Soma

Back pain is a common complaint. Four out of five people in the United States will experience low back pain at least once during their lives. It’s one of the most common reasons people go to the doctor or miss work.

On the bright side, you can prevent most back pain. If prevention fails, simple home treatment and proper body mechanics will often heal your back within a few weeks and keep it functional for the long haul. Surgery is rarely needed to treat back pain.

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What is it?

Most everyone at one time or another develops pain in the neck or in the back. Usually, an activity brings on the pain, and the pain typically improves with rest. There are simple ways to bring relief and a few important signs that indicate when pain is more than a simple strain. Chronic pain usually gets worse despite bed rest, wakes you in the middle of the night, progresses despite medication and interferes with daily activity.

How bad is it?

Pain is a very good messenger. It tells us that something is wrong. The more mysterious it is, the more likely it is to be significant, either by itself or as an indicator of some other condition. Back and neck pain come in all degrees; from a brief, mild ache after a day of painting the ceiling to a crippling years-long misery that defies potent pain-relievers, intense physical therapy and even surgery.

What causes it?

Most back and neck pain is easily recognized as the result of overdoing some activity. It is amazing what the human body can be trained to do, but it is equally amazing how incapable it is of doing something it is not accustomed to.

There are two categories of strain that cause nearly identical pain - acute and cumulative. We all know what weekend warriors feel like on Monday morning, whether they just dug up the garden or began the tennis season. But there is a more insidious type of strain that takes many days or even months to notice. Cumulative stress injuries (CSI) in the workplace are now being recognized as major causes of disability and work loss. The human body is not used to the many activities required of us today. Probably the first CSI to be recognized was the pitcher’s elbow in baseball. Little leagues won’t let children pitch more than a few innings because of the strain it puts on their arm.

Another more common CSI is carpal tunnel syndrome, often the result of hours a day at a keyboard. The back and the neck can suffer similar strains by remaining in certain positions for long periods. The whole science of ergonomics has been developed to prevent these repetitive stress injuries by designing furniture and appliances that place body parts in the optimum position for working.

Not knowing immediately what brought on your current discomfort is the first warning sign to take a pain seriously. Some pains that seem to be coming from the spine are actually referred there from elsewhere inside the body. For instance, a sick gall bladder can masquerade as a strain of the mid-back and usually hurts just beneath the right shoulder blade. Heart attacks can mimic neck pains that pinch nerves going into the left arm.

Other symptoms that accompany the pain are more clues. Some of the most important are related to all nerves that pass through your spine on their way between the brain and the rest of your body. These nerves send feelings in one direction and movement commands in the other. If either of these functions - feeling or movement - is disturbed, something serious is happening. Numbness is the most common failure of feeling, and weakness is the most common disturbance of movement. Certain changes in feeling such as tingling, burning or extreme sensitivity are also signs of nerve problems. Paralysis is the extreme form of weakness. The urinary bladder can also be affected by nerve damage related to back pain. So if your back pain comes with inability to control urinating, there is likely to be a significant relationship between the two.

How do I know I have it?

The important question is: How do you know what is causing it? If your pain is clearly related to what you are doing and has no peculiarities like numbness or weakness associated with it, chances are it’s just mechanical strain. But you should see a doctor for any pain that lasts more than a few days without improving, that has no obvious cause, that gets worse without provocation or that has associated symptoms.

What can I do about it?

If you decide to seek professional care for unusual spinal pain, first get a competent diagnosis from a doctor. This may require X-rays or special scans (CT or MRI) to identify unusual and serious causes such as tumors or bone and joint disease. When nothing beyond mechanical strain can be found, the first and foremost intervention is a good posture and exercise program. Secondly, for the more serious mechanical spinal pains, such as whiplash neck injuries and chronic low back pain that is crippling, a variety of helpful and sometimes controversial treatments are available. Osteopathic/chiropractic manipulations and acupuncture have helped some patients but have also failed in others. The foundation for treatment remains an accurate diagnosis.

Starting new activities

Your body is able to do extraordinary things but not all at once. Remember two things about any physical activity:

* If you are in generally good shape, new activities will be better tolerated.
* Begin any activity gradually.

