Insomnia, a disorder of sleep, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself naturally, and people return to a normal pattern of sleep. Insomnia may be short-term (less than three weeks) or chronic, lasting longer than three weeks. Contributing factors include, but are not limited to, poor sleeping habits, stress, jet lag, medications, disease, and depression. Chronic insomnia may warrant the use of sedative/hypnotics medications; however, it is important that the treating physician perform a complete diagnostic evaluation as well as take medication and substance abuse histories, to exclude secondary insomnia due to other conditions.
Hypnotics/sedatives medications (henceforth referred to as hypnotics) work, in general, by increasing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain. Neuro...
Methadose™ Oral Concentrate
(methadone hydrochloride oral concentrate USP)
and
Methadose™ Sugar-Free Oral Concentrate
(methadone hydrochloride oral concentrate USP) dye-free, sugar-free, unflavored
FOR ORAL USE ONLY
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 self- medicating 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). 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:
Methadose™ Oral Concentrate (methadone hydrochloride oral concentrate) (methadone hydrochloride USP) is supplied as a cherry flavored liquid concentrate. Methadose™ Sugar-Free Oral Concentrate (methadone hydrochloride 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 and a molecular weight of 345.91. Its molecular formula is C21H27NO•HCl and its structural formula is:
 |
Other ingredients of Methadose Oral Concentrate (methadone hydrochloride oral concentrate) : Artificial cherry flavor, citric acid anhydrous USP, FD&C Red No 40, D&C Red No 33, methylparaben NF, polaxamer 407 NF, propylene glycol USP, propylparaben NF, purified water USP, sodium citrate dihydrate USP, sucrose NF.
Other ingredients of Methadose Sugar-Free Oral Concentrate: Citric acid anhydrous USP, purified water USP, sodium benzoate NF.
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:
Less serious side effects may include:
Read All Potential Side Effects and See Pictures of Methadose Oral Concentrate »
Before taking methadone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus),...
Read All Potential Precautions of Methadose Oral Concentrate »
Last reviewed on RxList: 3/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Here is a collection of user reviews for the medication Methadose Oral Concentrate sorted by most helpful.
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.
Find out what women really need.
RxList does not provide medical advice, diagnosis or treatment. See additional information.
Updated & New