carisoprodol (Oral route)

kar-eye-soe-PROE-dol

Commonly used brand name(s):

In the U.S.

• Soma
• Vanadom

Available Dosage Forms:

• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Uses For carisoprodol

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, carisoprodol 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.

carisoprodol is available only with your doctor's prescription.

Before Using carisoprodol

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 carisoprodol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to carisoprodol 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.

Pediatric

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.

Geriatric

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.

Pregnancy

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.

Interactions with Medicines

Using carisoprodol 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.

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Bromazepam
• Brotizolam
• Butabarbital
• Butalbital
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Diazepam
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Flurazepam
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nitrazepam
• Nordazepam
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentobarbital
• Phenobarbital
• Prazepam
• Primidone
• Propoxyphene
• Quazepam
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Temazepam
• Thiopental
• Triazolam

Interactions with Food/Tobacco/Alcohol

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of carisoprodol. 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 carisoprodol

Take carisoprodol 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 carisoprodol is taken for a long time, it may become habit-forming (causing mental or physical dependence). carisoprodol should only be used for 2 to 3 weeks.

Dosing

The dose of carisoprodol 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 carisoprodol. 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 carisoprodol, 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 carisoprodol

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

carisoprodol 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.

carisoprodol 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 carisoprodol.

Do not stop using carisoprodol 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.

carisoprodol Side Effects

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:

• 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:

• 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:

• Drowsiness

• 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.

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