BUFENCON INJECTION 1ML AMP

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE SODIUM PHOSPHATE; BETAMETHASONE DIPROPIONATE

Available from:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (International Name):

BETAMETHASONE SODIUM PHOSPHATE; BETAMETHASONE DIPROPIONATE

Units in package:

1ml mL

Manufactured by:

YUNG SHIN PHARMACEUTICAL IND. CO., LTD.

Summary of Product characteristics

R
DESCRIPTION: A white to off-white suspension.
INGREDIENTS: Each ml contains:
Betamethasone (as dipropionate)
..........................................................................
5mg
Betamethasone (as phosphate disodium)
...............................................................
2mg
Preservatives:
Benzyl Alcohol
......................................................................................................
5mg
Methyl Paraben
...................................................................................................
1.8mg
Propyl Paraben
....................................................................................................
0.2mg
PHARMACOLOGY:
_Pharmacodynamic:_
Betamethasone
decreases
or
prevents
tissue
responses
to
inflammatory
processes,
thereby
reducing
the
development
of
symptoms
of
inflammation
without
affecting
the
underlying
cause.
It
inhibits
accumulation
of
inflammatory
cells
including
macrophages
and
leukocytes
at
sites of inflammation.
_Pharmacokinetic:_
Prompt
therapeutic
activity
in
corticosteroid-responsive
conditions
is
achieved
by
the
so-
luble
ester,
betamethasone
sodium
phosphate,
which
is
quickly
absorbed
after
injection.
Sustained
activity
is
provided
by
betamethasone
dipropionate,
which
is
only
slightly
soluble
and
affords
a
repository
for
slow
absorption,
thereby
controlling
symptoms
over
a
prolonged
period.
Betamethasone
is
primarily
metabolized
in
the
liver,
others
in
the
kidney
and
tissue,
to
mostly inactive metabolites which are excreted in the urine.
INDICATIONS:
_Rheumatic disorders:_ As adjunctive therapy for short term
administration (to tide the patients over an
acute episode or exacerbation) in: post traumatic osteoarthritis;
synovitis of osteoarthritis; rheumatoid
arthritis, including juvenile rheumatoid arthritis (selected cases may
require low-dose maintenance
therapy); acute and subacute bursitis; epicondylitis; acute
nonspecific tenosynovitis; acute gouty arthritis;
psoriatic arthritis; ankylosing spondylitis.
_Collagen disease:_ During a