Tygacil

WYETH Broad spectrum antibiotic approved for cSSSIs and cIAIs

This first-in-class glycylcycline antibiotic exerts its bacteriostatic effect by inhibiting bacterial protein translation. Tigecycline was approved on June 15, 2005, for the treatment of complicated skin and skin structure infections (cSSSIs) and complicated intra-abdominal infections (cIAIs) cause by susceptible strains of specific pathogens.

Efficacy. The efficacy of tigecycline in the treatment of cSSSIs was evaluated in 2 randomized, double-blind, active-controlled studies. Patients received either tigecycline (100 mg IV initial dose followed by 50 mg every 12 h) or vancomycin (1 g IV every 12 h)/aztreonam (2 g IV every 12 h) for 5 to 14 days. The primary efficacy end point was the clinical response at the test of cure (TOC) visit in the co-primary populations of the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) patients. Clinical cure rates were 86.5% and 79.7% for the CE and c-mITT patients receiving tigecycline, respectively, compared with rates of 88.6% and 81.9% for the CE and c-mITT patients receiving vancomycin/aztreonam, respectively. The efficacy of tigecycline in the treatment of cIAIs was evaluated in 2 randomized, double-blind, active-controlled trials. Patients received either tigecycline (100 mg IV initial dose followed by 50 mg every 12 h) or imipenem/ cilastatin (500 mg IV every 6 h) for 5 to 14 days. The primary efficacy end point was the clinical response at the TOC visit in the co-primary populations of the microbiologically evaluable (ME) and microbiologic modified intent-to-treat (m-mITT) patients. Clinical cure rates were 86.1% and 80.2% for the ME and m-mITT patients receiving tigecycline, respectively, compared with rates of 86.2% and 81.5% for the ME and m-mITT patients receiving imipenem/cilastatin, respectively.

Dosing. Tigecycline should be administered as an initial dose of 100 mg, followed by 50 mg every 12 hours. IV infusions of tigecycline should be administered over 30 to 60 minutes. Duration of treatment should be 5 to 14 days and should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress. In patients with severe hepatic impairment (Child-Pugh Class C), the initial dose of tigecycline should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.