May 29, 2016
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Methadose Oral Concentrate

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Methadose Oral Concentrate

Methadose™ Oral Concentrate
(methadone hydrochloride oral concentrate USP) and
Methadose™ Sugar-Free Oral Concentrate
(methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored




Deaths have been reported during initiation of methadone treatment for opioid dependence. In some cases, drug interactions with other drugs, both licit and illicit, have been suspected. However, in other cases, deaths appear to have occurred due to the respiratory or cardiac effects of methadone and too-rapid titration without appreciation for the accumulation of methadone over time. It is critical to understand the pharmacokinetics of methadone and to exercise vigilance during treatment initiation and dose titration (see DOSAGE AND ADMINISTRATION). Patients must also be strongly cautioned against selfmedicating with CNS depressants during initiation of methadone treatment.

Respiratory depression is the chief hazard associated with methadone hydrochloride administration. Methadone's peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects, particularly in the early dosing period. These characteristics can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration.

Cases of QT interval prolongation and serious arrhythmia (torsades de pointes) have been observed during treatment with methadone. Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction.

Conditions for Distribution and Use of Methadone Products for the Treatment of Opioid Addiction

Code of Federal Regulations, Title 42, Sec 8

METHADONE PRODUCTS WHEN USED FOR THE TREATMENT OF OPIOID ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY OPIOID TREATMENT PROGRAMS (AND AGENCIES, PRACTITIONERS OR INSTITUTIONS BY FORMAL AGREEMENT WITH THE PROGRAM SPONSOR) CERTIFIED BY THE SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION AND APPROVED BY THE DESIGNATED STATE AUTHORITY. CERTIFIED TREATMENT PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL OPIOID TREATMENT STANDARDS (42 CFR 8.12). See below for important regulatory exceptions to the general requirement for certification to provide opioid agonist treatment.

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.

Regulatory Exceptions to the General Requirement for Certification to Provide Opioid Agonist Treatment:

  1. During inpatient care, when the patient was admitted for any condition other than concurrent opioid addiction (pursuant to 21 CFR 1306.07(c)), to facilitate the treatment of the primary admitting diagnosis.
  2. During an emergency period of no longer than 3 days while definitive care for the addiction is being sought in an appropriately licensed facility (pursuant to 21 CFR 1306.07(b)).

DRUG DESCRIPTION

Methadose™ Oral Concentrate (methadone hydrochloride oral concentrate USP) is supplied as a cherry flavored liquid concentrate. Methadose™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride. Each liquid concentrate contains 10 mg of methadone hydrochloride per mL.

Methadone hydrochloride is chemically described as 3-heptanone, 6-(dimethylamino)-4, 4-diphenyl-, hydrochloride. Methadone hydrochloride is a white, essentially odorless, bitter-tasting crystalline powder. It is very soluble in water, soluble in isopropanol and in chloroform, and practically insoluble in ether and in glycerine. It is present in Methadose as the racemic mixture. Methadone hydrochloride has a melting point of 235°C, a pKa of 8.25 in water at 20°C, a solution (1 part per 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.4 in octanol/water. Its structural formula is:

Methadose™ Oral Concentrate (methadone hydrochloride oral concentrate USP) Structural Formula Illustration

C21H27NO•HCl     MW = 345.91

Other ingredients of Methadose oral concentrate: artificial cherry flavor, citric acid anhydrous, FD&C Red No 40, D&C Red No 33, methylparaben, poloxamer 407, propylene glycol, propylparaben, purified water, sodium citrate dihydrate, sucrose.

Other ingredients of Methadose sugar-free oral concentrate: citric acid anhydrous, purified water, sodium benzoate.

What are the possible side effects of methadone (Diskets, Dolophine, Methadose)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing;
  • hallucinations or confusion;
  • chest pain, dizziness, fainting, fast or pounding heartbeat; or
  • trouble breathing, feeling light-headed, or fainting.

Less serious side effects may include:

  • feeling anxious, nervous, or restless;
  • sleep problems...

Read All Potential Side Effects and See Pictures of Methadose Oral Concentrate »

Last reviewed on RxList: 5/17/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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