SOMA 250MG Carisoprodol Tablets

Important Information

Prescribing Information

 

Powerful Relief With SOMA® 250 mg

Help your patients with acute, painful musculoskeletal conditions get back to their normal lives sooner.

Powerful Efficacy
SOMA 250 mg (carisoprodol) offers powerful, proven efficacy. Two double-blind, randomized, placebo-controlled, multicenter trials with over 1,300 patients demonstrated:1

  • Significant backache relief 3 days earlier than placebo (P≥.0001)
  • Relief comparable to SOMA® 350 mg

Powerful Relief
SOMA 250 mg relieves backache up to 3 days earlier than placebo, and as quickly as SOMA 350 mg2.

Global Impression of Change (P<.0005)*

*Primary efficacy endpoints were assessed by patients on on Study Day 3.
Days 4-6 were not measured.

Global impression of change is an exercise that asked patients to compare how they felt before taking the study medication to how they felt after (regardless of whether or not they attributed changes to medication). Change was measured on a 5-point scale with 4=marked improvement and 0=worsening.

Relief from Starting Backache (P<.005)*

*Primary efficacy endpoints were assessed by patients on on Study Day 3.
Days 4-6 were not measured.

Relief from starting backache is a patient rated daily assessment using diary cards to record the degree of relief with study medication. Change was measured on a 5-point scale with 4= complete relief and 0=no relief.

Acute Use
SOMA 250 mg is for short-term use up to 2 or 3 weeks, and is recommended for patients 16 years of age and older.

Reference
(1) Data on file. Meda Healthcare, Inc.

(2) SOMA [package insert]. Somerset, NJ: Meda Healthcare Inc.; 2007.

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Important Information
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 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.

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 full Prescribing Information.

SOMA® 250 mg is distributed by Meda Pharmaceuticals.

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