What is the recommended tigecycline dosing regimen for an adult without renal or hepatic failure, and how should the dose be adjusted for severe hepatic impairment (Child‑Pugh class C), mild‑to‑moderate renal or hepatic dysfunction, and for adolescents (≥12 years) or children weighing at least 30 kg?

Tigecycline Dosing

For adults without renal or hepatic impairment, administer tigecycline as a 100 mg IV loading dose followed by 50 mg IV every 12 hours over 30-60 minutes. 1

Standard Adult Dosing (Normal Organ Function)

• Loading dose: 100 mg IV infused over 30-60 minutes 1
• Maintenance dose: 50 mg IV every 12 hours 1
• Treatment duration:
  • Complicated skin/skin structure infections and complicated intra-abdominal infections: 5-14 days 1
  • Community-acquired bacterial pneumonia: 7-14 days 1

Dose Adjustment for Severe Hepatic Impairment (Child-Pugh Class C)

Patients with severe hepatic impairment (Child-Pugh C) require a 50% dose reduction in the maintenance dose. 1

• Loading dose: 100 mg IV (unchanged) 1
• Maintenance dose: 25 mg IV every 12 hours 1, 2
• Tigecycline clearance is reduced by approximately 55% in Child-Pugh C patients, necessitating this dose reduction 2, 3
• These patients should be monitored closely for treatment response 1

Mild-to-Moderate Hepatic Impairment (Child-Pugh A and B)

No dosage adjustment is required for patients with mild to moderate hepatic impairment. 1

• Use standard dosing: 100 mg loading dose, then 50 mg every 12 hours 1, 4
• Tigecycline clearance in Child-Pugh A patients (31.2 L/h) is comparable to healthy subjects (29.8 L/h) 2
• Child-Pugh B patients show only modest reduction in clearance (22.1 L/h) that does not warrant dose adjustment 2

Renal Impairment (All Degrees)

No dosage adjustment is necessary for any degree of renal impairment, including patients on hemodialysis. 1, 5

• Renal clearance represents only approximately 20% of total tigecycline systemic clearance 5
• In severe renal impairment (CrCl <30 mL/min), tigecycline clearance is reduced by only 20% and AUC increases by approximately 30%—changes not clinically significant enough to warrant dose adjustment 5
• Tigecycline is not efficiently removed by hemodialysis and can be administered without regard to timing of dialysis 5
• Use standard dosing: 100 mg loading dose, then 50 mg every 12 hours 1

Pediatric Dosing (≥12 Years or ≥30 kg)

Tigecycline should be avoided in pediatric patients unless no alternative antibacterial drugs are available due to increased mortality risk observed in adults. 1

When no alternatives exist:

• Ages 12-17 years: 50 mg IV every 12 hours 1, 6
• Ages 8-11 years: 1.2 mg/kg IV every 12 hours (maximum 50 mg per dose) 1, 6
• The safety and efficacy of these pediatric regimens have not been formally established 1
• No data exist to guide dosing in pediatric patients with hepatic impairment 1

Critical Clinical Considerations

High-Dose Tigecycline in Severe Infections

• For critically ill patients with carbapenem-resistant infections, high-dose tigecycline (200 mg loading dose, then 100 mg every 12 hours) in combination therapy has shown significantly lower mortality compared to standard dosing 6
• High-dose regimens reduced mortality in carbapenem-resistant bacterial infections (OR 0.20,95% CI 0.09-0.45) 6
• No difference in adverse event incidence between high-dose and standard-dose regimens 6

Important Limitations

• Not indicated for hospital-acquired or ventilator-associated pneumonia due to greater mortality and decreased efficacy in comparative trials 1, 6
• Not indicated for diabetic foot infections due to failure to demonstrate non-inferiority 1
• Tigecycline achieves low serum concentrations (Cmax ≤0.87 mg/L with standard dosing), making it suboptimal for bacteremia as monotherapy 6
• Very low concentrations in endothelial lining fluid (0.01-0.02 mg/L) limit efficacy in pneumonia 6

Common Pitfalls to Avoid

• Do not reduce the loading dose in any patient population—always give 100 mg initially (except in severe hepatic impairment where only maintenance dose is reduced) 1
• Do not use tigecycline monotherapy for bloodstream infections; combination therapy is strongly preferred 6
• Do not use standard-dose tigecycline for infections caused by organisms with MIC >0.5 mg/L, as this is associated with increased mortality 6
• Most common adverse events are gastrointestinal: nausea (28.5%), vomiting (19.4%), and diarrhea (11.6%) 4