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Baclofen (Baclofen) - Summary

 
 



BACLOFEN SUMMARY

Baclofen USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid.

Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function.

Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.


See all Baclofen indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Baclofen

Baclofen for the Treatment of Alcohol Dependence and Possible Role of Comorbid Anxiety. [2014]
baclofen in the treatment of alcohol dependence... CONCLUSIONS: In spite of the small sample for a 3-arm clinical trial, this study

Randomised clinical trial: arbaclofen placarbil in gastro-oesophageal reflux disease--insights into study design for transient lower sphincter relaxation inhibitors. [2013]
characteristics of patients who were responders... CONCLUSIONS: Arbaclofen placarbil was not superior to placebo in the primary

Baclofen reduces binge eating in a double-blind, placebo-controlled, crossover study. [2012]
Baclofen has shown promise in treating substance use disorders and also reduced binge frequency in an open-label trial...

Defining the Role of Baclofen for the Treatment of Alcohol Dependence: A Systematic Review of the Evidence. [2011.12.06]
The pharmacological properties of baclofen, a GABA(B) receptor agonist, have led to investigation of its use for the off-label treatment of alcohol dependence. Literature examining the role of baclofen in alcohol dependence suggests that it may be a useful medication in the treatment armamentarium with an additional benefit of promoting abstinence and reducing alcohol-associated cravings and anxiety...

treating alcohol withdrawal with oral baclofen: a randomized, double-blind, placebo-controlled trial. [2011.10]
BACKGROUND: Abrupt cessation of alcohol intake causes habituated drinkers to experience symptoms of alcohol withdrawal syndrome (AWS). OBJECTIVE: To determine the effect of the gamma-aminobutyric acid (GABA)-B agonist baclofen on the course of acute symptomatic AWS... CONCLUSIONS: We found that the use of baclofen was associated with a significant reduction in the use of high doses of benzodiazepine (lorazepam) in the management of symptomatic AWS. The use of low-dose baclofen in the management of AWS deserves further study, as reduced dependence on high-dose benzodiazepines in AWS management could improve patient safety. Copyright (c) 2011 Society of Hospital Medicine.

more studies >>

Clinical Trials Related to Baclofen

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity [Recruiting]
Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.

Baclofen for Smoking Cessation in a Non-Psychiatric Population [Recruiting]
The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures.

The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i. e. take the medication as directed for the trial period) than those in the placebo group.

The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State [Completed]
The objective of this study was to investigate the bioequivalence of Genpharm's baclofen tablets following a single, oral 20 mg (1 x 20 mg) dose compared to the Baclofen USP (Watson Laboratories Inc., USA) administered under fasting conditions. Twenty-seven (27) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M. D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's baclofen 20 mg tablets are bioequivalent to Baclofen USP 20 mg tablets (Watson Laboratories Inc., USA) administered under fasting conditions.

Baclofen and Hypoxia-induced Periodic Ventilation [Recruiting]

Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients [Recruiting]

more trials >>

Reports of Suspected Baclofen Side Effects

Overdose (86)Coma (65)Muscle Spasms (61)Neurotoxicity (59)Vomiting (52)Death (50)Completed Suicide (50)Muscle Spasticity (48)Dizziness (45)Convulsion (45)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Baclofen has an overall score of 8.50. The effectiveness score is 8.50 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Baclofen review by 31 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Muscle pain and stiffness due to fibromyalgia
Dosage & duration:   10mg taken 3x/day for the period of 2 years/ongoing
Other conditions:   Bipolar Disorder, Hypothyroidism, Fibromyalgia
Other drugs taken:   Levoxyl, Tramadol, Oxcarmazapine, Hydroxizine Pamoate, Clonazepam
  
Reported Results
Benefits:   Significant reduction in cramping, stiffness, and "knots" in muscles.
Side effects:   Drowsiness, somewhat impaired balance
Comments:   I was prescribed Baclofen with a number of other drugs to treat muscle and joint pain and stiffness due to fibromyalgia. When I first began taking the medication, I slept ALL the time--as much as 22 hours a day. I literally could not stay awake. This may have been due not only to the drug's sedating affect, but to the vast sleep deficit of that years of pain and insomnia had produced. As time went on, I slept less, and was less dependent on the Baclofen as a "maintenance" medication--I began to "save" it to take in slightly more concentrated doses when a severe muscle spasm or strain, or a "flare" occurs, which happens frequently in fibromyalgia patients. I have noticed that the drug is less effective than it used to be, requiring higher doses to treat the same level of stiffness or cramping.

 

Baclofen review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   30 mg qhs taken daily for the period of 3 months
Other conditions:   hypothyroid
Other drugs taken:   valium, trazadone, naturthroid
  
Reported Results
Benefits:   Helped with sleep. Could reduce valium, trazadone without withdrawal symptoms
Side effects:   A little drooziness in AM
Comments:   Was looking for another drug without as much addiction potential for life long sleep disorder. Found this through a friend, there are posts on the internet about it, also used for addictions off label. My MD agreed to try it.

 

Baclofen review by 62 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   insomnia
Dosage & duration:   30 mg qhs taken daily for the period of 3 months
Other conditions:   hypothyroid
Other drugs taken:   valium, trazadone, naturthroid
  
Reported Results
Benefits:   Helped with sleep. Could reduce valium, trazadone without withdrawal symptoms
Side effects:   A little drooziness in AM
Comments:   Was looking for another drug without as much addiction potential for life long sleep disorder. Found this through a friend, there are posts on the internet about it, also used for addictions off label. My MD agreed to try it.

See all Baclofen reviews / ratings >>

Page last updated: 2014-11-30

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