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Tigicyclin

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Do you mean tigecycline, the broad-spectrum glycylcycline antibiotic?
What would you like to know: uses, dose, adverse effects, spectrum, or exam notes?

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tigecycline

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FDA tigecycline prescribing information boxed warning mortality 2025

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https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/21…

Tigecycline

Class: Glycylcycline antibiotic, a semisynthetic derivative of minocycline.
Mechanism
  • Binds the 30S ribosomal subunit and inhibits bacterial protein synthesis.
  • Mainly bacteriostatic.
  • It evades common tetracycline resistance mechanisms, particularly ribosomal protection and some efflux mechanisms.
Antibacterial spectrum
  • Gram-positive: MRSA, many streptococci, Enterococcus including VRE.
  • Gram-negative: many Enterobacterales and anaerobes; activity can include ESBL-producing isolates.
  • Atypicals: some activity.
  • Not reliable / no activity: Pseudomonas aeruginosa, Proteus spp., Providencia spp., and Morganella morganii.
  • Low serum and urinary levels make it unsuitable as monotherapy for bacteremia, infective endocarditis, or UTI.
Approved adult uses
  1. Complicated skin and skin-structure infection
  2. Complicated intra-abdominal infection
  3. Community-acquired bacterial pneumonia
It is not indicated for diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. The current FDA prescribing information limits its use to situations where alternatives are unsuitable.
Usual adult IV dose
  • 100 mg IV loading dose, then 50 mg IV every 12 hours.
  • In severe hepatic impairment, maintenance dosing is reduced to 25 mg every 12 hours after the 100 mg loading dose.
  • Renal dose adjustment is generally not required.
Adverse effects
  • Very common: nausea and vomiting
  • Diarrhea and risk of Clostridioides difficile infection
  • Hepatic enzyme elevation and cholestatic liver injury
  • Acute pancreatitis
  • Hypersensitivity/anaphylaxis
  • Tetracycline-class effects: photosensitivity and, in children or during pregnancy, tooth discoloration and impaired enamel/bone development
  • Hypofibrinogenemia or coagulation abnormalities may occur, so monitor coagulation parameters in appropriate patients.
Major warning Tigecycline carries an FDA boxed warning for increased all-cause mortality compared with comparator antibiotics in clinical trials. The reported absolute risk difference was 0.6% (95% CI 0.1 to 1.2). Reserve it when other effective antibiotics are not appropriate, especially avoid its use for hospital-acquired or ventilator-associated pneumonia. See the FDA mortality warning.
Exam pearl:
Tigecycline covers MRSA, VRE, anaerobes, and many resistant organisms, but not Pseudomonas or Proteus. It has poor blood and urine concentrations and can cause severe nausea/vomiting plus increased mortality risk.
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