BEPROGENT OINTMENT

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

BETAMETHASONE DIPROPIONATE; GENTAMICIN SULPHATE

Saatavilla:

HOE PHARMACEUTICALS SDN. BHD.

INN (Kansainvälinen yleisnimi):

BETAMETHASONE DIPROPIONATE; GENTAMICIN SULPHATE

Kpl paketissa:

15 gm; 450 gm

Valmistaja:

HOE PHARMACEUTICALS SDN. BHD.

Pakkausseloste

_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BEPROGENT OINTMENT/CREAM
Betamethasone Dipropionate / Gentamicin Sulphate (0.064%w/w, 0.17%w/w)
1
_ _
WHAT IS IN THIS LEAFLET
1.
What Beprogent Ointment/
Cream is used for
2.
How Beprogent Ointment/
Cream works
3.
Before you use Beprogent
Ointment/Cream
4.
How to use Beprogent
Ointment/Cream
5.
While you are using
Beprogent Ointment/Cream
6.
Side effects
7.
Storage and Disposal of
Beprogent Ointment/Cream
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
This leaflet answers some common
questions
about
this
medicine.
It
does not contain all the available
information.
It
does
not
take
the
place of talking to your pharmacist
or doctor.
Your
pharmacist
or
doctor
has
weighed the risks of you taking this
medicine against the benefits they
expect it will have for you. If you
have any concerns about taking this
medicine, ask your pharmacist or
doctor.
Keep this leaflet with the medicin
E.
You may need to read it again.
WHAT BEPROGENT OINTMENT/
CREAM IS USED FOR
Beprogent Ointment/Cream is used
as topical treatment in inflammatory
skin
conditions,
where
bacterial
infection is also present or likely to
occur.
HOW BEPROGENT OINTMENT/CREAM
WORKS
Beprogent
Ointment/Cream
contains
active
ingredients
Betamethasone
Dipropionate
and
Gentamicin Sulphate.
Betamethasone
Dipropionate
is
a
type of corticosteroid (steroid) that
helps reduce swelling, itching and
redness.
Gentamicin Sulphate is an antibiotic
that provides antibacterial activity
against
most
germs
(bacteria)
on
skin.
Ask your pharmacist or doctor if you
have
any
questions
about
this
medicine.
BEFORE YOU USE BEPROGENT
OINTMENT/CREAM
_-When you must not use it _
Do not use this medicine if you
have an allergy or have had
an adverse reaction to;
- Betamethasone dipropionate or
any other corticosteroid
- Gentamicin sulphate
- Any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include shortness of
breath,
wheezing
or
diffic

Valmisteyhteenveto

Est. 1979
BEPROGENT OINTMENT
NAME
AND
STRENGTH
OF
ACTIVE
SUBSTANCES
:
Betamethasone
dipropionate
0.064% w/w (equiv. to Betamethasone 0.05% w/w) and Gentamicin sulphate
0.17% w/w (equiv.
to Gentamicin 0.1% w/w).
PRODUCT DESCRIPTION : A white ointment.
Other ingredients : White Soft Paraffin and Liquid Paraffin.
PHARMACODYNAMICS
:
_Betamethasone _
_dipropionate_
is
a
topically
active
fluorinated
corticosteroid which has anti-inflammatory, antipruritic and
vasoconstrictive actions. _Gentamicin _
_sulphate_ is a broad spectrum aminoglycoside antibiotic which is
bactericidal. It is effective
against many strains of gram-negative bacteria and _Staphylococcus
aureus_.
PHARMACOKINETICS
:
_Corticosteroids_
are
extensively
bound
to
plasma
protein.
Only
unbound corticosteroids has pharmacological effects or is metabolised.
They are metabolised mainly in the liver and also in the kidney, and
are excreted in the urine.
_Gentamicin sulphate_ is a bactericidal antibiotic which is active
against a wide variety of
pathogenic gram-positive and gram-negative bacteria. When applied
topically to large areas of
denuded body surface as the case of burn patients, plasma
concentrations can reach 1mcg/ml,
and 2% of the drug used may appear in the urine.
INDICATIONS : Treatment of impetigo, erythema and other localised
primary bacterial skin
infection
with
a
Gram-negative
component
and
also
for
secondary
bacterial
infections
complicating other pre-existing dermatoses.
CONTRAINDICATION : Hypersensitivity to betamethasone dipropionate,
gentamicin sulphate
or any component in the base.
DRUG INTERACTION : Not known.
ADVERSE EFFECT : _ Betamethasone Dipropionate_ - Reported local
adverse reactions are
burning sensation, itching, irritation, dryness, folliculitis,
hypertrichosis, acneiform eruptions,
hypopigmentation, maceration of the skin, secondary infection, skin
atrophy, striae and miliaria.
Systemic adverse reactions, such as vision blurred, have also been
reported with the use of
topical corticosteroids.
_Gentamicin Sulphate_ - Ototoxicit