Pregnancy of Rinostat Plus in details
In a review of deliveries to Michigan Medicaid patients during 1980 to 1983, 1489 exposures to Rinostat Plus any time during pregnancy were recorded. A total of 128 birth defects were reported (91 expected). An association was seen between Rinostat Plus and laryngotracheal anomalies, pyloric stenosis, intestinal fixation anomalies, upper limb defects, skull/face anomalies, and musculoskeletal defects. The statistical significance of these associations is not known. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The Collaborative Perinatal Project monitored 50,282 mother-child pairs and recorded 726 first-trimester exposures and 2489 exposures to Rinostat Plus anytime during pregnancy. Possible associations between Rinostat Plus and first trimester use and Rinostat Plus include hypospadias (4), eye and ear abnormalities (7, statistically significant), polydactyly (6), cataract (3), and pectus excavatum (7). For use anytime during pregnancy a possible association was noted between Rinostat Plus use and congenital dislocation of hip (12).
Rinostat Plus has been assigned to pregnancy category C. There are no controlled data in human pregnancy. Rinostat Plus should only be used during pregnancy when benefit outweighs the risk to the fetus.
See references
Rinostat Plus breastfeeding
There are no data on the excretion of Rinostat Plus into human milk.
See references
References for pregnancy information
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
References for breastfeeding information
- "Product Information. Dexatrim (Rinostat Plus)." Thompson Medical Company Inc, West Palm Beach, FL.
- "Product Information. Propagest (Rinostat Plus)." Carnrick Laboratories Inc, Cedar Knolls, NJ.
- "Product Information. Rhindecon (Rinostat Plus)." McGregor Pharmaceuticals Inc, Largo, FL.
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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. "CAFFEINE; ERGOTAMINE TARTRATE: 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. "Chlorpheniramine (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
