Highlights of prescribing information these highlights do not include all the information needed to use toujeo safely and effectively. These highlights do not include all the information needed to use advate safely and effectively. Ceftaroline fosamil oxford academic journals oxford university. Ceftaroline, the bioactive form of parenterally administered ceftaroline fosamil, is a unique broadspectrum cephalosporin with in vitro and in vivo activity against methicillinresistant staphylococcus aureus and was approved for clinical use by the united states food and drug administration in october 2010. Teflaro dosing regimen is dependent on the type of infection absssi, cabp. Data were collected between august 2011 and february 20, from 398 evaluable patients receiving treatment at 33 sites in the usa. Results from 7 years of the aware surveillance program 20102016. These highlights do not include all the information needed to use teflaro safely and effectively. Ilaris canakinumab for injection, for subcutaneous use ilaris canakinumab injection, for subcutaneous use initial u. The recommended dosage of teflaro is 600 mg administered every 12 hours by intravenous iv infusion over 5 to 60 minutes in patients. Stanford health care antimicrobial dosing reference guide.
Communityacquired bacterial pneumonia cabp remains a significant cause of morbidity and mortality in adults. Studies in 1960s documented reduction in medication errors by 60% mm. It is also approved for communityacquired bacterial pneumonia cabp, including cases with concurrent. Ceftaroline fosamil is a new blactam antibiotic with an altered 3. Consequently, the availability of a drug with potent activity. Jones rn, mendes re, sader hs 2010 ceftaroline activity against pathogens associated with complicated skin and skin structure infections. In the united states, a total of 8,434 isolates were. The duration of therapy should be guided by the severity and site of infection and the patients clinical and bacteriological progress. Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. Ucla health antimicrobial stewardship program log in.
When flagyl is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Teflaro is supplied in singleuse, clear glass vials containing either 600 mg or 400 mg of sterile ceftaroline fosamil. The sdd is a breakpoint category for which the susceptibility of an isolate depends on the. Teflaro ceftaroline fosamil forest laboratories, inc. The assessing worldwide antimicrobial resistance evaluation aware surveillance program is a sentinel resistance monitoring system designed to track the activity of ceftaroline and comparator agents. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Medications in patient care areas are available in the most ready to administer forms commercially available or, if feasible, in unit doses that.
Laboratories f 2010 teflaro ceftaroline fosamil package insert. Staphylococcus aureus including methicillinsusceptible and resistant isolates, streptococcus pyogenes, streptococcus agalactiae, escherichia coli, klebsiella. Evaluation of the in vitro activity of ceftaroline and. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. There is minimal potential for drugdrug interactions between teflaro and cyp substrates, inhibitors, or.
In healthy adults, peak plasma concentrations and auc increase approximately in proportion to dose following single iv doses of 50 mg of ceftaroline fosamil. Confidential page 1 of 53 highlights of prescribing information. For information regarding treatment of cap, consult current idsa clinical practice. See important safety information including boxed warning. Several studies evaluating the in vitro activity of ceftaroline have been carried out table 2. Preparation of 600 mg of teflaro dose in 50 ml infusion bag for adult patients. Available for adults and children 5 years and older to reduce the acute complications of sickle cell disease. Titrate the astagraf xl dosage based on clinical assessments of rejection and tolerability, and to achieve target trough concentration ranges see dosage and administration 2. Interim susceptibility testing for ceftaroline, a new mrsa. Further studies with a larger, more diverse patient cohort seem reasonable based on the current findings, but it is worth noting that patients receiving courses of ceftaroline longer than what is recommended in the package insert may be more likely to experience adrs that require premature discontinuation, and those adrs are not limited to.
It is eliminated renally with 60% of the administered dose recovered in the urine. There is minimal potential for drugdrug interactions between teflaro and cyp substrates, inhibitors, or inducers. Dosage and administration recommended dosage the recommended dosage of zerbaxa for injection is 1. Pharmacodynamics of ceftaroline fosamil for complicated skin and.
