Pregnancy of Prexanil in details
AU: Use is contraindicated. UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters. US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: Adequate methods of contraception should be encouraged.
Animal studies have revealed evidence of fetotoxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
See references
Prexanil breastfeeding
AU and UK: Use is not recommended. US: Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.
See references
References for pregnancy information
- "Product Information. Aceon (Prexanil)." Solvay Pharmaceuticals Inc, Marietta, GA.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
References for breastfeeding information
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Aceon (Prexanil)." Solvay Pharmaceuticals Inc, Marietta, GA.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References
- PubMed Health. "Perindopril (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).
- Human Metabolome Database (HMDB). "Perindopril: 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