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Soma (Carisoprodol) - Summary

 
 



SOMA SUMMARY

These highlights do not include all the information needed to use SOMA safely and effectively. See full prescribing information for SOMA.

SOMA (carisoprodol) Tablets for Oral Use
Initial U.S. Approval: 1959

SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture.

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration (2) ].


See all Soma indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Soma (Carisoprodol)

Muscle Spasms
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2017.06.07]
Title: Muscle Spasms
Category: Diseases and Conditions
Created: 6/16/2009 12:00:00 AM
Last Editorial Review: 6/7/2017 12:00:00 AM

more news >>

Published Studies Related to Soma (Carisoprodol)

Randomized, double-blind trial of carisoprodol 250 mg compared with placebo and carisoprodol 350 mg for the treatment of low back spasm. [2010.01]
CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250 mg was as effective as 350 mg three times daily and at bedtime with a lower incidence of adverse events and fewer discontinuations of therapy due to adverse events. Patients improved whether or not they reported sedation as an adverse event.

Randomized, double-blind trial of carisoprodol 250 mg compared with placebo and carisoprodol 350 mg for the treatment of low back spasm. [2010]
CONCLUSIONS: When administered three times daily and at bedtime, carisoprodol 250

Double-blind, placebo-controlled trial of carisoprodol 250-mg tablets in the treatment of acute lower-back spasm. [2008.02]
PURPOSE: The objective of this placebo-controlled trial was to determine the efficacy and safety of carisoprodol (Soma, MedPointe Pharmaceuticals, Somerset, NJ, USA), a centrally acting skeletal muscle relaxant used to treat acute, painful musculoskeletal conditions, at a dosage of 250 mg three times daily and at bedtime in patients with acute, painful muscle spasm of the lower back... CONCLUSIONS: In this study, patients with acute muscle spasm of the lower back had significantly greater and more rapid relief from starting backache, and had improved functional status, as measured by the RMDQ, during treatment with carisoprodol 250-mg tablets compared to placebo. Patients experienced clinical improvement with or without sedation.

Cognitive-behavioural therapy for patients with multiple somatoform symptoms--a randomised controlled trial in tertiary care. [2004.04]
OBJECTIVE: (a) To evaluate the effect of a cognitive-behavioural inpatient treatment and (b) to analyse the differential efficacy of an additional ("soma") group management training of somatisation... CONCLUSION: Considering the subjects' high initial impairment, the outcome results are encouraging. The specific effect on health care use highlights the socioeconomic relevance. Copyright 2004 Elsevier Inc.

Late toxicity results of the GORTEC 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems. [2003.01.01]
CONCLUSION: Concomitant radiochemotherapy increased overall survival and locoregional control rates. The difference between the two treatment groups for Grade 3-4 complications was only significant for the teeth. The late toxicity assessment of a treatment may depend on the toxicity scale used. The LENT/SOMA scale seems to be the most accurate scale, but most of the score results were not concordant with those obtained with other scales. The results of this study confirm the necessity of using a common late toxicity scale in clinical trials.

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Clinical Trials Related to Soma (Carisoprodol)

Supplementation With Omega-3: Mechanism of Action [Suspended]
This is a trial of two marketed fish oil supplements, one with a high EPA: DHA ratio and the other with a high DHA: EPA ratio, to examine differential effects on platelet function, blood pressure, and fasting triglyceride levels.

Effects of Berries on Post-meal Blood Sugar [Completed]
The purpose of this study is to investigate whether berries are effective in lowering blood glucose and insulin responses to meals containing starch or sucrose.

Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer [Active, not recruiting]
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy. Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation. The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation. Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study. The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22. 5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.

Parotid-Sparing Intensity-Modulated Radiation Therapy Compared With Conventional Radiation Therapy in Treating Patients With Oropharyngeal or Hypopharyngeal Cancer Who Are at High Risk of Radiation-Induced Xerostomia [Active, not recruiting]
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy delivers thin beams of radiation of different strengths directly to the tumor from many angles. This type of radiation therapy may reduce damage to the parotid (salivary) glands, prevent xerostomia (dry mouth), and improve quality of life. It is not yet known whether intensity-modulated radiation therapy is more effective than conventional radiation therapy in preventing xerostomia and improving quality of life in patients who have throat cancer. PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy to see how well it works compared to conventional radiation therapy in treating patients with oropharyngeal or hypopharyngeal cancer who are at risk of developing xerostomia caused by radiation therapy.

