Soma

Goal of the treatment is to protect the affected joints afrom repeated injury and the stresses of weight-bearing. This is usually done with orthosis wearing.

Progression of the disease is usually delayed with conservative management. Surgical measures are directed toward stabilization of the joint by arthrodesis. In the feet, bony prominences may be excised to facilitate shoe wear.

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In a normal limb, the injured joint is protected from further trauma by pain. In the absence of pain and proprioceptive sensation, however, the joint continues to be active and is repeatedly injured.

Synovial effusion and hemarthrosis are aggravated and, together with the abnormal stresses on the joint, cause extreme stretching and weakening of the capsule and supportive ligaments.

Local hyperemia causes bone atrophy and resorption.

Cartilage destruction, bone erosion, and minute fractures soon follow. Reparative response results in the formation of callus and metaplastic changes in surrounding traumatized soft tissues. With repeated injury, the joint becomes totally disorganized, subluxation ensues, and severe degenerative changes take place.

The affected joints are boggy, tense, swollen, nontender, and have an excessively abnormal range of motion on clinical examinaion. The local triad of swelling, instability, and absence of pain is nearly always suggestive of Charcot joint.

Radiographic Findings

The joint will show varying degrees of destructive and hypertrophic changes. There is loss of articular cartilage, fragmentation and absorption of subchondral bone, and osseous proliferation of the articular margins.

The bone overgrowth may be enormous, bizarre in configuration, and so great as to surround the joint as a spongy mass. The periarticular soft tissues are thickened and contain scattered calcifications.

Pathologic fractures involving the articular surface are common, as are irregular loose bodies within the joint.

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* Congenital insensitivity to pain
* Peripheral nerve injuries
* Diabetic neuropathy
* Chronic diseases of the spinal cord that lead to sensory disturbances of the limbs.

In myelomeningocele, absence of pain sensation is associated with flaccid paralysis and marked limitation of physical activity; thus, owing to associated severe osteoporosis, the bone and joint changes present a different picture.

The joints involved vary with the different etiologic conditions.

In congenital insensitivity to pain and diabetic neuropathy, the destructive changes occur primarily in the tarsal and metatarsal joints, less commonly in the ankle, and rarely in the knee.

In syringomyelia, the joints involved are those of the shoulder and elbow. In tabes dorsalis, the knee, hip, ankle, and thoracolumbar spine are frequent sites of the disease.

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This condition was described by Charcot, in 1868. He described it as a bizarre destruction of the knee joints with indolent swelling and instability in patients of tabes dorsalis. He proposed that the disease resulted from traumatization of a joint deprived of sensation.

Later Steindler classified the condition into the condition into the destructive, atrophic and hypertrophic proliferative forms.

Charcot-like changes in joints are seen in patients who have absence or depression of pain and proprioceptive sensation and who take part in extended continuous physical activity.

As a consequence their joints sustain repeated trauma.

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Generic name: Carisoprodol
Brand names: Soma

Why is Soma prescribed?

Soma is used, along with rest, physical therapy, and other measures, for the relief of acute, painful muscle strains and spasms.

Most important fact about Soma

Soma alone will not heal your muscles. You need to follow the program of physical therapy, rest, or exercise that your doctor prescribes. Do not attempt any more physical activity than your doctor recommends, even though Soma temporarily makes it seem feasible.

How should you take Soma?

Take Soma exactly as prescribed by your doctor.

If you miss a dose

Take it as soon as you remember if only an hour or so has passed. If you do not remember until later, skip the dose you missed and go back to your regular schedule. Do not take 2 doses at once.

Storage instructions

Store at room temperature in a tightly closed container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Soma.

More common side effects may include:
Agitation, depression, dizziness, drowsiness, facial flushing, fainting, headache, hiccups, inability to fall or stay asleep, irritability, light-headedness upon standing up, loss of coordination, nausea, rapid heart rate, stomach upset, tremors, vertigo, vomiting

Allergic reactions usually seen between the first and fourth doses of Soma in patients who have never taken Soma before include: itching, red welts on the skin, and skin rash. A more severe allergic reaction may include symptoms such as asthmatic attacks, dizziness, fever, low blood pressure, shock, stinging of the eyes, swelling due to fluid retention, and weakness.

