Description

    Carisoprodol and aspirin 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 an antiinflammatory agent that is often used for pain and fever.

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

    This product is available in the following dosage forms:

    • Tablet

    Before Using

    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.

    Pediatric

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

    Geriatric

    Appropriate studies have not been performed on the relationship of age to the effects of Soma® Compound in geriatric patients. Safety and efficacy have not been established.

    No information is available on the relationship of age to the effects of carisoprodol and aspirin combination in geriatric patients. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution in patients receiving carisoprodol and aspirin combination.

    Breastfeeding

    Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

    Drug Interactions

    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.

    • Abrocitinib
    • Defibrotide
    • Dichlorphenamide
    • Influenza Virus Vaccine, Live
    • Ketorolac
    • 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.

    • Acarbose
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Acetazolamide
    • Alclometasone
    • Aldosterone
    • Alfentanil
    • Alipogene Tiparvovec
    • Alprazolam
    • Alteplase, Recombinant
    • Amantadine
    • Amcinonide
    • Amikacin
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amobarbital
    • Amoxapine
    • Amphotericin B
    • Amtolmetin Guacil
    • Anagrelide
    • Anisindione
    • Apixaban
    • Aprobarbital
    • Ardeparin
    • Argatroban
    • Bacitracin
    • Beclomethasone
    • Bemetizide
    • Bemiparin
    • Benazepril
    • Bendroflumethiazide
    • Benzhydrocodone
    • Benzthiazide
    • Betamethasone
    • Betrixaban
    • Bivalirudin
    • Brinzolamide

    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.

    • Acebutolol
    • Atenolol
    • Betaxolol
    • Bisoprolol
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Delapril
    • Esmolol
    • Imidapril
    • Labetalol
    • Levobunolol
    • Metipranolol
    • Metoprolol
    • Nadolol
    • Nebivolol
    • Nitroglycerin
    • Oxprenolol
    • Penbutolol
    • Pindolol
    • Probenecid
    • Propranolol
    • Sotalol
    • Streptokinase
    • Tamarind
    • Temocapril
    • Tenecteplase
    • Timolol

    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

    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.

    • 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:

    • Aspirin-induced asthma, history of or
    • Bleeding disorders, history of or
    • Porphyria (an enzyme problem), history of or
    • Stomach or bowel problems (e.g., blockage, perforation), history of—Should not be used in patients with these conditions.
    • Drug abuse or dependence, or history of—Use with caution. Dependence on carisoprodol may develop.
    • Gastritis (inflammation of the stomach) or
    • Seizures, history of or
    • Stomach ulcers, 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

    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 regularly and in large amounts, it may become habit-forming (causing mental or physical dependence).

    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 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 and 325 mg of aspirin.
        • Children up to 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

    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.

    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 nonsteroidal anti-inflammatory medicine [NSAIDs]).

    This medicine 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.

    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.

    If your condition does not improve or become 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 has told you to.

    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

    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
    • shortness of breath
    • 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
    • wheezing

    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
    • coughing that sometimes produces a pink frothy sputum
    • decreased awareness or responsiveness
    • decreased urination
    • depression
    • diarrhea
    • difficult, fast, or noisy breathing, sometimes with wheezing
    • 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
    • muscle cramps
    • muscle pain or weakness
    • nausea
    • pale or blue lips, fingernails, or skin
    • pale, clammy skin
    • 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
    • sleeplessness
    • trouble sleeping
    • unable to sleep

    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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