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Soma
Fast Facts

What is Soma?

Soma, a trade name for prescription drug carisoprodol, is a muscle relaxant legitimately prescribed to relieve pain from muscle injuries and spasms. When taken in dosages exceeding those recommended by physicians, Soma causes drowsiness, giddiness, and relaxation. Soma is metabolized into meprobamate, a Schedule IV drug with a potential for abuse.

What does Soma look like?

Soma is available as a 350-milligram tablet. The round, convex, white tablets are inscribed with SOMA on one side and 37 WALLACE 2001 on the other. Soma also is available in tablet form combined with codeine or aspirin. Soma and codeine are combined in oval, two-layered, white and yellow tablets inscribed with SOMA CC on one side and WALLACE 2403 on the other–because of the codeine, this tablet is scheduled. Soma and aspirin are combined in round, twolayered, white and lavender tablets inscribed with Par 246.

How is it abused?

Abusers typically ingest Soma orally. Many abusers take it in combination with other drugs to enhance the effects of those drugs. Alcohol, codeine, diazepam, heroin, hydrocodone (especially Vicodin), meprobamate, and propoxyphene commonly are abused in combination with Soma. Abusers who combine Soma with Vicodin claim that this combination produces effects similar to those of heroin.

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Who abuses Soma?

Individuals of all ages abuse Soma. Data reported in the National Survey on Drug Use and Health indicate that 2,276,000 U.S. residents aged 12 and older used Soma nonmedically at least once in their lifetime.

Law enforcement officers indicate that youths living in Arizona and California often obtain carisoprodol at pharmacies in Mexico. Carisoprodol is sold in Mexico under the brand name Somacid. Prescriptions for Soma and Somacid can be purchased from some doctors and pharmacists in Mexico.

What are the risks?

Soma is generally safe when prescribed by a physician and used as directed. However, individuals who abuse Soma can develop psychological addictions to the drug. Common side effects of Soma abuse include blurred vision, dizziness, drowsiness, and loss of coordination. More serious side effects include chills, depression, racing heartbeat, tightness in chest, vomiting, and unusual weakness. Withdrawal symptoms associated with Soma dependency include abdominal cramps, headache, insomnia, and nausea. Signs that an overdose has occurred include difficulty in breathing, shock, and coma. A Soma overdose may result in death.

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What is it called?

The most common street names for Soma are listed below.

Street Terms for Soma

Ds
Dance
Las Vegas Cocktail (combination of Soma and Vicodin)
Soma Coma (combination of Soma and codeine)

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Is it illegal to abuse Soma ?

Yes, abusing Soma is illegal. Reports of Soma abuse have resulted in a number of states scheduling Soma as a controlled substance. States that have taken this action are Alabama, Arizona, Arkansas, Florida, Georgia, Hawaii, Indiana, Kentucky, Minnesota, New Mexico, Oklahoma, Oregon, and West Virginia. Soma is not scheduled at the federal level. However, reports of Soma abuse are being monitored by the Drug Enforcement Administration, and Soma could be listed under the Controlled Substances Act if warranted.

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Carisoprodol

Carisoprodol is the generic form of the prescription drug Soma, which is used to relax muscles and help alleviate pain from muscle spasms.

Carisoprodol belongs to a group of drugs known as muscle relaxants.

It was originally approved by the Food and Drug Administration (FDA) in 2007. Soma is manufactured by Meda Pharmaceuticals.

The ‘Carisoprodol High’ and Abuse

Among muscle-relaxant drugs, carisoprodol causes the most drowsiness and has the greatest abuse potential.

According to anecdotal reports, drug abusers may combine carisoprodol with two other medications, the benzodiazepine alprazolam (Xanax) and hydrocodone, to create a cocktail called “The Trinity” or the “The Holy Cocktail.”

Because of the potential for abuse, carisoprodol is a so-called FDA scheduled drug and is subject to the Controlled Substances Act.

Because of its abuse potential, and the risk of serious side effects, keep this and all medications away from children, teenagers, and anyone for whom it was not prescribed.

Carisoprodol Warnings

If you are allergic to carisoprodol or one of its ingredients, you should not use it.

If you have any of the following conditions, you should talk about your doctor before taking carisoprodol:

  • Sensitivity to the drug meprobomate
  • Sensitivity to the drug felbamate (Felbatol)
  • Acute intermittent porphyria
  • Poor kidney function
  • Poor liver function
  • A history of or risk of seizures
  • A history of drug or substance abuse

You may need to take carisoprodol with special care, under the guidance of your doctor, if you are of advanced age or if you have any physical disabilities.

Pregnancy and Carisoprodol

It’s uncertain whether carisoprodol will cause harm to an unborn baby or fetus.

