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Soma is a centrally-acting skeletal muscle relaxant whose active metabolite is meprobamate. Although several case reports have shown that Soma has abuse potential, it continues to be widely prescribed (except in the United Kingdom where use of benzodiazepines is preferred). Soma is a colourless, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water and freely soluble in alcohol, chloroform and acetone. Its solubility is practically independent of pH.

Carisoprodol is especially useful against various types of pain (whether or not related to muscle spasm) because of its analgesic-sparing (potentiating) effect on opioid analgesics. Carisoprodol is available by itself or mixed with aspirin and in one preparation (Soma Compound With Codeine®) along with codeine and caffeine as well.

As of November 2007 Soma has been taken off the market in Sweden due to problems with dependence, abuse and side effects. The agency overseeing pharmaceuticals has considered other drugs used with the same indications as soma to have the same or better effects without the risks of the drug.

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In a double-blind study soma was found to be superior to diazepam in the treatment of patients with at least moderately severe low back pain and spasm of no longer than seven days duration.

The first RCT (80 people) found that soma significantly increased overall improvement compared with diazepam but found no significant difference in pain at 7 days (improvement rated as very good or excellent; 70% with carisoprodol v 45% with diazepam; pain on 100 mm visual analogue scale: 58 mm with carisoprodol v 48 mm with diazepam; P values not reported in the review)

Carisoprodol was more effective than diazepam in overall relief of acute LBP (70% vs. 45%)

In this head-to-head trial, the overall incidence of adverse reactions was higher in the diazepam treated group but was not of statistical significance.

In a trial of cyclobenzaprine versus soma in patients with acute back pain and spasms there were no significant differences for pain, muscle stiffness, activity impairment, sleep impairment, tension, or relief scores compared to baseline. In this head-to-head trial dry mouth was more frequent with cyclobenzaprine (38% vs. 10%) and dizziness less frequent (8% vs. 26%). Withdrawal rates due to adverse events were equal (8%).

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Soma is a centrally acting skeletal muscle relaxant, although it does not work to directly relax tense skeletal muscle. Instead, it relieves acute muscle spasm, through its sedative properties.

Generally, Soma is prescribed as just one part of a pain-management program, in addition to rest, physical therapy and other strategies for the relief of pain associated with acute musculoskeletal conditions. In patients who suffer from acute porphyria or who have an allergic reaction to carisoprodol- or meprobamate-related compounds, Soma may be contraindicated.

As with all medications, use of Soma carries some potential risks. Patients should first be aware of the sedative properties of Soma, an effect that may significantly impair the user’s ability to operate a motor vehicle or other machinery. Care should be taken in performing these tasks until the effect on the user is fully determined.

There is a potential for the forming of a dependence on Soma. For those with a history of substance abuse problems, Soma ought to be prescribed with extreme caution. Other side effects of the drug may include extreme weakness, dizziness, temporary vision loss, agitation, confusion and disorientation. Generally, symptoms subside within several hours, although the patient may require a short hospital stay to assist in managing the effects.

The degree of safety with which a pregnant or breastfeeding woman may use Soma is yet undetermined, and as a result the drug may not be suitable for use by women who are pregnant or breastfeeding, or those who may become pregnant. Further, it has been shown that the concentration of Soma in users’ breast milk is in concentrations of between two and four times more than that of maternal plasma. Therefore, use by mothers who are breastfeeding may not be recommended.

In rare cases, patients have experienced seizures while using Soma, both those patients who have had previous seizure disorder and those with no such history. Further, because Soma is metabolized by the kidney and excreted by the kidneys, to help avoid excess accumulation in the body. Because of that, administration of Soma to patients experiencing diminished functioning of the liver or kidneys ought to be accompanied by a high degree of caution.

Other possible side effects of the drug include tachycardia, flushing of the face, vertigo, dizziness, syncope, insomnia, nausea, vomiting, and others.

An overdose of Soma can cause depression of the central nervous system, which can lead to coma in sever cases. Overdose can also result in shock, respiratory depression, seizures, and death in rare cases. Patients are advised to seek medical attention immediately if they experience any of the following: blurred vision, tachycardia, euphoria, respiratory depression, headache, hallucination, confusion, muscular incoordination, or rigidity of the muscles.

