Desud Plus 8mg2mg Sublingual Tablets

국가: 말레이시아

언어: 영어

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

유효 성분:

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

제공처:

Medicell Pharmaceutical(malaysia) Sdn.bhd

INN (International Name):

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

패키지 단위:

28tablet Tablets

Manufactured by:

Lotus Pharmaceutical Co Ltd

환자 정보 전단

_Consumer Medication Information Leaflet (RiMUP) _
___________________________________________________________________________
1
DESUD PLUS 8 MG/2 MG SUBLINGUAL TABLETS
Buprenorphine 8mg / Naloxone 2mg
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Desud Plus.
It
does
not
contain
all
the
available information. It does
not take the place of talking to
your doctor or pharmacist.
All
medicines
have
benefits
and
risks.
Your
doctor
has
weighed the risks of you taking
Desud Plus against the benefits
expected for you.
This
medicine
has
been
prescribed for you. Do not pass
it on to others. It may harm
them, even if their symptoms
are the same as yours.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR
OR
PHARMACIST.
IF ANY OF THE SIDE EFFECTS GETS
SERIOUS, OR IF YOU NOTICE ANY
SIDE EFFECTS NOT LISTED IN THIS
LEAFLET, PLEASE TELL YOUR DOCTOR
OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
YOUR
MEDICINE.
You may need to read it again.
WHAT DESUD PLUS IS USED FOR
Desud Plus is part of a medical,
social
and
psychological
treatment program for patients
addicted
to
opiate
(narcotic)
drugs. Treatment is prescribed
and
monitored
by
physicians
who
are
specialists
in
the
treatment of drug dependence.
Treatment with Desud Plus is
intended for use in adults and
adolescents
over
15
years
of
age. Desud Plus should be used
only
with
caution
in
adolescents aged 15 ≤ 18.
HOW DESUD PLUS WORKS
Desud Plus works by targeting
receptors
and
deterring
intravenous
misuse
of
this
product,
thus
suppressing
withdrawal
symptoms
and
reducing cravings.
If taken properly, Desud Plus
will not make you high, instead
it
will
reduce
withdrawal
symptoms and eventually lead
to
the
remission
of
opiate
addiction.
BEFORE YOU USE DESUD PLUS
_When you must not take it_
Do not take Desud Plus if you
have:
•
Hypersensitivity
towards
Buprenorphine,
Naloxone,
or
any
component
of
this
product
•
Severe
respiratory
insufficiency
•
Severe hepatic insufficiency
•
Acute
alcoholism
or
delirium tremens
•
Are
pregnant
and/or

제품 특성 요약

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1
Controlled Medicine
DESUD PLUS 8 MG/ 2 MG SUBLINGUAL TABLETS
COMPOSITION
EACH DESUD PLUS 8 MG/2 MG SUBLINGUAL TABLET CONTAINS:
Buprenorphine
．
HCl…… 8.624mg and Naloxone
．
HCl
．
2H
2
O…….2.443mg
(Eq. to Buprenorphine……8.0mg and
Naloxone……………………..2.0mg)
PRODUCT DESCRIPTION
Desud Plus 8 mg/2 mg sublingual tablets contain buprenorphine HCI and
naloxone HCI dihydrate
with a 4:1 buprenorphine to naloxone ratio (free bases).
The tablets are orange, hexagon, biconvex tablets, debossed with
“LP” on one side and “24” on
the other side for identification purpose.
STRUCTURAL FORMULA OF BUPRENORPHINE HCL
Naloxone hydrochloride is a white to slightly off-white powder and is
soluble in water, in dilute
acids
and
in
strong
alkali.
Chemically,
naloxone
is
17-Allyl-4,5
α
-epoxy-3,
14-
dihydroxymorphinan-6-one hydrochloride. Naloxone hydrochloride has the
molecular formula
C
19
H
21
NO
4
HCl .2H
2
O and the molecular weight is 399.87
STRUCTURAL FORMULA OF NALOXONE HCI
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2
Desud Plus 8 mg/2 mg sublingual tablets are uncoated hexagonal orange
tablets intended for
sublingual administration at a dose of 8mg buprenorphine free base
plus 2mg naloxone free
base.
CLINICAL PHARMACOLOGY
_MAIN EFFECTS: _
Comparisons of buprenorphine with full agonists such as methadone and
hydromorphone
suggested that sublingual buprenorphine produced typical opioid
agonist effects which are
limited by a ceiling effect.
In
non-dependent
subjects,
acute
sublingual
doses
of
buprenorphine
＋
naloxone
tablets
produced opioid agonist effects, which reached a maximum between doses
of 8 mg and 16mg
of Buprenorphine sublingual tablets. The effects of 16mg buprenorphine
＋
naloxone sublingual
tablets were similar to those produced by 16mg buprenorphine
sublingual tablets
Opioid agonist ceiling effects were also observed in a double-blind,
parallel group, dose ranging
comparison of single doses of buprenorphine sublingual solution (1, 2,
4, 8, 16, or 32 mg),
placebo, and a full agonist control at various doses. Th