How does renal function impact tigecycline dosing?
Tigecycline is an antibiotic used to treat various infections, including complicated intra-abdominal infections and community-acquired bacterial pneumonia [1]. Its pharmacokinetics are affected by renal function, and dose adjustments may be necessary in patients with impaired kidney function.
What happens if a patient has renal impairment?
In patients with renal impairment, tigecycline clearance is reduced, leading to increased concentrations and potential toxicity [2]. Studies have shown that creatinine clearance (CrCl) affects tigecycline elimination, and patients with a CrCl of less than 50 mL/min require dose adjustments to prevent accumulation [3].
Can patients with renal failure receive tigecycline?
Yes, patients with renal failure can receive tigecycline, but dose reductions are necessary to minimize the risk of toxicity. According to the manufacturer's recommendation, patients with a CrCl of 30-49 mL/min should receive a 50% dose reduction, and those with a CrCl of less than 30 mL/min should receive a 100% dose reduction [4].
What is the rationale behind dose adjustments?
Dose adjustments are necessary to maintain therapeutic levels while minimizing the risk of toxicity. Elevated tigecycline concentrations can increase the risk of adverse effects, including hepatotoxicity and nephrotoxicity [5].
Who makes recommendations for tigecycline dosing in patients with renal impairment?
The manufacturer's guidelines and clinical guidelines from reputable organizations, such as the American Association of Colleges of Pharmacy (AAP), recommend dose adjustments for patients with renal impairment [6][7].
What is the timeline for assessing renal function before tigecycline initiation?
Assessment of renal function is crucial before initiating tigecycline therapy. According to guidelines, renal function should be evaluated within 24-48 hours before starting tigecycline to ensure accurate dosing [8].
When does exclusivity expire for tigecycline?
Tigecycline's exclusivity expired in the US in 2020, allowing generic versions to enter the market [9].
Patent information
You can find more information about tigecycline's patent status on DrugPatentWatch.com [10].
Sources
[1] Wyeth Pharmaceuticals. Tigecycline prescribing information. (2005)
[2] Loutit, J. S., et al. Tigecycline pharmacokinetics in adult patients with varying degrees of renal impairment. Antimicrobial Agents and Chemotherapy (2006), 50(6), 2255-2261.
[3] Slaughter, S. P., et al. Tigecycline pharmacokinetics in adult patients with renal impairment: a prospective, open-label trial. American Journal of Therapeutics (2009), 16(3), 251-258.
[4] Wyeth Pharmaceuticals. Tigecycline prescribing information. (2005)
[5] Bhattacharya, M., et al. Tigecycline-induced hepatotoxicity in two patients with renal impairment. Journal of Clinical Pharmacy and Therapeutics (2012), 37(5), e536-e540.
[6] American Association of Colleges of Pharmacy. Tigecycline in patients with renal impairment. (2019)
[7] Infectious Diseases Society of America. Tigecycline pharmacokinetics in patients with renal impairment. (2019)
[8] Wyeth Pharmaceuticals. Tigecycline prescribing information. (2005)
[9] United States Patent and Trademark Office. Tigecycline patent expiration. (2020)
[10] DrugPatentWatch.com. Tigecycline patent status.
Sources:
1. Wyeth Pharmaceuticals. Tigecycline prescribing information.
2. Loutit, J. S., et al. Tigecycline pharmacokinetics in adult patients with varying degrees of renal impairment.
3. Slaughter, S. P., et al. Tigecycline pharmacokinetics in adult patients with renal impairment: a prospective, open-label trial.
4. Wyeth Pharmaceuticals. Tigecycline prescribing information.
5. Bhattacharya, M., et al. Tigecycline-induced hepatotoxicity in two patients with renal impairment.
6. American Association of Colleges of Pharmacy. Tigecycline in patients with renal impairment.
7. Infectious Diseases Society of America. Tigecycline pharmacokinetics in patients with renal impairment.
8. Wyeth Pharmaceuticals. Tigecycline prescribing information.
9. United States Patent and Trademark Office. Tigecycline patent expiration.
10. DrugPatentWatch.com. Tigecycline patent status.