You should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

Although it is thought that carisoprodol might be safe for breastfeeding mothers, you should also alert your physician if you are breastfeeding or plan to breastfeed before taking carisoprodol.

Carisoprodol Coupons and Prices

Looking to save money on a prescription for Carisoprodol? SingleCare, a leading online service for prescription, dental, and vision discounts, has partnered with most major pharmacies around the country to help you save up to 80 percent off prescription costs. Click on “Free Coupon” below and sign up to get your free SingleCare pharmacy savings card. You’ll receive a coupon by email or text to get the best price at a local participating pharmacy near you.

Soma

Generic Name: carisoprodol
Dosage Form: tablet

Medically reviewed by Drugs.com. Last updated on Nov 21, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Indications and Usage for Soma

Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Carisoprodol tablets, USP 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 .

Soma Dosage and Administration

The recommended dose of carisoprodol tablets, USP is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol tablets, USP use is up to two or three weeks.

Dosage Forms and Strengths

350 mg Tablets: round, convex, white tablets, debossed with SG 109 on one side

Contraindications

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

Warnings and Precautions

Sedation

Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received carisoprodol 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. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol.

Since the sedative effects of carisoprodol 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.

Abuse, Dependence, and Withdrawal

Carisoprodol, the active ingredient in carisoprodol tablets, USP, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion. . Abuse of carisoprodol tablets, USP poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures, and other disorders .

Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse. Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of carisoprodol after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause dependence .

To reduce the risk of carisoprodol tablets, USP abuse assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.

Seizures

There have been post-marketing reports of seizures in patients who received carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) .

Adverse Reactions

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 carisoprodol, 350 mg of carisoprodol, 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 carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of carisoprodol, and 350 mg of carisoprodol, respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with carisoprodol in the two trials described above.

Post-marketing Experience

The following events have been reported during postapproval use of carisoprodol. 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 .

Gastrointestinal: Nausea, vomiting, and epigastric discomfort.

Hematologic: Leukopenia, pancytopenia

Drug Interactions

CNS Depressants

The sedative effects of carisoprodol 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 carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended .

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 carisoprodol 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 carisoprodol 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 carisoprodol is unknown.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C.

There are no data on the use of carisoprodol 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 to 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. Carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Labor and Delivery

There is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery.

Nursing Mothers

Very limited data in humans show that carisoprodol 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% to 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 carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when carisoprodol is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

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

Renal Impairment

The safety and pharmacokinetics of carisoprodol in patients with renal impairment have not been evaluated. Since carisoprodol is excreted by the kidney, caution should be exercised if carisoprodol is administered to patients with impaired renal function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.

Hepatic Impairment

The safety and pharmacokinetics of carisoprodol in patients with hepatic impairment have not been evaluated. Since carisoprodol is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired hepatic function.

Patients with Reduced CYP2C19 Activity

Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution should be exercised in administration of carisoprodol to these patients .

Drug Abuse and Dependence

Controlled Substance

Carisoprodol tablets, USP contains carisoprodol, USP a Schedule IV controlled substance. Carisoprodol has been subject to abuse, misuse, and criminal diversion for nontherapeutic use

Abuse

Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders . Patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other abused drugs.

Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) .

Dependence

Tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of carisoprodol. Reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not abruptly stop carisoprodol .

Overdosage

Overdosage of carisoprodol 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 carisoprodol overdosage. Serotonin syndrome has been reported with carisoprodol intoxication. Many of the carisoprodol overdoses have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol). The effects of an overdose of carisoprodol 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 carisoprodol 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 carisoprodol overdose. Vomiting should not be induced because of the risk of CNS and respiratory depression, and subsequent aspiration. 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.

For decontamination in cases of severe toxicity, activated charcoal should be considered in a hospital setting in patients with large overdoses who present early and are not demonstrating CNS depression and can protect their airway.

For more information on the management of an overdose of carisoprodol, contact a Poison Control Center.

Soma – Clinical Pharmacology

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.

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 carisoprodol is unknown.

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 carisoprodol (see Table 2). The exposure of carisoprodol and meprobamate was dose proportional between the 250 mg and 350 mg doses. The C max of meprobamate was 2.5 ± 0.5 mcg/mL (mean ± SD) after administration of a single 350 mg dose of carisoprodol tablets, which is approximately 30% of the C max of meprobamate (approximately 8 mcg/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 (T max) of carisoprodol was approximately 1.5 to 2 hours. Co-administration of a high-fat meal with carisoprodol (350 mg tablet) had no effect on the pharmacokinetics of carisoprodol. Therefore, carisoprodol 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% to 50% on a weight adjusted basis). Overall exposure of meprobamate is comparable between female and male subjects.

