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Description

Generic Name

Carisoprodol

Active Ingredient

Carisoprodol

Chemical Name and Composition

Carisoprodol is chemically described as N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate.

Carisoprodol is a white, crystalline powder with a mild, characteristic odor and a bitter taste. It is slightly soluble in water and freely soluble in alcohol, chloroform, and acetone. It has a molecular weight of about 260.33. Carisoprodol is broken down in the body to a compound called meprobamate, which contributes to its calming, sedating effects.

Medication Classification

Soma is a centrally acting skeletal muscle relaxant. It does not act directly on muscle. Instead, it works in the central nervous system to change how the brain and spinal cord sense pain and to produce a calming, sedating effect. This action is thought to help relieve discomfort from acute muscle and bone conditions.

Soma is a Schedule IV (CIV) controlled substance under U.S. federal law.

Indication

Soma is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. It should be used together with rest, physical therapy, and other measures. Soma is approved for short-term use only, generally up to 2 to 3 weeks, because evidence supporting its use for longer periods is limited.

Dosage Form and Available Strengths

• Dosage Form: Oral tablets
• Route of Administration: Oral
• Available Strengths: 250 mg and 350 mg

Inactive Ingredients

Inactive ingredients vary by strength and manufacturer. Soma tablets may contain alginic acid, magnesium stearate, microcrystalline cellulose, potassium sorbate, starch, tribasic calcium phosphate, and colorants that differ by tablet strength. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Soma exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Your provider will set your dose based on your condition and your overall health. Do not change your dose or take it longer than directed.

How to Take Soma

• Swallow the tablet with water.
• Soma is usually taken three times a day and at bedtime, or as directed by your provider.
• Because Soma can cause drowsiness, plan your activities carefully around your doses.
• Do not take more than prescribed, and do not take it more often than directed.

General Dosing Principles

• The recommended course of treatment is short, generally 2 to 3 weeks.
• Use Soma along with rest, physical therapy, and other measures your provider recommends.
• Your provider will select the exact dose and schedule for your situation.

Food Considerations

Soma may be taken with or without food. Taking it with food may help reduce stomach upset. Avoid alcohol entirely while taking Soma, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• If you miss a dose, take it as soon as you remember.
• If it is close to the time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• Because Soma causes drowsiness, do not take a missed dose if you plan to be active soon or need to drive.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Because Soma is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: The safety and effectiveness of Soma have not been established in patients younger than 16 years of age. It is not recommended for use in this age group. Keep the medication out of the reach of children. If a child swallows this medication, seek emergency care immediately.

Elderly Patients: Older patients may be more sensitive to the effects of Soma, including drowsiness, dizziness, confusion, and unsteadiness, which can raise the risk of falls. A provider may start at a lower dose and monitor closely. The safety and effectiveness of Soma in patients older than 65 have not been well studied.

Patients with Liver or Kidney Problems: Use with caution. A lower dose may be needed, since impaired organ function can increase drug levels and prolong effects. Your provider may adjust your dose and monitor you more closely.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, trouble waking the patient, or unusual changes in mood or behavior, and seek care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Soma suddenly after regular or prolonged use. Abrupt discontinuation can cause withdrawal symptoms.
• If you and your provider decide to stop treatment, the dose may be reduced gradually using a plan set by your provider.
• Withdrawal symptoms may include trouble sleeping, stomach cramps, headache, nausea, anxiety, tremor, muscle twitching, and, in some cases, hallucinations.
• Tell your provider if withdrawal symptoms occur so your plan can be adjusted.

Overdose Warning

An overdose of Soma can be serious and may be fatal, especially when combined with alcohol, opioids, or other central nervous system (CNS) depressants. Symptoms of overdose may include:

• Extreme drowsiness or difficulty staying awake
• Confusion or agitation
• Slowed or shallow breathing
• Loss of coordination or unsteadiness
• Vision changes, such as blurred or double vision
• Muscle stiffness or twitching
• Seizures
• Very low blood pressure
• Loss of consciousness, coma, or shock

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Treatment focuses on supportive care.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Soma and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Seizures
• Severe allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing. Serious reactions may occur even after the first few doses.
• Extreme sedation or trouble breathing: Slow, shallow, or difficult breathing, or extreme sleepiness or difficulty waking, especially when combined with other CNS depressants.
• Severe skin reactions: Widespread rash with blistering, peeling skin, or fever.
• A rare, severe first-dose reaction (idiosyncratic reaction): Extreme weakness, sudden loss of vision, confusion, dizziness, trouble speaking, agitation, or a feeling of being unable to move, sometimes appearing within minutes to hours of the first dose.
• Very low blood pressure: Severe dizziness, lightheadedness, or fainting.
• Fast heartbeat

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Drowsiness or sleepiness
• Dizziness
• Headache
• Nausea or vomiting
• Upset stomach
• Feeling nervous or irritable
• Blurred vision
• Tremor

