LUMIGAN 0.01% (bimatoprost ophthalmic solution)

País: Malasia

Idioma: inglés

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

Ingredientes activos:

BIMATOPROST

Disponible desde:

ABBVIE SDN BHD

Designación común internacional (DCI):

BIMATOPROST

Unidades en paquete:

3ml mL

Fabricado por:

ALLERGAN PHARMACEUTICALS IRELAND

Información para el usuario

LUMIGAN
®
0.01%
bimatoprost (0.01%) ophthalmic solution
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What LUMIGAN
®
0.01% is used
for
2.
How LUMIGAN
®
0.01% works
3.
Before you use LUMIGAN
®
0.01%
4.
How to use LUMIGAN
®
0.01%
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
LUMIGAN
®
0.01%
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
1. What LUMIGAN
®
0.01% is used for
LUMIGAN
®
0.01% is used to reduce
high pressure in the eye.
2. How LUMIGAN
®
0.01% works
LUMIGAN
®
0.01%
increases
the
amount of fluid flowing out of the eye
which reduces the internal eye pressure.
3. Before you use LUMIGAN
®
0.01%
- When you must not use it
Do not use LUMIGAN
®
0.01%:
- if you are allergic (hypersensitive to
bimatoprost,
or
any
of
the
other
ingredients of LUMIGAN
®
0.01%.
(for
a
full
list
of
ingredients,
see
section
8
“PRODUCT
DESCRIPTION”).
- if you have had to stop using eye
drops in the past because of a side
effect
of
the
preservative
benzalkonium chloride
- Pregnancy and lactation
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
taking
this
medicine.
Do
not
use
LUMIGAN
®
0.01%
if
you
are
pregnant
unless
your
doctor
still
recommends it.
LUMIGAN
®
0.01%
may
get
into
breast milk so you should not breast-
feed
while
you
are
taking
LUMIGAN
®
0.01%.
Children:
LUMIGAN
®
0.01%
has
not
been
tested in children under the age of 18
and
therefore
must
not
be
used
by
patients under 18 years.
- Before you start to use it
Take special care with LUMIGAN
®
0.01%. Talk to you doctor if:
- You
have
any
eye
surgery
or
suffered trauma or infection to the
eye.
- You have breathing problems
- You have liver or kidney problems
- You have dry eyes
- You have or have had any problems
with your cornea (front transparent
part of the eye)
- You wear contact lenses
- You have or had low blood pressure
or low heart rate
- You have had a viral

Ficha técnica

LUMIGAN® 0.01%
(BIMATOPROST OPHTHALMIC SOLUTION)
1
DESCRIPTION
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is a synthetic
prostamide analog with
ocular hypotensive activity. Its chemical name is
(Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-
hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its
molecular weight is
415.58. Its molecular formula is C25H37NO4. Its chemical structure is:
Bimatoprost is a powder, which is very soluble in ethyl alcohol and
methyl alcohol and slightly
soluble in water. LUMIGAN® 0.01% is a clear, isotonic, colorless,
sterile ophthalmic solution with
an osmolality of approximately 290 mOsmol/kg.
LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Preservative:
benzalkonium chloride
0.2 mg/mL; Inactives: sodium chloride; sodium phosphate, dibasic;
citric acid; and purified water.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.
The pH during its shelf
life ranges from 6.8-7.8.
2
INDICATIONS AND USAGE
LUMIGAN® 0.01% (bimatoprost ophthalmic solution) is indicated for the
reduction of elevated
intraocular pressure in chronic open-angle glaucoma and ocular
hypertension in adults (as
monotherapy or as adjunctive therapy to beta-blockers).
3
DOSAGE AND ADMINISTRATION
Dosage
The recommended dosage is one drop in the affected eye(s) once daily,
administered in the
evening. The dose should not exceed once daily, as more frequent
administration may lessen the
intraocular pressure lowering effect.
_Paediatric population: _
The safety and efficacy of LUMIGAN® in children aged 0 to 18 years
has not yet been established.
Patients with hepatic and renal impairment:
LUMIGAN®
has
not
been
studied
in
patients
with
renal
or
moderate
to
severe
hepatic
impairment and should therefore be used with caution in such patients.
In patients with a history
of mild liver disease or abnormal alanine aminotransferase (ALT),
aspartate aminotransferase
(AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops,
solution had no adverse
effect on liver function o