The first point doesn’t require more than common sense - 15 to 30 minutes a day of anything that tires you out is good. Swimming is close to ideal because you use everything at once, without being able to overuse or abuse anything. Water provides resistance without being as hard on the joints like pavement.

When starting new activities, you should start slowly and briefly. But each beginning should be preceded with a warm-up. Jog in place. Stretch the muscles you will be using. Plan your time.

Points to remember

* Nearly all back and neck pains are because of unwise over-activity.
* If you pay attention, your pain will tell you how serious it is.
* Seek medical advice if there is anything unusual about your pain.
* Stay in good shape and use common sense when beginning new activities.

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What Is Rheumatoid Arthritis?

Rheumatoid arthritis, or RA, is a systemic inflammatory disease that causes pain, stiffness, swelling and loss of motion in the joints. It is an autoimmune disease – one of many in which, for unknown reasons, a person’s immune system attacks his or her own body tissues. In RA, the immune system attacks the synovium, which is the tissue that lines the joints, causing inflammation in and overgrowth of this tissue.

How Do I Know If I Have RA?

The symptoms of RA vary from person to person and can mimic those of other inflammatory joint conditions, sometimes making the diagnosis difficult. Common RA symptoms include:

* Tender, warm, swollen and stiff joints, often first noticed in the hands and feet and usually symmetrical, e.g., both wrists are affected at the same time.
* Stiffness and pain that are usually worse after waking in the morning and last at least an hour before improving, which occurs with use and motion.
* Symptoms like tiredness, low-grade fever, weight loss and a general feeling of malaise that may develop even before the onset of joint symptoms.
* Systemic effects on other parts of the body such as the tear and salivary glands, lungs, heart and blood vessels.
* Soft lumps called rheumatoid nodules that range in size from a pea to a walnut, which occur in 20 to 30 percent of people with RA.

How Is RA Treated?

RA patients use a combination of treatments to relieve pain, improve mobility and slow down or perhaps even stop damage to the joints. A treatment plan may include:

* Lifestyle modifications: exercise, stress reduction, healthful eating
* Medications including non-steroidal anti-inflammatory drugs (NSAIDs), steroids, disease-modifying anti-rheumatic drugs (DMARDs), and biologic therapies
* Physical therapy
* Surgery to repair damaged joints
* Alternative and complementary therapies such as acupuncture, massage or biofeedback for pain control

Sports-related activities as well as falls and other trauma can injure the cartilage within a joint and, if it is not provided sufficient time to heal, chronic pain and persistent disability can follow. These activities and incidents may increase the risk of osteoarthritis, especially if there’s impact involved or there’s the risk of injury to ligaments. Additionally, damage to the bone surface can start a biological process that results in joint degeneration. This in turn, often leads to rheumatoid arthritis or osteoarthritis.

Arthritis is often a chronic disease meaning it can affect the person afflicted over a long period of time. It cannot be cured, but it can be treated through a variety of methods and products. Learning how to manage your joint pain over the long term is an important factor in controlling the disease and maintaining a good quality of life. This is a brief overview of some of the methods that arthritis sufferers can use to alleviate many of the symptoms associated with arthritis, especially joint pain. Products, both prescription and over-the-counter, for relieving arthritic joint pain are described in Joint Pain Products.

Heat and cold

Heat and/or cold therapy is not recommended to alleviate symptoms associated with all types of arthritis and as such, the decision whether to use it or not should be discussed with your doctor or physical therapist. If your care provider determines that the use of heat and/or cold is appropriate for use on your arthritis pain, it must be determined which kind of temperature treatment should be used. Moist heat, such as a warm bath or shower, or dry heat, such as a heating pad, placed on affected joint for about 15 minutes may relieve the pain. An ice pack or bag of frozen vegetables wrapped in a towel and placed on the sore area for about 15 minutes may help to reduce swelling and stop the pain. If you have poor circulation, do not use cold packs.

Joint protection

In order to relieve the stress of everyday activity on an afflicted joint, which can exacerbate the condition and may lead to additional injury, a splint or brace can be used to allow joints to rest and keep them from being used. As with many other treatments, a medical care provider such as a physician or physical therapist can make recommendations and possibly provide you with the brace.

