If you have any further questions, ask your doctor or nurse. This registry study captured patient characteristics, prescribing patterns, and treatment outcomes associated with telavancin use in realworld clinical practice. Positively charged, negatively charged, and neutral hydrophilic groups. The clinical positioning of telavancin in europe request pdf. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. To reduce the development of drugresistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ should be used only to treat or prevent infections that are proven or. Telavancin vibativ, a new option for the treatment of gram. While in circulation, the drug is 93% bound to human plasma proteins, primarily to albumin. When reconstituted as directed each 10 ml contains 500 mg and each 20 ml contains 1 gram. Telavancin is a rapidly bactericidal lipoglycopeptide, which is active against grampositive organisms, including meticillinresistant and vancomycinresistant s.
The diluted solution must have a final dalbavancin concentration of 1 mgml to 5 mgml. Vibativ is indicated in adults for the treatment of. Store vibativ in the original package keep vibativ refrigerated between 35. It is usually infused injected slowly over a period of 60 minutes once every 24 hours for 7 to 21 days. Each pharmacy bulk package contains vancomycin hydrochloride equivalent to 5 grams of vancomycin base. The most common pathogen in pediatric cystic fibrosis cf patients is staphylococcus aureus, and drugresistant species are associated with negative outcomes. Telavancin vibativ, a new option for the treatment of. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of c. Use of telavancin in adolescent patients with cystic. Evaluation of telavancin dose capping in a large community.
Chemical stability of telavancin in elastomeric pumps. Benlysta should not be infused concomitantly in the same intravenous line with other agents. Package of 10 vials ndc 07818795 vancomycin hydrochloride for injection, usp is supplied as a sterile powder in singledose fliptop vials that contain the vancomycin equivalent to 1 g, individually packaged in a carton. Nephrotoxicity has been noted with telavancin, with increased. Although licensed in europe in 2011 for the treatment of nosocomial pneumonia caused by meticillinresistant staphylococcus aureus mrsa, it. Telavancin is administered by intravenous infusion. Dalvancethe only 1 dose, 30minute iv antibiotic that provides a full course of outpatient treatment for appropriate absssi patients.
Renal tubular vacuolization, renal tubular degeneration, elevations of bunserum creatinine phase 3 trials. Notably, both telavancin and oritavancin interfere with. Information for the user vancomycin hydrochloride 500 mg and 1 g powder for concentrate for infusion vancomycin hydrochloride read all of this leaflet carefully before you start using this medicine. The commercial operations for telavancin have been restored, a new manufacturer has been secured, and. Knowledge of a drugs pharmacodynamics, defined as the relationship. Key points telavancin vibativ is a lipoglycopeptide antibiotic that inhibits the growth of susceptible bacteria through disrupting the cell wall has both the mechanism of action for vancomycin binding dala, dala as well as the mechanism of action for daptomycin causes depolarization active against many gram positive organisms, such as most mrsa fdaapproved for. Its early killing effect is greater than that of vancomycin and teicoplanin targocid, sanofiaventis p package insert. How to use telavancin solution, reconstituted recon soln read the medication guide provided by your pharmacist before you start using telavancin and each time you get a refill.
Telavancin is a semisynthetic derivative of vancomycin. Vibativ telavancin for injection, for intravenous use. Methicillinresistant staphylococcus aureus mrsa is notoriously hard to treat because many antibiotics are not fda approved for children and drug allergies or intolerances can prohibit the use of others. Etest is a wellestablished method for antimicrobial susceptibility testing in microbiology laboratories around the world. Highlights of prescribing information singleuse vials. At the time of initial approval the package insert included. Sterile vancomycin hydrochloride, usp is a lyophilized powder, for preparing intravenous iv infusions. Concentrations of telavancin in skin blister fluid were 40% of those in plasma auc 024hr ratio after 3 daily doses of 7. No contraindications are listed in the prescribing information. Telavancin is an antibiotic that is used to treat severe skin infections caused by bacteria telavancin is also used to treat pneumonia in a hospital setting, or pneumonia that can develop while using a ventilator artificial breathing machine telavancin may also be used for purposes not listed in this medication guide. Etest consists of a predefined gradient of antibiotic concentrations on a plastic strip and is used to determine the minimum inhibitory concentration mic of antibiotics, antifungal agents and antimycobacterial agents. Vibativ telavancin for injection, for intravenous use initial u. Elderly patients should receive a telavancin dose in accordance with their bodyweight and renal function see sections 4. Aseptically transfer the required dose of reconstituted dalbavancin solution.
