Pregnancy of Normovent in details
Chlorpheniramine (Normovent)-Codeine (Normovent) has been assigned to pregnancy category C by the manufacturer. Codeine (Normovent) has been assigned to pregnancy category C by the FDA. Codeine (Normovent) has shown a statistically significant association with teratogenicity (involving respiratory tract malformations). Like other narcotics, Codeine (Normovent) rapidly crosses the placenta. Neonatal Codeine (Normovent) withdrawal has occurred even in infants whose mothers were taking Codeine (Normovent) at cough suppressant doses for as little as ten days prior to delivery. There are no controlled data in human pregnancy. Chlorpheniramine (Normovent)-Codeine (Normovent) is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.
Normovent breastfeeding
Chlorpheniramine (Normovent) is excreted into human milk. The clinical significance is unknown, however, the anticholinergic action of Chlorpheniramine (Normovent) may suppress lactation if taken prior to nursing. Codeine (Normovent) 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 (Normovent) and are ultra-rapid metabolizers of Codeine (Normovent). Several small series and one small retrospective study suggest that Codeine (Normovent) may be causative in episodes of apnea, bradycardia, and cyanosis in the first week of life. Codeine (Normovent) is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that caution be used when administering Chlorpheniramine (Normovent)-Codeine (Normovent) is nursing women.
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 (Normovent) and are ultra-rapid metabolizers of Codeine (Normovent). When Codeine (Normovent) enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect Codeine (Normovent) metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change Codeine (Normovent) to morphine more rapidly and completely than other people. Nursing mothers taking Codeine (Normovent) 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 (Normovent). When prescribing Codeine (Normovent)-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 (Normovent) 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.
References
- DailyMed. "CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "CODEINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Codeine (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
