REVIA naltrexone hydrochloride 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

naltrexone hydrochloride

Available from:

Bristol-Myers Squibb Australia Pty Ltd

INN (International Name):

naltrexone hydrochloride

Authorization status:

Registered

Patient Information leaflet

REVIA
®
_Naltrexone hydrochloride (nal-TREX-own)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REVIA
®
. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking REVIA
against the benefits that are expected.
This leaflet does not contain
everything about REVIA. Your
doctor has been provided with full
information and can answer any
questions you may have. Follow your
doctor's advice even if it differs from
what is in this leaflet.
Please read this leaflet carefully and
keep it in a safe place so you may
refer to it later.
WHAT REVIA IS USED
FOR
REVIA is used to help opiate drug
addicts discontinue their habit. It is
also used to help alcoholics dry out
and remain abstinent. Your doctor
may have prescribed REVIA for
another use. Ask your doctor if you
have any questions about why
REVIA was prescribed for you.
REVIA is not addictive. This
medicine is available only with a
doctor's prescription.
HOW REVIA WORKS
REVIA tablets contain the active
ingredient, naltrexone hydrochloride.
It is an opiate antagonist. This means
it fights the effects of opiate drugs
(such as heroin) on the body, and
blocks euphoria (or "high") due to
these opiates.
The use of REVIA to treat your
condition can lead to side-effects,
which are discussed below.
BEFORE YOU TAKE
REVIA
REVIA is not suitable for everyone.
_WHEN YOU MUST NOT TAKE_
_REVIA:_
•
You must not take REVIA if you
have a history of severe allergic
reactions to REVIA or to any of
the ingredients listed at the end of
this leaflet.
•
DO NOT TAKE REVIA IF YOU ARE
STILL USING HEROIN OR DRUGS LIKE
IT.
If you take REVIA right after
taking an opiate you will suffer
withdrawal symptoms (cold
turkey) (such as nausea,
vomiting, shakiness, sweating and
anxiety) which may be severe.
•
Do not take REVIA if you are
experiencing withdrawal
symptoms.
•
Do not take REVIA if you are on
certain pain killers. Ask your
doctor or pharmac

Summary of Product characteristics

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PRODUCT INFORMATION
NAME OF MEDICINE
Naltrexone Hydrochloride
Naltrexone structure
CAS registry number of naltrexone hydrochloride is 16676-29-2.
DESCRIPTION
REVIA (naltrexone hydrochloride), an opioid antagonist, is a synthetic
congener of
oxymorphone with no opioid agonist properties. Naltrexone differs in
structure from
oxymorphone in that the methyl group on the nitrogen atom is replaced
by a
cyclopropylmethyl group. REVIA is also related to the potent opioid
antagonist,
naloxone, or n-allylnoroxymorphone [NARCAN® (naloxone
hydrochloride)]. The
chemical name of naltrexone hydrochloride is
17-(cyclopropylmethyl)-4,5

-epoxy-
3,14-dihydroxymorphinan-6-one hydrochloride.
Naltrexone hydrochloride is a white, crystalline compound. The
hydrochloride salt is
soluble in water to the extent of about 100 mg/mL. REVIA is available
in scored film
coated tablets containing 50 mg of naltrexone hydrochloride.
REVIA Tablets also contain lactose, microcrystalline cellulose,
crospovidone,
colloidal silicon dioxide, magnesium stearate, hydroxypropyl
methylcellulose,
titanium dioxide, polyethylene glycol, polysorbate 80, yellow iron
oxide and red iron
oxide.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
REVIA is a pure opioid antagonist. It markedly attenuates or
completely blocks,
reversibly, the subjective effects of all opioids.
When co-administered with morphine, on a chronic basis, REVIA blocks
the physical
dependence to morphine, heroin and other opioids.
REVIA has few, if any, intrinsic actions besides its opioid blocking
properties.
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Revia V4.0
However, it does produce some pupillary constriction, by an unknown
mechanism.
Clinical studies indicate that 50 mg of REVIA will block the
pharmacologic effects of
25 mg of intravenously administered heroin for periods as long as 24
hours. Other
data suggest that doubling the dose of REVIA provides blockade for 48
hours, and
tripling the dose of REVIA provides blockade for about 72 hours.
REVIA blocks the e