Telavancin is also used to treat pneumonia caused by bacteria in a hospital setting, or pneumonia that can develop while using a ventilator artificial breathing machine. Staphylococcus aureus including methicillinsusceptible and resistant isolates. Aseptically transfer the required dose of reconstituted dalbavancin solution from the vials to an intravenous bag or bottle containing 5% dextrose injection, usp. Highlights of prescribing information these highlights do not include all the information needed to use cubicin safely and effectively. The length of your treatment depends on the type of infection. Table 4 displays the incidence of treatmentemergent adverse drug reactions reported in. Telavancins excellent activity is based on the areaunderthebacterialkillcurve aubkc at 24 and 48 hours.
Telavancina lipoglycopeptide antibacterial agent active against grampositive. Vibativ is a prescription antibacterial medicine used alone, or with other medicines, to treat adults with certain types of bacterial infections. Order dalvance now through your wholesaler or through allergan direct by calling 1. Telavancin is used to treat severe skin infections. Telavancin is also used to treat pneumonia caused by bacteria in a hospital setting, or pneumonia that can develop while using a ventilator artificial breathing machine telavancin may also be used for purposes not listed in this medication guide.
Telavancin was the first marketed lipoglycopeptide. Sections or subsections omitted from the full prescribing information are not listed. Vibativ telavancin for injection, 250 mg and 750 mg company. Telavancin concentrations in elf and am exceeded the mic 90 for s. Effect of telavancin vibativ on routine coagulation test. Briefly, telavancin was derived from ndecylaminoethylvancomycin thrx689909 by regioselective reductive alkylation of the vancosamine nitrogen figure 1 4, 5. Discard any unused portion of the reconstituted solution. Analysis of vancomycin susceptibility testing results for. The reconstituted solution must be further diluted in 250ml of 0. Fig 1 a scattergram comparing the telavancin and vancomycin mic results tested against 15,314 s. The drug distributes into the pulmonary epithelial lining fluid and alveolar macrophages, with concentrations exceeding the minimum. Identification of the substancemixture and of the companyundertaking product name.
Dailymed vibativ telavancin hydrochloride injection. To reduce the development of drugresistant bacteria and maintain the effectiveness of vibativ and other antibacterial drugs, vibativ. The permanent jcode for dalvance helps simplify claims processing, eliminating the need to use a. Telavancin has the ability to bind to artificial phospholipids found in coagulation reagents, thereby reducing the in vitro clotting process, resulting in prolonged clotting times. The horizontal darker line represents the fdaapproved telavancinsusceptible breakpoint for s.
The telavancin drug product was reconstituted and diluted to concentrations of 0. Orbactiv is a lipoglycopeptide antibacterial drug indicated for the treatment. Telavancin injection comes as a powder to be mixed with liquid and injected intravenously into a vein. No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of benlysta with other agents. Staphylococcus aureus including methicillinsusceptible and resistant isolates, streptococcus. Telavancina lipoglycopeptide antibacterial agent active against grampositive pathogens including methicillinsensitive and resistant staphylococcus aureus mrsais approved in the usa for oncedaily intravenous use. Tilt the upright vial and insert a syringe with appropriately sized needle into the bottom corner of the vial and remove 4ml of the reconstituted solution. Vibativ telavancin dose, indications, adverse effects. Dailymed vancomycin hydrochloride injection, powder. Telavancin td6424 was discovered in 2000 and became the first marketed semisynthetic lipoglycopeptide in 2009. The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution.
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