Recommended Topic Related To:

Orlaam

"Potential drug treatments are tested on paper, in laboratories and eventually in thousands of people. But every drug that goes through this cycle “ every drug that FDA approves “ carries some risk. One of the first lines of defense against "...

Orlaam

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

ORLAAM (levomethadyl acetate) is indicated for the management of opiate dependence. ORLAAM (levomethadyl acetate) should be reserved for the use in treatment of opiate-addicted patients who fail to show an acceptable response to other adequate treatments for opiate addiction, either because of insufficient effectiveness or the inability to achieve effective dose due to intolerable adverse effects from those drugs (see Black Box Warning ).

DOSAGE AND ADMINISTRATION

ORLAAM (levomethadyl acetate) produces opioid effects and a high degree of opioid tolerance that inhibits drug-seeking behavior and blocks the euphoria produced by the usual doses of heroin. The dose of ORLAAM (levomethadyl acetate) in each patient should be adjusted to achieve the optimal therapeutic benefit with acceptable adverse opioid effects (see INDIVIDUALIZATION OF DOSAGE ).

ORLAAM (levomethadyl acetate) must always be diluted before administration, and should be mixed with diluent prior to dispensing. To avoid confusion between prepared doses of ORLAAM (levomethadyl acetate) and methadone, the liquid used to dilute ORLAAM (levomethadyl acetate) should be a different color from that used to dilute methadone in any specific clinic setting.

ORLAAM (levomethadyl acetate) DOSING

Dosing Schedules

ORLAAM (levomethadyl acetate) is usually administered three times a week, either on Monday, Wednesday and Friday, or on Tuesday, Thursday and Saturday. If withdrawal is a problem during the 72-hour inter-dose interval, the preceding dose may be increased. In some cases, an every-other-day schedule may be appropriate (see INDIVIDUALIZATION OF DOSAGE ).

The usual doses of ORLAAM (levomethadyl acetate) must not be given on consecutive days because of the risk of fatal overdose. No dose mentioned in this label is ever meant to be given as a daily dose (see WARNINGS ).

INDUCTION

The initial dose of ORLAAM (levomethadyl acetate) for street addicts should be 20 to 40 mg. Each subsequent dose, administered at 48- or 72-hour intervals, may be adjusted in increments of 5 to 10 mg until a pharmacokinetic and pharmacodynamic steady-state is reached, usually within 1 or 2 weeks (see INDIVIDUALIZATION OF DOSAGE ).

Patients dependent on methadone may require higher initial doses of ORLAAM (levomethadyl acetate) . The suggested initial 3-times-a-week dose of ORLAAM (levomethadyl acetate) for such patients is 1.2 to 1.3 times the daily methadone maintenance dose being replaced. This initial dose should not exceed 120 mg and subsequent doses, administered at 48- or 72-hour intervals, should be adjusted according to clinical response.

Most patients can tolerate the 72-hour inter-dose interval during the induction period. Some patients may require additional intervention (see INDIVIDUALIZATION OF DOSAGE ). If additional opioids are required, and the patient is not eligible or appropriate for take home doses of ORLAAM (levomethadyl acetate) , supplemental methadone in small doses should be given rather than giving ORLAAM (levomethadyl acetate) on two consecutive days. Take-home doses of ORLAAM (levomethadyl acetate) and methadone always pose a risk in this setting and physicians should carefully weigh the potential therapeutic benefit against the risk of diversion.

In some cases, where the degree of tolerance is unknown, patients can be started on methadone to facilitate more rapid titration to an effective dose, then converted to ORLAAM (levomethadyl acetate) after a few weeks of methadone therapy.

The crossover from methadone to ORLAAM (levomethadyl acetate) should be accomplished in a single dose; complete transfer to ORLAAM (levomethadyl acetate) is simpler and preferable to more complex regimens involving escalating doses of ORLAAM (levomethadyl acetate) and decreasing doses of methadone.

Dosage should be carefully titrated to the individual; induction too rapid for the patient's level of tolerance may result in overdose. Serious hazards, as seen in association with all narcotic analgesics, are respiratory depression and, to a lesser extent, circulatory depression.

MAINTENANCE

Most patients will be stabilized on doses in the range of 60 to 90 mg, 3-times-a-week. Doses as low as 10 mg and as high as 140 mg three times a week have been given in clinical studies.

Supplemental dosing over the 72-hour inter-dose interval (weekend) is rarely needed. For example, if a patient on a Mon./Wed./Fri. schedule complains of withdrawal on Sundays, the recommended dosage adjustment is to increase the Friday dose in 5 to 10 mg increments up to 40% over the Mon./Wed. dose or to a maximum of 140 mg.

Most patients do not experience withdrawal during the 72-hour inter-dose interval after reaching pharmacological steady-state with or without adjustment of the Friday dose. If additional opioids are required, and the patient is not eligible or appropriate for take home doses of ORLAAM (levomethadyl acetate) , small doses of supplemental methadone should be given rather than giving ORLAAM (levomethadyl acetate) on two consecutive days. Take-home doses of ORLAAM (levomethadyl acetate) and methadone always pose a risk in this setting and physicians should carefully weigh the potential therapeutic benefit against the risk of diversion (see

DOSAGE AND ADMINISTRATION

).

If withdrawal symptoms persist after adjustment of dose, consideration may be given to every-other-day dosing if clinic hours permit. If the clinic is not open seven days a week and every-other day dosing is not practical, the patient's schedule may be adjusted so the 72-hour interval occurs during the week and the patient can come to the clinic to receive a supplemental dose of methadone (see INDIVIDUALIZATION OF DOSAGE ).

The maximum total amount of ORLAAM (levomethadyl acetate) recommended for any patient is 140-140-140 mg or 130-130-180 mg on a thrice-weekly schedule or 140 mg every other day.

TAKE-HOME DOSES

If it is determined that a patient is responsible in handling opioid drugs then ORLAAM (levomethadyl acetate) take-home doses are permitted. Refer to 42 CFR Part 8 for specific restrictions.

REINDUCTION AFTER AN UNPLANNED LAPSE IN DOSING

Following a lapse of one ORLAAM (levomethadyl acetate) dose:

  1. If a patient comes to the clinic to be dosed on the day following a missed scheduled dose (misses Monday, arrives Tuesday), the regular Monday dose should be administered on Tuesday, with the scheduled Wednesday dose administered on Thursday and the Friday dose given on Saturday. The patient's regular schedule may be resumed the following Monday (misses Wednesday, receives the regular dose on Thursday and Saturday, and returns to the regular Monday/Wednesday/Friday dosing schedule the next week).
  2. If a patient misses one dose and comes to the clinic on the day of the next scheduled dose (misses Monday, arrives Wednesday), the usual dose will be well tolerated in most instances, although a reduced dose may be appropriate in selected cases.

Following a lapse of more than one ORLAAM (levomethadyl acetate) dose:

Patients should be reinducted at an initial dose of 1/2 or 3/4 their previous ORLAAM (levomethadyl acetate) dose, followed by increases of 5 to 10 mg every dosing day (48- or 72-hours intervals) until their previous maintenance dose is achieved. Patients who have been off of ORLAAM (levomethadyl acetate) treatment for more than a week should be reinducted.

TRANSFER FROM ORLAAM (levomethadyl acetate) TO METHADONE

Patients maintained on ORLAAM (levomethadyl acetate) may be transferred directly to methadone. Because of the difference between the two compounds' metabolites and their pharmacological half-lives, it is recommended that methadone be started on a daily dose at 80% of the ORLAAM (levomethadyl acetate) dose being replaced; the initial methadone dose must be given no sooner than 48 hours after the last ORLAAM (levomethadyl acetate) dose. Subsequent increases or decreases of 5 to 10 mg in the daily methadone dose may be given to control symptoms of withdrawal or, less likely, symptoms of excessive sedation, in accordance with clinical observations.

DETOXIFICATION FROM ORLAAM (levomethadyl acetate)

There is a limited experience with detoxifying patients from ORLAAM (levomethadyl acetate) in a systematic manner, and both gradual reduction (5 to 10% a week) and abrupt withdrawal schedules have been used successfully. The decision to discontinue ORLAAM (levomethadyl acetate) therapy should be made as part of a comprehensive treatment plan (see INDIVIDUALIZATION OF DOSAGE ).

SAFETY AND HANDLING

ORLAAM (levomethadyl acetate) is a solution of a potent narcotic (LAAM). There are no known specific hazards associated with dermal and aerosol exposure to ORLAAM (levomethadyl acetate) . In case of accidental dermal exposure, promptly remove contaminated clothing and rinse the affected skin with cool water.

Sales of ORLAAM (levomethadyl acetate) are restricted to clinics that have received training in its use. Since ORLAAM (levomethadyl acetate) can be potentially dangerous if diverted, appropriate security measures should be taken to safeguard stock of ORLAAM (levomethadyl acetate) as required by 21 CFR 1301.74.

HOW SUPPLIED

ORLAAM (levomethadyl acetate) Oral Solution (10 mg/mL) is a clear, colorless liquid supplied in plastic bottles as follows:

NDC 0054-3649-63: 500 mL per bottle

Store at controlled room temperature 15°-30°C (59°-86°F). Protect from direct sunlight.

ORLAAM (levomethadyl acetate) is compatible with the materials used in most dispensing systems. Information about obtaining appropriate dispensing systems suitable for use with ORLAAM (levomethadyl acetate) is available from the manufacturer upon request.

Roxane Laboratories, Inc.
Columbus, Ohio 43216

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations