Soma

Whenever we exert ourselves, we notice cramps or weakness in our legs. This is because the muscles in those areas tighten leading to pain and discomfort. In such cases, it is best to take a muscle relaxant as they help relax those muscles. They come in pill form and at times are available as an ointment. The muscle relaxing abilities of these muscle relaxants is due to the inhibition of the central polysynaptic neuronal, which nerve cells, in our body are.

While playing tennis, basketball after a long gap, what happens is our muscles are all tight, instead of loosening them we get right into the game. Because of no warning, it comes as a shock to our body and the muscles don’t have time to relax, stretch and then get into the game. The main reason why fitness trainers in gym and otherwise advise us to stretch, warm up before work out or practice. This gives our body the breathing it requires and prepares it for the upcoming workout.

Muscle relaxants are prescribed as treatment for acute lower back pain in order to help the patient get relieved from pain and make it easy for them to move around. The spasm they feel in their back will be sharp and enough to leave them paralyzed, and unable to move a few inches. With the help of these relaxants, the muscle spasm gets limited and improving range of motion will get better which allows the patient to go in for some form of exercise or therapy.

For people who have spent their life sitting in one place, doing a desk job, they too might face these leg pains, and back aches. They fall into the other extreme category. Those who did not do any exercise or get much of activity during the prime of their life. Meaning, their body is not used to any movement at all. And if they go to the beach or park for a walk, they might have difficulty beyond a couple of minutes.

If by using the muscle relaxant, they obtain some percentage of relief, they can then visit their doctor for further advice. There are some who are unable to bear the pain or are tired of taking treatment and steroids, when they go in for corrective surgery. However, this has to be the last resort and adopted only when all else has failed.

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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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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 (carisoprodol):  tablet for oral use
Initial U.S. Approval: 1959

INDICATIONS AND USAGE

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.

Important Limitations:

* Should only be used for acute treatment periods up to two or three weeks
* Not recommended in pediatric patients less than 16 years of age.

DOSAGE AND ADMINISTRATION

* Recommended dose is 250 mg to 350 mg three times a day and at bedtime.

DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg, 350 mg

CONTRAINDICATIONS

* Acute intermittent porphyria
* Hypersensitivity reactions to a carbamate such as meprobamate

WARNINGS AND PRECAUTIONS

* Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery
* Additive sedative effects when used with other CNS depressants including alcohol
* Cases of Drug Dependence, Withdrawal, and Abuse
* Seizures

ADVERSE REACTIONS

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache

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Soma is used for:

Treating muscle spasms. It may also be used to treat other conditions as determined by your doctor.

Soma is a skeletal muscle relaxant. It works by blocking nerves that stimulate muscles to contract.
Do NOT use Soma if:

* you are allergic to any ingredient in Soma
* you are taking fluvoxamine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Soma :

Some medical conditions may interact with Soma. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

* if you are pregnant, planning to become pregnant, or are breast-feeding
* if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
* if you have allergies to medicines, foods, or other substances
* if you have liver or kidney problems or prostate problems

Some MEDICINES MAY INTERACT with Soma. Tell your health care provider if you are taking any other medicines, especially any of the following:

* Alpha2-agonists (eg, clonidine), fluvoxamine, or medicines that act on the liver (eg, amiodarone, cimetidine, ciprofloxacin, ticlopidine) because the actions and side effects of these medicines may be increased
* Birth control pills because the effectiveness of Soma may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Soma may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Soma :

Use Soma as directed by your doctor. Check the label on the medicine for exact dosing instructions.

* Food can change the way your body absorbs and uses Soma. Be sure to discuss this with your doctor to determine the best way to take your dose, especially when changes to your dose are being considered, or if you are being prescribed a different dose form of Soma (eg, tablets or capsules).
* Do not stop taking Tizanidine suddenly. If Soma is stopped, the dose should be reduced slowly to prevent symptoms of withdrawal, including high blood pressure, fast heartbeat, tremor, anxiety, and muscle tension.
* If you miss a dose of Soma, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Soma.

Important safety information:

* Soma may cause drowsiness, dizziness, lightheadedness, or fainting. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Soma.
* Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Soma. Soma will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
* Soma may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.
* Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Soma.
* Little or no information is available on the possible side effects from long-term use (more than 1 year) of high single doses above 8 mg or multiple doses above 24 mg a day.
* LAB TESTS, such as liver tests, may be performed to check for side effects. Be sure to keep all doctor and lab appointments.
* Use Soma with caution in the ELDERLY because they may be more sensitive to its effects.
* Use Soma with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.
* PREGNANCY and BREAST-FEEDING: It is unknown if Soma causes harm to the developing fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Soma during pregnancy. It is unknown if Soma is excreted in breast milk. If you are or will be breast-feeding while you are using Soma, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Soma:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; flushing; tiredness; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in emotions, mood, or behavior; hallucinations; increased muscle spasms; muscle weakness; slow heartbeat; trouble urinating or lack of bladder control; urinary tract infection; yellowing of the skin or eyes.