Massage

Massage is associated with temporarily relieving joint pain, one of the major symptoms associated with arthritis, rather than treating the underlying cause of a loss of cartilage. A massage therapist will typically lightly stroke and/or knead the muscles around the joint, which increases blood flow to the stressed area. It is important to realize that arthritic joints are very sensitive, so the massage therapist must be familiar with the disease and problems associated with the affected joints.

Exercise

Low-impact exercises such as stretching exercises, swimming, walking, low-impact aerobics, and range-of-motion exercises may reduce joint pain and stiffness while increasing joint mobility. A physical therapist or gym trainer can help plan an exercise program that will give you the most benefit with the least stress on the arthritis-stressed joints.

Weight Reduction

In addition to alleviating some symptoms, the weight loss associated with an exercise program is beneficial in relieving the extra stress that extra pounds put on weight-bearing joints such as the hips and knees. Studies have shown that overweight women who lost approximately 10 pounds substantially reduced the development of osteoarthritis in their knees. In addition, these studies suggested that if osteoarthritis has already affected one joint such as the knee or hip, weight reduction would reduce the chance of it occurring in the other knee or hip. A physical therapist or gym trainer can help plan an exercise program that will give you the most benefit with the least stress on the arthritis-stressed joints.

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation uses a small devi ce that is placed near the joint afflicted with arthritis and directs mild electric pulses to nerve endings in and around the arthritic joint. It is theorized that TENS blocks the pain messages sent to the brain from the nerves and modifies the body’s perception of pain. Although TENS relieves some joint pain associated with arthritis, it doesn’t offset the joint inflammation that is associated with arthritis.

Surgery

In some extreme cases of persons with arthritis, surgery may be necessary. The surgeon may perform an operation to remove the synovium, realign the joint, or in extreme cases, replace the damaged joint with an artificial one. Total joint replacement provides not only dramatic pain relief but also significant improvement in joint motion and mobility for many people with arthritis.

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Alternative Medicine: The National Center for Alternative and Complementary Medicine (NCCAM) cites back pain as the No. 1 reason why people seek alternative medicine care. Neck pain is No. 3, still a major reason. Reasons for trying CAM include:

* it may work well in conjunction with more traditional type treatment
* other traditional treatments have been tried, with unsatisfactory results
* CAM is less expensive than traditional treatment
* conventional medical professionals suggest it.

Exercise: Consumer Reports Medical Guide rates exercise as the best of all the options for treatment of long-term back pain. Often your doctor or physical therapist will prescribe a set of exercises for your back or neck condition. There are several very popular forms of exercise that appear to help control back pain, among them yoga, Pilates, and the Egoscue Method. Ergonomic experts suggest taking frequent work mini-breaks to do back exercises, as well.

Back surgery: Back surgery is usually tried after conservative treatment methods such as physical therapy, home exercise programs, injections, and other methods have failed after six months or longer of use. While most people don’t need back surgery, the number of surgeries is on the rise. Not all back surgeries are successful. A back surgery that fails to remove the pain, or causes pain or problems not present prior to surgery is a condition known as failed back surgery syndrome.

Implanted Neurostimulation: Implanted neurostimulation, also known as spinal cord stimulation, helps to modulate chronic back pain. This treatment is not for everyone. For one thing, surgery is required to put the device in, take it out, and sometimes to maintain it. It can be inconvenient, as well.

Injections: Injections are an invasive technique that can diagnose the cause of pain, and can treat the pain itself. The great thing about injections for back pain is that they deliver medicine directly to the site of the pain. There are several types of injections. Recent advances in medicine have introduced two new types of injections:

* Botox injections for chronic neck and back pain
* Prolotherapy

Medication: According to the American Chronic Pain Association, analgesics and other medications are the most common chronic pain treatment. While short-term use of drugs from chronic back or neck pain probably won’t get you into trouble, prolonged use may increase the risk for serious side effects. For example, in 2004, Vioxx, a COX-2 inhibitor, was removed from the market after it became evident that prolonged use of these drugs could result in fatal heart problems.

Medications get the best results when used in conjunction with other treatments such as physical therapy, behavioral therapy and more.

Pain Management: The branch of medicine that helps patients manage their pain is called pain medicine or pain management. Pain medicine is a multi-disciplinary approach to managing the presence of pain in your life. Pain management treatment considers physical, social, and psycological lifestyle factors.

