A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Orlaam Indications, Dosage, Storage, Stability - Levomethadyl Acetate
Orlaam Indications, Dosage, Storage, Stability - Levomethadyl Acetate
INDICATIONS
AND USES
ORLAAM is indicated for the management of opiate dependence. ORLAAM 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 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 in each patient should be adjusted to achieve the
optimal therapeutic benefit with acceptable adverse opioid effects (see INDIVIDUALIZATION
OF DOSAGE ).
ORLAAM must always be diluted before administration, and should be mixed with
diluent prior to dispensing. To avoid confusion between prepared doses of ORLAAM
and methadone, the liquid used to dilute ORLAAM should be a different color
from that used to dilute methadone in any specific clinic setting.
ORLAAM DOSING
Dosing Schedules
ORLAAM 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 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 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.
The suggested initial 3-times-a-week dose of ORLAAM 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, supplemental methadone in small
doses should be given rather than giving ORLAAM on two consecutive days. Take-home
doses of ORLAAM 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 after a few weeks of methadone therapy.
The crossover from methadone to ORLAAM should be accomplished in a single dose;
complete transfer to ORLAAM is simpler and preferable to more complex regimens
involving escalating doses of ORLAAM 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, small doses of supplemental
methadone should be given rather than giving ORLAAM on two consecutive days.
Take-home doses of ORLAAM 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 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 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 dose:
- 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).
- 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 dose:
Patients should be reinducted at an initial dose of 1/2 or 3/4 their previous
ORLAAM 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 treatment for more than a week should be reinducted.
TRANSFER FROM ORLAAM TO METHADONE
Patients maintained on ORLAAM 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 dose being replaced; the initial methadone dose must be given
no sooner than 48 hours after the last ORLAAM 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
There is a limited experience with detoxifying patients from ORLAAM 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 therapy should
be made as part of a comprehensive treatment plan (see INDIVIDUALIZATION OF
DOSAGE ).
SAFETY AND HANDLING
ORLAAM is a solution of a potent narcotic (LAAM). There are no known specific
hazards associated with dermal and aerosol exposure to ORLAAM. In case of accidental
dermal exposure, promptly remove contaminated clothing and rinse the affected
skin with cool water.
Sales of ORLAAM are restricted to clinics that have received training in its
use. Since ORLAAM can be potentially dangerous if diverted, appropriate security
measures should be taken to safeguard stock of ORLAAM as required by 21 CFR
1301.74.
HOW SUPPLIED
ORLAAM 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 is compatible with the materials used in most dispensing systems. Information
about obtaining appropriate dispensing systems suitable for use with ORLAAM
is available from the manufacturer upon request.
Roxane Laboratories, Inc.
Columbus, Ohio 43216
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