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Soma Carisoprodol 250 - Relief without compromise
Soma Carisoprodol 250 - Relief without compromise

Important Information

Patient Prescribing Information

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Proven Efficacy
SOMA® 250 mg has comparable efficacy to SOMA® 350, providing the benefits you've come to expect with carisoprodol therapy, but with less drowsiness.

On this page:
Proven Efficacy
Study Design
Well-Controlled Clinical Trials


Proven Efficacy

  • SOMA® 250 mg demonstrated efficacy in 2 well-controlled, double-blind, randomized clinical studies of more than 1,300 patients1
  • These studies showed SOMA® 250 mg to be effective for the relief of discomfort associated with acute, painful musculoskeletal conditions1


Study Design

Significantly Improved Global Impression of Change
Reference: 1. SOMA (package insert). Somerset, NJ: Meda Pharmaceuticals Inc.; 2007.
The global impressions of change are comparable for SOMA 250 mg and SOMA 350 mg.

* To measure the treatment's effectiveness, patients were asked to give a Global Impression of Change. Global Impression of Change is an exercise that asked patients to compare how they felt before taking the study medication to how they felt afterward (regardless of whether or not they attributed changes to the medication). Change was measured on a 5-point scale, with 4 equaling a marked improvement and 0 equaling worsening symptoms.

+ In these studies, patients were randomized to 1 of 3 treatment groups (i.e. SOMA 250 mg, SOMA 350 mg, or a placebo). Patients received study medication 3 times a day and at bedtime for 7 days.

Significantly Improved Relief from Starting Backache
Reference: 1. SOMA (package insert). Somerset, NJ: Meda Pharmaceuticals Inc.; 2007.

+ In these studies, patients were randomized to 1 of 3 treatment groups (i.e. SOMA 250 mg, SOMA 350 mg, or a placebo). Patients received study medication 3 times a day and at bedtime for 7 days.

* To measure the treatment's effectiveness, patients were asked to rate their pain according to a "Relief From Starting Backache" system. Relief From Starting Backache is a patient-rated daily assessment using diary cards to record the degree of relief with study medication. Change is measured on a 5-point scale, with 4 standing for "Complete Relief" and 0 representing "No Relief".
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Well Controlled Clinical Trials1

Well-Controlled Clinical Trials
  • Population: 2 clinical trials studied 1,353 patients with acute lower back pain within 3 days of onset
  • Dosing: Patients were randomized and placed into 1 of 3 well-controlled treatment groups. Carisoprodol 250 mg tablets (SOMA 250 mg), carisoprodol 350 mg tablets (SOMA 350 mg), and a placebo were given to each respective group 3 times a day and at bedtime for 7 consecutive days
  • Co-primary endpoints: On Day 3 of the clinical trials, patients rated their global impression of change* and their relief from starting backache+
  • Drug exclusion: To avoid misinterpretation of study results, concomitant use of analgesics, other muscle relaxants, or sedatives/hypnotics were prohibited

* To measure the treatment's effectiveness, patients were asked to give a Global Impression of Change. Global Impression of Change is an exercise that asked patients to compare how they felt before taking the study medication to how they felt afterward (regardless of whether or not they attributed changes to the medication). Change was measured on a 5-point scale, with 4 equaling a marked improvement and 0 equaling worsening symptoms.

+ To measure the treatment's effectiveness, patients were asked to rate their pain according to a "Relief From Starting Backache" system. Relief From Starting Backache is a patient-rated daily assessment using diary cards to record the degree of relief with study medication. Change is measured on a 5-point scale, with 4 standing for "Complete Relief" and 0 representing "No Relief".
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References

1. SOMA® 250 mg (package insert). Somerset, NJ: Meda Pharmaceuticals Inc.; 2007.
SOMA 250(carisoprodol): Proven Efficacy
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References
1. SOMA [package insert]. Somerset, NJ: Meda Pharmaceuticals Inc.; 2007
2. Data on file. Meda Pharmaceuticals Inc.


Indication:

  • SOMA (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
  • SOMA should be used for short periods (up to 2 or 3 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.

Important Safety Information:

  • SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.
  • Patients should be advised that SOMA may cause drowsiness and/or dizziness and has been associated with motor vehicle accidents. Patients should advised to avoid using SOMA before engaging in potentially hazardous activities.
  • Since the effects of SOMA and CNS depressants (including alcohol) or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously.
  • In postmarketing experience with SOMA, cases of dependence, withdrawal, and abuse have been reported with prolonged use. SOMA should be used with caution in addiction-prone patients.
  • There have been postmarketing reports of seizures in SOMA treated patients with most cases having occurred in the setting of multiple drug overdoses.
  • Most common side effects include drowsiness, dizziness and headache.

Please see accompanying full Prescribing Information

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SOMA® 250 mg is manufactured by Meda Pharmaceuticals Inc.

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