Trial of Safety Nets In Hospitalized Patients [Completed]
This study compared standard hospital restraints to a newer safety net restraint system to compare them for acceptability, tolerance, duration of restrain, length of stay in the hospital, and satisfaction of MD, nurse, and relatives of patients.

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Reports of Suspected Soma (Carisoprodol) Side Effects

Anxiety (17)Pain (15)Tremor (11)Drug Ineffective (9)Fatigue (9)Insomnia (9)Aggression (8)Blood Cholesterol Increased (7)Unevaluable Event (7)Muscle Spasms (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Soma has an overall score of 4.25. The effectiveness score is 6.50 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Soma review by 44 year old male patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   back pain
Dosage & duration:   350mg taken every 6 hrs for the period of 3 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The pain in my back and neck caused stress and spasms. The medication relived the pain , nearly completlly, and allowed the spasms to subside. I tried anti inflamatories before for this re occuring problem and found them to be nearly useless. Strong pain killers like darvocet and vicadin are affective but do not allow me to maintain any normal activity during the drug use.
Side effects:   I found that after two to three doses ther seems to be a cumulative affect of the drug on my sense of balance. This is very mild, and only leaves me feeling a bit light headed at times. I am still able to engage in most of my normal neccessary activities around my home. I do refrain from driving or any other possibly risky activity when on this medication. Also , when I have prolonged pain and require several days of medication, I have noticed slight constipation. This is no where near as bad as the constipation caused by vicoden or darvocet.
Comments:   I suffered form damage to soft tissues on my neck and back from an accedent. i crashed on a mountain bike and after the inisial recovery period, I found that certain activited can cause a sharp pain in my back at the base of my neck. This, if not medicated, will grow in the course of a hours, into spasms and tense pain. It will cause me to contort my neck and everything I do brings more pain and discomfort. The medication when taken at the onset of the pain, cause the muscles to relax and the pain to subside in a day. If the pain becomes severe and medication is postponed, it may take several doses of medication over the next day or two to make the muscles relax.

 

Soma review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   migraines/upper back pain
Dosage & duration:   350 mg. taken several times a day for the period of at least a year
Other conditions:   none
Other drugs taken:   vicodin
  
Reported Results
Benefits:   None really. At the beginning it did relieve the pain and helped me to sleep.
Side effects:   It wasn't long until I became physically and psychologically dependant on the drug and the treatment became much worse than the problem for which it was prescribed. Soma is listed as a muscle relaxant which is quite misleading. Because it has been cleverly marketed, it is readily prescribed (or was) and very accessible. I think many pain management physicians prescribe soma for their patients without much thought as to the risks. The major adverse affects is the rapid tolerance developement and short term memory loss. There were a number of times that I'd forgotten if /or how much I had taken, which on one occasion precipitated an emergency room visit. It should be classified as a schedule 2 drug at least because of the potential for abuse and overdose. I think this drug should be taken off of the market.
Comments:   There aren't any treatment details. The pain management physician prescribed the medication each monthly visit and increased the dosage not long after introducing the drug as treatment. These kinds of physicians are really drug dealers cloaked in an DEA approved office.

 

Soma review by 52 year old female patient

  Rating
Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   migraines/upper back pain
Dosage & duration:   350 mg. taken several times a day for the period of at least a year
Other conditions:   none
Other drugs taken:   vicodin
  
Reported Results
Benefits:   None really. At the beginning it did relieve the pain and helped me to sleep.
Side effects:   It wasn't long until I became physically and psychologically dependant on the drug and the treatment became much worse than the problem for which it was prescribed. Soma is listed as a muscle relaxant which is quite misleading. Because it has been cleverly marketed, it is readily prescribed (or was) and very accessible. I think many pain management physicians prescribe soma for their patients without much thought as to the risks. The major adverse affects is the rapid tolerance developement and short term memory loss. There were a number of times that I'd forgotten if /or how much I had taken, which on one occasion precipitated an emergency room visit. It should be classified as a schedule 2 drug at least because of the potential for abuse and overdose. I think this drug should be taken off of the market.
Comments:   There aren't any treatment details. The pain management physician prescribed the medication each monthly visit and increased the dosage not long after introducing the drug as treatment. These kinds of physicians are really drug dealers cloaked in an DEA approved office.

See all Soma reviews / ratings >>

Page last updated: 2017-06-07

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