国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
METHADONE HYDROCHLORIDE (UNII: 229809935B) (METHADONE - UNII:UC6VBE7V1Z)
Direct_Rx
ORAL
PRESCRIPTION DRUG
Methadone hydrochloride tablets 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, 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 USP are not indicated as an as-needed (prn) analgesic. • Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). • Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate
16.1 Storage and Handling Methadone hydrochloride tablets contain methadone which is a controlled substance. Like fentanyl, morphine, oxycodone, hydromorphone, and oxymorphone, methadone is controlled under Schedule II of the Federal Controlled Substances Act. Methadone hydrochloride may be targeted for theft and diversion by criminals [see Warnings and Precautions (5.1)]. Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] 16.2 How Supplied Methadone Hydrochloride Tablets USP 5 mg tablets supplied as round, white, biconvex tablets debossed with product identification “54” above “210” on one side and scored on the other side. : Bottle of 100 Tablets : 4x25 Unit-Dose Tablets (reverse numbered) 10 mg tablets supplied as round, white, biconvex tablets debossed with product identification “54” above “142” on one side and scored on the other side. : Bottle of 100 Tablets : 4x25 Unit-Dose Tablets (reverse numbered) DEA order form required.
New Drug Application
METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET Direct_Rx ---------- MEDICATION GUIDE Methadone Hydrochloride Tablets USP CII (METH a done) Rx Only Methadone hydrochloride is: • 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: • Get emergency help right away if you take too much methadone hydrochloride (overdose). When you first start taking methadone hydrochloride, 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. • Never give anyone your methadone hydrochloride. They could die from taking it. Store methadone hydrochloride away from children and in a safe place to prevent stealing or abuse. Selling or giving away methadone hydrochloride is against the law. Do not take methadone hydrochloride if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. Before taking methadone hydrochloride, tell your healthcare provider if you have a history of: • head injury, seizures • liver, kidney, thyroid problems • problems urinating • pancreas or gallbladder problems • heart rhythm problems (Long QT syndrome) • abuse of street or prescription drugs, alcohol addiction, or mental health problems. Tell your healthcare provider if you are: • pregnant or planning to bec 完全なドキュメントを読む
METHADONE HYDROCHLORIDE- METHADONE HYDROCHLORIDE TABLET DIRECT_RX ---------- METHADONE HYDROCHLORIDE WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION Addiction, Abuse, and Misuse Methadone hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing methadone hydrochloride tablets, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)]. Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of methadone hydrochloride tablets. Monitor for respiratory depression, especially during initiation of methadone hydrochloride tablets or following a dose increase [see Warnings and Precautions (5.2)]. Accidental Ingestion Accidental ingestion of even one dose of methadone hydrochloride tablets, especially by children, can result in a fatal overdose of methadone [see Warnings and Precautions (5.2)]. Life-threatening QT Prolongation QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Closely monitor patients for changes in cardiac rhythm during initiation and titration of methadone hydrochloride tablets [see Warnings and Precautions (5.3)]. Neonatal Opioid Withdrawal Syndrome Prolonged use of methadone hydrochloride tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts 完全なドキュメントを読む