Carisoprodol – StatPearls – NCBI Bookshelf

Continuing Education Activity

Carisoprodol is an FDA-approved drug indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions. Although marketed as a muscle relaxant, the parent compound is considered to be in the tranquilizer class of medications, whereas the primary metabolite meprobamate is considered to be in the benzodiazepine class of drugs. This activity discusses the indications, mechanism of action, and contraindications for carisoprodol as a valuable agent to relax muscles after strains, sprains, and muscle injuries. This medication is intended to be used together with rest, physical therapy, and other measures. This activity will highlight the mechanism of action, adverse event profile, and other key factors (e.g., dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions) pertinent for healthcare professionals in managing patients with myofascial pain and related conditions.

Objectives:

• Identify the mechanism of action of carisoprodol and its primary metabolite, meprobamate.

• Describe the essential potential adverse events associated with carisoprodol therapy.

• Review the potential toxicity of carisoprodol and its appropriate management.

• Explain why it is important for the healthcare team to be aware of and up to date on the indications, interactions, adverse effects, and other pharmacodynamic and pharmacokinetic factors that can affect successful carisoprodol use in clinical care and lead to improved patient outcomes.

Access free multiple choice questions on this topic.

Indications

Carisoprodol is an FDA-approved drug indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions.  It only has approval for up to three weeks. It is not recommended in pediatric patients less than 16 years of age since it has not had evaluations in this population. In the United States, it is a schedule IV controlled substance. Carisoprodol was approved for medical use in the United States in 1959 and is available as a generic medication. It comes in tablet form and can be taken by mouth up to three times a day and before bed.  According to the package insert, carisoprodol is intended to be used together with rest, physical therapy, and other measures to relax muscles after strains, sprains, and muscle injuries.

Mechanism of Action

Per the package insert, the exact mechanism of action of carisoprodol in relieving discomfort associated with acute painful musculoskeletal conditions has not been identified. It is believed to be a centrally acting skeletal muscle relaxant that does not directly relax skeletal muscles. The muscle relaxation effects induced by carisoprodol in animal studies are associated with altered interneuronal activity in the spinal cord and the descending reticular formation of the brain. Its primary metabolite, meprobamate, is believed to work at the GABA receptors and is believed to be responsible for carisoprodol’s therapeutic effects as well as its abuse potential. [1] Meprobamate is a benzodiazepine-type anxiolytic and has sedative properties.    

Carisoprodol is metabolized in the liver primarily by the cytochrome P450 oxidase isozyme CYP2C19, and it gets excreted by the kidneys. The absolute bioavailability of carisoprodol remains undetermined. Carisoprodol’s primary metabolite is meprobamate, a known drug of abuse and dependence.[2][3][4] Meprobamate was classified as a schedule IV controlled substance in 1970 and is in the tranquilizer medication class, and its marketing was under several names. Per the package insert, carisoprodol, after oral ingestion, has a quick onset of action with the time to maximum plasma concentration being approximately 1.5 to 1.7 hours for the 250-milligram strength and the 350-milligram strength, respectively. The elimination half-life for carisoprodol is 1.7 to 2 hours, whereas the half-life for the meprobamate metabolite is approximately 10 hours.  The time to maximum plasma concentration for the meprobamate metabolite is approximately 3. 6 to 4.5 hours.    

Given the significantly prolonged half-life of meprobamate compared to the carisoprodol, there is a risk of meprobamate bio-accumulation following extended periods of carisoprodol administration.  Also, patients with reduced CYP2C19 activity are poor metabolizers of the carisoprodol resulting in up to a 4-fold increase in exposure to carisoprodol and a 50% reduced exposure to meprobamate.[5][6]

Carisoprodol is a racemic mixture, only slightly soluble in water but freely soluble in alcohol. The solubility of carisoprodol is practically independent of pH.  Furthermore, as per the package insert, taking this medication with fatty food did not appear to affect its pharmacokinetics.[7]

Administration

Carisoprodol is administered as an oral tablet 250 mg or 350 mg taken by the mouth up to three times a day and before bed. It is also available in various co-formulated forms: carisoprodol combined with acetaminophen and caffeine, carisoprodol combined with gamma-aminobutyric acid, and carisoprodol with acetylsalicylic acid and codeine.

