Aspirin, carisoprodol, and codeine

Name: Aspirin, carisoprodol, and codeine

What should I discuss with my healthcare provider before taking aspirin, carisoprodol, and codeine?

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking this medicine.

You should not use this medicine if you are allergic to aspirin, carisoprodol, or codeine, or if you have:

  • a bleeding or blood clotting disorder;

  • porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or

  • a history of asthma or severe allergic reaction (aspirin triad syndrome) caused by taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

This medicine should not be given to a child younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids. Do not give this medicine to a child or teenager who has a fever.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • a sulfite allergy;

  • liver or kidney disease;

  • a breathing disorder;

  • a stomach ulcer or intestinal blockage; or

  • drug or alcohol addiction.

If you use codeine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby. Aspirin use while breast-feeding could cause bleeding in the infant.

For the Consumer

Applies to aspirin / carisoprodol / codeine: oral tablet

Along with its needed effects, aspirin / carisoprodol / codeine 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 while taking aspirin / carisoprodol / codeine:

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 while taking aspirin / carisoprodol / codeine:

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 of aspirin / carisoprodol / codeine 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

Usual Adult Dose for Muscle Spasm

1 to 2 tablets 4 times a day
Maximum daily dose: carisoprodol: 1600 mg; aspirin: 2600 mg; codeine: 128 mg
Duration of therapy: Up to 2 or 3 weeks

Comments:
-Use should be limited to short periods (up to 3 weeks) since acute, painful musculoskeletal conditions are generally of short duration and evidence of effectiveness beyond this time period has not been established.

Use: For the relief of discomfort associated with acute, painful musculoskeletal conditions.

Other Comments

Administration advice:
-Duration of therapy should be limited to short-term treatment

General:
-Dependence, withdrawal, and abuse have been reported; the risk of abuse should be assessed prior to prescribing.
-Treatment duration should not exceed up to 2 to 3 weeks; if musculoskeletal symptoms persist, patients should be re-evaluated.

Monitoring:
-Monitor for sedation
-Monitor for signs of abuse and overdose

Patient advice:
-Patients should understand that this product contains aspirin and that aspirin may cause a wide range of gastrointestinal adverse reactions including potentially fatal events; patients should be informed of signs or symptoms to watch for and which require prompt medical attention.
-Patients should be advised that this drug may cause drowsiness and dizziness and that there have been reports of motor vehicle accidents following use; patients should be advised to avoid hazardous activities such as driving while taking this drug.
-Patients should be advised to avoid concomitant use with alcohol and to check with their health care professional before taking other CNS depressants.
-Patients should understand that this drug has been associated with cases of dependence, withdrawal, and abuse; use should be limited to less than 3 weeks duration.
-Patients should understand the risks of life-threatening respiratory depression and when this risk is greatest; patients should be aware that a genetic mutation may result in greater toxicity in some patients.
-For women who are breastfeeding and have this genetic mutation, their infant will be at risk for morphine toxicity; nursing mothers should be instructed to seek immediate medical attention for infants experiencing increased sleepiness, difficulty breastfeeding, breathing difficulties, or limpness.
-Women of child bearing potential should understand that prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome and that prompt recognition and treatment will be necessary.

Aspirin / carisoprodol / codeine Pregnancy Warnings

There are no animal reproduction studies with this combination product. Animal studies with carisoprodol have shown effects on fetal growth and postnatal survival. Salicylic products have shown to be teratogenic and embryocidal in rodents at doses considered much greater than usual therapeutic human doses. Aspirin use within 1 week of delivery or during labor may prolong delivery or lead to excessive blood loss in the mother or baby. The use of codeine during labor and delivery may lead to respiratory depression in the neonate. There are no controlled data in human pregnancy. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless clearly needed. US FDA pregnancy category D Comments: -Aspirin should be avoided after 30 weeks gestation as it may lead to premature closure of the fetal ductus arteriosus. - Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

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