BOX WARNING Hepatotoxicity:
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.
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NALTREXONE SUMMARY
Naltrexone Hydrochloride Tablets, USP
(50 mg)
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.
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NALTREXONE NEWS HIGHLIGHTS Media Articles Related to Naltrexone
Positive Preclinical Data On Novel, Proprietary Molecule, RDC-1036, Designed To Improve Outcomes For Patients Taking Opioid Analgesics
Source: Cancer / Oncology News From Medical News Today [2008.11.19]
Published Studies Related to Naltrexone
Very low dose naltrexone addition in opioid detoxification: a randomized, controlled trial. [2008.08.19]
A placebo-controlled randomized clinical trial of naltrexone in the context of different levels of psychosocial intervention. [2008.07]
Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial. [2008.07]
Using topiramate or naltrexone for the treatment of alcohol-dependent patients. [2008.07]
Naltrexone attenuates the subjective effects of amphetamine in patients with amphetamine dependence. [2008.07]
Clinical Trials Related to Naltrexone
Injectable Versus Oral Naltrexone Treatment of Alcohol Dependence In Serious Mental Illness (SMI) [Active, not recruiting]
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treament: A Pilot Trial [Recruiting]
Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone [Active, not recruiting]
Behavioral Therapy Plus Naltrexone for Alcoholism [Active, not recruiting]
Behavioral Naltrexone Therapy: A Novel Treatment for Heroin Dependence [Recruiting]
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NALTREXONE PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 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. |
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Page last updated: 2008-11-19
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