BUPREN 2MG0.5MG SUBLINGUAL TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Unit dalam pakej:

28tablet Tablets; 7tablet Tablets

Dikeluarkan oleh:

Noripharma Sdn. Bhd.

Risalah maklumat

BUPREN SUBLINGUAL
TABLET
Buprenorphine (as hydrochloride) 8mg / Naloxone (as hydrochloride) 2mg
Buprenorphine (as hydrochloride) 2mg / Naloxone (as hydrochloride)
0.5mg
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What BUPREN is used for?
2.
How BUPREN works
3.
Before you use BUPREN
4.
How to use BUPREN
5.
While you are using BUPREN
6.
Side effects
7.
Storage and disposal of BUPREN
8.
Product description
9.
Manufacturer
and
product
registration Holder
10.
Date of revision
WHAT
BUPREN
IS
USED
FOR?
Medicinal
product
used
in
opioid
dependence.
BUPREN
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
BUPREN sublingual tablets is intended
for use in adults and adolescents over 15
years of age.
HOW BUPREN WORKS
BUPREN contain the active ingredients
buprenorphine
and
naloxone.
Buprenorphine acts as a substitute for
opiate drugs like heroin or morphine and
it helps withdrawal from opiate drugs
over
a
period
of
time.
When
taken
sublingually
(under
the
tongue)
as
prescribed, naloxone has no effect, as it
is
very
poorly
absorbed.
However,
if
BUPREN sublingual tablet is injected,
naloxone will act to block the effects of
other opiates like heroin or morphine,
leading
to
bad
withdrawal
symptoms.
Therefore,
naloxone
is
included
in
BUPREN
to
discourage
misuse
by
injection, (intravenous abuse) as it can
cause very bad withdrawal symptoms.
BUPREN
sublingual
tablet
should
be
used exactly as prescribed.
BEFORE YOU USE BUPREN
When you must not take it

If you are allergic (hypersensitive)
to buprenorphine, naloxone or any
of
the
other
ingredients
of
BUPREN,

If
you
have
serious
breathing
problems,

If you have serious problems with
your liver,

If
you
are
intoxicated
due
to
alcohol or have delirium tremens.
USING BUPREN
, WITH FOOD AND DRINK
Do
not
take
BUPREN
together
with
alcoholic
beverages
as
alco

Ciri produk

1
BUPREN SUBLINGUAL TABLET
DESCRIPTION:
BUPREN 8MG/2MG: A white to off white hexagonal shaped tablet with a
dimension of
11mmx10mm
BUPREN 2MG/0.5MG: A white to off white hexagonal shaped tablet with a
dimension of
6.5mmx5.9mm
PHARMACODYNAMICS:
Buprenorphine is an opioid partial agonist/antagonist which binds to
the µ (mu) and K (kappa)
receptors of the brain. Its activity in opioid maintenance treatment
is attributed to its slowly
reversible properties with the µ receptors, which over a prolonged
period, might minimize the need
of addicted patients for drugs.
Naloxone is an antagonist at µ (mu)-opioid receptors. Because of its
almost complete first pass
metabolism, naloxone administered orally or sublingually has no
detectable pharmacological
activity. However, when administered intravenously to opioid dependent
persons, the presence of
naloxone in BUPREN produces marked opioid antagonist effect and opioid
withdrawal, thereby
deterring intravenous abuse.
PHARMACOKINETIC:
BUPRENORPHINE
Absorption
Buprenorphine when taken orally undergoes first-pass metabolism with
N-dealkylation and
glucuroconjugation in the small intestine and the liver. The use of
this medicinal product by the oral
route is therefore inappropriate.
Peak plasma concentrations are achieved 90 minutes after sublingual
administration. Plasma levels
of buprenorphine increases with the sublingual dose.
Distribution:
The absorption of buprenorphine is followed by a rapid distribution
phase.
Metabolism and elimination:
Buprenorphine is metabolized by 14 N-dealkylation and
glucuroconjugation of the parent molecule
and the dealklated metabolite.
Elimination of buprenorphine is bi-or tri-exponential, with
t1/2
from plasma of 32 hours.
Buprenorphine is eliminated in the feces by biliary excretion of the
glucuroconjugated metabolites
(70%), the rest being eliminated in the urine.
NALOXONE:
Absorption and distribution:
Plasma naloxone concentration are low and decline rapidly following a
sublingual
administration.
Metabolism and elimination: The drug is me