Acetaminophen, butalbital, caffeine, and codeine

Name: Acetaminophen, butalbital, caffeine, and codeine

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to acetaminophen, butalbital, caffeine, or codeine, or if you have:

  • severe breathing problems;

  • a stomach or bowel obstruction;

  • porphyria; or

  • if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

This medicine should not be given to a child younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

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

  • liver or kidney disease;

  • asthma or other breathing disorders;

  • a history of head injury, brain tumor, or seizures;

  • urination problems;

  • problems with your gallbladder, thyroid, or adrenal gland;

  • mental illness, or a history of drug or alcohol addiction; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use butalbital or codeine while you are pregnant, your baby could become dependent on these drugs. 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.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medicine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;

  • a slow heart rate or weak pulse;

  • a light-headed feeling, like you might pass out;

  • chest pain, fast or pounding heart rate, feeling short of breath;

  • confusion, hallucinations, unusual thoughts or behavior, feelings of extreme happiness or sadness;

  • little or no urination;

  • muscle twitching, seizure (convulsions);

  • infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex;

  • liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects include:

  • drowsiness, dizziness, feeling "drunk";

  • nausea, vomiting, stomach pain, constipation; or

  • headache, feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Liver Dose Adjustments

Use with caution

Acetaminophen / butalbital / caffeine / codeine Breastfeeding Warnings

Codeine is present in breast milk. For women with normal codeine metabolism (normal CYP450 2D6 activity) the amount of codeine secreted is low and dose-dependent; however, in women who are ultra-rapid metabolizers (those with multiple copies of the gene for CYP450 2D6) higher-than-expected serum levels of morphine (active metabolite) may be present in their breast milk leading to dangerously high serum morphine levels in their breastfed infants. In most cases, a person's specific CYP2D6 genotype is unknown. Several small series and 1 small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. A death of a breastfeed infant due to respiratory depression has been reported; the mother was found to be a CYP450 2D6 ultrarapid metabolizer. The significance of small amounts of acetaminophen, butalbital, and caffeine excreted into human milk has not been reported, but due to the potential for serious adverse reactions in nursing infants, other agents may be preferred.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (acetaminophen); Yes (barbiturates); Yes (caffeine); Yes (codeine) Comments: -The American Academy of Pediatrics recommends against use of codeine during breastfeeding as other agents are preferred. -Monitor breastfed infants for signs of morphine toxicity including increase sleepiness, difficulty breastfeeding, breathing difficulties, or limpness; seek medical attention promptly if these signs occur.

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