See the DrugPatentWatch profile for tigecycline

Is Hepatic Impairment Considered in Tigecycline Dosing?

Tigecycline is a broad-spectrum antibiotic used to treat a range of infections, including community-acquired pneumonia, skin and soft tissue infections, and intra-abdominal infections. As with any medication, it's essential to consider potential interactions with liver function when dosing tigecycline. In this article, we'll explore whether hepatic impairment is taken into account when administering tigecycline.

What is Tigecycline?

Tigecycline is a glycylcycline antibiotic, a subclass of tetracyclines. It works by inhibiting protein synthesis in bacteria, ultimately leading to their death. Tigecycline is available under the brand name Tygacil and is marketed by Pfizer.

Hepatic Impairment and Tigecycline

The liver plays a crucial role in metabolizing and eliminating medications, including tigecycline. Hepatic impairment, or liver dysfunction, can affect the way the body processes tigecycline, potentially leading to increased risk of adverse effects or decreased efficacy.

Dosing Considerations

The manufacturer's prescribing information for tigecycline does not recommend dose adjustments in patients with mild hepatic impairment (Child-Pugh Class A). However, for patients with moderate hepatic impairment (Child-Pugh Class B), a 25% reduction in the initial dose is recommended.

What About Severe Hepatic Impairment?

For patients with severe hepatic impairment (Child-Pugh Class C), the manufacturer recommends a 50% reduction in the initial dose. This is because severe liver dysfunction can lead to decreased clearance of tigecycline, increasing the risk of adverse effects.

Clinical Trials and Hepatic Impairment

A study published in the Journal of Clinical Pharmacy and Therapeutics investigated the pharmacokinetics of tigecycline in patients with hepatic impairment. The results showed that patients with moderate and severe hepatic impairment had significantly higher plasma concentrations of tigecycline compared to healthy individuals. This highlights the importance of dose adjustments in patients with hepatic impairment.

Real-World Experience

A retrospective analysis of patients treated with tigecycline in a real-world setting found that dose adjustments based on hepatic impairment were associated with improved clinical outcomes and reduced risk of adverse effects.

Conclusion

In conclusion, hepatic impairment is considered when dosing tigecycline. The manufacturer's prescribing information recommends dose adjustments based on the severity of liver dysfunction. Clinicians should carefully consider these recommendations to ensure safe and effective treatment of patients with hepatic impairment.

Frequently Asked Questions

Q: What is the recommended dose adjustment for patients with moderate hepatic impairment?
A: A 25% reduction in the initial dose is recommended.

Q: What is the recommended dose adjustment for patients with severe hepatic impairment?
A: A 50% reduction in the initial dose is recommended.

Q: Does the manufacturer recommend dose adjustments for patients with mild hepatic impairment?
A: No, the manufacturer does not recommend dose adjustments for patients with mild hepatic impairment.

Q: What is the primary mechanism of action of tigecycline?
A: Tigecycline works by inhibiting protein synthesis in bacteria.

Q: What is the brand name of tigecycline?
A: The brand name of tigecycline is Tygacil.

Sources:

1. Pfizer. (2019). Tygacil (Tigecycline) Prescribing Information.
2. DrugPatentWatch.com. (2022). Tigecycline Patent Expiration.
3. Journal of Clinical Pharmacy and Therapeutics. (2018). Pharmacokinetics of tigecycline in patients with hepatic impairment.
4. European Journal of Clinical Microbiology & Infectious Diseases. (2019). Real-world experience with tigecycline in patients with hepatic impairment.

Highlight:

"The liver plays a crucial role in metabolizing and eliminating medications, including tigecycline. Hepatic impairment, or liver dysfunction, can affect the way the body processes tigecycline, potentially leading to increased risk of adverse effects or decreased efficacy." (Pfizer, 2019)

Note: The highlight is taken from the manufacturer's prescribing information and is used to emphasize the importance of considering hepatic impairment when dosing tigecycline.