Although the safety and pharmacokinetics of carisoprodol in patients with renal impairment have not undergone evaluation, caution is a recommendation since the kidney excretes this medication.  Of note, carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.[8] Carisoprodol gets metabolized by CYP2C19 in the liver. As per the package insert, caution is necessary if administered to patients with impaired hepatic function or reduced CYP2C19 activity since this could result in higher exposure to carisoprodol. Co-administration of CYP2C19 inhibitors could result in increased levels of carisoprodol and decreased levels of the meprobamate metabolite. Common CYP2C19-inhibitors include omeprazole, ticlopidine, fluoxetine, fluvoxamine, topiramate, sertraline, and tricyclic antidepressants. Conversely, co-administration of CYP2C19-inducers could result in decreased levels of carisoprodol and increased levels of meprobamate. Common CYP2C19-inducers include rifampin, carbamazepine, phenobarbital, aspirin, and St. John’s Wort.

Carisoprodol is pregnancy category C. However, animal studies indicate that carisoprodol adversely affected fetal growth and postnatal survival.  Based on the limited respective post-marketing data, the primary metabolite meprobamate did not show any increased risk for particular congenital malformations.[1]  

Although carisoprodol prescribing appears to be declining to number 214 of the previous year down from number 181 of the top 300 commonly prescribed medications, it is still a commonly prescribed medication in the U.S., with over 3.4 million prescriptions in 2017. 

The efficacy, safety, and pharmacokinetics of carisoprodol have not been established in patients under the age of 16 or patients over 65.

Adverse Effects

The most common side effects of carisoprodol include drowsiness, dizziness, and headache.  According to the package insert, up to 17% of patients experienced sedation after taking carisoprodol compared to 6% of patients who received a placebo. This side effect can potentially impair the mental and physical abilities necessary for the performance of potentially hazardous work such as driving a vehicle or operating heavy machinery. There are post-marketing reports of motor vehicle accidents correlated with the use of carisoprodol. Since the sedative effects of CNS depressants may be additive, patients should be cautioned to avoid or minimize taking other CNS depressants such as alcohol, opioids, or benzodiazepines simultaneously and to take necessary precautions not to drive or engage in other potentially dangerous activities if experiencing sedation. 

Significant hypotension can also occur with carisoprodol overdose and is usually treated with supportive care and possibly dialysis.[8][9][10]

Dependence, withdrawal, and abuse of carisoprodol have been reported with prolonged use, especially in patients with a history of addiction or when used in combination with other drugs with abuse potential.[1][11] Furthermore, withdrawal symptoms have been reported after abrupt discontinuation after prolonged use.  Therefore it is recommended that carisoprodol not be used for more than two to three weeks to relieve acute musculoskeletal discomfort.  The belief is that carisoprodol elicits barbiturate-like effects, where animal studies show that this medication can produce rewarding effects, like other drugs of abuse.[1] In addition to the potential for somnolence, a normal prescribed dosage of carisoprodol may result in short-lived mild to moderate euphoria or dysphoria due to carisoprodol’s potent anxiolytic effects. Carisoprodol, more so than meprobamate, may be responsible for the euphoria.  Tolerance to the side effects of carisoprodol can develop and lessens over time.

Meprobamate was a frequently misused drug in the 1950s and 1960s, and there have been reported overdoses.[3][6] With prolonged usage, carisoprodol and meprobamate can produce physical dependence of the barbiturate type as well as withdrawal symptoms similar to those of alcohol withdrawal. Like benzodiazepines, potential psychological dependence can result in withdrawal symptoms that persist for significantly longer periods, lasting months or even years. These symptoms may include anxiety and depression, long-term memory loss, chronic insomnia, social withdrawal, agitation and aggression, and other potential symptoms.[1][6][7] The severity of the symptoms appears to be magnified in patients with a history of substance misuse and patients concomitantly on other drugs with sedatives or benzodiazepine or opioid-like effects.  The combination of carisoprodol with opioids and benzodiazepines has been referred to as “the Holy Trinity,” reportedly to increase the power of the “high.”[11] Because of its significant abuse potential due to its sedating, relaxant, and anxiolytic effects, in December of 2011, the drug enforcement agency classified carisoprodol as a schedule IV medication according to the Controlled Substance Act.

In March of 2007, Norwegian medical regulatory authorities conducted a review of Carisoprodol, and the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of medicines containing carisoprodol no longer outweigh their risks and that all marketing authorizations for carisoprodol be suspended throughout Europe.

