国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)
McKesson Corporation
METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE 10 mg
ORAL
PRESCRIPTION DRUG
Methadone hydrochloride tablets, USP are indicated for the: - Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Warnings and Precautions (5.1)], reserve methadone hydrochloride tablets for use in patients for whom alternative analgesic treatment options (e.g., non-opioid analgesics or immediate-release opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Methadone hydrochloride tablets are not indicated as an as-needed (prn) analgesic. - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with long-acting opioids [see Wa
Product: 63739-006 NDC: 63739-006-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE
Abbreviated New Drug Application
McKesson Corporation ---------- MEDICATION GUIDE Methadone Hydrochloride Tablets, CII (METH a done hy.dro.chlo.ride) Methadone hydrochloride tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse than can lead to death. • Not for use to treat pain that is not around-the-clock. • Also used to manage drug addiction. Important information about methadone hydrochloride tablets: • Get emergency help right away if you take too much methadone hydrochloride tablets (overdose). When you first start taking methadone hydrochloride tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. • Taking methadone hydrochloride tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. • Never give anyone your methadone hydrochloride tablets. They could die from taking it. Store methadone hydrochloride tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away methadone hydrochloride tablets is against the law. Do not take methadone hydrochloride tablets if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • head injury, seizures • liver, kidney, thyroid problems • problems urinating • heart rhythm problems (Long QT syndrome) • pancreas o 阅读完整的文件
METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET MCKESSON CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHADONE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE TABLETS, FOR ORAL USE, CII. INITIAL U.S. APPROVAL: 1947 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P-450 ISOENZYMES; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ;AND TREATMENT FOR OPIOID ADDICTION _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ Methadone hydrochloride tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2) Accidental ingestion of methadone hydrochloride tablets, especially in children, can result in fatal overdose of methadone. (5.2) QT interval prolongation and serious arrhythmia (_torsades de pointes_) have occurred during treatment with methadone. Closely monitor patients with risk factors for development of prolonged QT interval, a history of cardiac conduction abnormalities, and those taking medications affecting cardiac conduction (5.3) Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of use of methadone hydrochloride tablets during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. The balance between the risks of NOWS and the benefits of maternal methadone hydrochloride tablets use may differ based on the risks associated with the mother's underlying conditi 阅读完整的文件