Pronunciation:

kar-eye-soe-PROE-dol

Brand Names:

• Soma
• Vanadom

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Skeletal Muscle Relaxant, Centrally Acting

Uses of This Medicine:

Carisoprodol is used to relax certain muscles in your body and relieve the discomfort caused by acute (short-term), painful muscle or bone conditions. However, this medicine does not take the place of rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical condition.

Carisoprodol is a skeletal muscle relaxant. It acts on the central nervous system (CNS) to relax muscles.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of carisoprodol in children below 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of carisoprodol have not been performed in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Alprazolam
• Amantadine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Aprobarbital
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Dantrolene
• Daridorexant
• Desipramine
• Dexmedetomidine
• Diazepam
• Dibenzepin
• Dihydrocodeine
• Doxepin
• Doxylamine
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Flunitrazepam
• Flurazepam
• Gabapentin
• Gabapentin Enacarbil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Halazepam
• Hydrocodone
• Hydromorphone
• Imipramine
• Ketamine
• Ketazolam
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofepramine
• Lofexidine
• Lorazepam
• Lormetazepam
• Loxapine
• Magnesium Oxybate
• Medazepam
• Melitracen
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methacholine
• Methadone
• Methocarbamol
• Methohexital
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Nortriptyline
• Olanzapine
• Opipramol
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Protriptyline
• Quazepam
• Quetiapine
• Remifentanil
• Remimazolam
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Secretin Human
• Sodium Oxybate
• Sparsentan
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Tianeptine
• Tiotropium
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trimipramine
• Zolpidem
• Zuranolone

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Drug abuse or dependence, or history of—Use with caution. Dependence on carisoprodol may develop.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Porphyria (an enzyme problem), history of—Should not be used in patients with this condition.

• Seizures—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence). This medicine should only be used for 2 to 3 weeks.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For relaxing muscles:
  • For oral dosage form (tablets):
    • Adults and teenagers 16 years of age and older—250 to 350 milligrams (mg) three times a day and at bedtime.
    • Children and teenagers younger than 16 years of age—Use and dose must be determined by your child's doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Avoid driving, using machines, or do anything else that could be dangerous if you are not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Do not stop using this medicine suddenly without first asking your doctor. You may need to slowly decrease your dose before stopping it completely.

If your condition does not improve within two to three weeks, or if it becomes worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Black, tarry stools

chest pain

chills

cold sweats

confusion

convulsions

cough

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, pounding, or irregular heartbeat or pulse

fever

loss of bladder control

muscle spasm or jerking of all extremities

painful or difficult urination

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden loss of consciousness

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bigger, dilated, or enlarged pupils (black part of the eye)

blurred vision

change in consciousness

confusion as to time, place, or person

difficult or troubled breathing

false or unusual sense of well-being

hallucinations

headache

holding false beliefs that cannot be changed by fact

inability to move the eyes

increased blinking or spasms of the eyelid

increased sensitivity of the eyes to light

irregular, fast or slow, or shallow breathing

loss of consciousness

muscle stiffness or tightness

pale or blue lips, fingernails, or skin

sticking out of the tongue

trouble with breathing, speaking, or swallowing

uncontrolled eye movements

uncontrolled twisting movements of the neck, trunk, arms, or legs

unusual excitement, nervousness, or restlessness

unusual facial expressions

weakness of the arms and legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

Incidence not known

Anxiety

deep or fast breathing with dizziness

dry mouth

face is warm or hot to touch

fainting feeling of constant movement of self or surroundings

heartburn

irritability

nausea

nervousness

numbness of the feet, hands, and around the mouth

pain or discomfort in the chest, upper stomach, or throat

redness to face

restlessness

sensation of spinning

shakiness and unsteady walk

sleeplessness

trouble sleeping

unable to sleep

unsteadiness, trembling, or other problems with muscle control or coordination

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.