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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).
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: -The effects in the nursing infant are unknown; potential risk of serious side effects (including articular damage) in the nursing infant. -This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.
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. Levels found in breast milk have ranged from 85% (at 24 hours postdose) to 214% (at 4 hours postdose) of maternal serum level. Postpartum (time not specified), 10 lactating women received 750 mg orally every 12 hours for 3 doses. At 2 hours after the third dose, milk drug levels were highest and averaged 3.79 mg/L. Milk levels then declined and averaged 2.26 mg/L at 4 hours, 0.86 mg/L at 6 hours, 0.51 mg/L at 9 hours, 0.2 mg/L at 12 hours, and 0.02 mg/L at 24 hours after the dose. Based on peak milk levels in this study, an exclusively breastfed infant would receive up to 0.57 mg/kg daily (estimated) with this maternal dose regimen, which is much lower than the dose used to treat neonates. A single 500 mg oral dose was given to a mother recovering from acute renal failure; this dose was administered with a prenatal vitamin and ferrous sulfate, which would be expected to decrease ciprofloxacin bioavailability. Milk levels were 3.5 mg/L at 4, 8, and 12 hours after the dose and 2.3 mg/L at 16 hours after the dose. Levels were probably elevated and elimination prolonged due to the renal dysfunction. A woman took 500 mg orally daily for 10 days. Drug level in breast milk was 0.98 mg/L at 10 hours and 40 minutes after the last dose. After breastfeeding once (8 hours after the dose), this drug was not detectable (less than 30 mcg/L) in the infant's serum 2.7 hours after nursing. In 1 case report, a 2-month-old girl with history of necrotizing enterocolitis developed perforated pseudomembranous colitis, most likely due to ingestion of this drug via her mother's milk, and subsequently required a bowel resection. The mother admitted self-treatment while breastfeeding her infant. This drug was used as part of multi-drug regimens to treat 3 pregnant women with multidrug-resistant tuberculosis throughout pregnancy and postpartum. Their 3 infants were breastfed (extent and duration not specified). At age 1.25, 1.8, and 3.9 years, 2 of the children were developing normally while the other child had failure to thrive, possibly due to contracting tuberculosis after birth. This drug is recommended by the US CDC as a preferred 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). "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).