Pregnancy of Ciprofloxacin in details
Contraindicated in pregnancy (safety and efficacy in women during pregnancy has not been established); ciprofloxacin crosses the placenta, excreted in breast milk.
In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with ciprofloxacin in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of ciprofloxacin 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg ciprofloxacin did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of ciprofloxacin in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.
Category of the fetus by FDA - C.
Ciprofloxacin is excreted in breast milk, so the period of lactation should decide, stop taking ciprofloxacin or breastfeeding based on the degree of importance of the use of drugs for the mother.
With careful use of local forms of ciprofloxacin in breast-feeding (not known whether ciprofloxacin is excreted in breast milk when applied topically).
There are no data on the excretion of ciprofloxacin otic into human milk. Concentrations of orally administered ciprofloxacin found in breast milk have ranged from 85% (at 24 hours post dose) to 214% (at 4 hours post dose) of maternal serum concentration. In one case report, an infant developed perforated pseudomembranous colitis following ingestion of ciprofloxacin via the mother's milk. In addition, 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. However, limited data indicate that systemic absorption after otic administration is extremely low. Plasma levels of ciprofloxacin and hydrocortisone are expected to be below the level of quantitation after administration of 3 drops of suspension into the ear. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.
- Human Metabolome Database (HMDB). "Ciprofloxacin: 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/HMDB00146... (accessed September 18, 2017).
- 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/DataStan... (accessed September 18, 2017).
Information checked by Dr. Sachin Kumar, MD Pharmacology