Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
methadone hydrochloride, Quantity: 10 mg/mL
Phebra Pty Ltd
Methadone hydrochloride
Injection, solution
Excipient Ingredients: water for injections
Subcutaneous, Intramuscular
10
Medicine Registered
(S8) Controlled Drug
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.
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
Licence status A
2010-02-05
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 Baca dokumen lengkapnya
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 Baca dokumen lengkapnya