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methadone hydrochloride 10 MG Oral Tablet

1 INDICATIONS AND USAGE 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. 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 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 is an opioid agonist 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 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. 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 social and medical services. ( 1 )

American Health Packaging


7 months ago ROUND WHITE ASC 116 methadone hydrochloride 10 MG Oral Tablet

ROUND WHITE ASC 116

7 months ago ROUND WHITE ASC 116 methadone hydrochloride 10 MG Oral Tablet

ASC 116 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Storage and Handling

METHADONE HYDROCHLORIDE tablets, USP contains 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 tablets, USP may be targeted for theft and diversion by criminals [see Warnings and Precautions ( 5.1 )]. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. 16.2 How Supplied

METHADONE HYDROCHLORIDE Tablets, USP 10 mg Tablets: white, round, biconvex tablet, scored on one side and debossed “ASC 116” on the other side. Unit dose packages of 100 (10 x 10) NDC 68084-738-01. DEA order form required.

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