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carisoprodol, aspirin, and codeine (Oral route)

kar-eye-soe-PROE-dol, AS-pir-in, KOE-deen FOS-fate

Oral route(Tablet)

Death Related to Ultrarapid Metabolism of Codeine to Morphine: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultrarapid metabolizers of codeine due to CYP2D6 polymorphism .

Available Dosage Forms:

  • Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting/Analgesic Combination

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Aspirin

Uses For carisoprodol, aspirin, and codeine

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, carisoprodol, aspirin, and codeine 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.

carisoprodol, aspirin, and codeine is available only with your doctor's prescription.

Before Using carisoprodol, aspirin, and codeine

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, aspirin, and codeine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to carisoprodol, aspirin, and codeine 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, aspirin, and codeine combination in children younger than 16 years of age. Safety and efficacy have not been established.

Soma® compound with codeine should not be used to relieve pain after surgery to remove tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of carisoprodol, aspirin, and codeine combination in geriatric patients. Safety and efficacy have not been established.

Pregnancy

Pregnancy Category Explanation
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.

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

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 carisoprodol, aspirin, and codeine, 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 carisoprodol, aspirin, and codeine 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
  • Ketorolac
  • Naltrexone

Using carisoprodol, aspirin, and codeine 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.

  • Abciximab
  • Acenocoumarol
  • Adinazolam
  • Alfentanil
  • Alipogene Tiparvovec
  • Alprazolam
  • Alteplase, Recombinant
  • Amobarbital
  • Anagrelide
  • Anileridine
  • Anisindione
  • Apixaban
  • Aprobarbital
  • Ardeparin
  • Argatroban
  • Beta Glucan
  • Bivalirudin
  • Bromazepam
  • Brotizolam
  • Buprenorphine
  • Bupropion
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Certoparin
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorzoxazone
  • Cilostazol
  • Citalopram
  • Clobazam
  • Clonazepam
  • Clopidogrel
  • Clopidogrel Hydrogen Sulfate
  • Clorazepate
  • Clovoxamine
  • Codeine
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Dantrolene
  • Desirudin
  • Desvenlafaxine
  • Dezocine
  • Diazepam
  • Dicumarol
  • Dipyridamole
  • Duloxetine
  • Enoxaparin
  • Eptifibatide
  • Erlotinib
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estazolam
  • Ethchlorvynol
  • Femoxetine
  • Fentanyl
  • Feverfew
  • Flesinoxan
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Fluvoxamine
  • Fondaparinux
  • Ginkgo
  • Gossypol
  • Halazepam
  • Heparin
  • Hydrocodone
  • Hydromorphone
  • Ketazolam
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Meadowsweet
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Methotrexate
  • Midazolam
  • Milnacipran
  • Morphine
  • Morphine Sulfate Liposome
  • Nadroparin
  • Nalbuphine
  • Naproxen
  • Nefazodone
  • Nitrazepam
  • Nordazepam
  • Opium
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentazocine
  • Pentobarbital
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenobarbital
  • Phenprocoumon
  • Pralatrexate
  • Prasugrel
  • Prazepam
  • Primidone
  • Propoxyphene
  • Protein C
  • Quazepam
  • Remifentanil
  • Reteplase, Recombinant
  • Reviparin
  • Rivaroxaban
  • Secobarbital
  • Sertraline
  • Sibutramine
  • Sodium Oxybate
  • Sufentanil
  • Tacrolimus
  • Tapentadol
  • Temazepam
  • Thiopental
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Treprostinil
  • Triazolam
  • Varicella Virus Vaccine
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Warfarin
  • Zimeldine

Using carisoprodol, aspirin, and codeine 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.

  • Acebutolol
  • Acetohexamide
  • Alacepril
  • Alprenolol
  • Amiloride
  • Amlodipine
  • Anagrelide
  • Arotinolol
  • Atenolol
  • Azilsartan Medoxomil
  • Azosemide
  • Befunolol
  • Bemetizide
  • Benazepril
  • Bendroflumethiazide
  • Benzthiazide
  • Bepridil
  • Betamethasone
  • Betaxolol
  • Bevantolol
  • Bisoprolol
  • Bopindolol
  • Bucindolol
  • Bumetanide
  • Bupranolol
  • Buthiazide
  • Candesartan Cilexetil
  • Canrenoate
  • Captopril
  • Carteolol
  • Carvedilol
  • Celecoxib
  • Celiprolol
  • Chlorothiazide
  • Chlorpropamide
  • Chlorthalidone
  • Cilazapril
  • Clopamide
  • Cortisone
  • Cyclopenthiazide
  • Deflazacort
  • Delapril
  • Dexamethasone
  • Dilevalol
  • Diltiazem
  • Enalaprilat
  • Enalapril Maleate
  • Eprosartan
  • Esmolol
  • Ethacrynic Acid
  • Felodipine
  • Flunarizine
  • Fosinopril
  • Furosemide
  • Gallopamil
  • Gliclazide
  • Glimepiride
  • Glipizide
  • Gliquidone
  • Glyburide
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Ibuprofen
  • Imidapril
  • Indapamide
  • Irbesartan
  • Isradipine
  • Labetalol
  • Lacidipine
  • Landiolol
  • Levobetaxolol
  • Levobunolol
  • Lidoflazine
  • Lisinopril
  • Losartan
  • Manidipine
  • Mepindolol
  • Methyclothiazide
  • Methylprednisolone
  • Metipranolol
  • Metolazone
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Nicardipine
  • Nifedipine
  • Nilvadipine
  • Nimodipine
  • Nipradilol
  • Nisoldipine
  • Nitrendipine
  • Nitroglycerin
  • Olmesartan Medoxomil
  • Oxprenolol
  • Paramethasone
  • Penbutolol
  • Pentopril
  • Perampanel
  • Perindopril
  • Pindolol
  • Piretanide
  • Polythiazide
  • Pranidipine
  • Prednisolone
  • Prednisone
  • Probenecid
  • Propranolol
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Sotalol
  • Spirapril
  • Spironolactone
  • Streptokinase
  • Talinolol
  • Tamarind
  • Tasosartan
  • Telmisartan
  • Temocapril
  • Tenecteplase
  • Tertatolol
  • Timolol
  • Tolazamide
  • Tolbutamide
  • Torsemide
  • Trandolapril
  • Triamcinolone
  • Triamterene
  • Trichlormethiazide
  • Valproic Acid
  • Valsartan
  • Verapamil
  • Xipamide
  • Zofenopril

