Ciclodin Special Precautions

Carcinogenicity/Tumorigenicity: Long-term carcinogenicity studies (up to 2 years) in rats and mice with oral ciprofloxacin have shown no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects.
Mutagenicity: In vitro mutagenicity studies have shown both positive and negative results. Negative results were obtained in the Salmonella microsome test, Escherichia coli DNA repair test, Chinese hamster V79 cell HGPRT test, Syrian hamster embryo cell transformation assay, Saccharomyces cerevisiae point mutation assay. Positive results were obtained in the mouse lymphoma cell forward mutation assay and the rat hepatocyte DNA repair assay, micronucleus test in mice, and the dominant lethal test in mice.
Pediatrics: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in infants and children. Patients younger than 18 years of age usually have been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints.
Fluoroquinolones and other related quinolones have been reported to cause arthropathy in immature animals of various species; the effects vary with animal species and with quinolone treatment. The mechanism by which quinolones produce this cartilage damage is unknown.
Adolescents: With the exception of ciprofloxacin when used post-exposure for inhalational anthrax, fluoroquinolones currently are not recommended for use in adolescents. Patients younger than 18 years of age usually have not been included in clinical trials because fluoroquinolones caused lameness in immature dogs due to permanent lesions of the cartilage of weight-bearing joints. One clinical report of 1219 adolescent patients (74 of whom had cystic fibrosis) who received ciprofloxacin at least once did not reveal any cases of newly diagnosed acute arthritis or joint toxicity that were likely to have been caused by the medication. In general, arthralgias have been reported primarily in adolescent females who received fluoroquinolones; these arthralgias were not severe, were transient, and disappeared with either a dosage reduction or discontinuation of the medication.
Geriatrics: Studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluoroquinolones in the elderly. However, tendinitis or tendon rupture, central nervous system (CNS) effects (e.g., hallucinations), and other side effects may occur more frequently in the elderly. Elderly patients also are more likely to have an age-related decrease in renal function, which may require an adjustment of dosage in patients receiving any of these medications.