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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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Better Tolerability vs Soma 350 mg*
Improved tolerability leads to improved treatment options

SOMA® 250 mg has improved tolerability in terms of drowsiness when compared to SOMA® 350 mg but with the same relief as SOMA 350 mg. In clinical research, 87% of patients who took SOMA 250 mg did not report drowsiness.

On this page:
Better Tolerability
Study Design


Better Tolerability*

Non drowsy

TOTAL N=548



  • SOMA 250 mg is generally well tolerated. In clinical trials, less than 1% of patients (2 out of 548 patients) suffering from acute backache reported severe drowsiness 1.
  • Those patients taking SOMA 250 mg had fewer discontinuations of treatment. The level of SOMA 250 mg discontinuations due to adverse reactions was found to be similar to placebo2.

* Versus SOMA 350 mg.
86.7% of backache patients did not report drowsiness when taking SOMA 250 mg. Of those that did report it, the majority described their sleepiness as mild or moderate.


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Study Design


* Versus SOMA® 350 mg.
Reference: 1. SOMA (package insert). Somerset, NJ: Meda Pharmaceuticals Inc.; 2007.


In clinical trials, fewer patients experienced drowsiness with SOMA 250 mg.

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Fewer Discontinuations Due to Adverse Reactions1

  • Those patients taking SOMA 250 mg had fewer discontinuations of treatment. The level of SOMA 250 mg discontinuations due to adverse reactions was found to be similar to placebo2.
    • 2% discontinuations for SOMA 250 mg

    • 5.4% discontinuations for SOMA 350 mg

    • 2.7% discontinuations for placebo

  • 24% fewer patients reported drowsiness with SOMA 250 mg than with SOMA 350 mg.

  • 87% of patients taking SOMA 250 mg did not report drowsiness2

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