Ceftaroline is currently available for iv administration and is given over 1 hour. Csl behring immune globulin subcutaneous human igsc. Press straight down to fully insert the clear plastic spike through the diluent vial stopper figure b. He is calling your office complaining of continued diarrhea. See important risk information and full prescribing information for zenpep. Pdf ceftaroline fosamil for the treatment of acute bacterial skin. It is given as an injection into a vein intravenously, or by iv.
Teflaro ceftaroline fosamil powder, for solution dailymed. Ceftaroline package insert pdf wonderful australia. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of. Comparison of adverse drug reactions between patients. Clinical evaluation of the role of ceftaroline in the. A 66 yo wm was recently admitted to the hospital for pneumonia. Dosing for zerbaxa ceftolozane and tazobactam official site. Discover how to dose the 5 to 60 minute iv infusion of teflaro treatment for.
Idweek 20 antimicrobial activity of ceftaroline tested. Before therapy with teflaro is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. Oct 29, 2010 teflaro ceftaroline fosamil injection company. Dilution of the constituted solution of teflaro in the 50 ml infusion bags only. Department of health and human services food and drug administration silver spring md 20993 nda 200327s016.
Ensure that moisture condensing on the outer surface has evaporated completely before opening the package. Clinical and laboratory standards institute, 2012, clinical and laboratory standards institute, 20 breakpoints. Ceftaroline applications for therapy in the united states. Ceftaroline fosamil for the treatment of community.
Grip the baxject ii hiflow package at its edge and pull the package off the. Teflaro ceftaroline fosamil clinical trials for absssi. Maintain clinical supervision if this product is to be given to a penicillin or other betalactamallergic patient. Remember my login on this computer forgot your password. Ic50, drug concentration required to block 50% of bocillin fl binding to each pbp. However, this may change after december 2018, when the first patent expires. Sterile vancomycin hydrochloride, usp is a lyophilized powder, for preparing intravenous iv infusions.
Crcl 25 crcl 10 25 crcl jul 14, 2012 there are many limitations to the current antibiotics used for the treatment of severe methicillinresistant staphylococcus aureus mrsa infections. The recommended dose is 600 mg iv every 12 hours for 514 days in sssi, and for 57 days in cap. Dosage of teflaro by indication in adult and pediatric patients. A randomized, doubleblinded, multicentre, phase iii trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in communityacquired pneumonia. Dosage of teflaro by indication in pediatric patients 2 months of age and older. Ceftaroline is a new fifthgeneration cephalosporin approved for the treatment of skin and soft tissue infections caused by mrsa and communityacquired pneumonia. Ceftaroline has demonstrated activity against a broad spectrum of grampositive pathogens table 1. Teflaro ceftaroline fosamilcleanlabeling text20101108.
Ceftaroline activity against organisms isolated from. Taytulla is the first and only oral contraceptive available in a softgel capsule. The current study also advocates for clinician awareness regarding the risk of neutropenia, which exceeds that stated in the package insert for ceftaroline teflaro is a type of antibiotic that is currently available only in brandname form. Clinical evaluation of the role of ceftaroline in the management of community acquired bacterial pneumonia diego j maselli, 1 juan f fernandez, 1 christine y whong, 2 kelly echevarria, 1, 3 anoop m nambiar, 1, 3 antonio anzueto, 1, 3 and marcos i restrepo 1, 3, 4. For the treatment of epi due to cystic fibrosis or other conditions. Teflaro ceftaroline fosamil is indicated in adult and pediatric patients at least 34 weeks gestational age and 12 days postnatal age and older for the treatment of acute bacterial skin and skin structure infections absssi caused by susceptible isolates of the following grampositive and gramnegative microorganisms. Safety and effectiveness of teflaro for the treatment of absssi in pediatric patients less than 34 weeks gestational age and less than 12 days postnatal age have not been established. Zerbaxa ceftolozane and tazobactam for injection, for intravenous use initial u. The first treatment for sickle cell disease in nearly 20 years. If a decline in the anc is detected, then biweekly or more frequent monitoring should be instituted. Department of health and human services food and drug administration silver spring md 20993 nda 200327s001. Integra meshed bilayer wound matrix package insert.
