NEO BETASONE CREAM

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
07-08-2020
Ciri produk Ciri produk (SPC)
29-10-2020

Bahan aktif:

BETAMETHASONE; NEOMYCIN SULPHATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

BETAMETHASONE; NEOMYCIN SULPHATE

Unit dalam pakej:

15 gm mcg/mL

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

                                Consumer Medication Information Leaflet (RiMUP)
NEO BETASONE CREAM
(Betamethasone (as 17-valerate) 0.1% w/w, Neomycin (as Sulphate) 0.5%
w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Neo Betasone Cream is
used for
2.
How Neo Betasone Cream
works
3.
Before you use Neo Betasone
Cream
4.
How to use Neo Betasone
Cream
5.
While you are using Neo
Betasone Cream
6.
Side effects
7.
Storage and disposal of Neo
Betasone Cream
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT NEO BETASONE CREAM IS USED
FOR
Neo Betasone is useful in treating
infective acute or chronic
inflammatory dermatoses such as:

Localized neurodermatitis (itchy
patch of skin)

Psoriasis (raised, red, scaly patches
to appear on the skin)

Atopic or seborrheoic dermatitis
(dry, itchy rash skin)

Inflammatory phase of xerosis (dry
skin)

Anogenital pruritus (itching, acute
or chronic, affecting the anal,
perianal, perineal and genital skin)

Discoid lupus erythematosus
(recurring scaly rash)

Lichen planus (chronic itchy skin
of unknown origin)

Granuloma annulare (raised
reddish or skin-colored bumps
(lesions) in a ring pattern)

Psoriatic plaques (dry, raised, red
skin lesions)

Allergic contact dermatitis or
irritant dermatitis
HOW NEO BETASONE WORKS
This cream contains topical
corticosteroids. Topical
corticosteroids are used to help
reduce inflammation in the affected
area which helps to reduce redness
and itchiness caused by the skin
disease. It also contains other
ingredient to help prevent or clear up
some bacterial infections of the skin.
BEFORE YOU USE NEO BETASONE_ _
_ _
_When you must not use it _
Do not use if you are allergic to
corticosteroids, neomycin or any
other ingredients contained in this
medicine as listed at the end of this
leaflet. Do not use on deep or
puncture wounds, serious burns or
raw areas unless directed by your
doctor.
If you are not sure whether you
should start using this medicine, talk
to your doctor or pharmacist.
_Before you start
                                
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Ciri produk

                                DESCRIPTION
White opaque cream.
COMPOSITION
Betamethasone (as 17-valerate)
0.1% w/w
Neomycin Sulphate
0.5% w/w
ACTIONS AND PHARMACOLOGY
•
PHARMACODYNAMICS
-
_BETAMETHASONE - 17 - VALERATE:_
Betamethasone - 17- valerate is a corticosteroid. Its
action is similar to that of cortisone. Betamethasone
diffuse
across
cell
membranes
and
complex
with
specific cytoplasmic receptors. These complexes then
enter the cell nucleus, bind to DNA (chromatin) and
stimulate transcription of messenger RNA (mRNA)
and subsequent protein synthesis of various enzymes
thought
to
be
ultimately
responsible
for
anti-inflammatory
effects
of
tropical
application
of
betamethasone.
-
_NEOMYCIN:_
Neomycin, an aminoglycoside effective against most
aerobic gram-negative bacilli, is actively transported
across the bacterial cell membrane. It then binds to a
specific
receptor
protein
on
the
30s
subunit
of
bacterial ribosomes. This interferes with an initiation
complex between mRNA (messenger RNA) and the
30s subunit, inhibiting protein synthesis. DNA may be
misread,
thus
producing
non-functional
proteins.
Polyribosomes
are
split
apart
and
are
unable
to
synthesize protein. Propagation of bacteria controlled.
•
PHARMACOKINETICS
-
_ABSORPTION: _
After topical application, small amounts of the vale rate
may be absorbed systematically during prolonged usage.
Topical
neomycin
is
readily
absorbed
from
large
denuded, burned or granulating areas.
-
_HALF-LIFE:_
Biological half-life of neomycin is about 2 hours.
-
_DISTRIBUTION:_
Neomycin may enter the cerebrospinal fluid and may
accumulate in renal function impairment.
-
_PROTEIN BINDING:_
About 60 to 65% of Betamethasone- 17-Valerate is
bound to plasma proteins.
-
_EXCRETION:_
Absorbed neomycin and betamethasone is excreted
through the urine.
INDICATIONS
For treatment of infective acute or chronic inflammatory
dermatoses such as:
•
Localized neurodermatitis
•
Psoriasis
•
Atopic or seborrhoeic dermatitis
•
Inflammatory phase of xerosis
•
Anogenital pruritus
•
Discoid lupus erythematosus
•
L
                                
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