Why should Soma not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Soma or drugs of this type, such as meprobamate (Miltown), you should not take Soma. Make sure your doctor is aware of any drug reactions you have experienced.

Unless you are directed to do so by your doctor, do not take Soma if you have porphyria (an inherited blood disorder).
Special warnings about Soma

In rare cases, the first dose of Soma may cause unusual symptoms that appear within minutes or hours of taking the medication. Symptoms reported include: agitation, confusion, disorientation, dizziness, double vision, enlargement of pupils, extreme weakness, exaggerated feeling of well-being, lack of coordination, speech problems, temporary loss of vision, and temporary paralysis of arms and legs. These symptoms usually subside within a few hours. If you experience any of them, contact your doctor immediately.

Soma may impair the mental or physical abilities you need to drive a car or operate dangerous machinery. Do not participate in hazardous activities until you know how Soma affects you.

If you have a history of drug dependence, make sure your doctor is aware of it before you start taking Soma.

Withdrawal symptoms, including abdominal cramps, chilliness, headache, insomnia, and nausea, have occurred in people who suddenly stop taking Soma.

Take Soma cautiously if you have any kidney or liver problems.
Possible food and drug interactions when taking Soma

Soma may intensify the effects of alcohol. Be careful drinking alcoholic beverages while you are taking Soma.

If Soma is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Soma with the following:

- Antidepressant drugs such as Elavil, Tofranil, and Nardil
- Major tranquilizers such as Haldol, Stelazine, and Thorazine
- Sedatives such as Nembutal and Halcion
- Tranquilizers such as Librium, Valium, and Xanax
- Special information if you are pregnant or breastfeeding

The effects of Soma during pregnancy have not been adequately studied. If you are pregnant or plan to become pregnant, inform your doctor immediately. This drug appears in breast milk and could affect a nursing infant. If Soma is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment is finished.

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Three out of four people experience lower back pain. A majority of these pain symptoms normally subside on their own unless they stem from serious back injuries. Keeping fit and maintaining an active lifestyle can keep lower back pain at bay. Painkillers can also alleviate pain symptoms. However, chronic back pain can develop in some people, which may make additional treatment necessary.

The Anatomy of the Lower Back

The lower back is mainly composed of muscles which envelope and connect to the spine. The spine is a column made up of generally circular bones known as the vertebrae. Between each vertebra are tough elastic discs which allow the spine adequate flexibility. Fibrous ligaments connected to each nearby vertebra also work to support and strengthen the spine. The muscles that surround the spine help it accomplish a wide range of motion.

Enclosed within the spine is the spinal cord which houses the nerves connecting to the brain. These nerves which intertwine within the vertebrae are responsible for sending and receiving messages from all the different body parts to the brain, and vice versa.

Types of lower back pain

1) Simple lower back pain

The most prevalent type of lower back pain is the simple lower back pain, also known as non-specific lower back pain. This means that pain symptoms are not caused by any other disease. A sprain, or an overstretched ligament or muscle can be a cause for pain.

So can minimal disc or facet joint problems that occur between vertebrae. Even for a physician performing several tests, it is impossible to determine the cause of pain and where the pain originates from. Because of this, nearly 19 in 20 cases of acute lower back pain have been diagnosed as simpler lower back pain.

A sudden onset of pain may follow the lifting of a heavy object, or after making an uncomfortable twisting motion. Some people wake up to lower back pain.

Simple lower back pain can range from minimal to severe. The pain may be concentrated on a localized region on the lower back and may spread to the buttocks and thighs. Lying prone on a flat surface can sometimes ease symptoms, but any movement of the back, like a cough or a sneeze can exacerbate the pain. Simple lower back pain is mechanical in nature as it can vary depending on posture or movement.

