TIGECYCLINE

The mean pharmacokinetic parameters of tigecycline after single and multiple intravenous doses based on pooled data from clinical pharmacology studies are summarized in Table 3 . Intravenous infusions of tigecycline were administered over approximately 30 to 60 minutes. Table 3. Mean (CV%) Pharmacokinetic Parameters of Tigecycline Single Dose Multiple Dose a 100 mg 50 mg every 12h (N=224) (N=103) a 100 mg initially, followed by 50 mg every 12 hours b 30-minute infusion c 60-minute infusion C max...

14.1 Complicated Skin and Skin Structure Infections Tigecycline for injection was evaluated in adults for the treatment of complicated skin and skin structure infections (cSSSI) in two randomized, double-blind, active-controlled, multinational, multicenter studies (Studies 1 and 2). These studies compared tigecycline for injection (100 mg intravenous initial dose followed by 50 mg every 12 hours) with vancomycin (1 g intravenous every 12 hours)/aztreonam (2 g intravenous every 12 hours) for 5 to 14 days. Patients with complicated deep soft tissue infections including wound infections and cellu...

The following serious adverse reactions are described elsewhere in the labeling: All-Cause Mortality [see Boxed Warning and Warnings and Precautions ( 5.1 )] Mortality Imbalance and Lower Cure Rates in Hospital-Acquired Pneumonia [see Warnings and Precautions ( 5.2 )] Anaphylaxis [Warning and Precautions ( 5.3 )] Hepatic Adverse Effects [Warnings and Precautions ( 5.4 )] Pancreatitis [Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence >5%) are nausea, vomiting, diarrh...

Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.2 ) ] . Known hypersensitivity to tigecycline. ( 4 )

All-Cause Mortality: A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia. ( 5.1...

7 DRUG INTERACTIONS Warfarin: Suitable anticoagulation test should be monitored if tigecycline for injection is administered to patients receiving warfarin. ( 7.1 ) Calcineurin Inhibitors: Serum concentrations of calcineurin inhibitors (e.g., tacrolimus, cyclosporine) should be monitored during treatment with tigecycline for injection due to risk of toxicity. ( 7.2 ) 7.1 Warfarin Prothrombin time ...