Patients with Reduced CYP2C19 Activity: Carisoprodol 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% to 5% and in Asians is approximately 15% to 20%.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

Carisoprodol 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. Carisoprodol 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 carisoprodol 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 (Studies 1 and 2). 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., carisoprodol 250 mg, carisoprodol 350 mg, or placebo) and in Study 2 patients were randomized to two treatment groups (i.e., carisoprodol 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 carisoprodol 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.

The results for the primary efficacy evaluations in the acute, low back pain studies are presented in Table 3.

Patients treated with carisoprodol experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.

How Supplied/Storage and Handling

Carisoprodol Tablets, USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side; available in bottles of 100 (NDC 61442-450-01), available in bottles of 500 (NDC

61442-450-05), available in bottles of 1000 (NDC 61442-450-10).

Storage:

Store at 20-25°C (68-77°F) .

Patient Counseling Information

Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol.

Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery .

Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives .

Carisoprodol Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Distributed by:
Carlsbad Tech
5928 Farnsworth Court Carlsbad, CA 92008

Manufactured by:
ScieGen Pharmaceuticals, Inc.
Hauppauge, NY 11788 USA
Rev. 11/15

Soma Description

Carisoprodol tablets, USP are available as 350 mg round, white tablets. Carisoprodol USP is a white, crystalline powder, having a mild, characteristic odor. It is very 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 C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:

Other ingredients in the carisoprodol tablets USP, 350 mg include microcrystalline cellulose, lactose monohydrate, pregelatinized starch (botanical source: maize), croscarmellose sodium, povidone, silicon dioxide and magnesium stearate.

NDC 61442-450-10

Carisoprodol

Tablets, USP

350 mg

Rx Only

Carlsbad Tech

1000 Tablets

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL (PDP)

NDC 61442-450-01

Carisoprodol

Tablets, USP

350 mg

Rx Only

Carlsbad Tech

100 Tablets

NDC 61442-450-05

Carisoprodol

Tablets, USP

350 mg

Rx Only

Carlsbad Tech

500 Tablets

Soma
carisoprodol tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61442-450
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARISOPRODOL (CARISOPRODOL) CARISOPRODOL 350 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
POVIDONES
SILICON DIOXIDE
MAGNESIUM STEARATE
STARCH, CORN
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (white) Score no score
Shape OVAL (OVAL) Size 12mm
Flavor Imprint Code SG;109
Contains
Packaging
# Item Code Package Description
1 NDC:61442-450-01 100 TABLET, FILM COATED in 1 BOTTLE
2 NDC:61442-450-05 500 TABLET, FILM COATED in 1 BOTTLE
3 NDC:61442-450-10 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203374 01/27/2014

Labeler – Carlsbad Technology, Inc. (781047246)

Establishment
Name Address ID/FEI Operations
Carlsbad Technology, Inc. 781047246 manufacture(61442-450), analysis(61442-450)

Carlsbad Technology, Inc.

Medical Disclaimer

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Some comes in the form of pills which are round and white. The active ingredient of it is carisoprodol and it is a white substance that has a mild odor and that tastes bitter, so the pills might also be of a bitter taste. These pills come in two different doses and these are a 250mg dose and a 350mg dose. The right dosage will be determined for you by your doctor based on many different factors such as the severity of your injury. The pills are taken orally with a glass of water, four times a day – three times during a day and once at bedtime. The food does not affect the efficacy of the pill so you may take it with or without food.

During the treatment, Soma is combined with physical therapy, ample rest and possibly some other treatments such as some anti-inflammatory medications. It is a short term medication which means that is taken up to two or three weeks during which your injury should heal. If this, however, does not happen, you should talk to your doctor for the problem you have had might need a different treatment.

Once you start the treatment it might happen that you experience some of the side effects of Soma. These are really not serious and most people do not experience any at all. However, if you do experience some, although they will probably not require medical attention, you should inform your doctor about it. It might be necessary that your dosage should be lowered. It may also happen that you feel like the drug is not working for you. In this case you should also tell your doctor about it and they will probably prescribe you a dosage higher than the originally prescribed. Anyway, you should never increase the dosage on your own for if you take too much you will also increase the risk of side effects or you may even overdose.

Warnings,to sum up, Soma is a very useful and effective medication when it comes to treating muscle injuries. It comes in the form of pills and in two different doses. The dosage that you should take will be determined by your doctor and you should never adjust it on your own. The usual length of the treatment is two to three weeks and if the problem does not go away over this time, you should consult your doctor. In fact, all you need to do is stick to the prescription of your doctor and you will experience the proper effectiveness of Soma.

The Effects of Carisoprodol Use

  • OR
  • Enter treatment at a recovery center or rehab facility.
  • Additionally, should any of the grave, potentially life-threatening side effects be experienced, the individual should be immediately taken to an emergency room or qualified medical facility.

