be used if you
are pregnant or might become pregnant
or are breast feeding, unless your doctor
recommends it.
-
_ Children_
The use of
ACULAR
®
in children has
not been studied.
-
_ Before you start use it_
Take special care with
ACULAR
®
.
If any of the following apply, talk to
your doctor before using
ACULAR
®
.
If you suffer from, or have in the past
suffered from:
- Viral or bacterial infections of the eye
-
Bleeding
tendencies
(for
example,
anaemia) or stomach ulcers
- or if you have had recent eye surgery
- you
have
had
an
allergy
to
any
medicines or any other substances,
such as foods, preservatives or dyes.
- you
have
defects
of
the
cornea,
diseases of the eye , or

Ciri produk

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 s olution 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
ad ministered 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 tromethami ne
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 d oes 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 ef fective 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
inflam mation (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 patie