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Moxifloxacin Acino 400mg Pregnancy |
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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 Acino 400mg 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.
Cartilage erosion and arthropathy have been reported in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; 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.
LactMed: Short-term use is considered acceptable; however, use of an alternate drug is preferred. -AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. -GB: Use is contraindicated. Excreted into human milk: Yes (small amounts) Comments: The effects in the nursing infant are unknown.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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