What is the recommended dose of tigecycline (Tygacil) for patients with normal renal function?

Tigecycline Dosing

The FDA-approved standard dose of tigecycline for patients with normal renal function is a 100 mg IV loading dose, followed by 50 mg IV every 12 hours, infused over 30-60 minutes. 1

Standard Dosing Regimen

• Loading dose: 100 mg IV 1
• Maintenance dose: 50 mg IV every 12 hours 1
• Infusion time: 30-60 minutes 1
• No renal dose adjustment required - tigecycline dosing remains unchanged regardless of renal function, including patients on continuous renal replacement therapy 2

Duration of Therapy by Indication

• Complicated skin and skin structure infections (cSSSI): 5-14 days 1
• Complicated intra-abdominal infections (cIAI): 5-14 days 1
• Community-acquired bacterial pneumonia (CAP): 7-14 days 1

Higher Dose Regimens for Severe Infections

While the FDA-approved standard dosing is appropriate for approved indications, higher doses may be considered for severe infections, particularly pulmonary infections:

• High-dose regimen: 200 mg IV loading dose, followed by 100 mg IV every 12 hours 2
• This higher dosing achieves cure rates of 85% compared to 69.6% with standard dosing in severe infections 2
• Higher dosing is particularly important for hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), though tigecycline is not FDA-approved for these indications due to increased mortality risk 1

Critical Dosing Considerations

Hepatic impairment dosing adjustments:

• Mild to moderate hepatic impairment (Child-Pugh A and B): No dose adjustment needed 1
• Severe hepatic impairment (Child-Pugh C): 100 mg loading dose, then reduce maintenance dose to 25 mg IV every 12 hours 1, 3

Pharmacokinetic rationale for dosing:

• Standard dosing achieves serum Cmax of only 0.87 mg/L, which may be insufficient for bloodstream infections 2
• Tigecycline has a large volume of distribution (7-9 L/kg) and long elimination half-life (42.4 hours), supporting twice-daily dosing 4
• The drug penetrates well into tissues but has low concentrations in endothelial lining fluid (0.01-0.02 mg/L), explaining lower efficacy in VAP with standard dosing 2

Important Clinical Caveats

• Tigecycline should not be used as monotherapy for bacteremia due to poor outcomes with standard dosing 2
• Increased all-cause mortality has been observed in tigecycline-treated patients versus comparators (0.6% mortality risk difference), and the drug should be reserved for situations when alternative treatments are not suitable 1
• Not indicated for diabetic foot infections - a clinical trial failed to demonstrate non-inferiority 1
• Not indicated for hospital-acquired or ventilator-associated pneumonia due to greater mortality and decreased efficacy 1
• For multidrug-resistant organisms, combination therapy is generally preferred over tigecycline monotherapy 2