Types of Doctors for Back and Neck Pain: Many doctors specialize in one or two areas. Sometimes doctors’ specialty areas overlap with one another. The most important thing to remember when choosing a doctor who specializes is to find one with excellent skills in diagnosing and treating your condition.

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Sedation is the most commonly reported adverse effect of muscle relaxant medications. These drugs should be used with caution in patients driving motor vehicles or operating heavy machinery. More absolute contraindications do exist to the use of carisoprodol, cyclobenzaprine, and diazepam. Rare idiosyncratic reactions have also been reported to carisoprodol and its metabolites such as meprobamate. Benzodiazepines have potential for abuse and their use should be avoided. By initially prescribing muscle relaxants at bedtime, the physician might take advantage of their sedative effects and minimize daytime drowsiness.

These agents have been found to be effective when used either alone or in combination with an analgesic/anti-inflammatory agent within seven days of symptom onset. The prescribing physician should monitor patients receiving these medications and tailor dosages in an attempt to minimize the drowsiness and sedation often associated with their use. The use of benzodiazepines does not appear to offer any significant benefit to patients experiencing acute low back pain. Further research is needed before the role of baclofen and dantrolene sodium in the treatment of muscle spasm of local origin can be more clearly defined.

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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.

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Back Pain

Back pain in the lower back or low back pain Low back pain is not a specific disease. Rather, it is a symptom that may occur from a variety of different processes. Back pain is common and the largest single cause of sickness absence in the UK. Although it can be very painful, it is normally not serious. Low back pain means a pain, or ache, anywhere on your back, in between the bottom of the ribs and the top of the legs. Pain in the lower back is a symptom of stress or damage to your ligaments, muscles, tendons or discs. In some cases the back pain can spread to the buttocks and thighs. Simple low back pain means that the pain is not due to any underlying disease that can be found. In some cases the cause may be a sprain (an over-stretch) of a ligament or muscle. In other cases the cause may be a minor problem with a disc between two vertebrae, or a minor problem with a small ‘facet’ joint between two vertebrae.

Symptoms of Back Pain

Pain may come on suddenly or gradually. It may vary from mild to severe, and it can be constant or it may come and go. It is usually sharp and burning and is made worse by sneezing, coughing, or straining to pass stools. Some people describe it as a shooting pain. The pain usually affects only one leg.

Aches, spasm and stiffness-You may have painful muscle spasms in your back. (Muscle spasms are when your muscles tighten on their own). These are very common, as your back has a network of muscles and nerves that can easily be strained or torn.1 The pain may be a constant dull ache, or it may be sharp and burn when you move around. Your back may be tender when you touch it.

Pain can also be made worse by activities that cause you to forcefully contract the core muscles of your trunk such as a cough, sneeze, or a difficult bowel movement, or if you hold your breath during an activity.

Neuropathic pain is caused by damage to nerve tissue. It is often felt as a burning or stabbing pain. One example of neuropathic pain is a “pinched nerve.

Treatment

Heat Application
Applications of heat packs help ease much of the discomfort associated with muscle spasm causing low back pain. Patients can use heating pad, hot water bottles, or even a hot bath to help ease the muscle discomfort that often causes low back pain.

Medications
Your doctor may prescribe nonsteroidal anti-inflammatory drugs or in some cases, a muscle relaxant, to relieve mild to moderate back pain that doesn’t get better with over-the-counter pain relievers. Narcotics, such as codeine or hydrocodone, may be used for a short period of time with close supervision by your doctor.

Surgery
Few people ever need surgery for back pain. There are no effective surgical techniques for muscle- and soft-tissue-related back pain. Surgery is usually reserved for pain caused by a herniated disk. If you have unrelenting pain or progressive muscle weakness caused by nerve compression, you may benefit from surgery.

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DESCRIPTION

SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33.

Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.

INDICATIONS AND USAGE

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. SOMA should only 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 [ see Dosage and Administration.

DOSAGE AND ADMINISTRATION

The recommended dose of SOMA is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of SOMA use is up to two or three weeks.

DOSAGE FORMS AND STRENGTHS

250mg Tablets: round, convex, white tablets, inscribed with SOMA 250
350mg Tablets: round, convex, white tablets, inscribed with SOMA 350

CONTRAINDICATIONS

SOMA is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

WARNINGS AND PRECAUTIONS

1. Sedation

SOMA may have sedative properties (in the low back pain trials, 13% to 17% of patients who received SOMA experienced sedation compared to 6% of patients who received placebo) and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery.