Simple lower back pain can ease by itself within a short period of time, in a week or two. In 3 out of 4 sufferers, pain symptoms disappear entirely or are significantly reduced in a months time.

Nine out of ten cases report the absence or considerable reduction of pain within six weeks. Although the pain symptoms do improve, they may reoccur periodically afterwards. Minimal twinges of pain may be felt in one instance or another after the first big bout of back pain. Other sufferers experience a persistence of these minor pains for more than a month or two, giving rise to what is known as chronic back pain.

2) Nerve root pain

Nerve root pain is caused by a trapped nerve from the spinal cord that is subject to compression or constriction. Arising in less than one in twenty cases, the pain is felt along the course of the nerve and may travel down the leg, calf or foot. Often symptoms are more severe in the leg or foot than it is at the nerve origin. An example of nerve root pain is Sciatica, a condition where pressure is placed on the sciatic nerve, irritating it and causing pain.

Pain can range from mild to severe. Similar to simple back pain, symptoms can be alleviated by lying flat on a surface, or aggravated by back movement, coughing or sneezing. Other symptoms include tingling, numbness, and a feeling of weakness along the regions of the buttocks, leg or foot.

One of the causes of nerve irritation or pressure can stem from the inflamed conditions of a sprained ligament or muscle. Another is slipped disc, where the disc does not literally slip, but is manifested when its soft interior portion prolapses or protrudes out of a breach in the harder outer disc perimeter. This protrusion can put pressure on a nearby nerve and cause pain (refer to the separate leaflet on Prolapsed Disc). Other lesser known conditions may also cause nerve root pain.

Other Causes of Lower Back Pain

1) Arthritis: this condition is caused by inflammation of the joints. When it occurs within the spine, it can cause back pain.
2) Osteoarthritis: the most common form arthritis in older people.
3) Ankylosing spondylitis: may be manifested in young adults, causing lower back pain and stiffness.
4) Rheumatoid arthritis: can affect the spine as well as other joints in the body (refer to separate leaflet on the different types of arthritis).
5) In less than one in a hundred cases, lower back pain can be caused by rare bone disorders, tumors, infectious diseases, and constrictions caused by other bone structures close to the spine.

Determining the Type of Back Pain

In the normal course of events, lower back pain may suddenly occur (acute onset), caused by simple low back pain. In most cases, sufferers bear with the symptoms and undertake self medication, with varying degrees of success. In case of doubt as to the cause of the pain symptoms, it is also advisable to consult with a physician for proper diagnosis.

Some symptoms may arise as a result of an underlying problem related to the pain. It is best to schedule an appointment with a doctor when the following signs are manifested:

1) Patient is under the age of 20 or over the age of 55.
2) Pain symptoms are constant, and are not alleviated by either lying down or resting.
3) Pain runs through to the chest, and originates from the upper back, just behind the chest.
4) Pain began gradually, and progressed to severe symptoms through the course of days or weeks, differentiated from simple lower back pain which can occur all of a sudden.
5) Other symptoms may include:

* Weak leg or foot muscles.
* Numbness experienced within the region of the buttocks, around the anal area, or in a leg or foot.
* Bladder or bowel disorders, like inability to urinate or incontinence.
* Fever, loss of weight, and general feeling of poor health.
* Recent occurrence of violent injury or trauma to the back.
* An existing cancer diagnosis.
* Steroid use for more than a month.
* A generally compromised immune system (e.g., usually brought about by chemotherapy or HIV/AIDS).
* Doubt about any of the symptoms manifested.

The Rare but Critical Cauda Equina syndrome

Cauda equine syndrome is a very serious type of nerve root problem that is classified as an emergency case. Although uncommon, this syndrome leads to lower back pain, inability to urinate, numbness within the anal area, and a feeling of weakness in one or both legs. The disorder, which requires urgent medical attention, is caused when the nerves at the end of the spinal cord are subject to constriction. If left unattended, Cauda equine syndrome can permanently destroy the nerves connecting to the bladder and bowels. As soon as symptoms of this ailment put in an appearance, it is advised to consult a doctor as soon as possible.

