From the FDA Drug Label
A single dose study compared 6 subjects with severe renal impairment (creatinine clearance < 30 mL/min), 4 end stage renal disease (ESRD) patients receiving tigecycline 2 hours before hemodialysis, 4 ESRD patients receiving tigecycline 1 hour after hemodialysis, and 6 healthy control subjects The pharmacokinetic profile of tigecycline was not significantly altered in any of the renally impaired patient groups, nor was tigecycline removed by hemodialysis. No dosage adjustment of tigecycline is necessary in patients with renal impairment or in patients undergoing hemodialysis
The recommended dosage of tigecycline for patients with impaired renal function is the same as for patients with normal renal function.
- No dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis 1.
From the Research
No dosage adjustment of tigecycline is required for patients with impaired renal function, including those with severe renal impairment or on hemodialysis. The standard recommended dosage for adults is a 100 mg initial loading dose followed by 50 mg every 12 hours administered intravenously over 30-60 minutes. This consistent dosing across renal function levels is possible because tigecycline is primarily eliminated through biliary excretion and undergoes minimal renal clearance (less than 15% of the dose is excreted unchanged in urine) 2, 3. The drug's pharmacokinetics remain largely unaltered in renal impairment, making it a suitable option for patients with kidney disease when clinically indicated. However, while no renal adjustment is needed, clinicians should still monitor these patients closely for adverse effects, particularly nausea and vomiting which are common side effects of tigecycline therapy 4, 5. Some key points to consider when using tigecycline include:
- The drug is effective against a wide range of bacteria, including those resistant to other antibiotics 6, 3
- Tigecycline has been shown to be safe and effective in the treatment of complicated skin and skin structure infections and complicated intra-abdominal infections 5
- The potential for significant drug interactions with tigecycline appears to be minimal 3
- For patients with severe hepatic impairment (Child-Pugh C), a dosage adjustment is recommended with maintenance dose reduced to 25 mg every 12 hours after the standard 100 mg loading dose. It is essential to note that tigecycline lacks activity in vitro against Pseudomonas and Proteus spp 3, and the MIC value must be determined if tigecycline is to be used in the treatment of Acinetobacter (MDR Acinetobacter, in particular) infections 5.