Pregnancy of Levofloxacin 0.5.% Ohara in details
Levofloxacin 0.5.% Ohara Prem Pharmaceuticals is contraindicated during pregnancy and lactation.
Category effects on the fetus by FDA - C.
Levofloxacin 0.5.% Ohara breastfeeding
LactMed: Use is considered acceptable with monitoring of the infant for possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]); avoiding breastfeeding between 4 to 6 hours after maternal dosing should decrease the infant's exposure to this drug in breast milk. -According to some authorities, use is contraindicated. -According to other authorities, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes Comments: -This drug is the L-isomer (S-enantiomer) of ofloxacin, which is excreted into human milk. -The effects in the nursing infant are unknown; potential risk of serious side effects in the nursing infant
Cartilage erosion and arthropathy have been observed 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. Postpartum (time not specified), 10 lactating women received ofloxacin (the racemic mixture) 400 mg orally every 12 hours for 3 doses. At 2 hours after the third dose, milk ofloxacin levels were highest and averaged 2.4 mg/L. Milk levels then declined and averaged 1.9 mg/L at 4 hours, 1.25 mg/L at 6 hours, 0.64 mg/L at 9 hours, 0.29 mg/L at 12 hours, and 0.05 mg/L at 24 hours after the dose. Based on peak milk levels in this study, an exclusively breastfed infant would receive up to 0.36 mg/kg daily (estimated) with this maternal dose regimen. A woman received Levofloxacin 0.5.% Ohara 500 mg once a day (IV for 9 days, then orally for 17 days); 26 breast milk samples were collected, starting on day 10 of therapy and continuing for 6 days after therapy was stopped. Using a pharmacokinetic model, a peak milk level of 8.2 mg/L at 5 hours after dosing was predicted. Milk levels declined with a half-life of 7 hours (estimated); at 65 hours after the dose, traces of this drug were still detectable in breast milk. According to author calculation, a fully breastfed infant of a mother taking 500 mg/day would receive 1.25 mg/day in breast milk, which is much lower than the dose used to treat children. This drug has been recommended by the US CDC as an alternative agent for postexposure prophylaxis and treatment of anthrax in lactating women. The Working Group on Civilian Biodefense has recommended this drug as an alternative for plague.
- Human Metabolome Database (HMDB). "Levofloxacin: 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/HMDB00019... (accessed September 18, 2017).
Information checked by Dr. Sachin Kumar, MD Pharmacology