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Warnings & Precautions

Conditions to Disclose to Your Healthcare Provider

Before taking Soma, tell your healthcare provider if you have or have had any of the following:

• Liver or kidney problems
• Seizures or a seizure disorder
• A blood disorder called acute intermittent porphyria
• Breathing problems or a history of slowed breathing
• Depression, mood problems, or thoughts of suicide
• A history of alcohol, prescription medicine, or street drug abuse or dependence
• A previous unusual or allergic reaction to carisoprodol or meprobamate
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Soma if you:

• Have a history of acute intermittent porphyria
• Have a known hypersensitivity to carisoprodol, meprobamate, or any component of the formulation. Reactions have included serious allergic responses.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Key interactions include:

• CNS depressants: Sedatives, tranquilizers, sleep medicines, benzodiazepines, other muscle relaxants, and certain antihistamines can add to drowsiness and the risk of slowed breathing.
• Opioids: Combining Soma with opioid pain medicines increases the risk of severe drowsiness, respiratory depression, coma, and death.
• Alcohol: Drinking alcohol while taking Soma can dangerously increase sedation and slowed breathing. Avoid alcohol entirely.
• Monoamine oxidase inhibitors (MAOIs): Combined use may increase sedation and other CNS effects. Talk to your provider before using these together.
• CYP2C19 inhibitors and inducers: Because carisoprodol is processed mainly by the CYP2C19 enzyme, drugs such as omeprazole or fluvoxamine (inhibitors) may raise carisoprodol levels, while drugs such as rifampin or St. John's wort (inducers) may lower them.
• Other sedating medicines: Any medicine that causes drowsiness may increase the sedative effects of Soma.

Monitoring Requirements

Your healthcare provider may monitor:

• Your response to treatment and level of pain relief
• Signs of excessive sedation or slowed breathing, especially with other CNS depressants
• New or worsening mood, behavior, or mental health changes
• Signs of tolerance, dependence, or misuse
• Signs of withdrawal if the dose is reduced or the medication is stopped

Abuse, Dependence, and Misuse Warnings

Soma is a Schedule IV controlled substance.

• Carisoprodol can be misused and may be a target for people who abuse prescription medicines. The risk may be higher in people with a history of substance abuse.
• Carisoprodol breaks down into meprobamate, which has its own potential for abuse and dependence.
• Physical dependence and tolerance can develop with continued use. Physical dependence means you should not stop suddenly.
• Withdrawal symptoms have been reported after stopping carisoprodol following prolonged use.
• Do not increase your dose on your own.
• Do not sell or give away Soma. Doing so may harm others and is against the law.
• Misusing this medication can cause overdose and death, especially when combined with other substances.

Long-Term Use Considerations

• Soma is approved for short-term use only, generally up to 2 to 3 weeks. There is little evidence that it is effective for longer periods, and most painful muscle conditions are short-lived.
• The safety and effectiveness of long-term use have not been established.
• If your symptoms do not improve within the treatment period, tell your provider. This may signal a condition that needs different treatment.
• The risk of dependence increases with longer use and higher doses. Any decision to stop after prolonged use should involve your provider.

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Patient Counseling Information

Safe Medication Use

• Take Soma exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Use Soma only for the short time your provider recommends, generally 2 to 3 weeks.
• Take it along with rest, physical therapy, and other measures your provider advises.
• Do not stop taking Soma suddenly after regular use. Talk to your healthcare provider about a safe plan to stop.
• Do not share Soma with anyone else. Sharing is dangerous and against the law.
• Keep Soma in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read any patient information provided with your prescription.

Risk Prevention

• Opioids and CNS depressants: Do not use these with Soma unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Soma. Alcohol adds to the sedative effect and can be dangerous.
• Driving and machinery: Soma can cause drowsiness and dizziness and can slow your thinking and reaction time. Do not drive or operate heavy machinery until you know how it affects you.
• First-dose reactions: Rare but serious reactions can occur soon after the first dose. Get medical help right away if you feel extreme weakness, sudden vision loss, confusion, or trouble moving.
• Mental health: Tell your provider about any new or worsening mood or behavior changes.
• Pregnancy: Tell your provider if you are pregnant or plan to become pregnant, so treatment can be managed safely.
• Breastfeeding: Carisoprodol can pass into breast milk and may cause drowsiness or feeding problems in a nursing baby. Talk to your provider before breastfeeding while taking Soma.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have a seizure
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Develop a severe skin reaction, such as blistering or peeling skin with fever
• Have slow, shallow, or difficult breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Feel extreme weakness, sudden vision loss, confusion, or trouble moving shortly after a dose
• Feel faint, very dizzy, or lightheaded
• Experience withdrawal symptoms, such as trouble sleeping, stomach cramps, headache, nausea, anxiety, or tremor, after reducing or stopping the medication
• Have any symptom that concerns you or does not go away