OPTICLATE EYE DROPS 2.0% WV

Šalis: Malaizija

kalba: anglų

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

Veiklioji medžiaga:

SODIUM CROMOGLYCATE

Prieinama:

Gopharma Sdn. Bhd.

INN (Tarptautinis Pavadinimas):

SODIUM CROMOGLYCATE

Vienetai pakuotėje:

5ml mL; 10ml mL

Pagaminta:

MICRO LABS LTD

Pakuotės lapelis

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
OPTICLATE EYE DROPS 2.0 % W/V
Sodium Cromoglicate 20 mg/ml Eye Drops
1
WHAT IS IN THIS LEAFLET?

What Opticlate Eye Drops 2.0%
w/v is used for

How Opticlate works

Before you use opticlate

How to use Opticlate

While you are using it

Side Effects

Storage
and
Disposal
of
Opticlate

Product description

Manufacturer
&
Product
registration holder

Date of Revision
WHAT OPTICLATE EYE DROPS 2.0%
W/V IS USED FOR
The
active
ingredient
Sodium
Cromoglicate belongs to a group
of
medicines
called
anti-
inflammatory/anti-allergy
agents.
Sodium Cromoglicate Eye Drops
are used to treat red, watery, itchy
eyes
caused
by
ocular
allergic
disorders.
HOW OPTICLATE WORKS
The active ingredient in Opticlate
is Sodium cromoglicate which act
by inhibiting the degranulation of
sensitized
mast
cells
which
normally occurs after exposure to
allergens and thereby prevents the
release of allergic mediators such
as histamine.
BEFORE YOU TAKE OPTICLATE
_-When you must not take it _
If
you
are
allergic
or
hypersensitive
to
Sodium
Cromoglicate or to any of other
ingredients in this medicine.
_ _
_-Before you start use it _
Before you take this medicine, tell
your doctor:

If you develop an eye infection
during this treatment

If
you
are
wearing
contact
lenses.
_-Taking other medicines _
Please
tell
your
doctor
or
pharmacist
if
you
are
applying
any other type of eye drops or eye
ointment before you start to use
this medicine. Your medicine may
affect their action and could alter
their effect. Please tell your doctor
or pharmacist if you are taking or
have
recently
taken
any
other
medicines,
including
medicines
obtained without any prescription.
HOW TO USE OPTICLATE
_-How much to take _
Always use Opticlate exactly as
your
doctor
has
told
you.
You
should check with your doctor or
pharmacist if you are not sure.
The
usual
dose
is
one
or
two
drops in each eye four times daily
or as directed by your doctor. If
you are using in combination with
another eye drop m

Prekės savybės

OPTICLATE EYE DROPS 2.0% W/V
(SODIUM CROMOGLICATE EYE DROPS, SOLUTION 2.0% W/V)
Name and Strength of active ingredient:
Each ml contains:
Sodium cromoglicate… 20mg
Benzalkonium Chloride (as preservative)… 0.1mg
water for injection … q.s. to 1ml
DOSAGE FORM
:
EYE PREPARATIONS IN FORM OF EYE DROPS
PRODUCT DESCRIPTION
Clear colorless to pale
yellow solution.
PHARMACODYNAMICS
Cromoglicate appears to act mainly through the local effect on the
eyes. Cromoglicate prevents release of mediator of type I allergic
reactions, including histamine and cycteinyl leukotrienes
(slow‐reacting substance of anaphylaxis [SRS‐ A]) , from
sensitized mast cells
after the antigen‐antibody union has taken place.
Cromoglicate suppresses IgE mediated release of substance
(e.g.,histamine,cycteinyl leukotrienes)from mast cells, inhibits type
III (late
allergic, Arthus) reactions to a lesser extent, also inhibit secretion
induced by other mast cell secretagogues (e.g.,theployamine 48/80).
Cromoglicate appears to inhibit phospho lipase A‐induced mast cell
degranulation and subsequent release of chemical mediators invitro.
It has been suggested that the drug may block calcium channels in the
mast cell membranes. It has also been suggested that cromoglicate
may inhibit histamine release from mast cells by regulating
phosphorylation of a specific mast cell protein involved in secretory
mechanisms.
PHARMACOKINETICS
Sodium cromoglicate is only minimally absorbed from the eye following
topical administration. Drug excretion studies in healthy
individuals indicate that ~ 0.03% of on ophthalmic dose of
cromoglicate as solution is absorbed systemically. Trace amounts (less
than
0.01%) of the sodium cromoglicate dose penetrate in to the aqueous
humor and clearance from this chamber is virtually complete within
24 hours after treatment is stopped. Sodium cromoglicate does not
cross most of the biologic membranes. It is not known if the drug is
distributed in human milk. The elimination half‐life of sodium
cromoglicate is reported to be 81