Pregnancy of Ofloxacina Merck in details
Ofloxacina Merck has been assigned to pregnancy category C by the FDA. Animal studies using high doses have revealed evidence of fetotoxicity and teratogenicity. There are no controlled data in human pregnancy. Surveillance studies have not reported an increased risk of major birth defects. However, cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Because safer alternatives are available, some experts consider Ofloxacina Merck contraindicated during pregnancy, especially during the first trimester. The manufacturer only recommends use of Ofloxacina Merck during pregnancy when benefit outweighs risk.
Of 549 cases reported by the European Network of Teratology Information Services involving fluoroquinolone exposure (including Ofloxacina Merck), congenital malformations were reported in 4.8%; however, this was not higher than the background rate.
See references
Ofloxacina Merck breastfeeding
Ofloxacina Merck is excreted into human milk. Breast milk concentrations approximate maternal serum concentrations. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
See references
References for pregnancy information
- Ramakrishnan K, Scheid DC "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician 71 (2005): 933-42
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- "Product Information. Floxin (Ofloxacina Merck)." Ortho Pharmaceutical Corporation, Raritan, NJ.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Giamarellou H, Kolokythas E, Petrikkos G, Gazis J, Aravantinos D, Sfikakis P "Pharmacokinetics of three newer quinolones in pregnant and lactating women." Am J Med 87 (1989): s49-51
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- "Product Information. Floxin (Ofloxacina Merck)." Ortho Pharmaceutical Corporation, Raritan, NJ.
- 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 -]):
References
- DailyMed. "OFLOXACIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Ofloxacin (Into the eye) (Ocuflox): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Ofloxacin: 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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology