Levomethadyl acetate hydrochloride

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Levomethadyl acetate hydrochloride
Levomethadyl acetate hydrochloride (ORLAAM)
Levomethadyl acetate hydrochloride
(lee-voh- METH-ah-dill)
Pregnancy Category: C ORLAAM (Rx) (C-II)

Classification: Narcotic analgesic only for use in opiate dependence

See Also: See also Narcotic Analgesics .

Action/Kinetics: Onset: 2-4 hr. Peak: 1.5-2 hr. Duration: 48-72 hr. t 1/2: 2-6 days.

Uses: Treatment of opiate dependence. NOTE: This drug can be dispensed only by treatment programs approved by the FDA, DEA, and the designated state authority. The drug can be dispensed only in the oral form and according to treatment requirements stated in federal regulations. The drug has no approved uses outside of the treatment of opiate dependence.

Contraindications: Pregnancy. Use during labor and delivery unless potential benefits outweight potential hazards.

Special Concerns: Usual dose must not be given on consecutive days due to the risk of fatal overdosage.

Side Effects: See Narcotic Analgesics. Induction with levomethadyl that is too rapid for the level of tolerance of the client may result in overdosage, including symptoms of both respiratory and CV depression. Withdrawal symptoms (nasal congestion, abdominal symptoms, diarrhea, muscle aches, anxiety) may be seen over the 72-hr dosing period if the dose is too low.

How Supplied: Oral Solution: 10 mg/mL

?Oral Solution Induction.
Initial: 20-40 mg administered at 48-72-hr intervals; then, dose may be increased in increments of 5-10 mg until steady state is reached (usually within 1-2 weeks). Clients dependent on methadone may require higher initial doses of levomethadyl; the suggested initial 3-times/week dose for such clients is 1.2-1.3 times the daily methadone maintenance dose being replaced. This initial dose should not exceed 120 mg with subsequent doses given at 48- or 72-hr intervals, depending on the response. If additional opioids are required, supplemental amounts of methadone should be given rather than giving levomethadyl on 2 consecutive days.
Most clients are stabilized on doses of 60-90 mg 3 times/week although the dose may range from 10 to 140 mg 3 times/week. The maximum total amount of levomethadyl recommended for any client is either 140, 140, 140 mg or 130, 130, 180 mg on a thrice-weekly schedule.
Reinduction after an unplanned lapse in dosing: following a lapse of one levomethadyl dose.
If the client comes to the clinic the day following a missed scheduled dose (e.g., misses Monday and arrives at clinic on Tuesday), the regular Monday dose is given, with the scheduled Wednesday dose given on Thursday and the Friday dose given on Saturday. The client's regular schedule can be resumed the following Monday. If the client misses one dose and comes to the clinic the day of the next scheduled dose (i.e., misses Monday, comes to clinic on Wednesday), the usual dose will be well tolerated in most cases although some clients will need a reduced dose.
Reintroduction after a lapse of more than one levomethadyl dose.
Restart the client at an initial dose of 50%-75% of the previous dose, followed by increases of 5-10 mg every dosing day (i.e., intervals of 48-72 hr) until the previous maintenance dose is reached.
Transfer from levomethadyl to methadone.
Transfer can be done directly, although the dose of methadone should be 80% of the levomethadyl dose being replaced. The first methadone dose should not be given sooner than 48 hr after the last levomethadyl dose. Increases or decreases of 5-10 mg may be made in the daily methadone dose to control symptoms of withdrawal or symptoms of excessive sedation.
Detoxification from levomethadyl.
Both gradual reduction (i.e., 5%-10% a week) and abrupt withdrawal have been used successfully.

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