300 mg IV over 1 hour once every 4 weeks
-Only prescribers registered in the CD TOUCH (R) Prescribing Program may prescribe this drug for Crohn's disease.
-This drug should not be used with concomitant immunosuppressants (., 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or concomitant inhibitors of TNF-alpha.
-Aminosalicylates may be continued during treatment with this drug.
-If the patient has not experienced therapeutic benefit by 12 weeks of induction therapy, this drug should be discontinued.
-For patients who start this drug while on chronic oral corticosteroids, steroid tapering should commence as soon as a therapeutic benefit of this drug has occurred; if the patient cannot be tapered off of oral corticosteroids within 6 months of starting this drug, then this drug should be discontinued.
-Other than the initial 6 month taper, prescribers should consider discontinuing this drug for patients who require additional steroid use that exceeds 3 months in a calendar year to control their Crohn's disease.
-Patients should be observed during the infusion and for one hour after the infusion is complete.
Use: Crohn's Disease (CD): For inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate conventional CD therapies and inhibitors of TNF-alpha
The absolute bioavailability of oral ciprofloxacin is within a range of 70–80% with no substantial loss by first pass metabolism. An intravenous infusion of 400-mg ciprofloxacin given over 60 minutes every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by a 500-mg oral dose given every 12 hours. An intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 8 hours has been shown to produce an AUC at steady-state equivalent to that produced by a 750-mg oral dose given every 12 hours. A 400-mg intravenous dose results in a C max similar to that observed with a 750-mg oral dose. An infusion of 200 mg CIPRO given every 12 hours produces an AUC equivalent to that produced by a 250-mg oral dose given every 12 hours (Table 10).
Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.