Since the sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

2. Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with SOMA, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used SOMA in combination with other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of SOMA dependence, withdrawal, or abuse, SOMA should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and SOMA should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

One of the metabolites of SOMA, meprobamate (a controlled substance), may cause dependence.

3. Seizures

There have been postmarketing reports of seizures in patients who received SOMA. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol).

ADVERSE REACTIONS

1. Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain. In these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to central nervous system adverse reactions.

2. Postmarketing Experience

The following events have been reported during postapproval use of SOMA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Tachycardia, postural hypotension, and facial flushing.
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures.
Gastrointestinal: Nausea, vomiting, and epigastric discomfort.
Hematologic: Leukopenia, pancytopenia

DRUG INTERACTIONS

1. CNS Depressants

The sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of SOMA and meprobamate, a metabolite of SOMA, is not recommended.

2. CYP2C19 Inhibitors and Inducers

Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate. Co-administration of CYP2C19 inhibitors, such as omeprazole or fluvoxamine, with SOMA could result in increased exposure of carisoprodol and decreased exposure of meprobamate. Co-administration of CYP2C19 inducers, such as rifampin or St. John’s Wort, with SOMA could result in decreased exposure of carisoprodol and increased exposure of meprobamate. Low dose aspirin also showed an induction effect on CYP2C19. The full pharmacological impact of these potential alterations of exposures in terms of either efficacy or safety of SOMA is unknown.

USE IN SPECIFIC POPULATIONS

1. Pregnancy

Pregnancy Category C. There are no data on the use of SOMA during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolytic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol. There was no increase in the incidence of congenital malformations noted in reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1-1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. SOMA should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

2. Labor and Delivery

There is no information about the effects of SOMA on the mother and the fetus during labor and delivery.

3. Nursing Mothers

Very limited data in humans show that SOMA is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4-6% of the maternal daily dose through breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning were decreased. This information suggests that maternal use of SOMA may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when SOMA is administered to a nursing woman.

4. Pediatric Use

The efficacy, safety, and pharmacokinetics of SOMA in pediatric patients less than 16 years of age have not been established.

5. Geriatric Use

The efficacy, safety, and pharmacokinetics of SOMA in patients over 65 years old have not been established.

6. Renal Impairment

The safety and pharmacokinetics of SOMA in patients with renal impairment have not been evaluated. Since SOMA is excreted by the kidney, caution should be exercised if SOMA is administered to patients with impaired renal function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.

7. Hepatic Impairment

The safety and pharmacokinetics of SOMA in patients with hepatic impairment have not been evaluated. Since SOMA is metabolized in the liver, caution should be exercised if SOMA is administered to patients with impaired hepatic function.

8. Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution should be exercised in administration of SOMA to these patients.

OVERDOSAGE

Overdosage of SOMA commonly produces CNS depression. Death, coma, respiratory depression, hypotension, seizures, delirium, hallucinations, dystonic reactions, nystagmus, blurred vision, mydriasis, euphoria, muscular incoordination, rigidity, and/or headache have been reported with SOMA overdosage. Many of the SOMA overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) can be additive even when one of the drugs has been taken in the recommended dosage. Fatal accidental and non-accidental overdoses of SOMA have been reported alone or in combination with CNS depressants.

Treatment of Overdosage: Basic life support measures should be instituted as dictated by the clinical presentation of the SOMA overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.

The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of SOMA: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of SOMA, contact a Poison Control Center.

CLINCIAL PHARMACOLOGY

1. Mechanism of Action

The mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been clearly identified.

In animal studies, muscle relaxation induced by carisoprodol is associated with altered interneuronal activity in the spinal cord and in the descending reticular formation of the brain.

2. Pharmacodynamics

Carisoprodol is a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles.

A metabolite of carisoprodol, meprobamate, has anxiolytic and sedative properties. The degree to which these properties of meprobamate contribute to the safety and efficacy of SOMA is unknown.

