No

Analgesic, Narcotic

Management of opiate dependence

C-II; must be dispensed in a designated clinic setting only

C

Not recommended for use outside of the treatment of opiate addiction; shall be dispensed only by treatment programs approved by FDA, DEA, and the designated state authority. Approved treatment programs shall dispense and use levomethadyl in oral form only and according to the treatment requirements stipulated in federal regulations. Failure to abide by these requirements may result in injunction precluding operation of the program, seizure of the drug supply, revocation of the program approval, and possible criminal prosecution.

>10%:

Central nervous system: Malaise

Miscellaneous: Flu syndrome

1% to 10%:

Central nervous system: CNS depression, sedation, chills, abnormal dreams, anxiety, euphoria, headache, insomnia, nervousness, hypesthesia

Endocrine & metabolic: Hot flashes (males 2:1)

Gastrointestinal: Abdominal pain, constipation, diarrhea, xerostomia, nausea, vomiting

Genitourinary: Urinary tract spasm, difficult ejaculation, impotence, decreased sex drive

Neuromuscular & skeletal: Arthralgia, back pain, weakness

Ocular: Miosis, blurred vision

<1%:

Cardiovascular: Postural hypotension

Neuromuscular & skeletal: Myalgia

Ocular: Tearing

Sedative, tranquilizers, propoxyphene, antidepressants, benzodiazepines, alcohol used in combination with ORLAAM® may result in serious overdose

ORLAAM® used in combination with naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine may result in withdrawal symptoms

Meperidine and propoxyphene may be ineffective in patients taking ORLAAM®

Carbamazepine, phenobarbital, rifampin, phenytoin may enhance the metabolism of ORLAAM® leading to an increase in ORLAAM®'s peak effect and shorten its duration of action

Erythromycin, cimetidine, and ketoconazole may slow the onset, lower the activity, and/or increase the duration of action of ORLAAM® via enzyme inhibitors

Store at room temperature

A synthetic opioid agonist with actions similar to morphine; principal actions are analgesia and sedation. Its clinical effects in the treatment of opiate abuse occur through two mechanisms: 1) cross sensitivity for opiates of the morphine type, suppressing symptoms of withdrawal in opiate-dependent persons; 2) with chronic oral administration, can produce sufficient tolerance to block the subjective high of usual doses of parenterally administered opiates

Adults: Oral: 20-40 mg 3 times/week, with ranges of 10 mg to as high as 140 mg 3 times/week; always dilute before administration and mix with diluent prior to dispensing

Patient adherence with regimen and avoidance of illicit substances; random drug testing is recommended

No information available to require special precautions

No effects or complications reported

Drug administration and dispensing is to take place in an authorized clinic setting only; can potentially cause Q-T prolongation on EKG (not dose related)

Solution, oral: 10 mg/mL (474 mL)

Blaine JD, Renault PR, Thomas DB, et al, "Clinical Status of Methadyl Acetate (LAAM)," Ann N Y Acad Sci, 1981, 362:101-15.

Kaiko RF and Inturrisi CE, "Disposition of Acetylmethadol in Relation to Pharmacologic Action," Clin Pharmacol Ther, 1975, 18(1):96-103.