Health Vidya

Methadone Hydrochloride Oral Concentrate (Intensol™) contains methadone, 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 oBecause 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 (5.5)], reserve Methadone Hydrochloride Intensol™ 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. oMethadone Hydrochloride Intensol™ 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 21 CFR, Title 42, Sec. 8 [see Dosage and Administration (2.1)].