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Naltrexone (Naltrexone Hydrochloride) - Summary

 
 



BOX WARNING

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Naltrexone does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms of acute hepatitis.

 

NALTREXONE SUMMARY

NALTREXONE HYDROCHLORIDE TABLETS, USP

Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethyl group. Naltrexone hydrochloride is also related to the potent opioid antagonist, naloxone, or n-allylnoroxymorphone. Naltrexone hydrochloride has the chemical name of 17-(cyclopropylmethyl)-4, 5α-epoxy-3, 14-dihydroxymorphinan-6-one hydrochloride.

Naltrexone hydrochloride tablets are indicated:

In the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids.

Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.


See all Naltrexone indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Naltrexone

The specific receptor targeted by naltrexone to enhance diabetic wound closure is OGFr
Source: Dermatology News From Medical News Today [2014.10.15]
A major complication associated with diabetes is delayed cell replication in epithelium and skin.

FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic
Source: Pain / Anesthetics News From Medical News Today [2014.10.21]
The U.S. Food and Drug Administration has approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe...

FDA Okays Third Abuse-Deterrent Opioid
Source: MedPage Today Neurology [2014.10.18]
(MedPage Today) -- Agency says morphine-naltrexone combo meets anti-abuse standard.

more news >>

Published Studies Related to Naltrexone

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. [2013]
fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone

Evaluation of naltrexone for dissociative symptoms in borderline personality disorder. [2012.01]
Data from a pilot study suggest that naltrexone might reduce dissociative symptoms in patients with borderline personality disorder. However, the interpretation of these data is limited by the lack of a control group and by the nonblind nature of this study...

Does adding low doses of oral naltrexone to morphine alter the subsequent opioid requirements and side effects in trauma patients? [2012.01]
OBJECTIVE: The present study aims to assess the influence of ultra-low doses of opioid antagonists on the analgesic properties of opioids and their side effects... CONCLUSION: The combination of ultra-low-dose naltrexone and morphine in extremity trauma does not affect the opioid requirements; it, however, lowers the risk of nausea. Copyright (c) 2012 Elsevier Inc. All rights reserved.

Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. [2012]
CONCLUSIONS: XR-NTX can be used safely in eligible patients with opioid

The combination very low-dose naltrexone-clonidine in the management of opioid withdrawal. [2012]
BACKGROUND: The management of withdrawal absorbs substantial clinical efforts in opioid dependence (OD)... CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Preliminary results elucidate neurobiological mechanisms of OD and support the utility of controlled studies on a novel VLNTX + low-dose clonidine combination for the management of opioid withdrawal.

more studies >>

Clinical Trials Related to Naltrexone

Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI) [Active, not recruiting]
The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone as compared with oral naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone as compared with oral naltrexone in reducing alcohol use from baseline levels

Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treament: A Pilot Trial [Recruiting]
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.

The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.

Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone [Active, not recruiting]
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.

Behavioral Therapy Plus Naltrexone for Alcoholism [Active, not recruiting]
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.

Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence [Recruiting]
The overall goal of this research project is to test the efficacy of a newly developed therapy, Behavioral Naltrexone Therapy (BNT), to enhance the success of naltrexone maintenance and long-term abstinence for individuals with heroin dependence.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Naltrexone has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Naltrexone review by 60 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Multiple Sclerosis
Dosage & duration:   4.5 mg. nightly taken 1 nightly for the period of 8 years (still taking it)
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   It stopped my Multiple Sclerosis progression. I still take it. There are a lot of MS patients who are using it now. It really works and is a very safe inexpensive drug.
Side effects:   I dream a little more.
Comments:   It is a FDA approved drug at 50 mg. for Drug dependent patients. It has been used in the 3 to 4.5 mg doses for MS for about 10 years. It has gained popularity in the past 5 years and is undergoing various double blind placebo testing at this time for MS, Crones Disease, Aids, and various other conditions. It is extremely safe in the Lower doses such as 4.5 mg. It is also called LDN, as an abbreviation for Low Dose Naltrexone. Once I started taking it for a few days, my MS symptoms improved and according to my Neurologist, my progression has absolutely stopped. I started taking it in 2000.

 

Naltrexone review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Crohn's
Dosage & duration:   Starting at 1.5 mg night taken 1 time at night for the period of Just started 1-1/2 months
Other conditions:   None
Other drugs taken:   Entocort, Pentasa
  
Reported Results
Benefits:   Within 1/1-/2 months I am now starting on 2 pills at night which is 3 mg. The pain that I normally get in my chest (from my Crohn's) is gone. I feel better and I am not as tired. It is a wonder drug and I wish they would run more trials so more people can gain the benefits of this drug. Other drugs started out this way and were tested off label for other diseases, why not LDN.
Side effects:   Do not have any
Comments:   I start out with 1 pill at night for 30 days, then increase to 2 pills a night for 30 days, then 3 pills a night and that is the maximum of dosage. I am assuming some people just need the 2 pills a night. Seems to be working great for me.

See all Naltrexone reviews / ratings >>

Page last updated: 2014-10-21

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