Drug Uses

Soma is a muscle relaxant used to relieve the pain and stiffness of muscle spasms and discomfort due to strain and sprain.

How Taken

Soma is taken orally. The usual adult dosage of soma is one 350 mg tablet, three times daily and at bedtime. Usage in patients under age 12 is not recommended. It is recommended that you take Soma with food, or with milk, to minimize the likelihood that you will suffer an upset stomach as a result of taking the medication.

Warnings/Precautions

Do not take Soma if you have acute intermittent porphyria. Before taking Soma, tell your doctor if you have kidney or liver disease. You may need a lower dose or special monitoring during your therapy. It is not known whether Soma will harm an unborn baby. Do not take Soma without first talking to your doctor if you are pregnant. It is also not known whether Soma passes into breast milk. Do not take Soma without first talking to your doctor if you are breast-feeding a baby. Soma is not approved for use in children younger than 12 years of age.

Missed Dose

If you miss a Soma dose, take it as soon as remembered if it is within an hour or so. If you do not remember until later, skip the missed dose and resume your usual dosing schedule. Do not 'double-up' the Soma dose to catch up.

Possible Side Effects

Soma may cause dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, and insomnia. Allergic or idiosyncratic reactions occasionally develop. They are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruption with cross reaction to meprobamate have been reported with Soma. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock.

Storage

Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight container.

Overdose

Seek emergency medical attention. Symptoms of a Soma overdose include low blood pressure (weakness, fainting, confusion), decreased breathing, and unconsciousness.

More Information

Use caution when driving, operating machinery, or performing other hazardous activities. Soma may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Soma.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Q: How does the online consultation for Soma work?
A: Online consultations utilizes the Internet to improve patient access to the physician. The patient no longer needs to receive a traditional physical exam by the physician. Now he simply completes an online questionnaire for Soma, and this questionnaire is then submitted to the physician using our secure order system. The online consultations can never take the place of traditional medicine, they do provide a valid means for patients to receive treatment for a number of conditions that, in many circumstances, do not actually require a physical exam.


MedPointe Pharmaceuticals announced that the Food and Drug Administration (FDA) has approved SOMA(R) (carisoprodol) 250 mg as a new recommended dose of SOMA for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. SOMA 250 mg offers comparable efficacy to the widely prescribed skeletal muscle relaxant SOMA 350 mg with a more favorable tolerability profile, including less drowsiness. SOMA 250 mg will be available by prescription nationwide immediately.
Back pain is the fifth leading reason for patient visits to physicians and ranks among the top ten most costly physical disorders. This ailment is responsible for direct health care expenditures of more than $20 billion annually and as much as $50 billion per year when indirect costs are included.
"The clinical benefits of SOMA 250 mg are in line with current treatment strategies for back pain which focus on helping patients to return to normal physical activity as quickly as possible," said Lee Ralph, M.D., Assistant Clinical Professor, Department of Family and Preventative Medicine, University of California, San Diego, LaJolla; physician partner, San Diego Sports Medicine and Family Health Center; and a lead author and investigator for the SOMA 250 mg clinical trials. "I look forward to offering my patients SOMA 250 mg as data indicates that it can help relieve discomfort from acute backache. Further, SOMA 250 mg demonstrated efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, including less drowsiness."
"The availability of SOMA 250 mg marks a significant milestone in the treatment of acute backache, a common and terribly painful condition which also has a tremendous economic impact on our nation's health care system," said Paul R. Edick, President & Chief Executive Officer of MedPointe Pharmaceuticals. "While SOMA has a long history in the treatment of discomfort associated with acute, painful musculoskeletal conditions with nearly 50 years on the market, we are pleased to provide a new recommended dose that provides a proven clinical benefit to help relieve the burden of these conditions."
Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability Profile
FDA approval of SOMA 250 mg was based on the results from two randomized, double-blind, placebo-controlled, multi-site parallel group studies (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that SOMA 250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to SOMA 350 mg.
Results from the studies also showed that SOMA 250 mg provided efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, resulting in fewer discontinuations due to treatment-related adverse events. In the studies, the discontinuation rate due to adverse events for SOMA 250 mg was comparable to placebo and lower than that for SOMA 350 mg (2% versus 2.7% versus 5.4% respectively). The most common side effects associated with SOMA 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for SOMA 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).
This new recommended dose of SOMA is 250 mg three times a day and at bedtime.
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.

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