Pregnancy of Roter Keel in details
Roter Keel oral rinse has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of teratogenicity when given at high doses. There are no controlled data in human pregnancy. Roter Keel oral rinse should only be used during pregnancy when need has been clearly established. Roter Keel chips have been assigned to pregnancy category C by the FDA. Animal studies have not been conducted with this dosage form; however, high dosages administered by gavage were not associated with fetotoxicity. There are no controlled data in human pregnancy. Roter Keel absorption is possible following periodontal insertion; in clinical trials systemic Roter Keel levels were below the limit of detection. Roter Keel chips should only be used during pregnancy when need has been clearly established.
Roter Keel breastfeeding
One infant experienced episodes of bradycardia and cyanotic spells which may have been due to the application of Roter Keel directly onto the mother's breast during breast-feeding. Roter Keel was detected in the blood of the infant.
There are no data on the excretion of Roter Keel into human milk when given as an oral rinse. Some studies have reported that any Roter Keel ingested is poorly absorbed; therefore, excretion into breast milk is unlikely. The manufacturer recommends that caution be used when administering Roter Keel to nursing women.
References
- DailyMed. "CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL: 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. "Hibiclens: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Chlorhexidine: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
