BACTOPIC (MUPIROCIN OINTMENT 2%)

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

MUPIROCIN

Доступна с:

SYNERRV SDN BHD

ИНН (Международная Имя):

MUPIROCIN

Штук в упаковке:

15 gm; 5 gm

Производитель:

KUSUM HEALTHCARE PVT. LTD.

тонкая брошюра

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BACTOPIC
®
Mupirocin Ointment 2%
1
WHAT IS IN THIS LEAFLET
1.
What BACTOPIC is used for
2.
How BACTOPIC works
3.
Before
you
use
BACTOPIC
4.
How to use BACTOPIC
5.
While you are using BACTOPIC
6.
Side effects
7.
Storage and Disposal of
BACTOPIC
8.
Product description
9.
Manufacturer and
Product
Registration Holder
10.
Date of Revision
WHAT BACTOPIC IS USED FOR
BACTOPIC is a topical antibacterial
ointment used to prevent or treat
bacterial skin infections such as an
infectious skin infection with
blistering and crusting known as
“impetigo”, infected hair follicles
which form pimples containing pus
known as “folliculitis” and recurring
boils known as “furunculosis”.
HOW BACTOPIC WORKS
BACTOPIC is an antibiotic
produced through fermentation by
the bacteria
_Pseudomonas _
_fluorescens_
. When absorbed into the
skin, it prevents formation of
bacterial protein and kills the
bacteria when applied to infected
skin area.
BEFORE YOU USE BACTOPIC
-
_When you must not use it _
Do not use BACTOPIC if:
•
you have an allergy or have had
an adverse reaction to any ofthis
medicine related ingredients. Some
of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin.
-
_Before you start to use it _
BACTOPIC can cause skin irritation
and allergic reactions
BACTOPIC is not suitable for:
•
eye infections
•
use inside your nose
•
skin near tubes inserted into your
body for the delivery or removal of
fluid (cannulae).
•
Keep the ointment away from your
eyes. If the ointment gets into your
eyes accidentally, wash them
thoroughly with water.
•
BACTOPIC ointment contains
polyethylene glycol, which in large
quantities can cause kidney damage.
Inform your doctor if you have
kidney problem. Avoid applying
BACTOPIC to large areas of broken
or damaged skin, especially if you
have problems with your kidneys.
Pregnancy and breast

Характеристики продукта

PACK INSERT
BACTOPIC®
MUPIROCIN OINTMENT 2% W/W
GENERAL CHARACTERISTICS
_GENERAL PHYSIO-CHEMICAL PROPERTIES: _
Whit e or almost whit e ointment.
COMPOSITION:
Each gram of ointment contains:
Mupirocin BP…….. 20 mg
EXCIPIENTS:
Polyethylene glycol 3350 & Polyethylene glycol 400
PHARMACODYNAMIC PROPERTIES:
PHARMACOTHERAPEUTIC GROUP:
Antibiotics and chemotherapeutics for dermatological use.
ATC CODE:
D06AX09
MODE OF ACTION
Mupirocin is a novel antibiotic produced through fermentation by
_Pseudomonas fluorescens_
.
Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby
arresting bacterial protein synthesis.
Mupirocin has bacteriostatic properties at minimum inhibitory
concentrations and bactericidal
properties at the higher concentrations reached when applied locally.
MECHANISM OF RESISTANCE
Low-level resistance in staphylococci is thought to result from point
mutations within the usual
staphylococcal chromosomal gene (ileS) for the target isoleucyl tRNA
synthetase enzyme. High-level
resistance in staphylococci has been shown to be due to a distinct,
plasmid encoded isoleucyl tRNA
synthetase enzyme.
Intrinsic resistance in Gram negative organisms such as the
_Enterobacteriaceae _
could be due to poor
penetration of the outer membrane of the Gram negative bacterial cell
wall.
Due to its particular mode of action, and its unique chemical
structure, Mupirocin does not show any
cross-resistance with other clinically available antibiotics.
MICROBIOLOGICAL SUSCEPTIBILITY
The prevalence of acquired resistance may vary geographically and with
time for selected species,
and local information on resistance is desirable, particularly when
treating severe infections. As
necessary, expert advice should be sought when the local prevalence of
resistance is such that the
utility of the agent in at least some types of infection is
questionable.
COMMONLY SUSCEPTIBLE SPECIES
_Staphylococcus aureus* _
_Streptococcus pyogenes* _
_Streptococcus _
spp
_. _
(βhaemolytic, other than
_S. pyogenes_
)
SPECIES FOR WHICH ACQUIRED RESIS