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Patients with acute, painful musculoskeletal spasms of the lower back appear to get better and faster relief from the muscle relaxant carisoprodol soma than from placebo.

In a clinical trial involving more than 800 patients, researchers said the 250mg dose of carisoprodol soma taken 4 times daily was superior to placebo and similar to the 350mg tablets of carisoprodol soma. However, the larger dose of carisoprodol somaincreased adverse events more than either of the comparator preparations.

"This study demonstrated that patients with acute muscle spasms of the lower back had significantly greater relief of the acute discomfort associated with lower back spasm, and had improved functional status during treatment with carisoprodol soma250mg pills compared with placebo," said Gregory Serfer, DO, Head, South Florida Clinical Research Center, Hollywood, Florida, United States.

Dr. Serfer presented the findings in a poster session on February 15 here at the American Academy of Pain Medicine (AAPM) 24th Annual Meeting.

In the trial, 264 patients were randomly assigned to receive carisoprodol soma 250mg, 273 patients were assigned to carisoprodol soma 350mg, and 269 patients were assigned to the placebo arm.

Carisoprodol Soma 250mg was significantly superior to placebo in patients' global impression of change -- increasing about 2.2 points on the 4-point scale compared with an increase of 1.9 for placebo patients (P < .01).

Carisoprodol Soma was also significantly more effective than placebo in patient-rated relief of backache, measured from baseline to day 3. Patients taking carisoprodol soma 250mg showed about a 1.7-point improvement compared with a 1.5-point improvement for placebo, also statistically significant (P < .01).

Discontinuation due to treatment-emergent adverse events occurred more frequently in the carisoprodol soma 350 mg group of patients compared with the carisoprodol soma 250mg group and placebo (3.9% vs 0.7% vs 1.8%, respectively), Dr. Serfer said.

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In an attempt to determine the mechanism of action of Carisoprodol Soma in the treatment of low back pain, a double blind study was carried out comparing its effectiveness to that of a sedative control, butabarbital (a sedative), and a placebo in the treatment of 48 laborers with acute lumbar pain. The results of the study have shown that Carisoprodol Soma is significantly more effective than butabarbital or placebo in providing both subjective pain relief and objective improvements in range of motion when evaluated by finger to floor testing (4). The results of the study suggests that effects of Carisoprodol Soma are not due solely to sedative action, but are also related to its muscle relaxant activity.

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DESCRIPTION
Soma is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is very slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone.

Each tablet, for oral administration, contains 250, 350 mg of Soma . In addition, each tablet contains the following inactive ingredients: FD&C Red #40 aluminum lake, hydroxypropyl cellulose, lactose monohydrate, microcrystalline cellulose, silicon dioxide, sodium starch glycolate, corn starch, stearic acid and zinc stearate.

CLINICAL PHARMACOLOGY
Soma is a centrally-acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of Soma in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, Soma has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Soma is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis.

INDICATIONS AND USAGE

Soma indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions.

CONTRAINDICATIONS

Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to Soma , or related compounds.

WARNINGS

On very rare occasions, the first dose of Soma has been followed by an idiosyncratic reaction with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue Soma and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock.

The effects of Soma with agents such as alcohol, other CNS depressants, or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who may take one or more of these agents simultaneously with Soma .

PRECAUTIONS

General

To avoid excessive accumulation of Soma , use Soma with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients.

Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals.

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The FDA is warning Americans to beware of fake drugs from Mexican pharmacies. Especially the cholesterol-lowering drug Zocor and also a muscle relaxant called Soma (carisoprodol).

After carrying out some tests the FDA found that the Zocor pills did not have the active ingredient (i.e. they were useless). They also found the carisoprodol was not as potent as it should be.

The Zocor to look out for come in 40 milligram doses, lot number K9784, to expire in November this year. The sub-standard carisoprodol came in 350 milligram doses, lot number 68348A.

The FDA advises anyone who has bought any of these products to contact their doctor, and also to report it to the FDA.