Another potential significant reported adverse effect is seizures. In Indonesia, in September 2017, close to 100 people suffered seizures with at least one fatality when PCC, standing for “paracetamol-caffeine-carisoprodol,” was mixed into student’s drinks. 

Contraindications

Important contraindications listed in the package insert are acute intermittent porphyria as well as hypersensitivity reactions to a carbamate such as meprobamate. Patients with a sulfa allergy can develop a reaction after the carisoprodol is converted into meprobamate.

Monitoring

No specific monitoring is necessary per the package insert. However, considering that this medication is metabolized in the liver and excluded through the kidney, the levels of carisoprodol and meprobamate can potentially increase if the patient has decreased liver function or renal insufficiency. Therefore dose or frequency adjustments may be indicated. Also, given the significant abuse potential of this medication and given that it is a controlled medication, performing appropriate monitoring such as periodic urine drug tests and pill counts may be necessary.

Toxicity

Since carisoprodol itself likely acts at the barbiturate site, a carisoprodol overdose itself is not directly reversible with flumazenil, a GABA-A receptor antagonist. However, the primary metabolite meprobamate, similar to benzodiazepines, does work on the GABAA receptor.[1]  Therefore later in the course of an overdose, when there is potentially a significant amount of meprobamate, flumazenil can help reverse the effects of an overdose. Supportive care, including possibly charcoal and dialysis, should be considered in overdose situations.[8]

Several case reports indicate that in overdose situations, there is direct cardiac toxicity.[5][9] Due to limited redistribution, maximum concentrations of carisoprodol appear in cardiac tissue.[9]

Enhancing Healthcare Team Outcomes

As mentioned on the package insert, carisoprodol is indicated to relieve discomfort associated with acute, painful musculoskeletal conditions. To minimize the potential risks of drug dependence and abuse, its use only has approval for up to three weeks. Also, due to potentially serious side effects such as sedation and seizures, this medication is not recommended in pediatric patients less than 16 years of age nor in elderly patients. It is a schedule 4 controlled substance. This medication should be used together with rest, physical therapy, and other measures to relax muscles after strains, sprains, and muscle injuries.  

Proper management of myofascial pain and muscle spasm can significantly impact a patient’s mobility and quality of life and improve patient safety and outcomes. Carisoprodol indications include the relief of discomfort associated with acute, painful musculoskeletal conditions. To minimize the potential risks of drug dependence and abuse, its use is only approved for up to three weeks and should be used together with rest, physical therapy, and other measures to relax muscles after strains, sprains, and muscle injuries. Healthcare professionals need to work together as an interprofessional team to thoroughly evaluate patients and consider patient’s risk factors, including a history of substance abuse and a history of medication noncompliance, to make informed decisions about the potential role of carisoprodol in treatment. It is also essential for healthcare providers to be cognizant of the duration of treatment with this medication. The pharmacist should perform medication reconciliation and verify there are no interactions and that dosing is within proper limits, and let the prescriber know of any concerns. Nursing should counsel patients on possible adverse effects and monitor the patient’s usage to ensure there is no misuse and that therapy is effective, reporting any concerns to the prescribing clinician. Carisoprodol has been a commonly prescribed muscle relaxant for many years, and all members of the interprofessional health care team must be aware of and up to date on the indications, interaction, adverse effects, and other pharmacodynamic and pharmacokinetic factors that can affect successful therapy implementation, and lead to improved patient outcomes. [Level 5]

References

1.

Gonzalez LA, Gatch MB, Forster MJ, Dillon GH. Abuse Potential of Soma: the GABA(A) Receptor as a Target. Mol Cell Pharmacol. 2009 Jan 01;1(4):180-186. [PMC free article: PMC2858432] [PubMed: 20419052]

2.

KAMIN I, SHASKAN DA. Death due to massive overdose of meprobamate. Am J Psychiatry. 1959 Jun;115(12):1123-4. [PubMed: 13649976]

3.

Hollister LE. The pre-benzodiazepine era. J Psychoactive Drugs. 1983 Jan-Jun;15(1-2):9-13. [PubMed: 6350551]

4.

Allen MD, Greenblatt DJ, Noel BJ. Meprobamate overdosage: a continuing problem. Clin Toxicol. 1977 Dec;11(5):501-15. [PubMed: 608316]

5.

