Pregnancy of Ciprofloxacin Actavis 250mg in details
Contraindicated in pregnancy (safety and efficacy in women during pregnancy has not been established); Ciprofloxacin Actavis 250mg crosses the placenta, excreted in breast milk.
In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with Ciprofloxacin Actavis 250mg 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 Actavis 250mg 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 Actavis 250mg did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of Ciprofloxacin Actavis 250mg in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.
Category of the fetus by FDA - C.
Ciprofloxacin Actavis 250mg is excreted in breast milk, so the period of lactation should decide, stop taking Ciprofloxacin Actavis 250mg or breastfeeding based on the degree of importance of the use of drugs for the mother.
With careful use of local forms of Ciprofloxacin Actavis 250mg in breast-feeding (not known whether Ciprofloxacin Actavis 250mg is excreted in breast milk when applied topically).
Ciprofloxacin Actavis 250mg breastfeeding
There are no data on the excretion of Ciprofloxacin Actavis 250mg otic into human milk. Concentrations of orally administered Ciprofloxacin Actavis 250mg 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 Actavis 250mg 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 Actavis 250mg 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.
See references
References for pregnancy information
- "Product Information. Cetraxal (Ciprofloxacin Actavis 250mg otic)." WraSer Pharmaceuticals, Madison, MS.
References for breastfeeding information
- "Product Information. Cetraxal (Ciprofloxacin Actavis 250mg otic)." WraSer Pharmaceuticals, Madison, MS.
References
- DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: 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. "Ciprofloxacin (Into the eye) (Ciloxan): 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). "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/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
