XALANOTIM EYE DROPS SOLUTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TIMOLOL MALEATE; LATANOPROST

Boleh didapati daripada:

Generic Partners (M) Sdn Bhd

INN (Nama Antarabangsa):

TIMOLOL MALEATE; LATANOPROST

Unit dalam pakej:

2.5ml x 1 bottle BOTTLE

Dikeluarkan oleh:

S.C. ROMPHARM COMPANY S.R.L.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
XALANOTIM EYE DROPS
latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml
1
WHAT IS IN THIS LEAFLET
1.
What XALANOTIM is used for
2.
How XALANOTIM works
3.
Before you use XALANOTIM
4.
How to use XALANOTIM
5.
While you are using
XALANOTIM
6.
Side Effects
7.
Storage and disposal of
XALANOTIM
8.
Product description
9.
Manufacturer
1.
WHAT XALANOTIM IS USED FOR
Reduction of intraocular pressure
(lOP) in patients with open angle
glaucoma and ocular
hypertension
who are
insufficiently responsive to
topical beta-blockers.
2.
HOW XALANOTIM WORKS
XALANOTIM contains two
medicines: latanoprost and
timolol. Latanoprost belongs to
a group of
medicines known as
prostaglandin analogues. Timolol
belongs to a group of medicines
known as beta-
blockers.
Latanoprost works by increasing
the natural outflow of fluid from
the eye into the
bloodstream.
Timolol works by slowing the
formation of fluid in the eye.
XALANOTIM is used to reduce
the pressure in your eye if you
have conditions known as open
angle
glaucoma or ocular
hypertension. Both these
conditions are linked to an
increase in the pressure within
your eye, eventually affecting
your eyesight. Your doctor will
usually prescribe you
XALANOTIM when
other
medicines have not worked
adequately.
3.
BEFORE YOU USE XALANOTIM
XALANOTIM can be used in
adult men and women (including
the elderly), but is not
recommended for
use if you are
less than 18 years of age.
_WHEN YOU MUST NOT USE IT: _

When you must not use it:
Do not use XALANOTIM:
-
if you are allergic
(hypersensitive) to either of
the medicines in
XALANOTIM (latanoprost
or
timolol), beta-blockers, or
any of the other ingredients
of XALANOTIM (see
Section 10 Product
Description).
-
if you have not or have had
in the past respiratory
problems such as asthma,
severe chronic
obstructive
bronchitis (severe lung
disease which may cause
wheeziness, difficulty in
breathing and/or long-
standing cough)
-
if you have serious heart
problems or heart rhythm
disorders
-

Ciri produk

1
XALANOTIM EYE DROPS, SOLUTION
BRAND OR PRODUCT NAME
_Xalanotim _Eye Drops, solution
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Latanoprost 0.05 mg/mL (0.005 % w/v)
Timolol maleate 6.83mg/ml equivalent to timolol 5.0 mg/mL (0.5% w/v)
PRODUCT DESCRIPTION
The solution is a clear and colourless liquid, filled in a transparent
low density polyethylene
(LDPE) bottles, equipped with transparent LDPE dropper, and a white
HDPE screw cap.
_ _
PHARMACODYNAMICS
Latanoprost/timolol eye drops consist of two components; latanoprost
and timolol maleate. These
two components decrease elevated intraocular pressure (IOP) by
different mechanisms of action
and the combined effect results in additional IOP reduction compared
to either compound
administered alone.
Latanoprost is a prostaglandin F 2-alpha analogue and a selective FP
prostanoid receptor agonist.
It reduces intraocular pressure by increasing the outflow of aqueous
humor. Studies suggest that
the main mechanism of action is increased uveoscleral outflow.
Timolol maleate is a beta1 and beta2 (non-selective) adrenergic
receptor blocking agent that does
not have significant intrinsic sympathomimetic, direct myocardial
depressant, or local anaesthetic
(membrane-stabilising) activity. Timolol lowers IOP by decreasing the
formation of aqueous
humour in the ciliary epithelium. The precise mechanism of action is
not clearly established.
PHARMACOKINETICS
_Absorption_
Latanoprost is absorbed through the cornea where the isopropyl ester
prodrug is hydrolyzed to
the acid form to become biologically active.
The peak concentration of latanoprost in the aqueous humor is reached
about two hours after
topical administration.
The maximum concentration of timolol in the aqueous humour is reached
about 1 hour after
topical administration of eye drops. Part of the dose is absorbed
systemically and a maximum
plasma concentration of 1 ng/mL is reached 10-20 minutes after topical
administration of one eye
drop to each eye once daily (300 µg/day).
_Distribution_
Latanoprost: Active metabolite has