Pregnancy of Rudduck's Antiseptic Intra-uterine Pessary in details
Rudduck's Antiseptic Intra-uterine Pessary 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. Rudduck's Antiseptic Intra-uterine Pessary oral rinse should only be used during pregnancy when need has been clearly established. Rudduck's Antiseptic Intra-uterine Pessary 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. Rudduck's Antiseptic Intra-uterine Pessary absorption is possible following periodontal insertion; in clinical trials systemic Rudduck's Antiseptic Intra-uterine Pessary levels were below the limit of detection. Rudduck's Antiseptic Intra-uterine Pessary chips should only be used during pregnancy when need has been clearly established.
Rudduck's Antiseptic Intra-uterine Pessary breastfeeding
One infant experienced episodes of bradycardia and cyanotic spells which may have been due to the application of Rudduck's Antiseptic Intra-uterine Pessary directly onto the mother's breast during breast-feeding. Rudduck's Antiseptic Intra-uterine Pessary was detected in the blood of the infant.
There are no data on the excretion of Rudduck's Antiseptic Intra-uterine Pessary into human milk when given as an oral rinse. Some studies have reported that any Rudduck's Antiseptic Intra-uterine Pessary ingested is poorly absorbed; therefore, excretion into breast milk is unlikely. The manufacturer recommends that caution be used when administering Rudduck's Antiseptic Intra-uterine Pessary 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
