METHADONE HYDROCHLORIDE Methadone Hydrochloride 10 MG Oral Tablet
1 INDICATIONS AND USAGE Methadone hydrochloride tablets are indicated for the: 1. Management of severe and persistent pain that requires an extended treatment period with daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [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 are an opioid agonist indicated for the: 1. Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. (1) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opioids, reserve methadone hydrochloride tablets 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 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 )
Mallinckrodt, Inc.
RECTANGLE WHITE M 57 71
M 57 71 RECTANGLE WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
METHADONE HYDROCHLORIDE Tablets USP 5 mg are white to off-white, modified rectangle shaped convex tablets, one side debossed with a score between “57” and “55”; M on the other side. Bottles of 100 ...................NDC 0406-5755-01 Unit Dose (10 x 10)...........NDC 0406-5755-62
METHADONE HYDROCHLORIDE Tablets USP 10 mg are white to off-white, modified rectangle shaped convex tablets, one side debossed with a score between “57” and “71”; M on the other side. Bottles of 100 ...................NDC 0406-5771-01 Unit Dose (10 x 10)...........NDC 0406-5771-62 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]. Store
METHADONE HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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