What is the recommended dosage and administration of tigecycline (Tygacil) for treating infections?

Tigecycline Dosing and Administration

The standard FDA-approved dosage regimen for tigecycline is an initial loading dose of 100 mg IV, followed by 50 mg IV every 12 hours, administered over 30-60 minutes. 1

Standard Dosing for Approved Indications

• For complicated skin and skin structure infections: 100 mg IV loading dose, then 50 mg IV every 12 hours for 5-14 days 1
• For complicated intra-abdominal infections: 100 mg IV loading dose, then 50 mg IV every 12 hours for 5-14 days 1
• For community-acquired bacterial pneumonia: 100 mg IV loading dose, then 50 mg IV every 12 hours for 7-14 days 1
• Intravenous infusions should be administered over approximately 30 to 60 minutes 1

Special Population Dosing Considerations

• Renal impairment: No dosage adjustment required, even for patients on continuous renal replacement therapy 2, 1
• Hepatic impairment:
  • Mild to moderate impairment (Child-Pugh A and B): No dosage adjustment needed 1
  • Severe impairment (Child-Pugh C): 100 mg IV loading dose, followed by reduced maintenance dose of 25 mg IV every 12 hours 1

Higher Dosing for Severe Infections

• For severe infections, particularly pulmonary infections or those caused by multidrug-resistant organisms, higher dosing may be warranted: 200 mg IV loading dose followed by 100 mg IV every 12 hours 2
• This high-dose regimen has shown improved clinical outcomes with cure rates of 85% compared to 69.6% with standard dosing in hospital-acquired pneumonia 2

Specific Clinical Scenarios

• For carbapenem-resistant Enterobacterales (CRE) infections: Tigecycline can be used in combination therapy with polymyxins or meropenem, with a recommended dose of 100 mg IV loading dose, then 50 mg IV every 12 hours 3, 2
• For vancomycin-resistant Enterococci (VRE) complicated intra-abdominal infections: 100 mg IV loading dose, then 50 mg IV every 12 hours 3, 2
• For Acinetobacter baumannii infections: Standard dosing is appropriate for approved indications, but higher doses may be needed for severe infections 3, 2

Preparation and Administration

• Reconstitute each vial with 5.3 mL of 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, or Lactated Ringer's Injection, USP to achieve a concentration of 10 mg/mL 1
• Withdraw 5 mL of the reconstituted solution and add to a 100 mL intravenous bag for infusion 1
• The maximum concentration in the intravenous bag should be 1 mg/mL 1
• Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer's Injection, USP 1

Important Clinical Considerations

• Tigecycline should not be used as monotherapy for bacteremia due to poor outcomes with standard dosing (serum Cmax of only 0.87 mg/L) 2, 3
• For multidrug-resistant organisms, combination therapy is generally preferred over tigecycline monotherapy 2
• Tigecycline is not indicated for the treatment of diabetic foot infections or hospital-acquired/ventilator-associated pneumonia with standard dosing 1
• Duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress 1

Pharmacokinetic Considerations

• Tigecycline has a large volume of distribution, indicating extensive tissue penetration 4
• The drug has a long terminal elimination half-life (approximately 40 hours), which supports twice-daily dosing 4
• Standard dosing may be insufficient for bloodstream infections due to low serum concentrations 2
• For difficult-to-treat infections with higher MICs, increased dosing regimens may be necessary to achieve adequate PK/PD targets 5, 6