3. Pharmacokinetics

The pharmacokinetics of carisoprodol and its metabolite meprobamate were studied in a crossover study of 24 healthy subjects (12 male and 12 female) who received single doses of 250 mg and 350 mg SOMA. The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses. The Cmax of meprobamate was 2.5 ± 0.5 μg/mL (mean ± SD) after administration of a single 350 mg dose of SOMA, which is approximately 30% of the Cmax of meprobamate (approximately 8 μg/mL) after administration of a single 400 mg dose of meprobamate.

Absorption: Absolute bioavailability of carisoprodol has not been determined. The mean time to peak plasma concentrations (Tmax) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with SOMA (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol. Therefore, SOMA may be administered with or without food.

Metabolism: The major pathway of carisoprodol metabolism is via the liver by cytochrome enzyme CYP2C19 to form meprobamate. This enzyme exhibits genetic polymorphism (see Patients with Reduced CYP2C19 Activity below).

Elimination: Carisoprodol is eliminated by both renal and non-renal routes with a terminal elimination half-life of approximately 2 hours. The half-life of meprobamate is approximately 10 hours.

Gender: Exposure of carisoprodol is higher in female than in male subjects (approximately 30-50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.

Patients with Reduced CYP2C19 Activity: SOMA should be used with caution in patients with reduced CYP2C19 activity. Published studies indicate that patients who are poor CYP2C19 metabolizers have a 4-fold increase in exposure to carisoprodol, and concomitant 50% reduced exposure to meprobamate compared to normal CYP2C19 metabolizers. The prevalence of poor metabolizers in Caucasians and African Americans is approximately 3-5% and in Asians is approximately 15-20%.

NONCLINICAL TOXICOLOGY

1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

SOMA was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vivo mouse micronucleus assay of circulating blood cells.

SOMA was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spent in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison. The significance of these findings for human fertility is not known.

CLINICAL STUDIES

The safety and efficacy of SOMA for the relief of acute, idiopathic mechanical low back pain was evaluated in two, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trials. Patients had to be 18 to 65 years old and had to have acute back pain (≤ 3 days of duration) to be included in the trials. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.

In Study 1, patients were randomized to one of three treatment groups (i.e., SOMA 250 mg, SOMA 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., SOMA 250 mg or placebo). In both studies, patients received study medication three times a day and at bedtime for seven days.

The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in both studies. The primary statistical comparison was between the SOMA 250 mg and placebo groups in both studies.

The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.

HOW SUPPLIED/STORAGE AND HANDLING

250mg Tablets: round, convex, white tablets, inscribed with SOMA 250; available in bottles of 100 (NDC 0037-2250-10).

350mg Tablets: round, convex, white tablets, inscribed with SOMA 350; available in bottles of 100 (NDC 0037-2001-01).

Storage:
Store at 25° C (77° F); excursions permitted between 15° and 30° C (59° and 86° F) (see USP Controlled Room Temperature).

PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to SOMA.

1. Sedation

Since SOMA may cause drowsiness and/or dizziness, patients should be advised to assess their individual response to SOMA before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery.

2. Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking SOMA and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives.

3. SOMA Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with SOMA should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. If symptoms still persist, patients should contact their healthcare provider for further evaluation.

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Back pain is a common complaint. Four out of five people in the United States will experience low back pain at least once during their lives. It’s one of the most common reasons people go to the doctor or miss work.

On the bright side, you can prevent most back pain. If prevention fails, simple home treatment and proper body mechanics will often heal your back within a few weeks and keep it functional for the long haul. Surgery is rarely needed to treat back pain.

Causes

Your back is an intricate structure composed of bones, muscles, ligaments, tendons and disks - the cartilage-like pads that act as cushions between the segments of your spine. Back pain can arise from problems with any of these component parts. In some people, no specific cause for their back pain can be found.

Strains

Back pain most often occurs from strained muscles and ligaments, from improper or heavy lifting, or after a sudden awkward movement. Sometimes a muscle spasm can cause back pain.

