What are the Ingredients in DOLOPHINE?
Active Ingredient: methadone hydrochloride, USP
Inactive Ingredients: magnesium stearate, microcrystalline cellulose, and starch.
Deaths, cardiac and respiratory, have been reported during initiation and conversion of pain patients to methadone treatment from treatment with other opioid agonists. It is critical to understand the pharmacokinetics of methadone when converting patients from other opioids (see DOSAGE AND ADMINISTRATION). Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose titration.
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.
In addition, 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.
Methadone treatment for analgesic therapy in patients with acute or chronic pain should only be initiated if the potential analgesic or palliative care benefit of treatment with methadone is considered and outweighs the risks.
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.
DOLOPHINEŽ HYDROCHLORIDE (Methadone Hydrochloride Tablets, USP), for oral administration, each contain 5 mg or 10 mg of methadone hydrochloride.
DOLOPHINE is indicated for the following:
1. For the treatment of moderate to severe pain not responsive to non-narcotic analgesics.
2. For detoxification treatment of opioid addiction (heroin or other morphine-like drugs).
3. For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services.
NOTE: Outpatient maintenance and outpatient detoxification treatment may be provided only by Opioid Treatment Programs (OTPs) certified by the Federal Substance Abuse and Mental Health Services Administration (SAMHSA) and registered by the Drug Enforcement Administration (DEA). This does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone.
Published Studies Related to Dolophine (Methadone)
Effectiveness of naltrexone in the prevention of delayed respiratory arrest in
opioid-naive methadone-intoxicated patients. 
Acute methadone toxicity is a major public health concern in Iran... Further studies are warranted before the generalization of this approach to other
The effects of gabapentin on methadone based addiction treatment: a randomized
controlled trial. 
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. 
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. 
provide such evidence... CONCLUSIONS: Under double-blind conditions, dosages of methadone over 100mg/day,
Tramadol versus methadone for treatment of opiate withdrawal: a double-blind,
randomized, clinical trial. 
The aim of this study was to compare the efficacy and safety of tramadol versus
methadone for treatment of opiate withdrawal. Seventy patients randomly were
assigned in two groups to receive either prescribed methadone (60 mg/day) or
tramadol (600 mg/day)... Tramadol may be as effective as methadone in the
control of withdrawal and could be considered as a potential substitute for
methadone to manage opioids withdrawal.
Clinical Trials Related to Dolophine (Methadone)
Methadone Pharmacokinetics and Cardiac Effects in Newborns [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.
Drug Interaction Study Of Filibuvir With Methadone, Among Subjects On Chronic Methadone Maintenance [Not yet recruiting]
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C
infection. Given the likelihood of co administration of filibuvir and methadone, this study
will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
Methadone Maintenance & HIV Risk in Ukraine [Recruiting]
Treatment of opioid dependence is an important way to reduce the spread of HIV and other
infectious diseases, particularly in Ukraine since intravenous opioid use is the major way
these infections are being spread. This proposal will be done at the Kiev City Narcology
Hospital and the City AIDS Center with collaborators from the University of Alabama and the
University of Colorado. It will study the acceptability and impact of a 3-month course of
methadone maintenance on 50 persons with opioid dependence, 25 who are HIV+ and 25 HIV-.
The proposed work will build on a relationship that was established with the Ukrainian
Co-Principal Investigator, Sergiy Dvoryak, M. D., during his Humphrey Fellowship at Johns
Hopkins in 1999-2000 when he spent time with Dr. Woody and Metzger at the Penn Addiction and
Treatment and Research Center. It will also extend studies of pharmacologic treatment for
opioid dependence and risk reduction behavioral interventions that are being done by Drs.
Woody, Schumacher and Booth in Russia and Ukraine. Primary aims are to: measure the
acceptability and compliance with a 3-month course of methadone maintenance in HIV+ and HIV-
patients; measure the impact of a 3-month course of methadone in reducing opioid use in HIV+
and HIV- patients; measure the impact of a 3-month course of methadone on reducing HIV risk
behavior in HIV+_and HIV- patients. Secondary aims are to: assess the degree to which a
3-month course of methadone maintenance reduces illegal activities and improves employment
and psychiatric symptoms; determine short-term outcome after completion of methadone
treatment; and obtain pilot data on the prevalence of hepatitis B and C among study
patients. This study will provide pilot data on the acceptability and efficacy of a
short-term course of methadone maintenance on HIV+ and HIV- persons in a setting where this
treatment has not been evaluated, on the feasibility of conducting the kind of work that is
proposed, and will enhance research capabilities of Kiev investigators for future HIV
prevention and treatment studies.
Methadone-Dolutegravir (DTG - GSK1349572) Drug Interaction Study. [Not yet recruiting]
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor that is currently in Phase 3
clinical development for the treatment of HIV infection. As HIV-infected subjects may also
be receiving methadone for opioid dependence, an evaluation of the potential interaction
between DTG and methadone is warranted. The primary objective of this study is to determine
whether concomitant administration of DTG can affect the pharmacokinetics (PK) of methadone.
As a secondary endpoint, the PK of DTG will be compared to historical data. This study
will be open-label with subjects receiving DTG and stable doses of methadone. The study
will be conducted at one center in Canada in adult male and female subjects.
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123 AM3) [Recruiting]
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will
be given boceprevir. Blood samples will be taken at specified intervals to find out whether
boceprevir affects the pharmacokinetics of methadone or buprenorphine/naloxone.
Page last updated: 2014-11-30