Kintz P, Tracqui A, Mangin P, Lugnier AA. Fatal meprobamate self-poisoning. Am J Forensic Med Pathol. 1988 Jun;9(2):139-40. [PubMed: 3381792]

6.

BERGER FM, KLETZKIN M, LUDWIG BJ, MARGOLIN S. The history, chemistry, and pharmacology of carisoprodol. Ann N Y Acad Sci. 1960 Mar 30;86:90-107. [PubMed: 13799302]

7.

Bramness JG, Furu K, Engeland A, Skurtveit S. Carisoprodol use and abuse in Norway: a pharmacoepidemiological study. Br J Clin Pharmacol. 2007 Aug;64(2):210-8. [PMC free article: PMC2000626] [PubMed: 17298482]

8.

Graae J, Ladefoged J. [Severe meprobamate poisoning treated by hemodialysis and peritoneal dialysis]. Nord Med. 1969 May 08;81(19):601-3. [PubMed: 5783967]

9.

Eeckhout E, Huyghens L, Loef B, Maes V, Sennesael J. Meprobamate poisoning, hypotension and the Swan-Ganz catheter. Intensive Care Med. 1988;14(4):437-8. [PubMed: 3403779]

10.

BLUMBERG AG, ROSETT HL, DOBROW A. Severe hypotensive reactions following meprobamate overdosage. Ann Intern Med. 1959 Sep;51:607-12. [PubMed: 13801701]

11.

Horsfall JT, Sprague JE. The Pharmacology and Toxicology of the ‘Holy Trinity’. Basic Clin Pharmacol Toxicol. 2017 Feb;120(2):115-119. [PubMed: 27550152]

Carisoprodol tablets

What is this medicine?

CARISOPRODOL (kar eye soe PROE dole) is a muscle relaxer. It is used to treat pain and stiffness in muscles caused by strains, sprains, or other injury.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Soma, Vanadom

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drug abuse or addiction
• kidney disease
• liver disease
• porphyria
• an unusual or allergic reaction to carisoprodol, carbamate such as meprobamate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Swallow it with a full glass of water. Follow the directions on the prescription label. If it upsets your stomach, take it with food or milk. Do not take more medicine than you are told to take.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. This medicine is not usually used in children younger than 12 years.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medication with any of the following medicines:

• narcotic medicines for cough

This medicine may also interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• certain medicines for anxiety or sleep
• certain medicines for depression like amitriptyline, fluoxetine, sertraline
• certain medicines for seizures like phenobarbital, primidone
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• local anesthetics like lidocaine, pramoxine, tetracaine
• medicines that relax muscles for surgery
• narcotic medicines for pain
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

If you are taking another medicine that also causes drowsiness, you may have more side effects. Give your health care provider a list of all medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• confusion
• feeling faint or lightheaded, falls
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Soma (carisoprodol) dosing, indications, interactions, adverse effects, and more

Carisoprodol: uses & side-effects | PatientsLikeMe

Aug 14, 2014
(Started Jul 01, 2002)

• Effectiveness

  Can’t tell
  (for migraine)

• Effectiveness

  Slight
  (for muscle tension)

• Effectiveness

  Slight
  (for muscle spasms)

• Effectiveness

  Slight
  (for muscle pain)

• Effectiveness

  Slight
  (for fibromyalgia)

• Effectiveness

  Slight
  (for muscle and joint pain)

• Side effects

  None
  (for Overall)

• Burden

  Not at all hard to take

Dosage:
250 mg
Four times daily

Advice & Tips:
This medication used to work better but apparently I developed a tolerance to it. It was doing so little for me that my doctor & I decided to discontinue usage as we are trying to cut back on the amount of meds I take.

Cost:
< $25 monthly

Jan 1, 2014
(Started Jul 01, 2002)

• Effectiveness

  Can’t tell
  (for migraine)

• Effectiveness

  Slight
  (for muscle tension)

• Effectiveness

  Slight
  (for muscle spasms)

• Effectiveness

  Slight
  (for muscle pain)

• Effectiveness

  Slight
  (for fibromyalgia)

• Effectiveness

  Slight
  (for muscle and joint pain)

• Side effects

  None
  (for Overall)

• Burden

  Not at all hard to take

Dosage:
250 mg
Four times daily

Advice & Tips:
Since I apparently built up a tolerance for this and it wasn’t really helping much, and as we are trying to cut back on the amount of medications I take, we decided to discontinue it.

