Drug Name

Soma (Carisoprodol)

Generic Name

Carisoprodol Tablets (kar-EYE-soe-PROE-dol)

Manufacturer / Distributor

MedPointe Pharmaceuticals

Looks like

Soma is available with a prescription under the brand name Soma. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• 350mg Tablets: round, convex, white tablets, inscribed with Soma 350

Dosage Form

Tablets

Route Of Administration

ORAL

Imprint Code

Soma;350

Size

22mm

Alternatives

Muscle Spasm
Skelaxin (Metaxalone), Baclofen, Valium, Cyclobenzaprine, Diazepam, Flexeril

Drug Uses

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

Drug class

Treating discomfort associated with certain painful muscle conditions. It is usually used along with rest and physical therapy.
Soma is a skeletal muscle relaxant. It works in the brain and spinal cord to relax the muscles. It also causes drowsiness.

Contains

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

Chemical formula

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. The structural formula is:

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.

How Taken

Take carisoprodol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
The maximum amount of carisoprodol you should take in one day is 1,400 mg (4 tablets).

Dosage and Administration

ADULTS
The usual dosage of Soma is one 350-milligram tablet, taken 3 times daily and at bedtime.
The recommended maximum duration of Soma use is up to two or three weeks.

CHILDREN
The safety and effectiveness of Soma have not been established in children under 12 years of age.

Missed Dose

Take the missed dose as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose.
Do not take a double dose of this medication.
Try to keep your doses at least 4 hours apart.

Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately.
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.

Storage

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

How Supplied

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

What is the most important information I should know about Soma (Carisoprodol)?

This medication may be habit-forming and should be used only by the person it was prescribed for. Soma should never be given to another person, especially someone who has a history of drug abuse or addiction.
Keep the medication in a secure place where others cannot get to it.
You may have withdrawal symptoms when you stop using Soma after using it over a long period of time.
Do not stop using Soma suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.
Soma can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase drowsiness and dizziness caused by Soma.

What should I discuss with my doctor before taking Soma (Carisoprodol)?

Do not take carisoprodol if you have acute intermittent porphyria.
Before taking carisoprodol, tell your doctor if you have kidney or liver disease. You may need a lower dose or special monitoring during your therapy.
It is not known whether carisoprodol will harm an unborn baby. Do not take carisoprodol without first talking to your doctor if you are pregnant.
It is also not known whether carisoprodol passes into breast milk. Do not take carisoprodol without first talking to your doctor if you are breast-feeding a baby.
Carisoprodol is not approved for use in children younger than 12 years of age.

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).

Excretion

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.

Special Populations

Geriatric

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

Pediatric

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

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.

Renal Insufficiency

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.

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.

Possible side effects

If you experience any of the following serious side effects, stop taking carisoprodol and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• paralysis (loss of feeling) or extreme weakness;
• vision loss; or
• agitation or tremor.

Other, less serious side effects may be more likely to occur. Continue to take carisoprodol and talk to your doctor if you experience

• drowsiness or dizziness;
• headache;
• depression;
• blurred vision;
• insomnia; or
• hiccups.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Soma (Carisoprodol)?

Many drugs can increase the effects of carisoprodol, which can lead to heavy sedation. Before taking this medication, tell your doctor if you are taking any of the following medicines:

• antihistamines such as brompheniramine (Dimetane, Bromfed, others), chlorpheniramine (Chlor-Trimeton, Teldrin, others), azatadine (Optimine), clemastine (Tavist), and many others;
• narcotics (pain killers) such as meperidine (Demerol), morphine (MS Contin, MSIR, others), propoxyphene (Darvon, Darvocet), hydrocodone (Lorcet, Vicodin), oxycodone (Percocet, Percodan), fentanyl (Duragesic), and codeine (Fiorinal, Fioricet, Tylenol #3, others);
• sedatives such as phenobarbital (Solfoton, Luminal), amobarbital (Amytal), and secobarbital (Seconal);
• phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon), prochlorperazine (Compazine), thioridazine (Mellaril), and trifluoperazine (Stelazine); or
• antidepressants such as doxepin (Sinequan), imipramine (Tofranil), nortriptyline (Pamelor), fluoxetine (Prozac), paroxetine (Paxil), sertraline (Zoloft), phenelzine (Nardil), and tranylcypromine (Parnate).

Drugs other than those listed here may also interact with carisoprodol. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

What should I avoid while taking Soma (Carisoprodol)?

Use caution when driving, operating machinery, or performing other hazardous activities. Carisoprodol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking carisoprodol.

Contraindications

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

Warnings

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.

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.

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).

Information For Patients

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.

Pregnancy

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.

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.

Pediatric Use

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

Geriatric Use

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

Special warnings about Soma

In rare cases, the first dose of Soma may cause unusual symptoms that appear within minutes or hours of taking the medication. Symptoms reported include: agitation, confusion, disorientation, dizziness, double vision, enlargement of pupils, extreme weakness, exaggerated feeling of well-being, lack of coordination, speech problems, temporary loss of vision, and temporary paralysis of arms and legs. These symptoms usually subside within a few hours. If you experience any of them, contact your doctor immediately.
Soma may impair the mental or physical abilities you need to drive a car or operate dangerous machinery. Do not participate in hazardous activities until you know how Soma affects you.
If you have a history of drug dependence, make sure your doctor is aware of it before you start taking Soma.
Withdrawal symptoms, including abdominal cramps, chilliness, headache, insomnia, and nausea, have occurred in people who suddenly stop taking Soma.
Take Soma cautiously if you have any kidney or liver problems.
 

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About MedPointe Pharmaceuticals

MedPointe Pharmaceuticals is the U.S. subsidiary of Meda AB. MedPointe specializes in respiratory, allergy, central nervous system, and cough-cold products. The company maintains a manufacturing facility in Decatur, Illinois.
For more information on MedPointe, visit http://www.medpointepharma.com.
For more information on Meda, visit http://www.meda.se

References

References and complaints