    Carisoprodol Effects question 6

    Withdrawal Treatment

    Carisoprodol Detox

    Carisoprodol withdrawal can come with symptoms such as:

    • Lack of concentration.
    • Insomnia.
    • Rebound muscle pain, aches and stiffness.
    • Ataxia or loss of muscular coordination.
    • Shaky limbs or tremulousness.
    • Gastrointestinal disturbance.
    • Hallucinations and delusions (less common).
    • Strong cravings for the drug.

    These symptoms can make the withdrawal and recovery processes difficult; however, it’s important to remember that, despite the struggle, recovery is entirely possible. The drug often changes the brain’s chemistry, and a brain going through withdrawal often needs time in order to alter its chemicals back to a more natural state.

    Carisoprodol Addiction Treatment

    Options for treatment include inpatient rehab, outpatient services, and 12-step programs, among others. Inpatient treatment is a great option for those who need focused and continuous care to stop using. Patients typically stay in rehab for a period of 30-90 days, or longer depending on their needs.

    Some people, however, are unable to leave work or other responsibilities for an extended period of time and may find outpatient treatment to be a better option. However, when considering the benefits and drawbacks, it’s important to note that recovery enables you to effectively fulfill your responsibilities, so even if you have to spend a certain amount of time in rehab, it will be worth it in potentially saving your life and letting you perform better as an employee, a spouse, a parent, etc.

    If you or a loved one is suffering from Carisoprodol addiction, there is a way to get help. Give us a call at 1-888-744-0069Who Answers? and let us help you find the right treatment program for your personal needs so that you can get back to living a clean and sober lifestyle.

    Last updated on December 3, 2018 2018-12-03T23:38:30+00:00 Finding the perfect treatment is only one phone call away!

    WARNINGS

    Included as part of the “PRECAUTIONS” Section

    PRECAUTIONS

    SOMA has 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. There have been post-marketing reports of motor vehicle accidents associated with the use of SOMA.

    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.

    Abuse, Dependence, And Withdrawal

    Carisoprodol, the active ingredient in SOMA, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion. . Abuse of SOMA poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders .

    Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse. Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of SOMA after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause dependence .

    To reduce the risk of SOMA abuse assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.

    There have been post-marketing 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) .

    Carcinogenesis, Mutagenesis, Impairment Of Fertility

    Carcinogenesis

    Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

    Mutagenesis

    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.

    Impairment Of Fertility

    SOMA was not formally evaluated for effects on fertility. A published reproductive study in which female mice received carisoprodol orally at doses of 300, 750, or 1200 mg/kg/day (approximately 1, 2.6, and 4.1 times the MRHD of 1400 mg per day based on body surface area comparison) from 1-week prior to mating, to 27-weeks post-mating 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 13week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day (maternal doses equivalent to 4.2-times the MRHD based on BSA comparison). In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6-times the MRHD based on a BSA comparison. The significance of these findings for human fertility is not known.

    Use In Specific Populations

    Pregnancy

    Risk Summary

    Data over many decades of carisoprodol use in pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Data on meprobamate, the primary metabolite of carisoprodol, also do not show a consistent association between maternal use of meprobamate and an increased risk of major birth defects (see Data).

    In a published animal reproduction study, pregnant mice administered carisoprodol orally at 2.6 and 4.1-times the maximum recommended human dose ( of 1400 mg per day based on body surface area comparison) from gestation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival (see Data).

    The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    Data

    Human Data

    Retrospective case-control and cohort studies of meprobamate use during the first trimester of pregnancy have not consistently identified an increased risk or pattern of major birth defects. For children exposed to meprobamate in-utero, one study found no adverse effect on mental or motor development or IQ scores.

    Animal Data

    Embryofetal development studies in animals have not been completed.

    In a published pre-and post-natal development animal study, pregnant mice administered carisoprodol orally at 300, 750, or 1200 mg/kg/day (approximately 1-, 2.6-, and 4.1-times the MRHD based on BSA comparison) from 7-days prior to gestation through birth and from lactation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival at 2.6-and 4.1-times the MRHD.

    Lactation

    Data from published literature report that carisoprodol and its metabolite, meprobamate, are present in breastmilk. There are no data on the effect of carisoprodol on milk production. There is one report of sedation in an infant who was breastfed by a mother taking carisoprodol (see Clinical Considerations). Because there have been no consistent reports of adverse events in breastfed infants over decades of use, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SOMA and any potential adverse effects on the breastfed infant from SOMA or from the underlying maternal condition.

    Clinical Considerations

    Infants exposed to SOMA through breast milk should be monitored for sedation.

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

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

    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.

    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.

    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. .

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