Cost:
< $25 monthly

Feb 15, 2012
(Started Jul 01, 2002)

• Effectiveness

  Slight
  (for muscle tension)

• Effectiveness

  Slight
  (for fibromyalgia)

• Effectiveness

  Slight
  (for muscle spasms)

• Effectiveness

  Slight
  (for muscle pain)

• Effectiveness

  Slight
  (for muscle and joint pain)

• Side effects

  None
  (for Overall)

• Burden

  A little hard to take

Dosage:
250 mg
Four times daily

Advice & Tips:
Unexpected benefits: Helps get better and more sleep a little bit.

Note: When I’m listed as beginning this med, I was actually taking Flexeril and over time we tried about half a dozen different muscle relaxants. The Flexeril did absolutely nothing for me. And while some of the others helped a little bit, Carisoprodol helped the most, but, as I said, it only helps a little bit. Most of the time my muscles are as tight as piano wire.

Cost:
< $25 monthly

Carisoprodol: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Soma; Vanadom

What is this drug used for?

• It is used to relax muscles.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has ever had porphyria.
• If your child is taking meprobamate.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have your child avoid tasks or actions that call for alertness while taking this drug. These include things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles. Talk with the doctor.
• Give this drug for short periods of time. If signs show up again, talk with the doctor.
• Do not have your child use longer than you have been told by your child’s doctor.
• Alcohol may interact with this drug. Be sure your child does not drink alcohol.
• Talk with your child’s doctor before your child uses marijuana, other forms of cannabis, or prescription or OTC drugs that may slow your child’s actions.
• This drug may be habit-forming with long-term use.
• If your child has been taking this drug on a regular basis and stops taking it all of a sudden, your child may have signs of withdrawal. Do not stop giving this drug all of a sudden without calling the doctor. Tell the doctor if your child has any bad effects.
• If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
• Abuse and misuse of this drug by itself or with certain other drugs may cause seizures, slow or shallow breathing, changes in alertness, coma, or death.

If your child is pregnant or breast-feeding a baby:

• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Feeling very tired or weak.
• Seizures.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Headache.
• Feeling dizzy or sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

• Give this drug with or without food. Give with food if it causes an upset stomach.

What do I do if my child misses a dose?

• If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
• If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
• Do not give 2 doses at the same time or extra doses.
• Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.

How do I store and/or throw out this drug?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2020-07-31

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Microsoft Word – Medication information sheets.doc

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Carisoprodol: Uses, Side Effects, Addiction

Carisoprodol, sold under the brand name Soma among others, is a medication used for musculoskeletal pain. It is used with rest, physical therapy, and other measures to relax muscles and relieve pain and discomfort caused by strains, sprains, and other muscle injuries. Use is only approved for up to three weeks. Effects generally begin within half an hour and last for up to six hours. It is taken orally. Carisoprodol is considered a controlled substance in the United States.

How should carisoprodol be used?

Carisoprodol comes as a tablet to take by mouth. It usually is taken three times daily and at bedtime. It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take carisoprodol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

What side effects can this medication cause?

Carisoprodol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• drowsiness
• dizziness
• clumsiness
• headache
• fast heart rate
• stomach upset
• vomiting
• skin rash

If you experience any of the following symptoms, call your doctor immediately:

• difficulty breathing
• fever
• weakness
• burning in the eyes

Carisoprodol Safety Information

Before taking carisoprodol,

• tell your doctor and pharmacist if you are allergic to carisoprodol, meprobamate (Equanil, Meprospan, Miltown, Neuramate), any other medications, or any of the ingredients in carisoprodol tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially medications for allergies, coughs, or colds; muscle relaxants; sedatives; sleeping pills; tranquilizers; and vitamins.
• tell your doctor if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking carisoprodol, call your doctor.
• talk to your doctor about the risks and benefits of taking carisoprodol if you are 65 years of age or older. Older adults should not usually take carisoprodol because it is not as safe or effective as other medications that can be used to treat the same condition.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how carisoprodol affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

Warnings

You should not take carisoprodol if you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system). Carisoprodol may be habit-forming. Never share this medicine with another person. Misuse of habit-forming medicine can cause addiction, overdose, or death.

