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Ciprofloxacin dosing renal impairment, hepatic and decreased fluid volume may be seen in patients with concomitant drug therapy that increases hepatic clearance [see Drug Interactions (7)].
Renal Impairment
As CYP16A1 has been shown in vitro to inhibit ciprofloxacin binding human renal tubular cells to a greater extent than do its substrates, concomitant use of ciprofloxacin and cyclosporin acetate may be expected to reduce the clearance of ciprofloxacin. This is particularly likely for patients with decreased renal function who take concomitant drugs that are known to reduce renal function.
Increased Hepatic Impairment
Ciprofloxacin-mediated increase in hepatic clearance has been shown in vitro association with inhibition of human CYP17-2 activity by ciprofloxacin. However, no data are available in patients. Hepatic impairment associated with concomitant use of antibiotics or corticosteroids may be dose-related and will require careful monitoring by physicians.
Increased Renal Impairment
Ciprofloxacin increases the clearance of both water- and mineralocorticoid-sensitive drugs in vitro, ciprofloxacin can interact with drugs that modulate ion channels, such as quinidine. The drug interacts with quinidine to prevent its uptake into renal tubules, resulting in increased plasma quinidine levels and ciprofloxacin in plasma following quinidine ingestion. Thus, concomitant use of quinidine increases the risk potentially fatal renal toxicity, especially when a lower dose of quinidine is required for quinine dihydrochloride-treated patients [see Drug Interactions (7)].
Use In Specific Populations
Pregnancy
Teratogenic Effects
Pregnancy Category D
Pregnancy Category D is established for Ciprofloxacin in animals. It is not known whether Ciprofloxacin should be used during pregnancy or if there is any risk to the fetus when administered a pregnant woman. This drug should be used during pregnancy only if the potential benefit justifies risk to the fetus.
Lactation
Females using Ciprofloxacin and given a dose greater than 250 mg/kg on day 0 or 1 of gestation did not show developmental toxicity in vivo [see Clinical Studies (14)].
Ciprofloxacin has not been studied in human lactating women and clinical studies are not currently available. For safety and efficacy, a decision should be made on a case-by-case basis based upon clinical, pharmacokinetic, and other factors.
Nursing Mothers
Ciprofloxacin administration to nursing mothers was not associated with significant developmental and reproductive toxicity. This drug has not been studied in nursing mothers and clinical studies are not currently available. If safety and efficacy data are available, an immediate decision to treat nursing mothers with Ciprofloxacin should be made on a case-by-case basis and then annually.
Pediatric Use
Safety and efficacy of Ciprofloxacin in children <12 years of age with severe chronic bronchitis and atopic dermatitis, as well those with pulmonary impairment due to disease and/or drug treatment, have not been established. However, children and adolescents should be instructed to report any suspected adverse reactions and to seek medical care promptly for a suspected adverse event.
In view of the large patient pool, dose selection in pediatric patients is difficult. Dose selection of adult patients using
Provigil 200mg 90 pills US$ 380.00 US$ 4.22 Ciprofloxacin-containing products for treatment of severe acute infectious respiratory infection must also be considered because of the increased risk for infection from Ciprofloxacin and other fluoroquinolones in pediatric patients. These considerations should be taken into account when prescribing and administering fluoroquinolones in pediatric patients.
Ciprofloxacin should not be administered in combination with other anti-HIV drugs including those prescribed to treat acquired immunodeficiency syndrome (AIDS) (see PRECAUTIONS and WARNINGS). Also, since drug-drug interactions can produce severe reactions, fluoroquinolone and quinolones should be used with caution in the treatment of patients with underlying immunodeficiency syndrome. In addition, fluoroquinolones should not be used for the treatment of acquired immune deficiency syndrome.
Adverse Reactions
The following adverse reactions have been identified during use of single or multiple courses treatment as well during therapy termination. These are not all events that have been reported. The incidence and severity of effects reported are similar in all patients. general, adverse reactions reported at recommended doses and durations for Ciprofloxacin.
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