Please provide your email address to receive an email when new articles are posted on. You've successfully added to your alerts. You will receive an email when new content is published. Click Here to Manage Email Alerts. We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice slackinc. Ceftobiprole has had a long road to the United States market. It was initially sent to the FDA for approval in , but has yet to be approved due to concerns regarding the conduct of the clinical trials.
Its new drug application was first submitted to the FDA on Dec. Ceftaroline is administered as a prodrug — ceftaroline fosamil — that is rapidly dephosphorylated in the blood to the active form.
Ceftaroline is currently available for IV administration and is given over 1 hour. Dose reductions for renal impairment are included in the package labeling. Common adverse effects seen with ceftaroline include nausea, diarrhea, headache and insomnia.
Rare but severe adverse effects include respiratory and infectious complications, but these were not more common than in comparator groups in clinical trials. Ceftaroline was compared with ceftriaxone in two randomized, double blind, phase 3 trials treating a total of 1, hospitalized patients with CAP. Patients received IV ceftaroline mg every 12 hours or ceftriaxone 1 g every 24 hours for 5 to 7 days.
Ceftaroline was found to be as effective as ceftriaxone in reaching clinical cure 8 to 15 days after completion of therapy. Clinical and microbiologic success rates were greater with ceftaroline than ceftriaxone in the pooled study results, but the study was not powered to determine ceftaroline superiority.
Of note, no patients receiving ceftaroline had microbiologic cultures containing MRSA. Ceftaroline was compared with vancomycin plus aztreonam for the treatment of SSSI in two identical phase 3 clinical trials.
The two studies and the combined data showed ceftaroline was as effective as vancomycin and aztreonam combination therapy in the rate of clinical cure. This was also true in a subgroup analysis for MRSA isolates. Ceftaroline is also being developed for use in combination with a novel beta-lactamase inhibitor NXL , which will improve activity against beta-lactamase—producing organisms, including Enterobacteriaceae. This combination of ceftaroline and NXL is currently being studied in patients with complicated urinary tract infections.
Ceftaroline is also being studied against linezolid for SSSI and in to year-olds for pharmacokinetic data. Fortunately, we have not yet reached the end of the road for new antimicrobials. Ceftaroline given for 5 to 7 days was also found to be noninferior to ceftriaxone in two as-yet-unpublished manufacturer-sponsored trials involving patients with CABP.
Ceftaroline is given by intravenous infusion at a dose of mg every 12 hours, administered over 1 hour. It is primarily eliminated by the kidneys, and dosage adjustment is needed for patients with moderate-to-severe renal impairment.
Ceftaroline has a side-effect profile similar to those of other cephalosporins. It is not expected to interact with drugs metabolized through the cytochrome P enzyme system. Of note, ceftaroline's gram-negative coverage is not adequate for empirical treatment of nosocomial pneumonia.
Teflaro ceftaroline fosamil [package insert]. Citation s : Teflaro ceftaroline fosamil [package insert].
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