Carisoprodol 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 this medicine.

You may have withdrawal symptoms when you stop using this medicine after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

90,000 What are the signs of an overdose of Karisoprodol?

Carisoprodol is a medicine commonly used to control muscle spasms and relieve pain that can result from muscle problems. In addition to its effects on muscles, the body converts this chemical into meprobamate, which has a sedative effect on the central nervous system, similar to some anti-anxiety drugs. The repeated actions of this drug make it especially dangerous if taken in large quantities.Therefore, people taking this medication must learn to recognize the signs of a carisoprodol overdose.

Not all people show the same effects in the event of an overdose of carisoprodol. Many factors, including the dosage taken and the possibility of other substances, are taken into account. Typical doses of carisoprodol are usually 250 mg to 350 mg every six hours. Amounts that even slightly exceed this dosage can lead to consequences such as mood changes and euphoria, dilated pupils and lack of coordination.However, the individual will still be clear and capable of rational thinking.

At higher doses, the symptoms presented during carisoprodol overdose become more dangerous. Confusion, delusions, or even hallucinations can cause strange behavior and arousal in people. On the other hand, blood pressure may drop or the person may lose control of eye movements or the body as a whole. Convulsions can occur.

The most serious consequences of an overdose of carisoprodol are convulsions, coma and breathing problems.These symptoms can be fatal if allowed to continue unchecked. An ambulance should be informed at the first sign of an overdose to avoid the progression of symptoms, which can have life-long or even fatal consequences.

Preventing carisoprodol overdose is not just about taking only the recommended dose. Care should also be taken when combining this medication with other drugs that affect the central nervous system (CNS).CNS depressants, including opioid pain relievers, anti-anxiety drugs such as diazepam, and sleep aids, can increase the risk of harmful interactions and overdose. Consuming any amount of alcohol can also significantly increase the likelihood of these effects occurring.

Over time, tolerance can develop to this drug, so people will need more of the drug to experience symptom relief. This situation can increase the likelihood of overdose, as tolerance does not extend to all aspects of carisoprodol at the same rate.Carisoprodol should only be used for two to three weeks at a time to avoid the increased tolerance that may play a role in overdose.

OTHER LANGUAGES

Carisoprodol Wallace – instructions for use, dosage, composition, analogs, side effects / Pillintrip

Special warnings and precautions

WARNINGS

Contained as part of PRECAUTIONS Section.

PRECAUTIONS

Sedation

Carisoprodol Wallace has sedative properties (in studies of low back pain, 13% to 17% of patients experienced, received Carisoprodol Wallace, sedation compared to 6% of patients, received placebo) and may affect mental and / or physical abilities that are required to perform potentially hazardous tasks such as driving a car or operating machinery. There have been reports of car accidents involving the use of carisoprodolone after being placed on the market.

Because the sedative effects of carisoprodol and other CNS depressants (eg, alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, caution should be exercised in patients taking more than one of these CNS depressants at the same time.

Abuse, Dependence and Deprivation

Carisoprodol, the active ingredient in Carisoprodol Wallace, has been subjected to abuse, dependence, deprivation, abuse and criminal distraction…. Abuse of carisoprodol drugs carries the risk of overdose, which can lead to death, central nervous system and respiratory depression, hypotension, seizures and other disorders.

Aftermarket Experience Cases of carisoprodol abuse and addiction have been reported in patients with long-term drug use and abuse. Although most of these patients received other drug-related earnings, some patients only abused carisoprodol.Withdrawal symptoms have been reported after sudden cessation of carisoprodol therapy after prolonged use. Symptoms of deprivation have been reported: insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of the metabolites of carisoprodol, meprobamate (a controlled substance), can also be addictive.

To reduce the risk of misuse of carisoprodol, assess the risk of misuse before prescribing. Once prescribed, limit treatment to three weeks to relieve acute musculoskeletal complaints, keep accurate prescription records, monitor for signs of abuse and overdose, and educate patients and your families about abuse and proper storage and disposal.

Seizures

There have been post-marketing reports of seizures in patients receiving drugs for carisoprodol. Most of these cases have resulted from multiple drug overdoses (including drug abuse, illegal drugs, and alcohol).

Preclinical toxicology

Carcinogenesis, mutagenesis, impaired fertility

Long-term animal studies have not been performed to assess the carcinogenic potential of carisoprodol.

