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Methadone Hydrochloride 10 MG Oral Tablet

1 INDICATIONS & 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, reserve Methadone Hydrochloride Tablets, USP 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. 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. (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 [see Dosage and Administration (2.1)] . Methadone Hydrochloride Tablets, USP is an opioid agonist 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, 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 inadequate to provide sufficient management of pain. Methadone Hydrochloride Tablets, USP 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. ( 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 ).

Aurolife Pharma, LLC


2 years ago ROUND WHITE U42 Methadone Hydrochloride 10 MG Oral Tablet

ROUND WHITE U42

2 years ago ROUND WHITE U42 Methadone Hydrochloride 10 MG Oral Tablet

U42 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

METHADONE HYDROCHLORIDE Tablets, USP 5 mg are white to off white, round tablets debossed with ‘U41’on one side and break line on the other side. Bottles of 30 NDC 13107-088-30 Bottles of 100 NDC 13107-088-01 Bottles of 1000 NDC 13107-088-99

METHADONE HYDROCHLORIDE Tablets, USP 10 mg are white to off white, round tablets debossed with ‘U42’on one side and break line on the other side. Bottles of 30 NDC 13107-089-30 Bottles of 100 NDC 13107-089-01 Bottles of 1000 NDC 13107-089-99 Store at 20° to 25°C (68° to 77°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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