Therapeutic ClassificationsSkeletal Muscle Relaxant, Centrally Acting/Analgesic Combination
Addiction, Abuse, and Misuse:Carisoprodol, aspirin, and codeine phosphate tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing carisoprodol, aspirin, and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors or conditions.Life-Threatening Respiratory Depression:Serious, life-threatening, or fatal respiratory depression may occur with use of carisoprodol, aspirin, and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of carisoprodol, aspirin, and codeine phosphate tablets or following a dose increase.Accidental Ingestion:Accidental ingestion of even one dose of carisoprodol, aspirin, and codeine phosphate tablets, especially by children, can result in a fatal overdose of codeine.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children:Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. carisoprodol, aspirin, and codeine phosphate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of carisoprodol, aspirin, and codeine phosphate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeineNeonatal Opioid Withdrawal Syndrome:Prolonged use of carisoprodol, aspirin, and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interactions with Drugs Affecting Cytochrome P450 Isoenzymes:The effects of concomitant use or discontinuation of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of CYP3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with carisoprodol, aspirin, and codeine phosphate tablets requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants:Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of carisoprodol, aspirin, and codeine phosphate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .FDA is advising that the opioid addiction medications buprenorphine or methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by health care professionals can reduce these risks
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Carisoprodol, aspirin, and codeine combination 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. Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that is used for pain and fever. Codeine is a narcotic analgesic (pain medicine) that acts on the CNS to relieve pain.
This medicine is available only with your doctor's prescription.
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 carisoprodol and codeine are taken regularly and in large amounts, they may become habit-forming (causing mental or physical dependence).
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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):
- Carisoprodol, aspirin, codeine:
- Adults—1 or 2 tablets four times a day for 2 to 3 weeks. One tablet contains 200 milligrams (mg) carisoprodol, 325 mg aspirin, and 16 mg codeine.
- Children 12 years of age and older—Use and dose must be determined by your child's doctor.
- Children younger than 12 years of age—Should not be used in these patients.
- Soma® with codeine:
- Carisoprodol, aspirin, codeine:
- For oral dosage form (tablets):
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.
Use & StorageTOP
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.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of Soma® tablets or Soma® with codeine tablets in children younger than 16 years of age. Safety and efficacy have not been established.
Carisoprodol, aspirin, and codeine combination tablets should not be used to relieve pain after surgery to remove tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of carisoprodol, aspirin, and codeine tablets in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Appropriate studies have not been performed on the relationship of age to the effects of Soma® tablets or Soma® with codeine tablets in geriatric patients. Safety and efficacy have not been established.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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.
- Influenza Virus Vaccine, Live
- Methylene Blue
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.
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amtolmetin Guacil
- Chloral Hydrate
- Choline Salicylate
- Dabigatran Etexilate
- Eslicarbazepine Acetate
- Ethacrynic Acid
- Flufenamic Acid
- Mefenamic Acid
- Morphine Sulfate Liposome
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Nitrous Oxide
- Opium Alkaloids
- Pentosan Polysulfate Sodium
- Protein C
- Reteplase, Recombinant
- Salicylic Acid
- Secretin Human
- Sodium Oxybate
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
- Tolonium Chloride
- Varicella Virus Vaccine, Live
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Enalapril Maleate
- Valproic Acid
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 may cause an increased risk of certain side effects 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.
Other Medical ProblemsTOP
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:
- Alcohol abuse, history of or
- Brain tumors or
- Depression, history of or
- Drug abuse or dependence, or history of or
- Head injury, history of or
- Increased pressure in the head or
- Lung disease or breathing problems (eg, chronic obstructive pulmonary disease [COPD], respiratory depression, sleep apnea) or
- Mental illness, history of or
- Obesity (overweight) or
- Problems with passing urine or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Aspirin-induced asthma, history of or
- Asthma with nasal polyps and runny nose or
- Hemophilia (bleeding problem) or
- Porphyria (an enzyme problem) or
- Respiratory depression (serious breathing problem) or
- Reye's syndrome or
- Stomach or bowel blockage (including paralytic ileus) or
- Surgery, for pain after surgery in children (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
- Gastritis (inflammation of the stomach) or
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation of the pancreas) or
- Seizures, history of or
- Stomach ulcers, acute or history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
It is very important that your doctor check your progress at regular visits, especially within the first 24 to 72 hours of treatment to make sure this medicine is working properly and to check for unwanted effects.
If your condition does not improve or becomes worse, check with your doctor. Do not use this medicine for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor told you to.
Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine can cause serious unwanted effects in your newborn baby, including neonatal withdrawal syndrome. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.
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. Also, there may be a greater risk of bleeding problems if you drink 3 or more alcoholic beverages per day while you are taking aspirin. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
Do not change your dose or suddenly stop using this medicine without first checking with your doctor. You may need to gradually reduce your dose before stopping it completely. This will decrease your chance of having withdrawal symptoms such as abdominal or stomach cramps, hallucinations, headache, muscle twitching, tremors, trouble sleeping, or vomiting.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as a blood thinner or NSAIDs).
This medicine may also cause a serious allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:
- Children younger than 12 years of age.
- Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
- Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).
For nursing mothers taking this medicine:
Talk to your doctor if you have any questions about using codeine or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
Using narcotics (eg, codeine) for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
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 (eg, St John's wort) or vitamin supplements.