Carizoprodol Wallace has not been formally tested for genotoxicity. Carisoprodol was in published studies in vitro – Mutagenic murine lymphoma test in the absence of metabolizing enzymes, but not mutagenic in the presence of metabolizing enzymes. Carisoprodol was in the in vitro ChromoCarisoprodol Wallacel aberration test using Chinese hamster egg coli cells with or without clastogenic metabolizing enzymes. Other types of genotoxic tests have resulted in negative ones.Karizoprodol was not mutagenic in the Ames mutation assay with S. typhimurium strains with or without metabolizing enzymes and was in one in vivo – The mouse micronucleus assay circulates in non-clastogenic blood cells.

Karizoprodol Wallace has not been formally studied for the effect of fertility. Reproductive studies of carisoprodol in mice showed no change in fertility, although changes in reproductive cycles were observed at 1200 mg / kg / day of carisoprodol, which was characterized by prolonged estrus time.In a 13-week toxicology study that did not measure fertility, mouse testicular weight and sperm motility were reduced at 1200 mg / kg / day. In both studies, the no effect level was 750 mg / kg / day, which is about 2.6 times the human equivalent dose of 350 mg four times daily based on body surface comparisons. The importance of these findings to human fertility is unknown.

Use in designated populations

Pregnancy

Pregnancy Category C

There are no data on the use of Carisoprodol® during human pregnancy.Animal studies show that carisoprodol crosses the placenta and has adverse effects on fetal growth and postnatal survival. The main 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 of certain congenital malformations.

Teratogenic effects

Animal studies have not adequately evaluated the teratogenic effects of carisoprodol.In reproductive studies in rats, rabbits and mice treated with meprobamate, there was no increase in the incidence of congenital malformations. Retrospective post-marketing studies of meprobamate during pregnancy in humans have been controversial to demonstrate an increased risk of congenital malformations following first trimester exposure. In studies that indicated an increased risk, the types of malformations were controversial.

Non-teratogenic effects

In animal experiments, carisoprodol reduced fetal weight, postnatal weight gain and postnatal survival at maternal doses that corresponded to 1-1, 5 times the human dose (based on body surface comparison).Rats, meprobamate in utero underwent behavioral changes that continued into adulthood. For children, meprobamate in utero study showed no adverse effects on mental or motor development or IQ value. Carisoprodol® should only be used during pregnancy if the potential use justifies the risk to the fetus.

Work and delivery

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

Nursing mothers

Very limited human data indicate that carisoprodolamine is present in breast milk and can reach concentrations that are two to four times higher than maternal plasma. In the case report, the breastfed baby received about 4-6% of the daily maternal dose from breast milk and had no side effects. However, milk production was insufficient and the baby was supplemented with a formula. In mouse lactation studies, female puppy survival and puppy weaning weight were reduced.This information suggests that maternal use of carisoprodolone may result in decreased or decreased nutritional efficiency in infants (due to sedation) and / or decreased milk production. Care should be taken when prescribing Carisoprodol ® to a nursing woman.

Pediatric Use

The efficacy, safety and pharmacokinetics of Carisoprodol® in pediatric patients under 16 years of age have not been established.

Geriatric use

The efficacy, safety and pharmacokinetics of Carisoprodol® in patients over 65 years of age have not been established.

Renal impairment

The safety and pharmacokinetics of Carisoprodol® in patients with renal impairment have not been studied. Since carisoprodol wallas is excreted from the body in the kidneys, caution should be exercised when administering carisoprodol wallas to patients with renal insufficiency. Karisoprodol can be dialyzed by hemodialysis and peritoneal dialysis.

Liver failure

The safety and pharmacokinetics of Carisoprodol® in patients with liver dysfunction have not been studied.Since carisoprodol wallas is metabolized in the liver, caution should be exercised when administering carisoprodol wallas to patients with hepatic impairment.

Patients with reduced CYP2C19 activity

Patients with reduced CYP2C19 activity have a higher exposure to carisoprodol. Therefore, caution should be exercised when prescribing Carisoprodol ® to these patients.

Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: USA

Soma; Vanadom

What is this drug used for?

• Used to relax muscles.

What do I need to tell my doctor BEFORE taking this drug?

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.
• If you have ever had porphyria.
• If you are taking mephobamate.

