ACEP News - June 2008 - (Page 3)

TYGACIL A POWERFUL PARTNER A first-in-class antibiotic • Expanded broad spectrum of in vitro activity against many gram positives, gram negatives, anaerobes, and methicillin-resistant Staphylococcus aureus (MRSA)1* Simplified empiric management of polymicrobial infections • No dosage modifications necessary for patients with renal impairment1 • Low potential for drug interactions—not metabolized by, and does not inhibit or induce, cytochrome P4501 TYGACIL is indicated for: • The treatment of adults with complicated skin and skin structure infections caused by E. coli, E. faecalis (vancomycin-susceptible isolates only), S. aureus (methicillin-susceptible and -resistant isolates), S. agalactiae, S. anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), S. pyogenes, and B. fragilis • The treatment of adults with complicated intra-abdominal infections caused by C. freundii, E. cloacae, E. coli, K. oxytoca, K. pneumoniae, E. faecalis (vancomycin-susceptible isolates only), S. aureus (methicillin-susceptible isolates only), S. anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), B. fragilis, B. thetaiotaomicron, B. uniformis, B. vulgatus, C. perfringens, and P. micros *The clinical significance of in vitro activity is unknown. www.TYGACIL.com Important Safety Information • To reduce the development of drug-resistant bacteria and maintain the effectiveness of TYGACIL and other antibacterial drugs, TYGACIL should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria. • Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. • TYGACIL is contraindicated in patients with known hypersensitivity to tigecycline. • TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. • Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. • The safety and efficacy of TYGACIL in patients with hospital-acquired pneumonia have not been established. • In clinical trials, the most common treatment-emergent adverse events in patients treated with TYGACIL were nausea (29.5%) and vomiting (19.7%). • TYGACIL may cause fetal harm when administered to a pregnant woman. • The safety and effectiveness of TYGACIL in patients below age 18 and lactating women have not been established. • Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. • The use of TYGACIL during tooth development may cause permanent discoloration of the teeth. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Please see brief summary of Prescribing Information on adjacent page. Reference: 1. TYGACIL® (tigecycline) Prescribing Information, Wyeth Pharmaceuticals Inc. © 2007, Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101 208875-01 http://www.TYGACIL.com http://www.TYGACIL.com

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ACEP News - June 2008 Contents News - Time to Move Tricks of the Trade - Revealing Tips Focus On - Dengue Fever Practice Trends - EMTALA Results

ACEP News - June 2008

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