Formatting manuscripts in ajhp style authors are encouraged to use the accompanying checklist to ensure that their manuscripts comply with the major stylistic requirements of ajhp, which generally conform with the international committee of medical journal editors icmje recommendations for the conduct, reporting. Information on submitting spl files using elist may be found in the guidance for industry titled spl standard for content of labeling technical qs and as at. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram. Pdf skin infections have traditionally been classified by the us fda as. The compatibility of teflaro with other drugs has not been established. Aug 22, 2019 ceftaroline package insert pdf for injection. Update on antimicrobial susceptibility trends among. Highlights of prescribing information hyperglycemia or. Ceftaroline fosamil for the treatment of communityacquired.
Because this drug is protected by patents, companies are not allowed to make a generic teflaro product. Ceftaroline fosamil dosage for adults with renal impairment1. Ceftaroline is administered as ceftaroline fosamil, a prodrug that is inactive until converted in vivo to ceftaroline by a plasma phosphatase. Teflaro should only be used if the potential benefit justifies the potential risk in these populations. Integra meshed bilayer wound matrix package insert instructions for use integra meshed bilayer wound matrix without negative pressure therapy application 1. The use of ceftaroline fosamil in methicillinresistant. Highlights of prescribing information these highlights do not include all the information needed to use ilaris safely and effectively. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e. Highlights of prescribing information 250 mg and 125 mg. Ceftaroline is an intravenous, bactericidal cephalosporin approved by the us food and drug administration fda in 2010 for the treatment of acute skin and skinstructure infections absssi caused by susceptible microorganisms, including methicillinresistant staphylococcus aureus mrsa. Using aseptic technique, peel open the outer pouch and gently drop the inner foil pouch onto a sterile field or surface. Geographic influence on ceftaroline minimum inhibitory concentrations mics for methicillinresistant s. Summary of ceftaroline activity against pathogens in the. If druginduced hemolytic anemia is suspected, discontinuation of teflaro should.
Ceftaroline teflaro, cerexa was approved by the fda on oct. These prior approval supplemental new drug applications provide for revisions to the indications and usage 1 section of the package insert to include pediatric patients 2. For pediatric patients 2 months of age and older, teflaro is administered every 8 hours by intravenous infusion over 5 to 60 minutes. There is also the possibility that unknown infectious agents may be. We propose that ceftaroline can also be used successfully in more severe mrsa. Proceed to inject entire content of the teflaro vial into the bag to provide a total volume of 50 ml. Evaluation of the in vitro activity of ceftaroline and comparators against s. Taytulla norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules. Dosage adjustment for elderly patients should therefore be based on renal. The fda has approved ceftaroline for infections caused by the following. Teflaro is supplied as mg or mg of sterile ceftaroline fosamil powder in singledose, 20 ml clear glass. Ceftaroline package insert pdf download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro. Ceftaroline package insert pdf download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to.
Dailymed teflaro ceftaroline fosamil powder, for solution. Act fdca for teflaro cetaroline fosamil for injection. Zinforo, innceftaroline fosamil european medicines agency. Apr 01, 2014 read ceftaroline activity against organisms isolated from respiratory tract infections in usa hospitals. Aug 24, 2018 ceftaroline package insert ebook download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to. Ceftaroline package insert ebook download to reduce the development of drugresistant bacteria and maintain the effectiveness of teflaro and other antibacterial drugs, teflaro should be used to. Zenpep pancrelipase may help your body use fats, proteins, and sugars from food. Highlights of prescribing information these highlights do not include all the information needed to use zerbaxasafely and effectively. Only the usfda breakpoints for ceftaroline were utilized in this plot teflaro package insert, 2012. While admitted he was also diagnosed with c difficile diarrhea and has now completed a course of metronidazole. Patients and caregivers who administer forteo should receive appropriate training and instruction on the proper use of the forteo delivery device from a qualified health professionalsee patient counseling information 17. Staphylococcus aureus including methicillinsusceptible and resistant isolates.
1238 1267 77 126 390 1087 1428 1013 1431 206 1031 1410 350 929 953 598 421 1281 1054 1056 1215 1225 2 9 493 975 617 553 1244 1076 27