Otiprio Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.
-According to some authorities: Use is considered acceptable.
AU TGA pregnancy category: B3
US FDA pregnancy category:
-Otic solution: C
-Otic suspension: Not assigned.
Risk summary: Minimal risk for maternal and fetal toxicity expected when used during pregnancy.
Animal studies have not been reported. There are no controlled data in human pregnancy.
After systemic exposure to ciprofloxacin, animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. Since systemic exposure to ciprofloxacin is negligible after otic administration, no harmful effects are expected during 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.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
See references
Otiprio Breastfeeding Warnings
Use is considered acceptable; caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-Ciprofloxacin is excreted in human milk when administered systemically.
-Maternal use of a ciprofloxacin-containing ear drop presents negligible risk for nursing infants; the effects in the nursing infant are unknown.
See references