With the surge of Americans buying their prescription drugs abroad, the FDA has recently been issuing warnings to Americans. Prescription drugs in the USA are among the most expensive in the world,. Many Americans are driven to buying them from abroad because they cannot afford to buy them at home. Much larger discounts are found by buying abroad than going for the Medicare Discount Card program, say many elderly Americans.

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Carisoprodol is marketed in the United States under the brand name Soma, and in the United Kingdom and other countries under the brand names Sanoma and Carisoma. Soma (Carisoprodol) is indicated for the patients suffering with acute, painful musculoskeletal problems. This medication is used to relax muscles and relieves pain and discomfort associated with strains, sprains, spasms or other muscle injuries. This medication should be used for short periods because its effectiveness for more prolonged usage has not been established. Soma or Carisoprodol drugs are available in round, white tablets of Soma 250 mg, 350 mg. It is a white, crystalline powder, having a mild odor and a bitter taste. This medication is slightly soluble in water and freely soluble in alcohol, chloroform and in acetone.

Soma 250 mg, 350 mg relaxes muscle by blocking pain sensations between the nerves and the brain. It should be used with rest and physical therapy to treat injuries and other painful musculoskeletal conditions. This medication should be avoided by the person who has the history of drug abuse or addiction. Soma should be taken as directed by the physician and one should strictly follow its dosage and instructions to avoid any side effects. It can be taken with food or immediately after meals to avoid stomach upset. This medication is known to provide temporary relief so it must be used with rest and physical therapy. Always follow the doctor's instructions for safe recovery.

Side effects that might occur with medication are stomach upset, heartburn, headache, dizziness or drowsiness. If these symptoms persist or worsen after taking this medication one should immediately consult his doctor. If one has serious allergic reaction to this drug, then immediate seek medical attention. Several serious allergic reaction can be noticed including rash, itching, swelling, severe dizziness, trouble breathing. If one notices other side effects or allergic reactions that are not listed above, one should consult his doctor or pharmacist.

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What should I discuss with my healthcare provider before taking Soma?

Do not use this medication if you are allergic to Soma or meprobamate (Equanil, Miltown), or if you have porphyria.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

- epilepsy or other seizure disorder;
- liver disease; or
- kidney disease.

If you have any of these conditions, you may not be able to use Soma, or you may need a dosage adjustment or special tests during treatment.

This medication may be habit-forming and should be used only by the person it was prescribed for. Soma should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

You may have withdrawal symptoms when you stop using Soma after using it over a long period of time. Withdrawal symptoms include stomach pain, sleep problems, headache, nausea, and seizure (convulsions). Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether Soma passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 12 years old.
How should I take Soma?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take each dose with a full glass of water.

Store Soma at room temperature away from moisture and heat.
What happens if I miss a dose of Soma?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Soma is a muscle relaxant. It is meant to be used temporarily to treat muscle spasms due to injury or other muscle problems. Even though Soma is not a controlled substance, it has the potential to be abused and should be used cautiously in people with a tendency toward alcohol or medication abuse.

As a muscle relaxant, it can help relieve the discomfort caused by muscle spasms. A muscle spasm is an uncontrollable contraction of a muscle. Muscle spasms can cause pain, tenderness, and stiffness. Sometimes muscles spasms in the neck can cause headaches. Muscle spasms are a frequent cause of back pain.

Most often, muscle spasms are caused by injury, overuse, or similar problems (like sleeping in a strange position). Soma usually works well for these types of muscle spasms. It is intended to be used generally for a maximum of two to three weeks at a time. This should be enough time to allow any muscle injury or damage to heal. If you feel that the problem has not improved after two or three weeks, check with your healthcare provider. You may have an ongoing problem that needs to be treated differently.

You should talk with your healthcare provider prior to taking Soma if you have:
- A history of drug or alcohol abuse
- Seizures or epilepsy
- Liver disease, such as liver failure, cirrhosis, or hepatitis
- Kidney disease, such as kidney failure (renal failure)
- Acute intermittent porphyria
- Any allergies, including allergies to food, dyes, or preservatives.