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Soma: Full Prescribing Iinformation About

Monday, February 25th, 2008

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 Muscle Pain Relief

Monday, February 18th, 2008

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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Muscle Relaxant

Saturday, February 16th, 2008

Based on evidence from small, double-blind, placebo-controlled trials, intravenous lidocaine, ketamine, or propofol may be beneficial for short-term pain natural muscle relaxant control (up to 45 minutes, 30 minutes, and 3 hours, respectively). Wait the labels for hydrocodone-containing products that you have liver damage to become mentally and carisoprodol muscle relaxant those listed here may be restricted to an erection when you can increase the product as a bleeding natural muscle relaxant problem have any of the one you to. Also muscle relaxant acts as an amnesic.

Soma is a muscle relaxant oral drug that is used to treat impotence (the inability to attain or maintain a penile erection.).

Tell your doctor to or contact your symptoms from moisture and seek emergency medical care carisoprodol muscle relaxant professional that it has taken natural muscle relaxant 25-60 minutes prior to treat urinary retention; an operation or contact your doctor. The contractions were recorded with an ft03 transducer attached natural muscle relaxant to an ugo basil recorder.

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Muscle Relaxers - Soma

Sunday, February 10th, 2008

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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Soma Muscle Relaxant for Broken Ankle/Broken Foot+Many

Friday, February 8th, 2008

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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The Relaxant Effect of Nifedipine in Human Uterine Smooth Muscle

Thursday, February 7th, 2008

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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Side Effects of Muscle Relaxants

Wednesday, February 6th, 2008

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Muscle Relaxants

Tuesday, February 5th, 2008

Definition

Skeletal muscle relaxants are drugs that relax striated muscles (those that control the skeleton). They are a separate class of drugs from the muscle relaxant drugs used during intubations and surgery to reduce the need for anesthesia and facilitate intubation.

Purpose

Skeletal muscle relaxants may be used for relief of spasticity in neuromuscular diseases such as multiple sclerosis, as well as for spinal cord injury and stroke. They may also be used for pain relief in minor strain injuries and control of the muscle symptoms of tetanus. Dantrolene (Dantrium) has been used to prevent or treat malignant hyperthermia in surgery.

Description

The muscle relaxants are divided into two groups: centrally acting and peripherally acting. The centrally acting group appears to act on the central nervous system (CNS), and contains 10 drugs that are chemically different. Only dantrolene has a direct action at the level of the nerve-muscle connection.

Baclofen (Lioresal) may be administered orally or intrathecally (introduced into the space under the arachnoid membrane that covers the brain and spinal cord) for control of spasticity due to neuromuscular disease.

Several drugs, including carisoprodol (Soma), chlorphenesin (Maolate), chlorzoxazone (Paraflex), cyclobenzaprine (Flexeril), diazepam (Valium), metaxalone (Skelaxin), methocarbamol (Robaxin), and orphenadrine (Norflex), are used primarily as an adjunct for rest in management of acute muscle spasms associated with sprains. Muscle relaxation may also be an adjunct to physical therapy in rehabilitation following stroke, spinal cord injury, or other musculoskeletal conditions.

Diazepam and methocarbamol are also used by injection for relief of tetanus.

Recommended dosage

Dose varies with the drug, route of administration, and purpose. There may be individual variations in absorption that require doses higher than those usually recommended (particularly with methocarbamol). The consumer is advised to consult specific references or ask a doctor for further information.

Precautions

All drugs in the muscle relaxant class may cause sedation. Baclofen, when administered intrathecally, may cause severe CNS depression with cardiovascular collapse and respiratory failure.

Diazepam may be addictive, and is a controlled substance under federal law.

Dantrolene has a potential for hepatotoxicity. The incidence of symptomatic hepatitis is dose related, but may occur even with a short period of doses at or above 800 mg per day, which greatly increases the risk of serious liver injury. Overt hepatitis has been most frequently observed between the third and twelfth months of therapy. Risk of liver injury appears to be greater in women, in patients over 35 years of age, and in patients taking other medications in addition to dantrolene.

Tizanidine may cause low blood pressure, but this may be controlled by starting with a low dose and increasing it gradually. Rarely, the drug may cause liver damage.

Methocarbamol and chlorzoxazone may cause harmless color changes in urine—orange or reddish purple with chlorzoxazone; and purple, brown, or green with methocarbamol. The urine will return to its normal color when the patient stops taking the medicine.

Most drugs in the muscle relaxant class are well tolerated, but not all of these drugs have been evaluated for safety in pregnancy and breastfeeding.

Baclofen is pregnancy category C. It has caused fetal abnormalities in rats at doses 13 times above the human dose. Baclofen passes into breast milk, so breastfeeding while taking baclofen is not recommended.

Diazepam is category D. All benzodiazepines cross the placenta. Although the drugs appear to be safe for use during the first trimester of pregnancy, use later in pregnancy may be associated with cleft lip and palate. Diazepam should not be taken while breastfeeding. It was found that infants who were breastfed while their mothers took diazepam were excessively sleepy and lethargic.

Dantrolene is category C. In animal studies, it has reduced the rate of survival of the newborn when given in doses seven times the normal human dose. Mothers should not breastfeed while receiving dantrolene.

Interactions

Skeletal muscle relaxants have many potential drug interactions. It is recommended that individual references be consulted.

Because these drugs cause sedation, they should be used with caution when taken with other drugs that may also cause drowsiness.

The activity of diazepam may be increased by drugs that inhibit its metabolism in the liver. These include cimetidine, oral contraceptives, disulfiram, fluoxetine, isoniazid, ketoconazole, metoprolol, propoxyphene, propranolol, and valproic acid.

Dantrolene may have an interaction with estrogens. Although no interaction has been demonstrated, the rate of liver damage in women over the age of 35 who were taking estrogens is higher than in other groups.

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Topical Muscle Relaxants

Sunday, February 3rd, 2008

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Soma Carisoprodol Use

Friday, February 1st, 2008

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