LAMISOPT 20mgml EYE DROPS SOLUTION

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

DORZOLAMIDE HCL

Inapatikana kutoka:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

INN (Jina la Kimataifa):

DORZOLAMIDE HCL

Vitengo katika mfuko:

1 x 5 ml mL

Viwandani na:

RAFARM S.A.

Taarifa za kipeperushi

_Consumer Medication Information Leaflet (RiMUP) _
____________________________________________________________________________
1
LAMISOPT 20MG/ML EYE DROPS, SOLUTION
Dorzolamide 20mg/ml
WHAT IS IN THIS LEAFLET
1.
What LAMISOPT is used
for
2.
How LAMISOPT works
3.
Before you use
LAMISOPT
4.
How to use LAMISOPT
5.
While you are using
LAMISOPT
6.
Side effects
7.
Storage and disposal of
LAMISOPT
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT LAMISOPT IS USED FOR
LAMISOPT is prescribed to
lower increased pressure in the
eye and to treat glaucoma.
This medicine can be used
alone or in addition to other
medicines which lower the
pressure in the eye.
HOW LAMISOPT WORKS
LAMISOPT contains
dorzolamide which belongs to a
group of medicines called
"carbonic anhydrase inhibitors".
Dorzolamide inhibit production
of aqueous humor in the eye,
thus reduces high pressure in
the eye.
BEFORE YOU USE LAMISOPT
_-_
_ _
_When you must not use it_
Do not take LAMISOPT:

If you are allergic
(hypersensitive) to
dorzolamide hydrochloride
or any of the other
ingredients of LAMISOPT

If you have severe kidney
impairment, or a prior
history of kidney stones

If you are pregnant (or
trying to become pregnant).

If you are breastfeeding.
If you have one of these
conditions, do not take this
medicine and inform your
doctor.
_-_
_ _
_Before you start to use it _
Before treatment with
LAMISOPT eye drops, tell
your doctor if you:

have liver problems in the
past

have been told you have a
corneal defect

have any allergies to any
medicines

have, had or going to have
eye surgery

have suffered an eye injury
or have an eye infection

have a prior history of
kidney stones

are taking orally another
carbonic anhydrase
inhibitor

wear contact lenses.
If you have one of these
conditions, INFORM YOUR DOCTOR.
You doctor will take it into
account during your treatment
with LAMISOPT.
_-_
_ _
_Taking other medicines _
_ _
Please tell your doctor or
pharmacist if you are taki

Tabia za bidhaa

LAMISOPT 20mg/ml
EYE DROPS, SOLUTION
DORZOLAMIDE
CONTROLLED MEDICINE
PRODUCT PARTICULARS
1. NAME OF PRODUCT
LAMISOPT 20mg/ml EYE DROPS,
SOLUTION
2. NAME AND STRENGTH OF ACTIVE
INGREDIENT(S)
Lamisopt 20mg/ml Eye Drops
contain dorzolamide 20mg per ml, as
dorzolamide Hydrochloride.
3. DOSAGE FORM
Eye drops.
4. PRODUCT DESCRIPTION
Lamisopt 20mg/ml Eye Drops is
presented as slightly opalescent, nearly
colourless, slightly viscous solution.
5.1. PHARMACODYNAMICS
Carbonic anhydrase (CA) is an enzyme
found in many tissues of the body
including the eye. It catalyzes the
reversible reaction involving the
hydration of carbon dioxide and the
dehydration of carbonic acid. Carbonic
anhydrase exists as a number of
isoenzymes, the most active being
carbonic anhydrase II (CA-II), found
primarily in red blood cells (RBCs)
but also in other tissues. Inhibition
of carbonic anhydrase in the ciliary
processes of the eye decreases aqueous
humor secretion, presumably by slowing
the formation of bicarbonate ions with
subsequent reduction in sodium and
fluid transport. The result is a reduction
in intraocular pressure (IOP). Lamisopt
contains dorzolamide HCl, a potent
inhibitor of human carbonic anhydrase II.
Following topical ocular administration,
Lamisopt reduces elevated intraocular
pressure, whether or not associated
with glaucoma. Elevated intraocular
pressure is a major risk factor in the
pathogenesis of optic nerve damage
and glaucomatous visual field loss.
Unlike miotics, Lamisopt reduces
intraocular pressure without the
common side effects of miotics eg,
night blindness, accommodative spasm
and pupillary constriction. Unlike topical
β
-blockers, Lamisopt has minimal or no
effect on pulse rate or blood pressure.
Topically applied
β
-adrenergic-blocking
agents also reduce IOP by decreasing
aqueous humor secretion but by a
different mechanism of action. When
Lamisopt is added to a topical
β
-blocker,
additional reduction in IOP is observed.
5.2. PHARMACOKINETICS
Unlike oral carbonic anhydrase
inhibitors, topical administration o