MAXITROL SUSPENSION

Country: Malaysia

Language: English

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

Active ingredient:

DEXAMETHASONE; NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

DEXAMETHASONE; NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE

Units in package:

5ml mL

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Patient Information leaflet

MAXITROL SUSPENSION EYE DROP
Dexamethasone / Neomycin Sulfate / Polymyxin B Sulfate (1mg / 3,500 IU
/ 6000 IU)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Maxitrol Suspension is used
for
2.
How Maxitrol Suspension works
3.
Before you use Maxitrol Suspension
4.
How to use Maxitrol Suspension
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Maxitrol
Suspension
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MAXITROL SUSPENSION_ _IS USED FOR
Maxitrol is indicated eye inflammation
and bacterial infections in the external
part of the eye.
HOW MAXITROL SUSPENSION_ _WORKS
Maxitrol combines two antibiotics,
neomycin sulfate and polymyxin B
sulfate, offering broad spectrum
antibacterial activity with the anti-
inflammatory activity of a corticosteroid,
dexamethasone, for combating certain
microbial infections.
BEFORE YOU USE MAXITROL SUSPENSION_ _
_When you must not use it _
Do not use Maxitrol Suspension
•
If you are allergic to dexamethasone,
neomycin, polymyxin B or any of
the other ingredients of Maxitrol
Suspension.
•
If you think you have:
o
Herpes simplex keratitis,
Smallpox, Chickenpox /
Herpes Zoster, or any other
viral infection of the eye
o
Fungal diseases of the eye
or an untreated parasitic
eye infection
o
Tuberculosis of the eye
_ _
Safety and effectiveness of MAXITROL
in children have not been established.
_ _
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
you think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before using
this medicine. Maxitrol Suspension is not
recommended during pregnancy or
breast-feeding.
_ _
_ _
-
_Before you start to use it _
•
If you experience allergic reactions
with Maxitrol Suspension,
discontinue use and consult your
doctor. Allergic reactions may vary
from localized itching or skin redness
to severe allergic reactions
(anaphylactic reaction) or serious skin
reactions. These allergic reactions

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
MAXITROL
®
suspension
MAXITROL
®
sterile ophthalmic ointment
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MAXITROL
®
suspension
1 ml of suspension contains 1 mg dexamethasone, 3,500 (International
Units) IU of
neomycin sulfate and 6,000 IU polymyxin B sulfate.
Excipients with known effects: Benzalkonium Chloride 0.04 mg/ml.
MAXITROL
®
sterile ophthalmic ointment
1 g of ointment contains 1 mg dexamethasone, 3,500 IU neomycin sulfate
and 6,000 IU
polymyxin B sulfate.
Excipients
with
known
effects:
methyl
parahydroxybenzoate
(E218),
propyl
parahydroxybenzoate (E216), wool fat.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
MAXITROL
®
suspension
Sterile ophthalmic suspension
Opaque, white to pale yellow suspension, no agglomerates
MAXITROL
®
sterile ophthalmic ointment
Sterile ophthalmic ointment
A greasy, translucent to opaque and white to light yellow, homogeneous
ointment, free of
lumps.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MAXITROL
®
combines two antibiotics, neomycin sulfate and polymyxin B sulfate,
offering
broad spectrum antibacterial activity with the anti-inflammatory
activity of a corticosteroid,
dexamethasone, for combating certain microbial infections of the
anterior segment of the
eye(s).
The suspension also contains hypromellose for maximum effectiveness
and comfort.
MAXITROL
®
is indicated for ocular inflammation when concurrent use of an
antimicrobial
is judged necessary.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_General _
•
For ocular use.
•
If more than 1 topical ophthalmic medicinal product is being used, the
medicines
must be administered at least 5 minutes apart. Ointments should be
administered
last.
_Adults and Elderly _
MAXITROL
®
suspension
•
1 to 2 drops in the conjunctival sac 4 to 6 times daily. In severe
disease, drops may
be used hourly, being tapered to discontinuation as the inflammation
subsides.
•
Shake the bottle well before use.
•
Remove the loose collar from the cap when the bottl