Pregnancy of Mopac in details
Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity, such as increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when administered in late gestation. In mice, subcutaneous administration produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD). In rats, topical administration produced umbilical hernia at doses approximately 6 times the MRHD. Subcutaneous administration in rats, throughout pregnancy or late in gestation, had caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at doses approximately 8 times the MRHD. In rabbits, topical administration caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 3 times the MRHD. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comments: -Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. -Monitor signs of hypoadrenalism in infants born to mothers taking substantial corticosteroid doses during pregnancy.
Mopac breastfeeding
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.
See references
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Asmanex HFA (Mopac)." Merck & Company Inc, Whitehouse Station, NJ.
- "Product Information. Asmanex Twisthaler (Mopac)." Schering-Plough Corporation, Kenilworth, NJ.
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- "Product Information. Asmanex Twisthaler (Mopac)." Schering-Plough Corporation, Kenilworth, NJ.
- "Product Information. Asmanex HFA (Mopac)." Merck & Company Inc, Whitehouse Station, NJ.
References
- PubMed Health. "Mometasone (Into the nose): 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). "Mometasone: 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).
- FDA Pharm Classes. "FDA Pharmacological Classification: FDA published a final rule that amended the requirements for the content and format of approved labeling (prescribing information) for human prescription drug and biological products in January 2006.". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
