Patients should be provided the patient package insert for ORLAAM if they are new to the drug, and in addition should be advised that:

ORLAAM, unlike methadone, is not to be taken daily, and daily use of the usual doses will lead to serious overdose.

If a patient taking ORLAAM experiences symptoms suggestive of an arrhythmia (such as palpitations, dizziness, light-headedness, syncope, or seizures), that patient should seek medical attention immediately.

ORLAAM is slow acting and patients should be alerted to the risk of abusing any psychoactive drug, including alcohol, while on ORLAAM therapy. This is particularly important during the first 7 to 10 days of treatment, before ORLAAM has had time to exert its full pharmacologic effect.

In addition to being warned of the delay in onset of ORLAAM, patients who are transferring from ORLAAM to methadone should be informed that they should wait 48 hours after the last dose of ORLAAM before ingesting their first dose of methadone or other narcotic (see DOSAGE AND ADMINISTRATION ).

Patients should inform their adult family members that, in the event of overdose, the treating physician or emergency room staff should be told that the patient is being treated with ORLAAM, a long-acting opioid which is likely to outlast naloxone-induced reversal and which requires prolonged observation and careful monitoring. In addition, the treating physician or emergency room staff should be informed that the patient is physically dependent on narcotics and that naloxone should be administered with care so as to minimize any precipitated abstinence syndrome.

As with most mu agonists, ORLAAM may interact with other CNS depressants and should be used with caution, and in reduced dosage, in patients concurrently receiving other narcotic analgesics, antihistamines, benzodiazepines, phenothiazines or other major tranquilizers, anxiolytics, sedative-hypnotics, tricyclic antidepressants, and other CNS depressants, including alcohol. Patients should be warned of the importance of reporting the use of any of these compounds to their physicians, as serious side effects could result, including respiratory depression, hypotension, profound sedation or coma.

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