When Tests are Needed

When a physician has made an accurate diagnosis based on physical examination and evaluation of the pain symptoms, tests are usually unnecessary. Nerve root pain that occurs suddenly and subsides after a few weeks will require no tests. X-rays or back scans will show nothing out of the ordinary for symptoms of simple lower back pain. However, when nerve root pain remains constant or severe, or if there may be a suspected underlying cause for the pain, the doctor may recommend that an x-ray or scan be taken.

Treating Simple Lower Back Pain

1) Regular Exercise

It is important to maintain regular everyday activities despite the discomfort. Although this may initially prove difficult because of the pain, increasing ones range of motion incrementally can be bearable if not overdone. Goal setting can be a good idea to track progress and provide encouragement.

Medical advice in the past included recommendations of rest until the pain subsided. This has now been proven inconclusive as prolonged immobility increases the risk of developing chronic back pain. By continuing to move, faster recovery from pain is likely to occur. Likewise, past advice on sleeping positions - flat on one?s back on a firm mattress - has also been unproven in relieving pain symptoms. Current recommendations involve advising patients to sleep in a position and on a mattress they feel most comfortable in.

2) Pain Medication

When pain medication is necessary, it would be better to take them on a regular basis rather than intermittently as needed. Regular doses work better to ease pain symptoms and enable increased activity in the sufferer. Some examples of pain killing medication include:

Paracetamol: this analgesic works efficiently if full strength doses are taken regularly. Adult dosage amounts to 1000 mg, or two 500 mg tablets, taken four times in a day.

Anti-inflammatory painkillers: some pain sufferers have discovered that these provide more effective pain relief compared to paracetamol. Over-the-counter painkillers like ibuprogen, or prescription medication like diclofenac are widely available in pharmacies. However, anti-inflammatory drugs are dangerous for people suffering from asthma, high blood pressure, kidney ailments or heart disease.

Industrial strength painkillers: like codeine may be taken together with paracetamol. One side-effect of this drug is constipation, and straining during hard bowel movement can worsen back pain symptoms. Constipation can be avoided by consuming fibrous food and increasing fluid intake.

Muscle relaxants: work well if the back muscles are constantly tense. The muscle relaxant diazepam may be prescribed for a minimum of a few days to loosen tight back muscles that worsen back pain.

Physical treatments for Lower Back Pain

Physical remedies that include sessions with a physical therapist, chiropractor or osteopath can aid in providing short-term relief from back pain. Although not backed by scientific evidence, there have been cases where physical treatments have resulted in faster recovery from lower back pain.

Other Treatments

There are a lot of treatments for lower back pain, and programs for such should be monitored by a physician to determine whether they make symptoms worse, if pain continues for more than 4 to 6 weeks, or if the symptoms start to change. Trying different kinds of treatments for chronic back pain may be necessary until one finds a treatment that works.

Treatments for Other Types of Back Pain

Nerve root pain

The treatment for nerve root pain is similar to that of simpler lower back pain. Symptoms of this type of disorder usually disappear over a period of one or two weeks. Physical treatments may also provide temporary relief from pain. However, chronic back pain stemming from a slipped disc may require surgery for immediate relief of the pressured or irritated nerve.

Other Causes of Back Pain

Treatment for other types of back pain would have to depend on the main cause of pain symptoms. For instance, pain caused by arthritis can be remedied by different kinds of arthritis medications.

Preventing Reoccurrence of Back Pain

There has been a glut of evidence that point toward leading an active lifestyle and regular exercise as the best possible solutions to preventing back pain. Aerobic activities like walking, running or swimming can help keep the body in a general state of fitness. Although there is no supporting evidence that performing back strengthening exercises can prevent reoccurrence of back pain, it is advisable to be well-informed about proper lifting techniques to avoid injury, particularly when lifting objects while in an awkward or twisted position.

