What is the recommended dose of tigecycline (Tygacil) for surgical prophylaxis?

Recommended Dose of Tigecycline for Surgical Prophylaxis

Tigecycline is not recommended for surgical prophylaxis as it is not FDA-approved for this indication and there are no established dosing guidelines for prophylactic use.

Approved Indications and Standard Dosing

Tigecycline (Tygacil) is FDA-approved only for the following indications in adults 18 years and older 1:

• Complicated skin and skin structure infections
• Complicated intra-abdominal infections
• Community-acquired bacterial pneumonia

The standard FDA-approved dosing regimen for these indications is:

• Initial loading dose: 100 mg IV
• Maintenance dose: 50 mg IV every 12 hours
• Duration: 5-14 days (depending on infection type)

Alternative Options for Surgical Prophylaxis

For surgical prophylaxis in intra-abdominal procedures, the following antibiotics are recommended instead 2:

Non-critically ill patients:

• Amoxicillin/clavulanate 1.2-2.2 g IV every 6 hours
• Ceftriaxone 2 g IV every 24 hours + Metronidazole 500 mg IV every 6 hours
• Cefotaxime 2 g IV every 8 hours + Metronidazole 500 mg IV every 6 hours

Critically ill patients:

• Piperacillin/Tazobactam 4.5 g IV every 6 hours
• Cefepime 2 g IV every 8 hours + Metronidazole 500 mg IV every 6 hours
• For patients at risk for ESBL-producing organisms: carbapenems (meropenem, doripenem, or imipenem/cilastatin)

Important Considerations Regarding Tigecycline Use

If tigecycline must be used for treatment (not prophylaxis) of complicated intra-abdominal infections:

1. For standard indications: The recommended dose is 100 mg IV loading dose, followed by 50 mg IV every 12 hours 1.

2. For multidrug-resistant organisms: Higher doses may be considered:

   • For infections caused by MDR A. baumannii, a high-dose regimen of 200 mg IV loading dose followed by 100 mg IV every 12 hours may be used if the tigecycline MIC is ≤1 mg/L 2, 3.

3. Pharmacokinetic considerations:

   • Tigecycline has a large volume of distribution (21.0 L/kg) 4
   • It achieves high tissue concentrations in skin and soft tissue (3.8-5.2 times serum levels) 5
   • However, it has low serum concentrations (Cmax <0.87 mg/L with standard dosing) 2

Warnings and Limitations

• Tigecycline carries an FDA black box warning regarding increased all-cause mortality compared to comparator antibiotics 1
• It should be reserved for situations when alternative treatments are not suitable 1
• Tigecycline is not recommended for bloodstream infections due to poor outcomes with standard dosing 3
• When used for treatment (not prophylaxis) of complicated intra-abdominal infections involving multidrug-resistant organisms, it should ideally be used in combination with another active agent 2

Conclusion

For surgical prophylaxis, use standard recommended prophylactic regimens rather than tigecycline. Reserve tigecycline for treatment of established infections when other options are not suitable, and follow the appropriate dosing guidelines for the specific indication.