methadone hydrochloride 5 MG Oral Tablet
1 INDICATIONS AND USAGE Methadone Hydrochloride Tablets 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 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 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. 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 ).
Hikma Pharmaceuticals USA Inc.
ROUND WHITE 54 210
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16 HOW SUPPLIED/STORAGE AND HANDLING Methadone Hydrochloride Tablets USP 5 mg tablets are white, biconvex tablets, scored on one side and product identification “54 210” debossed on the other side. NDC 0054-4570-25: Bottle of 100 Tablets NDC 0054-8553-24: 10x10 Unit-Dose The 10 mg tablets are white, biconvex tablets, scored on one side and product identification “54 142” debossed on the other side. NDC 0054-4571-25: Bottle of 100 Tablets NDC 0054-8554-24: 10x10 Unit-Dose Store at 20º to 25ºC (68º to 77ºF), with excursions permitted between 15º to 30ºC (59º to 86ºF). [See USP Controlled Room Temperature.] Store Methadone Hydrochloride Tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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