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WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; LIFE-THREATENING QT PROLONGATION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and TREATMENT FOR OPIOID ADDICTION
Addiction, Abuse, and Misuse
Methadose exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Methadose, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions ].
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of
Methadose. Monitor for respiratory depression, especially during initiation of Methadose or following a dose increase [see Warnings and Precautions].
Accidental Ingestion
Accidental ingestion of even one dose of
Methadose, especially by children, can result in a fatal overdose of methadone [see Warnings and Precautions ].
Life-Threatening QT Prolongation
QT interval prolongation and serious arrhythmia (torsades de pointes) have occurred 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. Closely monitor patients for changes in cardiac rhythm during initiation and titration of Methadose [see Warnings and Precautions].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of
Methadose during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions ].
Conditions For Distribution And Use Of Methadone Products For The Treatment Of Opioid Addiction
For detoxification and maintenance of opioid dependence, methadone should be administered in accordance with the treatment standards cited in 42 CFR Section 8, including limitations on unsupervised administration [see Indications and Usage (1)].
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METHADOSE SUMMARY
Methadose® 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 (3-heptanone, 6-(dimethylamino)-4, 4-diphenyl-, hydrochloride) is a white, essentially odorless, bitter-tasting crystalline powder. It is very soluble in water, soluble in isopropranolol 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 235ºC, a pKa of 8.25 in water at 20°C, a solution (1 in 100) pH between 4.5 and 6.5, a partition coefficient of 117 at pH 7.
Methadose (Methadone) is indicated for the following:
- Detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
- Maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
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NEWS HIGHLIGHTS
Published Studies Related to Methadose (Methadone)
Topiramate for cocaine dependence during methadone maintenance treatment: a
randomized controlled trial. [2014]
CONCLUSION: Topiramate is not efficacious for increasing cocaine abstinence in
Effectiveness of naltrexone in the prevention of delayed respiratory arrest in
opioid-naive methadone-intoxicated patients. [2013]
Acute methadone toxicity is a major public health concern in Iran... Further studies are warranted before the generalization of this approach to other
patient populations.
The effects of gabapentin on methadone based addiction treatment: a randomized
controlled trial. [2013]
Gabapentin is a potentially useful drug in alleviating the hyperexcitatory
painful states in the control of opiate dependence in acute detoxification and
the stabilization phase. This study aim was to evaluate the effectiveness of
gabapentin adds-on methadone therapy on lowering the methadone... This drug leads to
relief of withdrawal symptoms and lower methadone consumption.
Effects of disulfiram on QTc interval in non-opioid-dependent and
methadone-treated cocaine-dependent patients. [2013]
clinical trial of disulfiram were prospectively determined... CONCLUSIONS: These results suggest that cocaine use and possibly MT status, but
A randomized investigation of methadone doses at or over 100 mg/day, combined
with contingency management. [2013]
provide such evidence... CONCLUSIONS: Under double-blind conditions, dosages of methadone over 100mg/day,
Clinical Trials Related to Methadose (Methadone)
Methadone in Pediatric Anesthesiology II [Recruiting]
Methadone Pharmacokinetics and Cardiac Effects in Newborns [Active, not recruiting]
The Primary objectives of this proposal are to determine the population kinetics for
methadone and its enantiomers in preterm newborns and infants at 29 weeks to 48 weeks post
menstrual age (PMA) who are 1 week old and older and establish any correlations of the
kinetics with PMA to determine the bioavailability for enterally administered methadone in
these newborns and young infants.
The secondary objectives of this proposal are to explore possible genotypic changes in
CYP3A4-3A7-3A5, CYP2B6, CYP2C8, CYP2C19, and CYP2D6 and PGO on the kinetics of methadone in
neonates and young infants and to test the safety of methadone in this population by
correlating the plasma concentrations of the methadone enantiomers, S-methadone and
R-methadone, with changes in cardiac repolarization by measurement of corrected QT, heart
rate, and blood pressure.
The Use of Methadone in Newborn Infants [Active, not recruiting]
This proposed investigation will test the following hypotheses: 1) Enzymatic activity of
CYP2B6 characterized by the formation clearance of methadone to EDDP (CLf,EDDP), is directly
related to both gestational and postnatal age; 2) variations in the CYP2B6 gene (SNPs) are
associated with variable activity of the CYP2B6 enzyme (as measured by the formation
clearance, CLf,EDDP), and 3) the elimination rate of methadone and its major metabolite EDDP
in neonates is dependent on the glomerular filtration rate and therefore on the stage of
development (defined by both gestational and postnatal age). The investigators propose to
develop a PK model for methadone dosing in neonates that takes into account both
developmental stage and genetic variability. The long-term goal of the proposed
investigations is to improve dosing of methadone in neonates exposed to opioids in utero or
post-natally, leading to improved control of their withdrawal syndrome and decreased adverse
drug reactions associated with the current use of methadone in these vulnerable patients.
More immediately, the investigators will develop a PK model for methadone dosing based on
relevant developmental and genetic characteristics. The acquired knowledge based on the
proposed study will lead to a more efficacious treatment of pain or opiate withdrawal
syndrome in newborn infants with a decreased chance of adverse drug reactions.
Methadone and Ketamine for Neuropathic Pain Treatment [Completed]
Methadone and ketamine are effective for neuropathic pain management. However, the benefits
of the association of both drugs are uncertain. Here, the investigators conducted a
randomized, double-blind, in parallel, active controlled clinical trial to test the
hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than
methadone or ketamine alone in reducing neuropathic pain.
Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone [Completed]
The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics
of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine
when co-administered with methadone. Symptoms of methadone withdrawal will also be
assessed.
Reports of Suspected Methadose (Methadone) Side Effects
Drug Withdrawal Syndrome Neonatal (374),
Foetal Exposure During Pregnancy (371),
Maternal Exposure During Pregnancy (176),
Premature Delivery (169),
Premature Baby (84),
Completed Suicide (25),
Cardio-Respiratory Arrest (22),
Nystagmus (22),
Maternal Drugs Affecting Foetus (21),
Strabismus (16), more >>
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Page last updated: 2015-08-10
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