A Summary of Back Pain Tips

* Acute lower back pain, even if severe, is normally not considered critical.
* Recovery from lower back pain is a speedy process taking as little as a week.
* Although nerve root pain and prolapsed (slipped) discs are an uncommon occurrence, they usually heal by themselves without requiring surgery.
* Keeping active as much as possible and continuing with routine everyday activities such as going to work, will hasten recovery from lower back pain. Limiting movement and doing little exercise will only increase the risk of developing chronic symptoms.
* Should the pain be severe, initial rest may be necessary, but incremental movement is encouraged for a speedier recovery something that constant bed rest will not provide. Warming up the muscles through motion is preferable to having them stiffen up from long periods of immobilization.
* Bearing some measure of pain and discomfort may be necessary while returning to everyday activities. Simple lower back pain will not be aggravated by movement. In fact, constant activity will help prevent the development of chronic long-term symptoms.
* Regular use of painkillers can alleviate the pain during the recovery period.
* If pain worsens or continues for more than 4 to 6 weeks, or if other uncommon symptoms develop, it is advisable to consult a doctor immediately.

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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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Soma (carisoprodol) is a muscle relaxant used to treat pain caused by muscle spasms. It is a centrally-acting skeletal muscle relaxant whose active metabolite is meprobamate. It is a colourless, crystalline powder, having a mild, characteristic odor and a bitter taste.

Soma (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.

Soma Side Effects

Side effects that may go away during treatment using Soma muscle pain relief include drowsiness, dizziness, nausea, or headache. If they continue or are bothersome, check with your doctor. Check with your doctor as soon as possible if you experience rash or itching. If you notice any unusual effects, contact your doctor, nurse, or pharmacist.

Soma Dosage

Soma medicine is a muscle relaxant used to treat pain caused by muscle spasms. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. Inform your doctor of any other medical conditions including kidney disorders, allergies, pregnancy, or breast-feeding. CARISOPRODOL - ORAL (kar-iss-oh-PRO-dole).

Health Tips

Stop Smoking. Health concerns associated with smoking include cancer, lung disease, early menopause, infertility, and pregnancy complications. Smoking triples the risk of dying from heart disease among those who are middle-aged. Second-hand smoke - smoke that you inhale when others smoke - also affects your health. If you smoke, quit today! Helplines, counseling, medications, and other forms of support are available to help you quit.

Eat Healthy. “An apple a day keeps the doctor away.” There’s more truth to this saying than we once thought. You are what you eat. What you eat and drink and what you don’t eat and drink can definitely make a difference to your health. Eating five or more servings of fruits and vegetables a day, less saturated fat and junk food can help improve your health and may reduce the risk of cancer and other chronic diseases. Have a balanced diet, and watch how much you eat.

Maintain a Healthy Weight

Obesity is at an all time high in the United States, and the epidemic may be getting worse. Those who are overweight or obese have increased risks for diseases and conditions such as diabetes, high blood pressure, heart disease, and stroke. Eat better, get regular exercise, and see your health care provider about any health concerns to make sure you are on the right track to staying healthy.

Excercise

More than 50% of American men and women do not get enough physical activity to provide health benefits. For adults, thirty minutes of moderate physical activity on most, preferably all, days of the week is recommended. It doesn’t take a lot of time or money, but it does take commitment. Start slowly, work up to a satisfactory level, and don’t overdo it. You can develop one routine, or you can do something different every day. Find fun ways to stay in shape and feel good, such as dancing, gardening, cutting the grass, swimming, walking, or jogging.

Stop Smoking

Health Tips: Be Smoke-Free - Stop SmokingHealth concerns associated with smoking include cancer, lung disease, early menopause, infertility, and pregnancy complications. Smoking triples the risk of dying from heart disease among those who are middle-aged. Second-hand smoke - smoke that you inhale when others smoke - also affects your health. If you smoke, quit today! Helplines, counseling, medications, and other forms of support are available to help you quit.

Get Appropriate Vaccinations

They’re not just for kids. Adults need them too. Some vaccinations are for everyone. Others are recommended if you work in certain jobs, have certain lifestyles, travel to certain places, or have certain health conditions. Protect yourself from illness and disease by keeping up with your vaccinations.

