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Chlorcyclizine / codeine Pregnancy and Breastfeeding Warnings

Chlorcyclizine / codeine is also known as: Notuss-NX

Chlorcyclizine / codeine Pregnancy Warnings

Chlorcyclizine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Codeine has been assigned to pregnancy category C by the FDA. 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. Codeine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Chlorcyclizine / codeine Breastfeeding Warnings

There no data on the excretion of chlorcyclizine into human milk. 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 ultrarapid 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.

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 ultrarapid 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 ultrarapid 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.

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