Pregnancy is always a special situation where every action or side effect of the drug varies when compared to a situation of a non-pregnant patient. It is not only because the pregnant woman's metabolism differs due to the hormonal and other changes happened to her, but also because every medicine or its metabolite passes to the baby and shows its action there. The only thing is, be cautious, attentive and well supervised when you take any single drug in pregnancy. The interactions can vary in pregnancy, and the dosage may differ as well. Strict supervision of the Physician is mandatory.
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This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus AU TGA pregnancy category: B3 US FDA pregnancy category: C
Animal studies have revealed evidence of embryotoxicity, foetotoxicity, and teratogenicity with high oral doses (25,000 to 57,000 times the recommended human ocular dose). Systemic absorption is low after ocular administration (plasma concentration range: 0.02 to 0.25 ng/mL). There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. 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.
Optilast breastfeeding
When a drug is taken when the patient is breast feeding, a part of the drug is secreted in her breast milk and is passed to the baby. The dosage of the medicine to mother and baby are different, and many drugs actions are side effects when you take them without a disease, and what if you the baby takes them without a disease? What if the drug is contraindicated in newborns, infants or children? So, breastfeeding is a very alarming situation when the mother is on medications. Ask your Physician or Pediatrician about the effect of the drug on the baby and how much is excreted in breast milk and if it harms the baby!
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UK: Not recommended AU and US: Benefit should outweigh risk Excreted into human milk: Yes Comment: To limit systemic absorption, apply pressure to the tear duct for at least 1 minute after eye drop instillation; blot excess solution with tissue.
References
PubMed Health. "Azelastine (Astelin): 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). "Azelastine: 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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