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People experience a broken bone (fracture) at some point in their lives. A broken ankle or broken foot is common. After all, you have 26 bones in each foot and three bones in each ankle joint. And these bones are susceptible to stress, stubbing, twisting and trauma.

The seriousness of a broken ankle or broken foot varies. Breaks in this part of your body can range from less-serious fractures, involving tiny cracks in your bones, to severe, shattering breaks that pierce your skin.

Treatment for a broken ankle or broken foot depends on the exact site and severity of the fracture. A severely broken ankle or broken foot may require surgery to implant wires, plates, rods or screws into the broken bone to maintain proper alignment during healing.

Signs and symptoms

If you have a broken ankle or broken foot, you may experience these signs and symptoms:

* Immediate, throbbing pain
* Pain that increases with activity and decreases with rest
* Swelling
* Bruising
* Tenderness
* Deformity
* Inability to walk or bear weight
* Cuts, puncture wounds or protrusion of bone fragments

Some people feel or hear a snap at the time of injury and assume that means something has broken. However, a snapping sound or feeling can be a sign of either a fracture or a sprain.

Causes

The terms “broken ankle” and “broken foot” are used to describe a range of fractures in this area of your body:

Causes of a broken ankle

Your ankle joint is made up of three bones — the shinbone (tibia), the lower leg bone (fibula) and the ankle bone (talus). One or more of these bones can break during a fall or blow to your ankle. However, the most common type of broken ankle is a fracture in one of the knobby bumps (each called a malleolus) at the lower ends of the tibia and fibula. These bones help support the joint where your ankle bone connects to your heel bone (calcaneus), which allows your foot to rock from side to side. They’re often injured when your ankle rolls inward or outward.

Causes of a broken foot

Each foot contains 26 bones. The most common foot fractures involve your toe bones and the long bones of your midfoot that connect to your toes (metatarsal bones). Both of these types of bones can be crushed by a falling object. (8, 11) Toe bones are also commonly broken by stubbing, while metatarsal fractures often occur during a fall or car accident.

Stress fractures

These tiny cracks can develop in the weight-bearing bones of your feet or ankles, such as the metatarsals. Stress fractures are usually caused by repetitive force or overuse, such as running long distances. But they can also occur with normal use of a bone that’s been weakened by a condition such as osteoporosis.

Risk factors

These factors may put you at risk of a broken ankle or broken foot:

* Being overweight. Carrying too much weight can make you more susceptible to rolling your ankle or stressing the bones in your feet.
* Participating in high-impact sports. The stresses, direct blows and twisting injuries that occur in football, hockey, gymnastics, ballet, tennis and soccer are common causes of foot and ankle fractures.
* Using improper sports equipment. Faulty equipment, such as shoes that are too worn or too stiff, can contribute to stress fractures and falls. Improper training techniques, such as not warming up, also can cause foot and ankle fractures.
* Working in certain occupations. Certain work environments, such as a construction site, put you at risk of falling from a height or injuring your feet.
* Keeping your home cluttered or poorly lit. Walking around in a house with too much clutter or too little light may lead to foot or ankle injuries.
* Having certain conditions. Osteoporosis or poor sensation in your feet (neuropathy) can put you at risk of injuries to your foot and ankle bones.

When to seek medical advice

Seek medical attention for any foot or ankle injury. Prompt realignment and treatment of any ankle or foot fracture is key to complete healing. However, broken toes often go undiagnosed. And many people mistake an ankle fracture for an ankle sprain — a less serious injury that involves stretching or tearing of ligaments. Many signs and symptoms of an ankle sprain may be similar to those of a fracture, but sprain and fracture injuries require different treatments.

Seek immediate medical care if you see bone protruding through the skin near your injury. This can lead to severe infection, if not treated promptly.

Screening and diagnosis

If you suspect that you have a broken ankle or broken foot, your doctor will inspect the affected area for tenderness, swelling, deformity or an open wound. You’ll also need X-rays to definitively diagnose a fracture and pinpoint the exact location of the break. If the fracture is difficult to see — such as a stress fracture — you may also need a bone scan or other imaging techniques.

A thorough evaluation and X-ray of your injury also helps your doctor classify your fracture into one of the following categories, which helps determine your treatment:

* Closed fracture. The bone is broken, but the surrounding skin remains intact. In general, a closed fracture is the least severe type of fracture.
* Open or compound fracture. The bone is broken, and the skin is pierced or cut by the broken bone. An open fracture is a serious condition that requires immediate, aggressive treatment to decrease your chance of an infection.
* Displaced fracture. In this fracture, the bone fragments on either side of the break are out of line. A displaced fracture may require surgery to align the bones properly.

