Tigecycline (2 brand names, 1 dosage form, 1 route)
Available dosage forms: POWDER.
Routes of administration: INTRAVENOUS.
Brand Names
- TIGECYCLINE
- TYGACIL
Boxed Warning
An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage (1.4), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)].
Contraindications
Tigecycline 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)].
Adverse Reactions
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)]
Mechanism of Action
Tigecycline is a tetracycline class antibacterial [see Microbiology (12.4)].
Overdosage
No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.