For the treatment of infections caused by susceptible microorganisms in the complicated skin and skin structure infections and complicated intra-abdominal infections for patients 18 years of age or older.

Tigecycline, a bacteriostatic glycylcycline, is a derivative of minocycline. It inhibits protein synthesis in susceptible bacteria by reversibly binding to 30S ribosomal subunit, thereby blocking entry of amino-acyl Trna molecules into the A site of the ribosome. Tigecycline has a broad spectrum of antibacterial activity. Tigecycline ’s role in therapy is an alternative treatment for severely ill patients, especially with resistant infections. But, tigecycline is not active against Pseudomonas aeruginosa, Proteus mirabilis, and Providencia species.

Tigecycline is extensively distributed into various tissues (Vd: 7-9 L/kg); protein binding: 71-89%; tigecycline is not extensively metabolized; primarily eliminated by biliary and fecal excretion (59%) as unchanged form and metabolites; 33% is eliminated in urine (22% as unchanged drug); in severe hepatic impairment, the clearance of tigecycline is reduced by 55%; Elimination half-life: 42.4hr, prolonged by 43% in severe hepatic impairment; tigecycline is not dialyzable by hemodialysis.

Hypersensitivity to Tigecycline.

D

Excretion in maternal milk unknown/ use caution.

Nausea (29.5%), vomiting (15.8 %), diarrhea (13%)

Adults: initial dose 100 mg, followed by 50 mg IV every 12 hours. Intravenous (IV) infusions should be administered over 30 to 60 minutes.
Pediatrics: tigecycline is not recommended in patients under 18 years old.

General dosing, bacterial infection:
Limited data available: Use should be reserved for situations when no effective alternative therapy is available and when benefits are expected to outweigh risks. Duration of therapy dependent on severity and site of infection and response to therapy.
● Infants and Children <8 years:
Use in in patients <8 years is not recommended due to adverse effects on tooth development and uncertain dosing; however, use has been described in scenarios where alternative options were unavailable.

Dose:
IV: 1.5 to 2 mg/kg loading dose once, then 1 to 2 mg/kg/dose every 12 hours; maximum dose: 50 mg/dose.Higher loading doses of up to 4 mg/kg/dose have also been reported to treat multidrug resistant gram-negative bacteria.

● Children 8 years and Adolescents:
IV: 1.5 to 2 mg/kg loading dose once, then 1.2 to 2 mg/kg/dose every 12 hours; usual maximum dose: 50 mg/dose. A higher dose (4 mg/kg loading dose [maximum dose: 200 mg/dose], followed by 2 to 3.2 mg/kg/dose [maximum dose: 100 mg/dose] every 12 hours) has been suggested to mimic high-dose therapy used in adults, particularly for infections caused by carbapenem-resistant Enterobacterales infections.

Mycobacterial infection, nontuberculous; pulmonary:
Use as part of an appropriate combination regimen; typically treat 12 months after culture conversion.
● Children 8 to <12 years:
IV: 1.2 mg/kg/dose every 12 hours; maximum dose: 50 mg/dose.

● Children 12 years and Adolescents:
IV: 100 mg loading dose once, followed by 50 mg every 12 to 24 hours. A reduced dosage regimen of 50 mg every 24 hours or 25 mg every 12 to 24 hours may be considered in patients who do not tolerate higher doses.

No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.

Initial or dose adjustment in patients with preexisting liver cirrhosis:
Child-Turcotte-Pugh class A and B: No dosage adjustment necessary.
Child-Turcotte-Pugh class C:
● Loading dose: No dosage adjustment necessary.
● Maintenance dose: IV: Administer 50% of indication-specific maintenance dose.

Stable in NS or D5W. The reconstituted solution must be immediately transferred and further diluted in 100 ml NS or D5W for IV infusion安定性：室溫：6 hrs (輸注液)；冷藏(2-8℃)：24 hrs (輸注液)