BEPROSONE CREAM 0.064% WW

국가: 말레이시아

언어: 영어

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

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Download 환자 정보 전단 (PIL)
03-07-2023
Download 제품 특성 요약 (SPC)
03-07-2023

유효 성분:

BETAMETHASONE DIPROPIONATE

제공처:

HOE PHARMACEUTICALS SDN. BHD.

INN (국제 이름):

BETAMETHASONE DIPROPIONATE

패키지 단위:

450 gm; 15 gm

Manufactured by:

HOE PHARMACEUTICALS SDN. BHD.

환자 정보 전단

                                * Outer Carton not applicable for 450g pack size.
                                
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제품 특성 요약

                                BEPROSONE CREAM AND OINTMENT 0.064% W/W
Est. 1979
NAME AND STRENGTH OF ACTIVE SUBSTANCE :
Betamethasone dipropionate 0.064% w/w (equivalent to Betamethasone
0.05% w/w).
PRODUCT DESCRIPTION :
CREAM : A white cream.
Other ingredients: Monobasic Sodium Phosphate (Sodium Dihydrogen
Phosphate Dihydrate),
Chlorocresol, Macrogol Cetostearyl Ether (Cetomacrogol 1000),
Propylene Glycol, White Soft
Paraffin,
Cetostearyl
Alcohol,
Phosphoric
Acid
85%,
Liquid
Paraffin
and
Purified Water.
OINTMENT : A white ointment.
Other ingredients: Liquid Paraffin and White Soft Paraffin.
PHARMACODYNAMICS
:
Betamethasone
dipropionate
is
a
topically
active
fluorinated
corticosteroids which has anti-inflammatory, antipruritic and
vasoconstrictive actions.
PHARMACOKINETICS
:
Corticosteroids
are
extensively
bound
to
plasma
protein.
Only
unbound
corticosteroids
have
pharmacological
effects
or
are
metabolised.
They
are
metabolised mainly in the liver and also in the kidney, and are
excreted in the urine.
INDICATIONS : For the relief of inflammatory manifestations of
corticosteroids-responsive
dermatoses.
CONTRAINDICATIONS : Hypersensitivity to betamethasone dipropionate,
other corticosteroids,
or any component in the base.
DRUG INTERACTIONS : Not known.
ADVERSE EFFECTS : 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.
WARNINGS AND PRECAUTIONS : Discontinue use if irritation, sensitivity
or other reaction
develops and institute appropriate treatment. Corticosteroid applied
to the skin can be absorbed in
sufficient amounts to produce systemic effects such as
hypothalamic-pituitary-adrenal axis
suppression,
manifestation
of
Cushing's
syndrome,
hyperglycaemia
and
glucosuria. Thus
suitable precautions should be taken during prolonged treatment, when
tr
                                
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