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Acetaminophen / codeine Pregnancy and Breastfeeding Warnings

Acetaminophen / codeine is also known as: Aceta w/ Codeine, Capital w/Codeine, Capital with Codeine Suspension, Cocet, Cocet Plus, Codrix, EZ III, Phenaphen with Codeine, Tylenol with Codeine, Tylenol with Codeine #2, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

Acetaminophen / codeine Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% lower in pregnant women compared to non-pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study has also suggested that acetaminophen does not affect thromboxane production.

Acetaminophen-codeine has been assigned to pregnancy category C by the FDA. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Codeine is the only narcotic analgesic which has shown a statistically significant association with teratogenicity (involving respiratory tract malformations) at the time of this writing. Like other narcotics, codeine rapidly crosses the placenta. Neonatal codeine withdrawal has occurred even in infants whose mothers were taking codeine at cough suppressant doses for as little as ten days prior to delivery. There are no controlled data in human pregnancy. Acetaminophen-codeine should only be given during pregnancy when benefit outweighs risk.

Acetaminophen / codeine Breastfeeding Warnings

One small study has reported that following a 1,000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose. The FDA issued a Public Health Advisory regarding a very rare, but serious, side effect. This may occur 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 not known if someone is an ultra-rapid metabolizer of codeine. When prescribing codeine-containing drugs to nursing mothers, it is recommended that the lowest effective dose be used for the shortest period of time. It is also recommended that the mother-infant pairs be closely monitored. There is an FDA cleared test for determining a patient's CYP450 2D6 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.

Acetaminophen is excreted into human milk in small concentrations. One case report of an adverse effect (involving a rash) has been reported in nursing infants. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Codeine is excreted into human milk in small amounts. The FDA issued a Public Health Advisory about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. Codeine is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics.

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