Methadone (Methadone Hydrochloride) - Indications and Dosage

DOSAGE AND ADMINISTRATION

For Relief of Pain — Dosage should be adjusted according to the severity of the pain and the response of the patient. Occasionally, it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who have become tolerant to the analgesic effects of narcotics.

The usual adult dosage is 2.5 mg to 10 mg every three or four hours as necessary.

For Detoxification Treatment — THE DRUG SHALL BE ADMINISTERED DAILY UNDER CLOSE SUPERVISION AS FOLLOWS:

A detoxification treatment course shall not exceed 21 days and may not be repeated earlier than 4 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/day in single or divided doses will usually constitute an adequate stabilizing dosage level. Stabilization can be continued for 2 to 3 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 2-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% 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 3 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.

If the patient is unable to ingest oral medication, parenteral administration may be substituted.

HOW SUPPLIED

Each Methadone Hydrochloride, USP 5 mg tablet contains 5 mg Methadone Hydrochloride, USP. It is available as a white to off-white, modified rectangle shaped convex tablet, one side debossed with a score between “57” and “55”;

Bottles of 100................NDC No. 0406-5755-01

Unit Dose (10x10)..........NDC No. 0406-5755-62

Each Methadone Hydrochloride, USP 10 mg tablet contains 10 mg Methadone Hydrochloride, USP. It is available as a white to off-white, modified rectangle shaped convex tablet, one side debossed with a score between “57” and “71”;

Bottles of 100...............NDC No. 0406-5771-01

Unit Dose (10x10).........NDC No. 0406-5771-62

Dispense in a tight, light-resistant container as defined in the USP/NF.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

tyco

Healthcare

Mallinckrodt

Mallinckrodt Inc.

St. Louis, Missouri 63134, U.S.A.      Rev. 092304