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Levofloxacin Pregnancy and Breastfeeding Warnings

Levofloxacin is also known as: Levaquin, Levaquin Leva-Pak

Levofloxacin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; according to some authorities, use is contraindicated. US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity; however, in rats, decreased fetal body weight and increased fetal mortality were observed at oral doses up to 810 mg/kg/day (9.4 times the maximum human dose based on relative body surface area) and delayed maturation occurred due to maternal toxicity. There are no controlled data in human pregnancy. Of 549 cases reported by the European Network of Teratology Information Services involving exposure to other fluoroquinolones, congenital malformations were reported in 4.8%; however, this was not higher than the background rate. This drug has been recommended by the US CDC as an alternative agent for postexposure prophylaxis and treatment of anthrax in pregnant women. The Working Group on Civilian Biodefense has recommended this drug as an alternative for plague. The risk of drug use during pregnancy is outweighed by the high fatality rates from these infections. Cartilage damage and arthropathy have been reported in immature animals of various species giving rise to concern over possible toxic effects on human fetal bone formation. Because safer alternatives are generally available, some experts consider fluoroquinolones contraindicated during pregnancy, especially during the first trimester. 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.

See references

Levofloxacin Breastfeeding Warnings

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 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.

See references

References for pregnancy information

  1. Ramakrishnan K, Scheid DC "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician 71 (2005): 933-42
  2. Inglesby TV, Dennis DT, Henderson DA, et al "Plague as a biological weapon: medical and public health management. Working Group on Civilian Biodefense." JAMA 283 (2000): 2281-90
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. Meaney-Delman D, Zotti ME, Greanga AA, et al; Workgroup on Anthrax in Pregnant and Postpartum Women "Special considerations for treatment of anthrax in pregnant and postpartum women. Available from: URL: http://dx.doi.org/10.3201/eid2002.130611" ([2014 Feb]):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. "Product Information. Levaquin (levofloxacin)." Ortho Pharmaceutical Corporation, Raritan, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Cahill JB Jr, Bailey EM, Chien S, Johnson GM "Levofloxacin secretion in breast milk: a case report." Pharmacotherapy 25 (2005): 116-8
  3. Inglesby TV, Dennis DT, Henderson DA, et al "Plague as a biological weapon: medical and public health management. Working Group on Civilian Biodefense." JAMA 283 (2000): 2281-90
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Meaney-Delman D, Zotti ME, Greanga AA, et al; Workgroup on Anthrax in Pregnant and Postpartum Women "Special considerations for treatment of anthrax in pregnant and postpartum women. Available from: URL: http://dx.doi.org/10.3201/eid2002.130611" ([2014 Feb]):
  7. "Product Information. Levaquin (levofloxacin)." Ortho Pharmaceutical Corporation, Raritan, NJ.

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