| Federal Narcotic Treatment Regulations: Language Specifically Relating
to Use of LAAM |
| 21 C.F.R. Part 291 Section 291.505 (1993) |
|
| (d)(1)(iii)(B)(6) |
|
| Patients who are or become pregnant should not be started or
continued on LAAM, except by the written orders of a physician who determines this to be
the best choice of therapy for that patient. Clinics providing treatment with LAAM must
advise all patients of childbearing potential of the risks of LAAM and make a medical
evaluation available to all patients who become pregnant while taking the drug. An initial
pregnancy test shall be performed for each prospective female patient of childbearing
potential before admission to LAAM comprehensive maintenance treatment and monthly
pregnancy tests performed thereafter on such female patients in LAAM comprehensive
maintenance treatment. Analysis of such tests shall be performed in a laboratory approved
under the Clinical Laboratory Improvement Amendments of 1988 or in a laboratory
certified by a State or private accrediting body approved by the Health Care Financing
Administration. |
|
| (d)(1)(iv)(B) |
|
| A person under 18 years of age shall not be admitted to LAAM
maintenance treatment. |
|
| (k)(1) LAAM |
|
| (i) Dosage and responsibility for administration. After a
patient's tolerance to LAAM is established, LAAM shall be administered no more
frequently than every other day. Dosage of LAAM shall be individualized at doses,
frequencies, and under conditions of usage described in approved labeling and as follows: |
|
| (A) New patients. The persons responsible for the
program shall ensure that the initial dose of LAAM to a patient whose tolerance for the drug
is unknown does not exceed 40 milligrams. |
|
| (B) Stabilized methadone maintenance patient. The
persons responsible for the program shall ensure that the initial dose of LAAM for a
previously stabilized methadone maintenance patient is less than or equal to 1.3 times the
patient's daily methadone dose, not to exceed 120 milligrams. |
|
| (C) A licensed physician shall assume responsibility for the
amount of the narcotic drug administered or dispensed and shall record, date, and sign or
countersign in each patient's record each change in dosage schedule. |
|
| (D) The administering licensed physician shall ensure that a
single dose of LAAM greater than 140 milligrams is justified in the patient's record. |
|
| (ii) Dosage form. LAAM may be administered in oral
form when used in a maintenance treatment program. Hospitalized patients under care for a
medical or surgical condition are permitted to receive LAAM in oral form when the
attending physician judges it advisable. Although syrup concentrate or other formulations
may be distributed to the program, all oral medication is required to be administered in a
liquid formulation. Clinics that administer both LAAM and methadone shall take
appropriate measures, including contrasting color and taste, to ensure that dosage forms of
LAAM and methadone are easily distinguished. |
|
| (iii ) Take-home medication. Take-home doses of
LAAM are not permitted. A patient who is eligible for one or more take-home doses of
methadone under paragraph (d)(6) of this section and who is unable to conform to the
applicable mandatory LAAM dosing schedule because of exceptional circumstances such as
illness, personal or family crises, travel, or other hardship, or official State holidays, may
be temporarily transferred to methadone. Take-home doses of methadone for a patient
eligible for a planned temporary discontinuation of treatment with LAAM shall be
individualized at doses, frequencies, and under conditions of usage described in the
approved labeling and the applicable provisions for take-home methadone medication under
paragraph (d)(6) of this section. The maximum number of take-home doses of methadone
shall be determined in accordance with the provisions of 21 C.F.R. Part 291
Section 291.505(d)(6)(v) and (d)(6)(vi) (1993). |
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