methadone hydrochloride tablet
1 INDICATIONS AND USAGE Methadone hydrochloride tablets, USP are indicated for the: 1. 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. 2. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 3. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 [see Dosage and Administration (2.1)] . Methadone hydrochloride tablets, USP are an opioid agonist indicated for the: 4. 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, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise • Methadone hydrochloride tablets, USP are not indicated as an as-needed (prn) analgesic.Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 5. Detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 6. Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.( 1 ) Limitations of Use • Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 42 CFR 8.12 ( 2.1 ).
epic pharma, llc
ROUND WHITE E 318
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16 HOW SUPPLIED/STORAGE AND HANDLING
METHADONE HYDROCHLORIDE Tablets, USP 5 mg are white to off-white, round flat-faced beveled-edge tablets, debossed “Є” above "317" on one side and bisect on the other side. They are supplied as follows: Bottles of 100 (NDC 42806-317-01)
METHADONE HYDROCHLORIDE Tablets, USP 10 mg are white to off-white, round biconvex tablets, debossed “Є” above "318" on one side and bisect on the other side. They are supplied as follows: Bottles of 100 (NDC 42806-318-01) Store at 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. Store
METHADONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17) ].
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