Complications

Complications of a broken ankle or broken foot are rare, but may include:

* Nerve or blood vessel damage. Trauma to the foot or ankle can injure adjacent nerves and blood vessels. Seek immediate attention if you notice any numbness or circulation problems.
* Bone infection (osteomyelitis). If you have an open fracture, your bone may be exposed to fungi and bacteria that cause infection.
* Compartment syndrome. This neuromuscular condition causes pain, swelling and sometimes disability in affected muscles of the legs or arms. Compartment syndrome usually occurs in high-impact injuries, such as a car or motorcycle accident.
* Arthritis. Fractures that extend into the joint can cause arthritis years later. If your ankle or foot starts to hurt long after a break, see your doctor for an evaluation.
* Persistent pain. You may experience ongoing pain in the affected area even after your broken bone has healed. Your doctor can evaluate persistent pain to see if a rehabilitation program can help.
* Poor healing. Smoking cigarettes is a risk factor for poor healing of fractures.

Treatment

Initial treatment for a broken ankle or broken foot often begins in an emergency room or urgent-care clinic. Here, doctors typically evaluate your injury and immobilize your foot or ankle with a splint. If you have a displaced fracture, your doctor may need to manipulate the pieces back into their proper positions before applying a splint — a process called reduction. Depending on the amount of pain and swelling you have, you may need a muscle relaxant, a sedative or even a general anesthetic before this procedure.

If you have a closed fracture, you’ll probably be sent home with the splint and directions to rest and ice the injury until you see your regular doctor or an orthopedic specialist for further treatment in a few days. If you have a more serious fracture, you may be admitted to the hospital for immediate attention. Treatment for a broken ankle or broken foot depends on the site and severity of the injury, but typically involves the following components:

Immobilization

Restricting the movement of a broken bone in your foot or ankle is critical to healing. This may be as simple as taping your broken toe to the neighboring toe — a technique called buddy-taping. Or it may involve splints, walking boots, leg braces or casts for several weeks or months, depending on your injury. You may also receive crutches and strict instructions on the amount of time you’re allowed to spend walking or standing on the affected leg.

Surgery

Immobilization heals most broken bones. However, you may need surgery to implant internal fixation devices, such as wires, plates, nails or screws, to maintain proper position of your bones during healing. Surgery may be recommended if you have the following injuries:

* Multiple fractures
* An unstable or displaced fracture
* Loose bone fragments that could enter a joint
* Damage to the surrounding ligaments
* Fractures that extend into a joint

Some internal fixation materials are removed after your bone heals. Others may be left in place, while some are made of materials that are absorbed into your body. Complications are rare, but can include wound-healing difficulties, infection and lack of bone healing.

Medications

To reduce pain and inflammation, your doctor may recommend an over-the-counter pain reliever, such as acetaminophen (Tylenol, others) or ibuprofen (Advil, Motrin, others). If you’re experiencing a lot of pain, you may need an opioid medication, such as codeine.

Rehabilitation

After your cast or splint is removed, you’ll probably need to loosen up stiff muscles and ligaments in your ankles and feet. A home exercise program of stretching, strengthening and range of motion exercises can help you ease back into your regular routine. Your doctor can suggest the best exercises for your particular injury or refer you to a therapist who can help.

Prevention

These basic sports and safety tips may help prevent a broken ankle or broken foot:

* Wear proper shoes. Use hiking shoes on rough terrain. Wear steel-toed boots in your work environment, if necessary. Choose appropriate athletic shoes for your sport. And never go barefoot on paved streets or sidewalks.
* Replace athletic shoes regularly. Discard sneakers as soon as the tread or heel wears out or if the shoes are wearing unevenly.
* Start slowly. That applies to a new fitness program and each individual workout.
* Cross-train. Alternating activities can prevent stress fractures. Rotate running with swimming or biking.
* Build bone strength. Calcium-rich foods, such as milk, yogurt and cheese, really can do your body good.
* Clean up spills immediately. Slippery floors can cause dangerous falls.
* Use night lights. Many broken toes are the result of nighttime stumbling.

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Objective

The purpose of this study was to investigate the effects of K+ channel blockade on the uterorelaxant effects of nifedipine in human myometrium during pregnancy.

Study Design

Biopsies of human myometrium were obtained at elective cesarean section (n = 24). Dissected myometrial strips suspended under isometric conditions, undergoing spontaneous and oxytocin-induced contractions, were subjected to K+ channel blockade using tetraethylammonium (TEA) or iberiotoxin (IbTX) followed by cumulative additions of nifedipine (1 nmol/L–10 μmol/L). Control experiments were run simultaneously. Integrals of contractile activity were measured using the PowerLab hardware unit and Chart v3.6 software. Data were analyzed using one-way analysis of variance (ANOVA) followed by post hoc analysis.

Results

Nifedipine exerted a potent and cumulative inhibitory effect on spontaneous contractions and oxytocin-induced contractions in human myometrium in vitro, in comparison to control measurements (P < .05, n = 6). Incubation of strips with TEA or IbTX, prior to addition of nifedipine, significantly attenuated the relaxant effect exerted by nifedipine (P < .05, n = 6).

Conclusion

This study demonstrates that the uterorelaxant effect of nifedipine is attenuated by potassium channel (K+) blockade. This suggests that K+ channel conductance, and particularly the BKCa channel, plays a role in the potent relaxant effect of nifedipine, hitherto presumed to act solely through L-gated calcium channels.

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