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Pregnancy of Moxifloxacin in details
Use is considered acceptable; according to some experts, this drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C
Animal studies have failed to reveal evidence of teratogenicity at oral doses up to 500 mg/kg/day in rats (about 21,700 to 25,000 times the maximum recommended daily human ophthalmic dose) and up to 100 mg/kg/day in cynomolgus monkeys (about 4300 to 5000 times the maximum recommended daily human ophthalmic dose); decreased fetal weight and slightly delayed fetal skeletal development were seen at 500 mg/kg/day in rats and increased incidence of smaller fetuses was seen at 100 mg/kg/day in cynomolgus monkeys. There are no controlled data in human pregnancy. Since the systemic exposure to moxifloxacin is negligible, no effects on pregnancy are expected. 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 is presumed to be excreted in human milk. Traditionally, systemic fluoroquinolones have not been used in infants due to concern over toxic effects on their developing joints; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove.
Use is considered acceptable; caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Maternal use of an ophthalmic drop containing this drug poses negligible risk for a nursing infant. -Placing pressure over the tear duct by the corner of the eye for at least 1 minute then removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches the breast milk after using eye drops.
- Human Metabolome Database (HMDB). "Moxifloxacin: 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/HMDB00143... (accessed September 18, 2017).
- 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/DataStan... (accessed September 18, 2017).
Information checked by Dr. Sachin Kumar, MD Pharmacology