Get Routine Exams and Screenings

Health Tips: Get Regular Doctor Check UpsSometimes they’re once a year. Other times they’re more or less often. Based on your age, health history, lifestyle, and other important issues, you and your health care provider can determine how often you need to be examined and screened for certain diseases and conditions. These include high blood pressure, high cholesterol, diabetes, sexually transmitted diseases, and cancers of the skin, cervix, breast, and colon. When problems are found early, your chances for treatment and cure are better. Routine exams and screenings can help save lives.

Manage Stress

Perhaps now more than ever before, job stress poses a threat to the health of workers and, in turn, to the health of organizations. Balancing obligations to your employer and your family can be challenging. What’s your stress level today? Protect your mental and physical health by engaging in activities that help you manage your stress at work and at home.

Know Yourself and Your Risks

Your parents and ancestors help determine some of who you are. Your habits, work and home environments, and lifestyle also help to define your health and your risks. You may be at an increased risk for certain diseases or conditions because of what you do, where you work, and how you play. Being healthy means doing some homework, knowing yourself, and knowing what’s best for you… because you are one of a kind.

Be Safe - Protect Yourself

What comes to mind when you think about safety and protecting yourself? Is it fastening seat belts, applying sunscreen, wearing helmets, or having smoke detectors? It’s all of these and more. It’s everything from washing your hands to watching your relationships. Did you know that women at work die most frequently from homicides, motor vehicle incidents, falls, and machine-related injuries? Take steps to protect yourself and others wherever you are.

Be Good to Yourself

Health Tips: Take Care of Yourself Health is not merely the absence of disease; it’s a lifestyle. Whether it’s getting enough sleep, relaxing after a stressful day, or enjoying a hobby, it’s important to take time to be good to yourself. Take steps to balance work, home, and play. Pay attention to your health, and make healthy living a part of your life.

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Materials and atethods medication the skeletal muscle relaxant used flexeril muscle relaxant in the present studies was metaxalone, a relatively new skeletal muscle relaxant.

Prolonged erections palpitations restlessness and soma muscle relaxer mg flexeril muscle relaxant concentration will be. Return to top asa contents gerontology cardiovascular and autonomic nervous system aging physiology of the cardiovascular effects of general anesthesia in the elderly cardiovascular response to spinal anesthesia in the elderly hemodilution tolerance in elderly patients aging and the respiratory system aging and the urinary system perioperative renal insufficiency and failure in elderly patients thermoregulation in the elderly pharmacokinetic and pharmacodynamic differences in the elderly induction agents opioids muscle relaxant selection and administration aging and the central nervous system postoperative delirium in the elderly safe sedation of the elderly outside the operating room age-related disease anesthetic risk and flexeril muscle relaxant the elderly perioperative complications in elderly patients preanesthetic evaluation for the elderly patient managing medical illness in the elderly surgical patient ethical challenges in the anesthetic care of the geriatric patient critical care of the elderly patient the elderly trauma patient postoperative pain control in the elderly patient chronic pain in older individuals: consequences and management palliative care in geriatric anesthesia the views expressed herein are those of the authors and do not necessarily represent or reflect the views, policies or actions of the american society of anesthesiologists. Native human sp-a was flexeril muscle relaxant obtained through the courtesy of dr.

This flexeril muscle relaxant freezes the entire body, making the patient unable even to blink. Their relaxant effect is particularly useful in patients whose anxiety produces flexeril muscle relaxant painful muscle tension.

The most common side flexeril muscle relaxant effect is some tenderness or a small bruise around the injection point.

I saw flexeril muscle relaxant the orthopod a week later. With these suggestions and he told me to try the celebrex, but not flexeril muscle relaxant the soma. Soma is not approved for use in children younger flexeril muscle relaxant than 12 years of age.Soma is not approved for use in children younger muscle relaxant drugs flexeril muscle relaxant than 12 years of age

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