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using carisoprodol, aspirin, and codeine 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 carisoprodol, aspirin, and codeine, 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 carisoprodol, aspirin, and codeine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Aspirin-induced asthma, history of or
  • Bleeding disorders, history of or
  • Porphyria (an enzyme problem), history of or
  • Stomach or bowel problems (eg, blockage, perforation), history of or
  • Surgery, for pain after surgery in children (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
  • Brain tumors or
  • Head injury, history of or
  • Lung disease or breathing problems (eg, chronic obstructive pulmonary disease [COPD], respiratory depression, sleep apnea)—Use with caution. May increase risk for respiratory depression.
  • Drug abuse or dependence, or history of—Use with caution. Dependence on carisoprodol and codeine may develop.
  • 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.

Proper Use of carisoprodol, aspirin, and codeine

Take carisoprodol, aspirin, and codeine 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, it may become habit-forming (causing mental or physical dependence).

Dosing

The dose of carisoprodol, aspirin, and codeine 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, aspirin, and codeine. 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 oral dosage form (tablets):
    • For relaxing muscles:
      • Adults and teenagers 16 years of age and older—1 or 2 tablets four times a day. One tablet contains 200 milligrams (mg) or carisoprodol, 325 mg of aspirin, and 16 mg of codeine.
      • Children 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, aspirin, and codeine, 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, aspirin, and codeine

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

If your condition does not improve or become worse, check with your doctor. Do not use carisoprodol, aspirin, and codeine for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor has told you to.

Using carisoprodol, aspirin, and codeine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

carisoprodol, aspirin, and codeine 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.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

carisoprodol, aspirin, and codeine 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 carisoprodol, aspirin, and codeine.

Do not stop using carisoprodol, aspirin, and codeine suddenly without first asking 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.

carisoprodol, aspirin, and codeine 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.

carisoprodol, aspirin, and codeine 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).

carisoprodol, aspirin, and codeine may also cause a serious type of 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. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

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.

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking carisoprodol, aspirin, and codeine:

Talk to your doctor if you have any questions about taking codeine or about how carisoprodol, aspirin, and codeine 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 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.

carisoprodol, aspirin, and codeine 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:

More common
  • Burning feeling in the chest or stomach
  • indigestion
  • stomach upset
  • tenderness in the stomach area
Less common
  • Cough
  • difficult or troubled breathing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy breathing
  • shakiness and unsteady walk
  • tightness in the chest
  • unsteadiness, trembling, or other problems with muscle control or coordination
Incidence not known
  • Chills
  • cold sweats
  • confusion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • flushing or redness of the skin
  • hearing loss
  • hives
  • itching
  • painful or difficult urination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusually warm skin

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

Symptoms of overdose
  • Agitation or combativeness
  • anxiety
  • black, tarry stools
  • bloody stools
  • blue lips and fingernails
  • change in consciousness
  • cold, clammy skin
  • confusion
  • confusion as to time, place, or person
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • decreased urination
  • depression
  • diarrhea
  • difficult, fast, or noisy breathing, sometimes with wheezing
  • difficulty with sleeping
  • disorientation
  • drowsiness to profound coma
  • dry mouth
  • expressed fear of impending death
  • extremely high fever or body temperature
  • fainting
  • fast or deep breathing
  • fast, weak pulse
  • hallucinations
  • headache
  • holding false beliefs that cannot be changed by fact
  • irregular, fast or slow, or shallow breathing
  • lethargy
  • loss of consciousness
  • loss of strength or energy
  • mood or other mental changes
  • muscle cramps
  • muscle pain or weakness
  • nausea
  • pale or blue lips, fingernails, or skin
  • pale, clammy skin
  • pinpoint pupils
  • severe sleepiness
  • sunken eyes
  • sweating
  • swelling in the legs and ankles
  • thirst
  • unusual excitement, nervousness, or restlessness
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • wrinkled skin

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
Less common
  • Feeling of constant movement of self or surroundings
  • sensation of spinning
Rare
  • Hyperventilation
  • irritability
  • shaking
  • trouble sleeping
Incidence not known
  • Constipation
  • constricted, pinpoint, or small pupils (black part of the eye)
  • relaxed and calm

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.

See also: Side effects (in more detail)

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