MAXITROL STERILE OPHTHALMIC OINTMENT

Country: Malaysia

Language: English

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

Active ingredient:

NEOMYCIN SULPHATE; DEXAMETHASONE; POLYMYXIN B SULPHATE

Available from:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Name):

NEOMYCIN SULPHATE; DEXAMETHASONE; POLYMYXIN B SULPHATE

Units in package:

3.5gm0 mcg/mL

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Patient Information leaflet

MAXITROL OINTMENT
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 Ointment is used for
2.
How Maxitrol Ointment works
3.
Before you use Maxitrol Ointment
4.
How to use Maxitrol Ointment
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Maxitrol
Ointment
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MAXITROL OINTMENT IS USED FOR
Maxitrol is indicated for eye
inflammation and bacterial infections in
the external part of the eye.
HOW MAXITROL OINTMENT_ _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 OINTMENT
_- When you must not use it _
Do not use Maxitrol Ointment
•
If you are allergic to dexamethasone,
neomycin, polymyxin B or any of
the other ingredients of Maxitrol
Ointment.
•
If you think you have viral, fungal or
bacterial infection in 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 Ointment is not
recommended during pregnancy or
breast-feeding.
_ _
-
_Before you start to use it _
•
If you experience allergic reactions
with Maxitrol Ointment, 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 may occur
with other antibiotics of the same
family (aminoglycosides).
•
If you use Maxitrol Ointment for a
long period of time, you may:
•
Have increased pressure in your
eye(s). You should

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 dropsin 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 bottle is first opened.