Drug Uses

Skelaxin is a muscle relaxant. Skelaxin is used to treat the pain and stiffness of muscle injuries, including strains, sprains and muscle spasms.

How Taken

Skelaxin comes as a tablet to take by mouth. The recommended dose for adults and children over 12 years of age is two tablets (800 mg) three to four times a day. Skelaxin may be taken with food or immediately after meals to prevent stomach upset. Do not increase your dose, take it more frequently or take it for a longer period of time than prescribed by your doctor.

Warnings/Precautions

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

Missed Dose

If you miss a dose of Skelaxin, take as soon as remembered within 1 hour. Otherwise skip that dose and resume usual dosing schedule. Do not "double-up" the dose to catch up.

Possible Side Effects

The most frequent reactions to Skelaxin include nausea, vomiting, gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or "irritability." Other adverse reactions are: hypersensitivity reactions, characterized by a light rash with or without pruritus; leukopenia; hemolytic anemia; jaundice.

Storage

Store Skelaxin at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe drowsiness or unconsciousness.

More Information

Use caution when driving, operating machinery, or performing other hazardous activities. Skelaxin 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 Skelaxin.

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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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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