BACTAFUZ-B Fusidic Acid and Betamethasone Valerate Cream

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FUSIDIC ACID; BETAMETHASONE VALERATE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

FUSIDIC ACID; BETAMETHASONE VALERATE

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

ENCUBE ETHICALS PVT LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
BACTAFUZ-B FUSIDIC ACID AND BETAMETHASONE
VALERATE CREAM
Fusidic Acid (micronized) (2% w/w) and Betamethasone (as Valerate
ester) 0.10% w/w
1
WHAT IS IN THIS LEAFLET
1.
What BACTAFUZ-B Fusidic Acid
and Betamethasone Valerate
Cream is used for.
2.
How BACTAFUZ-B works.
3.
Before you use BACTAFUZ-B
.
4.
How to use BACTAFUZ-B
.
5.
While you are using it.
6.
Side effects.
7.
Storage and Disposal of
BACTAFUZ-B .
8.
Product Description.
9.
Manufacturer and Product
Registration Holder.
10.
Date of revision.
1.
WHAT BACTAFUZ-B
IS USED FOR
BACTAFUZ-B
is
used
to
treat
conditions
where
the
skin
is
inflamed
(eczema
or
dermatitis)
and
also
infected
by
germs
(bacteria).
2.
HOW BACTAFUZ-B
WORKS
BACTAFUZ-B
contains
two
different
types
of
medicine.
One
medicine is called Fusidic acid. It
is a type of antibiotic. The other
medicine is called Betamethasone
Valerate.
It
is
a
type
of
corticosteroid (steroid).
BACTAFUZ-B
works
by
the
antibiotic killing germs that cause
infections and corticosteroid help
to reduce any swelling, redness or
itchiness of your skin.
Your doctor may have prescribed
this medication for another reason.
Ask your doctor if you have any
questions
about
why
this
medication has been prescribed for
you.
3.
BEFORE YOU USE BACTAFUZ-B
-_When you must not use it _
•
If
you
are
allergic
(hypersensitive) to Fusidic acid
or Betamethasone Valerate.
•
If
you
are
allergic
(hypersensitive)
to
any
of
the
other
ingredients
in
this
medicine.
•
If
you
have
skin
condition
caused by fungus.
•
If
you
have
skin
conditions
caused by a virus such as cold
sores or chickenpox.
•
If you have skin conditions such
as boils or spots.
•
If
you
have
skin
conditions
caused by tuberculosis (TB) or
syphilis.
•
If you have perioral dermatitis.
This is a red spotty rash around
your mouth or chin
•
If
you
have
a
skin
condition
called acne rosacea. This is the
redness
and
inflammation
over
your nose and cheeks. Ask your
doctor if you are unsure.
_ _
_Pregnancy and lactation _
_Pregnan

Ciri produk

EMA9SPBJBJMY64100
Font Size : 8 Point (Times new roman)
BACTAFUZ-B
Fusidic Acid and Betamethasone Valerate cream
PRODUCT NAME:
BACTAFUZ-B
: Fusidic Acid and Betamethasone Valerate cream
NAME AND STRENGTH OF ACTIVE INGREDIENTS:
BACTAFUZ-B:
Fusidic Acid Ph. Eur 2.0%w/w, Betamethasone (as Valerate ester) Ph.
Eur. 0.10% w/w and Chlorocresol
Ph. Eur. (As preservative) 0.10%w/w
PRODUCT DESCRIPTION:
BACTAFUZ-B
: A white to off white smooth, homogeneous cream.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS PROPERTIES
PHARMACOTHERAPEUTIC GROUP: BETAMETHASONE AND ANTIBIOTICS, ATC CODE:
D07CC01
Fusidic Acid and Betamethasone Valerate cream combines the well-known
anti-inammatory and antipruritic effects of
Betamethasone with the potent topical antibacterial action of Fusidic
Acid. Betamethasone valerate is a topical steroid
rapidly effective in those inammatory dermatoses which normally
respond to this form of therapy. More refractory
conditions can often be treated successfully. When applied topically,
Fusidic Acid is effective against
_Staphylococcus _
_aureus, Streptococci, Corynebacteria, Neisseria_
and certain
_Clostridia_
and
_Bacteroides_
. Concentrations of 0.03 to 0.12
microgram per ml inhibit nearly all strains of
_S. aureus_
. The antibacterial activity of Fusidic Acid is not diminished in the
presence of Betamethasone.
PHARMACOKINETICS PROPERTIES
There are no data which dene the pharmacokinetics of Fusidic Acid
and Betamethasone Valerate cream, following topical
administration in man.
However, in vitro studies show that Fusidic Acid can penetrate intact
human skin. The degree of penetration depends on
factors such as the duration of exposure to fusidic Acid and the
condition of the skin. Fusidic Acid is excreted mainly in the
bile with little excreted in the urine.
Betamethasone is absorbed following topical administration. The degree
of absorption is dependent on various factors
including skin condition and site of application. Betamethasone is
metabolised largely in the liver but also to a limited extent