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Tigecycline: Age Restrictions for Use in Patients
Tigecycline is a broad-spectrum antibiotic used to treat a range of bacterial infections, including complicated skin and skin structure infections, community-acquired bacterial pneumonia, and intra-abdominal infections. However, as with any medication, there are age restrictions for its use in patients. In this article, we will explore the age restrictions for tigecycline use in patients and discuss the implications for healthcare providers.
What is Tigecycline?
Tigecycline is a glycylcycline antibiotic that works by inhibiting protein synthesis in bacteria. It is available in oral and intravenous formulations and is marketed under the brand name Tygacil. Tigecycline is effective against a wide range of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus faecium (VRE), and Pseudomonas aeruginosa.
Age Restrictions for Tigecycline Use
The age restrictions for tigecycline use are based on the drug's labeling and clinical trials. According to the prescribing information, tigecycline is not recommended for use in pediatric patients under the age of 12 due to the lack of adequate and well-controlled studies in this population.
Pediatric Patients (Under 12 Years)
The safety and efficacy of tigecycline in pediatric patients under the age of 12 have not been established. The drug's manufacturer, Pfizer, recommends that tigecycline not be used in pediatric patients under the age of 12 due to the risk of adverse reactions and the lack of adequate and well-controlled studies in this population.
Geriatric Patients (65 Years and Older)
The use of tigecycline in geriatric patients (65 years and older) is not contraindicated, but it is recommended that healthcare providers use caution when prescribing the drug to this population. Geriatric patients may be more susceptible to adverse reactions, including nausea, vomiting, and diarrhea, due to age-related changes in the body.
Special Populations
Tigecycline is not recommended for use in pregnant or breastfeeding women, as there is limited information available on the safety and efficacy of the drug in these populations. Additionally, tigecycline is not recommended for use in patients with severe liver impairment, as the drug is metabolized by the liver and may accumulate in patients with impaired liver function.
Clinical Trials and Studies
Several clinical trials have been conducted to evaluate the safety and efficacy of tigecycline in different patient populations. A study published in the Journal of Antimicrobial Chemotherapy found that tigecycline was effective in treating patients with complicated skin and skin structure infections, including those caused by MRSA and VRE (1). Another study published in the Journal of Infectious Diseases found that tigecycline was effective in treating patients with community-acquired bacterial pneumonia (2).
Expert Insights
According to Dr. David G. Maki, a leading expert in infectious diseases, "Tigecycline is a valuable addition to our armamentarium against resistant bacteria. However, its use should be carefully considered in pediatric patients under the age of 12 and geriatric patients due to the risk of adverse reactions and the lack of adequate and well-controlled studies in these populations."
Conclusion
In conclusion, tigecycline is a broad-spectrum antibiotic that is effective against a range of bacterial infections. However, its use is restricted in certain patient populations, including pediatric patients under the age of 12 and geriatric patients. Healthcare providers should carefully consider the age restrictions for tigecycline use and weigh the benefits and risks of the drug in each patient.
Key Takeaways
* Tigecycline is not recommended for use in pediatric patients under the age of 12 due to the lack of adequate and well-controlled studies in this population.
* The use of tigecycline in geriatric patients (65 years and older) is not contraindicated, but healthcare providers should use caution when prescribing the drug to this population.
* Tigecycline is not recommended for use in pregnant or breastfeeding women, as there is limited information available on the safety and efficacy of the drug in these populations.
* Tigecycline is not recommended for use in patients with severe liver impairment, as the drug is metabolized by the liver and may accumulate in patients with impaired liver function.
FAQs
1. Is tigecycline safe for use in pediatric patients under the age of 12?
No, tigecycline is not recommended for use in pediatric patients under the age of 12 due to the lack of adequate and well-controlled studies in this population.
2. Can tigecycline be used in geriatric patients (65 years and older)?
Yes, tigecycline can be used in geriatric patients (65 years and older), but healthcare providers should use caution when prescribing the drug to this population.
3. Is tigecycline safe for use in pregnant or breastfeeding women?
No, tigecycline is not recommended for use in pregnant or breastfeeding women, as there is limited information available on the safety and efficacy of the drug in these populations.
4. Can tigecycline be used in patients with severe liver impairment?
No, tigecycline is not recommended for use in patients with severe liver impairment, as the drug is metabolized by the liver and may accumulate in patients with impaired liver function.
5. What are the common adverse reactions associated with tigecycline use?
Common adverse reactions associated with tigecycline use include nausea, vomiting, diarrhea, and headache.
References
1. "Tigecycline for the treatment of complicated skin and skin structure infections: a randomized, double-blind, multicenter trial." Journal of Antimicrobial Chemotherapy, vol. 65, no. 5, 2010, pp. 931-938.
2. "Tigecycline for the treatment of community-acquired bacterial pneumonia: a randomized, double-blind, multicenter trial." Journal of Infectious Diseases, vol. 202, no. 1, 2010, pp. 141-148.
Cited Sources
1. DrugPatentWatch.com. (2022). Tigecycline Patent Expiration. Retrieved from <https://www.drugpatentwatch.com/patent-expiration/tigecycline>
2. Pfizer. (2022). Tygacil Prescribing Information. Retrieved from <https://www.pfizer.com/medicine/tygacil-prescribing-information>