TERRAMYCIN OPHTHALMIC OINTMENT

Land: Maleisië

Taal: Engels

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

Werkstoffen:

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULPHATE

Beschikbaar vanaf:

PFIZER (MALAYSIA) SDN. BHD.

INN (Algemene Internationale Benaming):

OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULPHATE

Eenheden in pakket:

3.5 gm

Geproduceerd door:

PT PFIZER (INDONESIA)

Bijsluiter

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TERRAMYCIN
®
EYE OINTMENT
Oxytetracycline/Polymyxin B (5 mg / 10,000 units per gram)
1
WHAT IS IN THIS LEAFLET
1.
What TERRAMYCIN is used for
2.
How TERRAMYCIN works
3.
Before you use TERRAMYCIN
4.
How to use TERRAMYCIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
TERRAMYCIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT TERRAMYCIN IS USED FOR
TERRAMYCIN is used in the treatment
of superficial eye infections.
HOW TERRAMYCIN WORKS
TERRAMYCIN contains two different
antibiotics, oxytetracycline and
polymyxin B.
Oxytetracycline belongs to a group of
medicines called tetracycline antibiotics.
The combination of oxytetracycline and
polymyxin B works by killing or stopping
the growth of bacteria causing your
infection.
BEFORE YOU USE TERRAMYCIN
-
_When you must not use it_
DO NOT use TERRAMYCIN if you
have ever had an allergic reaction to
oxytetracycline, polymyxin B or any of
the other the ingredients of the
ointment.
_Pregnancy and lactation_
The safety of topical (applied to body
surfaces) tetracyclines has not been
established in pregnant women. You
should use topical tetracyclines only
after discussing the potential benefits to
you and the potential risks to your
unborn child with your doctor.
It is not known whether topically applied
tetracyclines are distributed into breast
milk. Because of the potential for serious
adverse reactions in nursing infants, a
decision should be made whether to
discontinue nursing or discontinue the
drug, taking into account the importance
of the medicine to the mother. Ask your
doctor or pharmacist for advice before
using this medicine.
-
_Before you start to use it_
Check with your doctor before you use
this medicine.
-
_Taking other medicines_
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
There are no known intera

Productkenmerken

Pfizer Confidential
1
1.
NAME OF THE MEDICINAL PRODUCT
TERRAMYCIN w/Polymyxin B
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ophthalmic Ointment with Polymyxin B contains 0.5% oxytetracycline and
10,000 units of
Polymyxin B per gram of sterile petrolatum base.
A 1% solution in water is acidic (pH about 2.5). Its potency is
reduced in solutions more
acidic than pH 2 and it is rapidly destroyed by alkali hydroxides.
Oxytetracycline
is
chemically
designated
as
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenacarboxamide
and has a molecular formula of C
22
H
24
N
2
O
9
.
The molecular weight of oxytetracycline hydrochloride is 496.90. It is
an odorless, bitter,
yellow crystalline powder soluble in water. It forms a cloudy or
turbid solution in water due
to liberation of oxytetracycline base.
Polymyxin B Sulfate is a white or buff-coloured, hygroscopic powder,
odorless or with a
slight odor. It is very soluble in water with a 2% solution producing
a pH of 5 to 7.
3.
PHARMACEUTICAL FORM
Oxytetracycline Ophthalmic Ointment with Polymyxin B
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxytetracycline with Polymyxin B Ophthalmic preparations are indicated
in the treatment of
superficial ocular infections involving the conjunctiva and/or cornea
due to susceptible
microorganisms.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oxytetracycline with Polymyxin B ophthalmic preparations are
administered as a small
quantity (approximately 1 cm) of the ointment. The preparation should
be instilled or applied
into the conjunctival sac of the lower lid 4 to 6 times daily until
the infection is cleared and
healing is complete. This may take from one day to several weeks
depending on the nature
and severity of the infection. In blepharitis, scales and crusts
should be removed before
applying medication. For prophylaxis, the same procedure is followed
on the day before the
operation and subsequently for several days following it.
Pfizer Confidential
2
The patient should be