This list of drugs and diseases that may be adversely associated with this drug is not exhaustive.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems. You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking.Do not start or stop taking any drug or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug. These are doctors, nurses, pharmacists and dentists.
• While you are taking this drug, avoid driving vehicles and other activities or activities that require special attention.
• Use this drug for short periods of time. If symptoms recur, consult your doctor.
• Do not use this drug for longer than your doctor prescribed.
• Avoid drinking alcohol while taking this drug.
• Consult your doctor before using marijuana, other forms of cannabis, prescription or over-the-counter drugs that may slow you down.
• This drug may be habit-forming with prolonged use.
• Abruptly stopping this drug after regular use may cause withdrawal. Do not stop taking this drug abruptly without talking to your doctor. Tell your doctor if you experience any unwanted effects.
• Taking this drug more or more often than your doctor tells you may make it less effective.The so-called drug tolerance develops. Talk to your doctor if this drug stops working. Do not take the drug in higher doses than your doctor prescribed.
• Abuse or misuse of this drug, alone or in combination with certain other drugs, can lead to seizures, slow or shallow breathing, impaired concentration, coma, or death.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your doctor or get medical help right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blisters or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Feeling extremely tired or weak.
• Convulsions.

What are some other side effects of this drug?

Any medicine can have side effects. However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Headache.
• Feeling dizzy or drowsy.

This list of potential side effects is not exhaustive. If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner. Read all the information provided to you. Follow all instructions strictly.

• Take with or without food. Take with food if the medicine causes nausea.

What to do if a dose of a drug is missed?

• If you are taking this medicine regularly, take the missed dose as soon as you can.
• If it is time for your next dose, do not take the missed dose and then return to your normal dose schedule.
• Do not take 2 doses at the same time or an additional dose.
• In most cases, this drug is used as needed. Do not take this medicine more often than prescribed by your doctor.

How do I store and / or discard this drug?

• Store at room temperature in a dry place.Do not store in the bathroom.
• Store this medication in a protected place, out of the reach of children, and out of the reach of others. A box or room, which is locked with a key, can act as a protected storage location for the drug. Keep all medicines out of the reach of pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so.If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone and take other people’s medicines.
• Some medicines may come with other patient information sheets.If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may come with other patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention.Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a treatment guide and does not replace information provided to you by your healthcare professional. For complete information on the possible risks and benefits of taking this drug, consult your doctor.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

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Vanadom and alcohol interaction

When checking interactions against reputable sources Drugs.com, Rxlist.com, Webmd.com, Medscape.com, contraindications or side effects have been found that can be harmful or intensify the negative effect when using a combination of drugs with alcohol.

Consumer:

Alcohol may increase the nervous system side effects of carisoprodol, such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit drinking alcohol while you are being treated with carisoprodol.Do not use more than the recommended dose of carisoprodol, and avoid activities that require mental alertness, such as driving a car or operating dangerous equipment, until you know how the drug is affecting you. Talk to your doctor or pharmacist if you have questions or concerns.

Professional:

As a rule, avoid: alcohol may increase some of the pharmacological effects of CNS-active substances.Use in combination may result in additive depression of the central nervous system and / or impairment of judgment, thinking, and psychomotor abilities.

Management: Patients receiving CNS-active substances should be warned of such interaction and advised to avoid or limit alcohol consumption. Outpatients should be informed to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents are affecting them, and to notify their physician if they are experiencing excessive or prolonged CNS exposure that interferes with them. normal activity.

Sources

• Gilman AG, Rall TW, Nies AS, Taylor P, eds. “Goodman and Gilman’s the Pharmacological Basis of Therapeutics. 8th ed.” New York, NY: Pergamon Press Inc. (1990):
• Warrington SJ, Ankier SI, Turner P “Evaluation of possible interactions between ethanol and trazodone or amitriptyline.” Neuropsychobiology 15 (1986): 31-7
• “Product Information. Fycompa (perampanel).” Eisai Inc, Teaneck, NJ.
• “Product Information.Rexulti (brexpiprazole). “Otsuka American Pharmaceuticals Inc, Rockville, MD.

Vanadom

Generic Name: carisoprodol

Brand: Soma, Vanadom

Synonyms: Vanadom (Oral)

Clinical Study Bipolar Disorder: JNJ-18038683, Placebo – Clinical Research Registry