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Codeine Oral
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. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Codeine, http://www.fda.gov/cder/drug/advisory/codeine.htm and http://www.fda.gov/cder/drug/infopage/codeine/default.htm. Posted 01/12/2007 The Centers for Disease Control and Prevention (CDC) issued a Morbidity and Mortality Weekly Report (MMWR) article describing three deaths in U.S. infants aged less than 12 months associated with cough and cold medications. These medications were determined by medical examiners or coroners to be the underlying cause of death. The cases described in this report underscore the need for clinicians to use caution when prescribing and caregivers to use caution when administering cough and cold medications to children aged less than 2 years. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#coughcold and http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5601a1.htm. |
Why is this medication prescribed? Codeine is used, usually in combination with other medications, to reduce coughing. It also is used to relieve mild to moderate 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. Codeine comes alone or in combination with other drugs as a tablet, capsule, and liquid to take by mouth. It usually is taken every 4-6 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 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. Shake the liquid well before measuring a dose. 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 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. 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? Keep all appointments with your doctor. 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. Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Brand names - Brontex®
- Cheracol® with Codeine Syrup
- Gani-Tuss® NR
- Guiatuss AC® Syrup
| - Guiatussin® with Codeine
- HaNew Riversin® AC
- Mytussin® AC Cough Syrup
- Robafen AC® Syrup
| - Robitussin A-C® Syrup
- Tussi-Organidin® NR
- Tussi-Organidin®-S NR
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Brand names of combination products - Ambenyl® Cough Syrup containing Codeine Phosphate and Bromodiphenhydramine Hydrochloride
- Bromanyl® Cough Syrup containing Codeine Phosphate and Bromodiphenhydramine Hydrochloride
- Codimal® PH Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Pyrilamine Maleate
- Colrex® Compound containing Codeine Phosphate, Acetaminophen, Chlorpheniramine Maleate, and Phenylephrine Hydrochloride
- Cycofed® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Cycofed® Expectorant Pediatric containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Decohistine® DH containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
- Decohistine® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Dihistine® DH Elixir containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
- Dihistine® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Guaifenesin DAC® containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Guiatuss DAC® Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Guiatussin® DAC Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- HaNew Riversin® DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- KG-Fed® Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- KG-Fed® Pediatric Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- KG-Fed® Syrup containing Codeine Phosphate and Pseudoephedrine Hydrochloride
- Mytussin® DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Novahistine® DH containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
| - Novahistine® Expectorant with Codeine containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Nucofed® containing Codeine Phosphate and Pseudoephedrine Hydrochloride
- Nucofed® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Nucofed® Pediatric Expectorant Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Nucofed® Syrup containing Codeine Phosphate and Pseudoephedrine Hydrochloride
- Nucotuss® Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Nucotuss® Pediatric Expectorant containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Pediacof® Cough Syrup containing Codeine Phosphate, Chlorpheniramine Maleate, Phenylephrine Hydrochloride, and Potassium Iodide
- Phenergan® VC with Codeine Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride
- Phenergan® with Codeine Syrup containing Codeine Phosphate and Promethazine Hydrochloride
- Phenhist® DH with Codeine Modified Formula containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
- Prometh® VC with Codeine Phosphate Cough Syrup containing Codeine Phosphate, Phenylephrine Hydrochloride, and Promethazine Hydrochloride
- Robitussin®-DAC containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Ryna-C® containing Codeine Phosphate, Chlorpheniramine Maleate, and Pseudoephedrine Hydrochloride
- Ryna-CX® containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Triacin-C® Cough Syrup containing Codeine Phosphate, Pseudoephedrine Hydrochloride, and Triprolidine Hydrochloride
- Tussar® SF Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
- Tussar®-2 Syrup containing Codeine Phosphate, Guaifenesin, and Pseudoephedrine Hydrochloride
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