Moxifloxacin-Mepha Pregnancy

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Pregnancy of Moxifloxacin-Mepha in details

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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-Mepha 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.

Moxifloxacin-Mepha breastfeeding

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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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ():
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  5. "Product Information. Avelox (Moxifloxacin-Mepha)" Bayer, West Haven, CT.

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ():
  3. "Product Information. Avelox (Moxifloxacin-Mepha)" Bayer, West Haven, CT.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. 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 -]):


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References

  1. PubMed Health. "Vigamox: This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
  2. 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/HMDB0... (accessed September 17, 2018).
  3. 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/Data... (accessed September 17, 2018).

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