METHADONE HYDROCHLORIDE POWDER MUST BE DISSOLVED IN AN APPROPRIATE LIQUID VEHICLE BEFORE ORAL ADMINISTRATION.
For Detoxification Treatment:
THE DRUG SHALL BE ADMINISTERED DAILY UNDER CLOSE SUPERVISION AS FOLLOWS:
A detoxification treatment course shall not exceed twenty-one days and may not be repeated earlier than four weeks after completion of the preceding course.
In detoxification, the patient may receive methadone when there are significant symptoms of withdrawal. The dosage schedules indicated below are recommended but could be varied in accordance with clinical judgment. Initially, a single oral dose of 15 to 20 mg. of methadone will often be sufficient to suppress withdrawal symptoms. Additional methadone may be provided if withdrawal symptoms are not suppressed or if symptoms reappear. When patients are physically dependent on high doses, it may be necessary to exceed these levels. Forty mg. per day in single or divided doses will usually constitute an adequate stabilizing dosage level. Stabilization can be continued for two to three days, and then the amount of methadone normally will be gradually decreased. The rate at which methadone is decreased will be determined separately for each patient. The dose of methadone can be decreased on a daily basis or at two-day intervals, but the amount of intake shall always be sufficient to keep withdrawal symptoms at a tolerable level. In hospitalized patients, a daily reduction of 20 percent of the total daily dose may be tolerated and may cause little discomfort. In ambulatory patients, a somewhat slower schedule may be needed. If methadone is administered for more than three weeks, the procedure is considered to have progressed from detoxification or treatment of the acute withdrawal syndrome to maintenance treatment, even though the goal and intent may be eventual total withdrawal.
For Maintenance Treatment:
In maintenance treatment, the initial dosage of methadone should control the abstinence symptoms that follow withdrawal of narcotic drugs but should not be so great as to cause sedation, respiratory depression, or other effects of acute intoxication. It is important that the initial dosage be adjusted on an individual basis to the narcotic tolerance of the new patient. If such a patient has been a heavy user of heroin up to the day of admission, he may be given 20 mg. four to eight hours later or 40 mg. in a single oral dose. If he enters treatment with little or no narcotic tolerance (e.g., if he has recently been released from jail or other confinement), the initial dosage maybe one-half these quantities. When there is any doubt, the smaller dose should be used initially. The patient should then be kept under observation, and, if symptoms of abstinence are distressing, additional 10 mg. doses may be administered as needed. Subsequently, the dosage should be adjusted individually, as tolerated and required, up to a level of 120 mg. daily. The patient will initially ingest the drug under observation daily, or at least six days a week, for the first three months. After demonstrating satisfactory adherence to the program regulations for at least three months, the patient may be permitted to reduce to three times weekly the occasions when he must ingest the drug under observation. He shall receive no more than a two-day take-home supply. With continuing adherence to the program’s requirements for at least two years, he may then be permitted twice-weekly visits to the program for drug ingestion under observation with a three-day take-home supply. A daily dose of 120 mg. or more shall be justified in the medical record. Prior approval from state authority and the Food and Drug Administration is required for any dose above 120 mg. administered at the clinic and for any dose above 100 mg. to be taken at home. A regular review of dosage level should be made by the responsible physician, with careful consideration given to reduction of dosage as indicated on an individual basis. A new dosage level is only a test level until stability is achieved.
Special Consideration for a Pregnant Patient:
Caution shall be taken in the maintenance treatment of pregnant patients. Dosage levels shall be kept as low as possible if continued methadone treatment is deemed necessary. It is the responsibility of the program sponsor to assure that each female patient be fully informed concerning the possible risks to a pregnant woman or her unborn child from the use of methadone.
Special Limitations:
Treatment of Patients Under Age Eighteen
1. The safety and effectiveness of methadone for use in the treatment of adolescents have not been proven by adequate clinical study. Special procedures are therefore necessary to assure that patients under age sixteen will not be admitted to a program and that patients between sixteen and eighteen years of age will be admitted to maintenance treatment only under limited conditions.
2. Patients between sixteen and eighteen years of age who were enrolled and under treatment in approved programs on December 15, 1972, may continue in maintenance treatment. No new patients between sixteen and eighteen years of age may be admitted to a maintenance treatment program after March 15, 1973, unless a parent, legal guardian, or responsible adult designated by the state authority completes and signs Form FD 2635, “Consent for Methadone Treatment.”
Methadone treatment of new patients between the ages of sixteen and eighteen years will be permitted after December 15, 1972, only with a documented history of two or more unsuccessful attempts at detoxification and a documented history of dependence on heroin or other morphine-like drugs beginning two years or more prior to application for treatment. No patient under age sixteen may be continued or started on methadone treatment after December 15, 1972, but these patients may be detoxified and retained in the program in a drug-free state for follow-up and aftercare.
3. Patients under age eighteen who are not placed on maintenance treatment may be detoxified. Detoxification may not exceed three weeks. A repeat episode of detoxification may not be initiated until four weeks after the completion of the previous detoxification.