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IMPORTANT WARNING:

Posted 08/17/2007 FDA issued a Public Health Advisory with important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

When prescribing codeine-containing drugs to nursing mothers, physicians should choose the lowest effective dose for the shortest period of time and should closely monitor mother-infant pairs. There is an FDA cleared test for determining a patient's CYP2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events.

Why is this medication prescribed?

This combination of drugs is used to relieve mild to moderately severe pain.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

The combination of aspirin and codeine comes as a tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aspirin and codeine exactly as directed.

Codeine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

  • Empirin with Codeine®

Other names

  • ASA and Codeine

Notes:
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EditText of this page (last edited February 28, 2008)

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