METHADOSE Oral Concentrate (methadone hydrochloride oral concentrate USP) contains methadone, an opioid agonist, and is available as a cherry flavored liquid concentrate for oral administration. METHADOSE™ Sugar-Free Oral Concentrate (methadone hydrochloride oral concentrate USP) is a dye-free, sugar-free, unflavored liquid concentrate of methadone hydrochloride for oral administration. 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.
DOSAGE AND ADMINISTRATION
METHADOSE is for oral administration only. The preparation must not be injected.
• Inform patients that METHADOSE should be taken only as directed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression), and the dose should not be adjusted without consulting a physician or other healthcare professional.
• Reassure patients initiating treatment with METHADOSE for opioid dependence that the dose of methadone will “hold” for longer periods of time as treatment progresses.
• Apprise patients seeking to discontinue treatment with methadone for opioid dependence of the high risk of relapse to illicit drug use associated with discontinuation of METHADOSE maintenance treatment.
•Advise patients not to discontinue METHADOSE without first discussing the need for a tapering regimen with the prescriber.
Sleep problems (insomnia)
Loss of appetite
Decreased sex drive
Impotence or Difficulty having an orgasm.
Tell your doctor if you experience serious side effects of methadone hydrochloride including:
Fast or pounding heartbeat
Lightheadedness and Fainting.
The major hazards of methadone are respiratory depression and, to a lesser degree, systemic hypotension. Respiratory arrest, shock, cardiac arrest, and death 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. In such individuals, lower doses are advisable.
Life-threatening respiratory depression, life threatening qt prolongation, accidental ingestion, abuse potential interactions with drugs affecting cytochrome p450 isoenzymes and treatment for opioid addiction.