Structural problems

In some cases, back pain may be caused by structural problems, such as:

* Bulging or ruptured disks. Disks act as cushions between the vertebrae in your spine. Sometimes, the soft material inside a disk may bulge out of place or rupture and press on a nerve. But many people who have bulging or herniated disks experience no pain from the condition.
* Sciatica. If a bulging or herniated disk presses on the main nerve that travels down your leg, it can cause sciatica - sharp, shooting pain through the buttock and back of the leg.
* Arthritis. The joints most commonly affected by osteoarthritis are the hips, hands, knees and lower back. In some cases arthritis in the spine can lead to a narrowing of the space around the spinal cord, a condition called spinal stenosis.
* Skeletal irregularities. Back pain can occur if your spine curves in an abnormal way. If the natural curves in your spine become exaggerated, your upper back may look abnormally rounded or your lower back may arch excessively. Scoliosis, a condition in which your spine curves to the side, also may lead to back pain.
    * Osteoporosis. Compression fractures of your spine’s vertebrae can occur if your bones become porous and brittle.

Rare but serious conditions

In rare cases, back pain may be related to:

* Cauda equina syndrome. This is a serious neurological problem affecting a bundle of nerve roots that serve your lower back and legs. It can cause weakness in the legs, numbness in the “saddle” or groin area, and loss of bowel or bladder control.
* Cancer in the spine. A tumor on the spine can press on a nerve, causing back pain.
* Infection of the spine. If a fever and a tender, warm area accompany back pain, the cause could be an infection.

Risk factors

Factors that increase your risk of developing low back pain include:

* Smoking
* Obesity
* Older age
* Female gender
* Physically strenuous work
* Sedentary work
* Stressful job
* Anxiety
* Depression

When to seek medical advice

Most back pain gradually improves with home treatment and self-care. Although the pain may take several weeks to disappear completely, you should notice some improvement within the first 72 hours of self-care. If not, see your doctor.

In rare cases, back pain can signal a serious medical problem. See a doctor immediately if your back pain:

* Is constant or intense, especially at night or when you lie down
* Spreads down one or both legs, especially if the pain extends below the knee
* Causes weakness, numbness or tingling in one or both legs
* Causes new bowel or bladder problems
* Is associated with pain or pulsation (throbbing) in the abdomen, or fever
* Follows a fall, blow to your back or other injury
* Is accompanied by unexplained weight loss

Also, see your doctor if you start having back pain for the first time after age 50, or if you have a history of cancer, osteoporosis, steroid use, or drug or alcohol abuse.

Screening and diagnosis

Diagnostic tests aren’t usually necessary to confirm the cause of your back pain. However, if you do see your doctor for back pain, he or she will examine your back and assess your ability to sit, stand, walk and lift your legs. He or she may also test your reflexes with a rubber reflex hammer. These assessments help determine where the pain comes from, how much you can move before pain forces you to stop and whether you have muscle spasms. They will also help rule out more serious causes of back pain.

If there is reason to suspect that you have a tumor, fracture, infection or other specific condition that may be causing your back pain, your doctor may order one or more tests:

* X-ray. These images show the alignment of your bones and whether you have arthritis or broken bones. X-ray images won’t directly show problems with your spinal cord, muscles, nerves or disks.
* Magnetic resonance imaging (MRI) or computerized tomography (CT) scans. These scans can generate images that may reveal herniated disks or problems with bones, muscles, tissue, tendons, nerves, ligaments and blood vessels.
* Bone scan. In rare cases, your doctor may use a bone scan to look for bone tumors or compression fractures caused by osteoporosis. In this procedure, you’ll receive an injection of a small amount of a radioactive substance (tracer) into one of your veins. The substance collects in your bones and allows your doctor to detect bone problems using a special camera.
* Nerve studies (electromyography, or EMG). This test measures the electrical impulses produced by the nerves and the responses of your muscles. Studies of your nerve-conduction pathways can confirm nerve compression caused by herniated disks or narrowing of your spinal canal (spinal stenosis).

Treatment

Most back pain gets better with a few weeks of home treatment and careful attention. A regular schedule of over-the-counter pain relievers may be all that you need to improve your pain. A short period of bed rest is okay, but more than a couple of days actually does more harm than good. If home treatments aren’t working, your doctor may suggest stronger medications or other therapy.

Medications

Your doctor may prescribe nonsteroidal anti-inflammatory drugs or in some cases, a muscle relaxant drug, to relieve mild to moderate back pain that doesn’t get better with over-the-counter pain relievers. Narcotics, such as codeine or hydrocodone, may be used for a short period of time with close supervision by your doctor.

