What is the recommended intravenous dosing and administration method for tigecycline in adults (including for complicated intra‑abdominal infections) and children, and how should the dose be adjusted in severe hepatic impairment?

Tigecycline Administration Method

Tigecycline is administered intravenously with a 100 mg loading dose infused over 30–60 minutes, followed by 50 mg every 12 hours, with dose reduction to 25 mg every 12 hours required only in severe hepatic impairment (Child-Pugh C). 1

Standard Adult Dosing and Administration

• The FDA-approved regimen consists of an initial 100 mg IV loading dose, followed by 50 mg IV every 12 hours. 1
• Each infusion should be administered over approximately 30 to 60 minutes. 1
• Treatment duration is 5–14 days for complicated skin/soft tissue infections and complicated intra-abdominal infections, and 7–14 days for community-acquired bacterial pneumonia. 1

Preparation and Reconstitution

• Reconstitute each vial with 5.3 mL of 0.9% sodium chloride, 5% dextrose, or lactated Ringer's solution to achieve a concentration of 10 mg/mL. 1
• Withdraw 5 mL of reconstituted solution and add to a 100 mL IV bag (use two vials for 100 mg dose, one vial for 50 mg dose). 1, 2
• The maximum concentration in the IV bag should be 1 mg/mL. 1
• The reconstituted solution should appear yellow to orange; discard if green or black discoloration is present. 1

Storage Stability

• Once reconstituted, tigecycline may be stored at room temperature (≤25°C/77°F) for up to 24 hours total (up to 6 hours in the vial and remaining time in the IV bag). 1
• Alternatively, when mixed with 0.9% sodium chloride or 5% dextrose, it may be refrigerated at 2–8°C (36–46°F) for up to 48 hours following immediate transfer to the IV bag. 1

Dose Adjustment in Severe Hepatic Impairment

• No dose adjustment is required for mild to moderate hepatic impairment (Child-Pugh A and B). 1
• In severe hepatic impairment (Child-Pugh C), reduce the maintenance dose by 50% to 25 mg IV every 12 hours after the standard 100 mg loading dose. 1, 3
• This adjustment is based on pharmacokinetic data showing tigecycline clearance decreases from approximately 30 L/h in healthy individuals to 13.5 L/h in Child-Pugh C patients. 3, 4
• Patients with severe hepatic impairment should be monitored closely for treatment response. 1

Renal Impairment

• No dose adjustment is necessary for any degree of renal impairment, including patients on continuous renal replacement therapy. 1, 4

Pediatric Dosing (Use Only When No Alternatives Exist)

• Tigecycline should be avoided in pediatric patients unless no alternative antibacterial drugs are available, due to increased mortality risk observed in adults. 1
• Ages 8–11 years: 1.2 mg/kg IV every 12 hours (maximum 50 mg per dose). 1, 2
• Ages 12–17 years: Adult dosing (100 mg loading dose, then 50 mg every 12 hours). 1, 2
• Contraindicated in children younger than 8 years due to risk of permanent tooth discoloration. 4

Specific Clinical Scenarios for Complicated Intra-Abdominal Infections

• For community-acquired intra-abdominal infections in patients at risk for ESBL-producing Enterobacteriaceae, use standard dosing: 100 mg IV loading dose, then 50 mg every 12 hours. 5
• For carbapenem-resistant Enterobacterales (CRE) complicated intra-abdominal infections, use standard dosing (100 mg loading, then 50 mg every 12 hours) for 5–7 days, often in combination with colistin or meropenem. 5, 4
• For vancomycin-resistant Enterococci (VRE) complicated intra-abdominal infections, use standard dosing: 50 mg IV every 12 hours after 100 mg loading dose for 5–7 days. 5, 4

Important Monitoring and Safety Considerations

• Monitor coagulation parameters (PT and aPTT) as tigecycline can prolong clotting times. 4, 2
• Monitor liver function tests periodically, as elevated hepatic enzymes have been reported. 4
• Monitor for hypoglycemia and hypoproteinemia, which have been observed during therapy. 4
• Tigecycline may be administered through a dedicated IV line or through a Y-site. 1

Contraindications

• Known hypersensitivity to tigecycline or any tetracycline class antibiotic. 4
• Pregnancy and breastfeeding (animal studies demonstrated fetal harm). 4
• Children under 8 years of age (risk of permanent tooth discoloration). 4

Common Pitfalls to Avoid

• Do not use tigecycline as monotherapy for bacteremia due to poor serum concentrations with standard dosing. 4
• The most common adverse events are gastrointestinal: nausea (28.5%), vomiting (19.4%), and diarrhea (11.6%). 6
• Higher mortality has been observed with tigecycline compared to comparator antibiotics in some clinical studies, particularly in hospital-acquired or ventilator-associated pneumonia. 2, 1