BEPROGENT CREAM

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE DIPROPIONATE; GENTAMICIN SULPHATE

Available from:

HOE PHARMACEUTICALS SDN. BHD.

INN (International Name):

BETAMETHASONE DIPROPIONATE; GENTAMICIN SULPHATE

Units in package:

15gm; 450gm

Manufactured by:

HOE PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

_ _
_ 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

Summary of Product characteristics

BEPROGENT CREAM
Est. 1979
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 cream.
Other ingredients: White Soft Paraffin, Liquid Paraffin,
Methylparaben, Propylparaben, Propylene
Glycol,
Macrogol
Cetostearyl
Ether,
Cetostearyl
Alcohol,
Sodium
Dihydrogen
Phosphate,
Phosphoric acid 85% and Purified water.
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, erythyma 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 miliar