Low doses of certain types of antidepressants - particularly tricyclic antidepressants, such as amitriptyline - have been shown to relieve chronic back pain, independent of their effect on depression.

Physical therapy and exercise

A physical therapist can apply a variety of treatments, such as heat, ice, ultrasound, electrical stimulation and muscle-release techniques, to your back muscles and soft tissues to reduce pain. As pain improves, the therapist can teach you specific exercises to increase your flexibility, strengthen your back and abdominal muscles, and improve your posture. Regular use of these techniques will help prevent pain from coming back.

Injections

If other measures don’t relieve your pain and if your pain radiates down your leg, your doctor may inject cortisone - an anti-inflammatory medication - into the space around your spinal cord (epidural space). A cortisone injection helps decrease inflammation around the nerve roots, but the pain relief usually lasts less than six weeks.

In some cases, your doctor may inject numbing medication into or near the structures believed to be causing your back pain. Early studies indicate that botulism toxin (Botox) also may help relieve back pain, perhaps by paralyzing strained muscles in spasm. Botox injections typically wear off within three to four months.

Surgery

Few people ever need surgery for back pain. There are no effective surgical techniques for muscle- and soft-tissue-related back pain. Surgery is usually reserved for pain caused by a herniated disk. If you have unrelenting pain or progressive muscle weakness caused by nerve compression, you may benefit from surgery. Types of back surgery include:

* Fusion. This surgery involves joining two vertebrae to eliminate painful movement. A bone graft is inserted between the two vertebrae, which may then be splinted together with metal plates, screws or cages. A drawback to the procedure is that it increases the chances of arthritis developing in adjoining vertebrae.
* Disk replacement. An alternative to fusion, this surgery inserts an artificial disk as a replacement cushion between two vertebrae.
  * Partial removal of disk. If disk material is pressing or squeezing a nerve, your doctor may be able to remove just the portion of the disk that’s causing the problem.
* Partial removal of a vertebra. If your spine has developed bony growths that are pinching your spinal cord or nerves, surgeons can remove a small section of the offending vertebra, to open up the passage.

Prevention

You may be able to avoid back pain by improving your physical condition and learning and practicing proper body mechanics.

To keep your back healthy and strong:

* Exercise. Regular low-impact aerobic activities - those that don’t strain or jolt your back - can increase strength and endurance in your back and allow your muscles to function better. Walking and swimming are good choices. Talk with your doctor about which activities are best for you.
* Build muscle strength and flexibility. Abdominal and back muscle exercises (core-strengthening exercises) help condition these muscles so that they work together like a natural corset for your back. Flexibility in your hips and upper legs aligns your pelvic bones to improve how your back feels.
* Quit smoking. Smokers have diminished oxygen levels in their spinal tissues, which can hinder the healing process.
* Maintain a healthy weight. Being overweight puts strain on your back muscles. If you’re overweight, trimming down can prevent back pain.

Use proper body mechanics:

* Stand smart. Maintain a neutral pelvic position. If you must stand for long periods of time, alternate placing your feet on a low footstool to take some of the load off your lower back.
* Sit smart. Choose a seat with good lower back support, arm rests and a swivel base. Consider placing a pillow or rolled towel in the small of your back to maintain its normal curve. Keep your knees and hips level.
* Lift smart. Let your legs do the work. Move straight up and down. Keep your back straight and bend only at the knees. Hold the load close to your body. Avoid lifting and twisting simultaneously. Find a lifting partner if the object is heavy or awkward.

Complementary and alternative medicine

Many people choose hands-on therapies to ease their back pain:

* Chiropractic care. Back pain is one of the most common reasons that people see a chiropractor. If you’re considering chiropractic care, talk to your doctor about the most appropriate specialist for your type of problem. In addition to chiropractors, many osteopathic doctors and some physical therapists have training in spinal manipulation.
* Acupuncture. Some people with low back pain report that acupuncture helps relieve their symptoms. The National Institutes of Health has found that acupuncture can be an effective treatment for some types of chronic pain. In acupuncture, the practitioner inserts sterilized stainless steel needles into the skin at specific points on the body.
  * Massage. If your back pain is caused by tense or overworked muscles, massage therapy may help loosen knotted muscles and promote relaxation.

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

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