Drug Uses

Zanaflex a muscle relaxant is used to help relax certain muscles in your body. It relieves the spasms and increased muscle tone caused by medical problems such as multiple sclerosis or spinal injury. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How Taken

Zanaflex comes as a tablet to take it orally. It usually is taken two or three times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zanaflex exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Warnings/Precautions

Before taking this medication, tell your doctor if you have liver disease, have kidney disease, have low blood pressure or you are on medication to treat high blood pressure; or you are taking birth control pills. You may not be able to take Zanaflex, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. Zanaflex is in the FDA pregnancy C. This means that it is not known whether Zanaflex will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether Zanaflex passes into breast milk. Do not take Zanaflex without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

If you take several doses per day, take the missed dose as soon as you remember it and take any remaining doses for that day at evenly spaced intervals. However, if you remember a missed dose when it is almost time for your next scheduled dose, skip the missed dose. Do not take a double dose to make up for a missed one.

Possible Side Effects

Side effects from Zanaflex can occur. Tell your doctor if any of these symptoms are severe or do not go away: dizziness, upset stomach, vomiting, tingling sensation in the arms, legs, hands, and feet, dry mouth, increased muscle spasms. If you experience either of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, unexplained flu-like symptoms.

Storage

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Overdose

Seek emergency medical attention. Symptoms of a Zanaflex overdose are not well known but include unconsciousness and irregular breathing.

More Information

Use caution when driving, operating machinery, or performing other hazardous activities. Zanaflex may cause drowsiness and dizziness. If you experience drowsiness or dizziness, avoid these activities. Dizziness is most likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall. Use caution with alcohol, other muscle relaxants, sleep or anxiety medicines, and pain medicines. These drugs may increase drowsiness and dizziness while you are taking Zanaflex. Do not take any other medicine during treatment with Zanaflex without first talking to your doctor or pharmacist.

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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