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METHADONE HYDROCHLORIDE TABLETS, USP
5 mg, 10 mg

CII

Rx only.

CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS:

Code of Federal Regulations,

Title 21, Sec. 291.505

METHADONE PRODUCTS, WHEN USED FOR TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY. APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505). FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM. A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY.

DESCRIPTION

Methadone Hydrochloride Tablets, USP are provided in tablet form for oral administration. Methadone Hydrochloride, USP 6-(dimethylamino)-4, 4-diphenyl-3-heptanone hydrochloride, is a white, essentially odorless, bitter-tasting powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. Methadone hydrochloride has a pKa of 8.25 in water at 20°C. Its molecular weight is 345.91 and it has the following structural formula.

Each tablet contains 5 mg (0.015 mmol) or 10 mg (0.029 mmol) methadone hydrochloride.

The tablets also contain Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF and Silicon Dioxide NF.

CLINICAL PHARMACOLOGY

Methadone hydrochloride is a synthetic narcotic analgesic with multiple actions quantitatively similar to those of morphine, the most prominent of which involve the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value are analgesia and sedation and detoxification or temporary maintenance in narcotic addiction. The methadone abstinence syndrome, although qualitatively similar to that of morphine, differs in that the onset is slower, the course is more prolonged, and the symptoms are less severe.

A parenteral dose of 8 to 10 mg of methadone is approximately equivalent in analgesic effect to 10 mg of morphine. With single-dose administration, the onset and duration of analgesic action of the 2 drugs are similar.

When administered orally, methadone is approximately one-half as potent as when given parenterally. Oral administration results in a delay of the onset, a lowering of the peak, and an increase in the duration of analgesic effect.

INDICATIONS AND USAGE

(see boxed note)

For relief of severe pain.

For detoxification treatment of narcotic addiction.

For temporary maintenance treatment of narcotic addiction.

NOTE

If methadone is administered for treatment of heroin dependence for more than 3 weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his/her stay or whose enrollment has been verified in a program approved for maintenance treatment with methadone.

CONTRAINDICATIONS

Hypersensitivity to methadone.

WARNINGS

Methadone Hydrochloride Tablets, USP are for oral administration only and must not be used for injection. It is required that Methadone Hydrochloride Tablets, USP, if dispensed, be packaged in child-resistant containers and kept out of the reach of children to prevent accidental ingestion.

PRECAUTIONS

Drug Interactions:

ADVERSE REACTIONS

THE MAJOR HAZARDS OF METHADONE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable. Some adverse reactions may be alleviated if the ambulatory patient lies down.

Other adverse reactions include the following:

Central Nervous System— Euphoria, dysphoria, weakness, headache, insomnia, agitation, disorientation, and visual disturbances.

Gastrointestinal— Dry mouth, anorexia, constipation and biliary tract spasm.

Cardiovascular— Flushing of the face, bradycardia, palpitation, faintness, and syncope.

Genitourinary— Urinary retention or hesitancy, antidiuretic effect, and reduced libido and/or potency.

Allergic— Pruritus, urticaria, other skin rashes, edema, and, rarely, hemorrhagic urticaria.

Hematologic— Reversible thrombocytopenia has been described in a narcotics addict with chronic hepatitis.

DRUG ABUSE AND DEPENDENCE

Methadone hydrochloride, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substances Act. Appropriate security measures should be taken to safeguard stocks of methadone against diversion.

OVERDOSAGE

DOSAGE AND ADMINISTRATION

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”; on the other side.

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”; on the other side.

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].

is a registered trademark of Mallinckrodt Inc.

tyco

Healthcare

Mallinckrodt

Mallinckrodt Inc.

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

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