Methadone Injection 10mg/1mL

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

methadone hydrochloride, Quantity: 10 mg/mL

から入手可能:

Phebra Pty Ltd

INN（国際名）:

Methadone hydrochloride

医薬品形態:

Injection, solution

構図:

Excipient Ingredients: water for injections

投与経路:

Subcutaneous, Intramuscular

パッケージ内のユニット:

10

クラス:

Medicine Registered

処方タイプ:

(S8) Controlled Drug

適応症:

Methadone Injection is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. Methadone Injection is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Methadone Injection is not indicated as an as-needed (PRN) analgesia. Methadone Injection is not recommended for use in ambulant patients.

製品概要:

Visual Identification: Clear colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2010-02-05

情報リーフレット

Methadone Injection 10mg in 1mL
Page 1 of 4
_Version 02 _
METHADONE INJECTION
METHADONE HYDROCHLORIDE 10MG IN 1ML
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Methadone Injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor.
All medicines have risks and benefits
.
Your doctor has weighed the risks of
you being given Methadone Injection
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE BEING TREATED.
YOU MAY NEED TO READ IT AGAIN.
WHAT METHADONE
INJECTION
IS USED FOR?
Methadone Injection
is used to relieve
moderate to severe pain.
Methadone Injection belongs to a
group of medicines called opioid
analgesics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another reason.
This medicine is available only with a
doctor’s prescription_. _
People who are given Methadone
Injection for a long time to treat their
pain rarely become addicted to it.
However, with time, your body will
become used to taking Methadone
Injection and you may experience
symptoms due to withdrawal if you
stop getting this medicine. The
symptoms may include body aches,
diarrhoea, nervousness, shivering,
nausea, sleep disturbance, sweating,
weakness and fever.
If you have not done so already, you
should discuss this further with your
doctor.
Methadone Injection should not be
stopped suddenly in patients who may
have developed a physical dependence
on the medicine.
This medicine should be given with
great care to infants, especially
neonates, children, the elderly and
debilitated patients.
BEFORE YOU ARE GIVEN
METHADONE INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT_
_ _
YOU SHOULD NOT BE GIVEN METHADONE
INJECTION IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
methadone hydrochloride
•
any other similar opioid analgesics.
•
Some of the sy

製品の特徴

PRODUCT INFORMATION
Product Information- Methadone Injection 10mg in 1mL
Page 1 of 7
Version 02
Methadone Injection 10mg in 1mL
NAME OF THE MEDICINE
Methadone Hydrochloride
The chemical name for methadone hydrochloride is
(6RS)-6-(Dimethylamino)-4,4-diphenyl-3-heptanone hydrochloride and
the chemical structure is:
Molecular formula: C
21
H
27
NO,HCl Relative molecular mass: 345.9
CAS Number: 61849-14-7
DESCRIPTION
Methadone hydrochloride is a synthetic opioid analgesic with the
general properties of morphine. Methadone is a racemic
mixture and levo-methadone is the active isomer. Methadone occurs as
odourless, colourless crystals or white crystalline
powder. It is soluble in water, freely soluble in alcohol and
chloroform; practically insoluble in ether and in glycerol.
Each Methadone Injection vial contains 10 mg of methadone
hydrochloride and water for injections to 1 mL.
PHARMACOLOGY
The pharmacological actions of methadone are qualitatively similar to
those of morphine. Significant quantitative differences
are its effective analgesic activity after administration by the oral
route, and its tendency to show persistent effects with
repeated administration.
Methadone undergoes considerable tissue distribution, and protein
binding is reported to be 60 to 90% with alpha1-acid
glycoprotein being the main binding protein in plasma. Metabolism to
the major metabolite 2-ethylidine-1,5- dimethyl-3,3-
diphenylpyrrolidine and the minor metabolite 2-ethyl-3,3- diphenyl-5-
methylpyrrolidine, both of them inactive, occurs in the
liver. These metabolites are excreted in the faeces and urine together
with unchanged methadone. Other metabolites,
including methadol and normethadol (reported to be pharmacologically
active), have also been described but account for a
small proportion of the dose. The liver may also serve as a major
storage site of unchanged methadone which is taken up,
bound nonspecifically by the liver and released again mainly
unchanged.
Plasma concentrations have been found to vary widely during methadone
main