High dose intermittent ticarcillin-clavulanate administration in pediatric cystic fibrosis patients
Jeffery T Zobell1, Krow Ampofo, Jared Cash
1Pharmacy, Intermountain Primary Children's Medical Center, 100 North Mario Capecchi Drive, Salt Lake City, UT 84113, USA. Jeffery.zobell@imail.org
Insights
Higher doses of ticarcillin-clavulanate are safe for pediatric cystic fibrosis patients. This study found no significant adverse effects in patients receiving higher than recommended ticarcillin-clavulanate dosages.
Area of Science:
- Pediatric pharmacology
- Infectious disease management
- Cystic Fibrosis therapeutics
Background:
- The Intermountain Cystic Fibrosis Pediatric Center uses a ticarcillin-clavulanate dosing regimen higher than FDA and CFF guidelines.
- This regimen involves 400mg/kg/day divided every 6 hours, with a maximum of 24g/day.
Purpose of the Study:
- To evaluate the safety of the higher-than-recommended ticarcillin-clavulanate dosing regimen in pediatric cystic fibrosis patients.
- To determine if this intensive dosing impacts key laboratory safety parameters.
Main Methods:
- Retrospective analysis of pediatric cystic fibrosis patients (CF) admitted between January 1, 2005, and December 31, 2009.
- Inclusion criteria required patients to receive the specified ticarcillin-clavulanate regimen for at least 7 days.
- Collected and analyzed baseline and follow-up laboratory data, including liver function tests, white blood cell count, platelet count, and serum creatinine.
Main Results:
- 127 pediatric CF patients met the study criteria.
- Mean ticarcillin dose was 3.5g every 6 hours, totaling 13.5g daily.
- No significant changes were observed in liver function tests, white blood cell count, or platelet count. Serum creatinine showed a statistically significant decrease.
Conclusions:
- The higher-than-FDA-approved doses of ticarcillin-clavulanate demonstrate a safe profile for treating exacerbations in pediatric cystic fibrosis patients.
- The observed decrease in serum creatinine warrants further investigation but did not indicate nephrotoxicity in this cohort.
Background:
The Intermountain Cystic Fibrosis Pediatric Center utilizes ticarcillin-clavulanate 400mg/kg/day divided every 6h, (maximum 24 g/day). This dosing strategy is higher than the Cystic Fibrosis Foundation (CFF) recommendations and the Food and Drug Administration (FDA) approved package labeling. The purpose is to determine the safety of this dosing regimen.
Methods:
A retrospective study of pediatric cystic fibrosis (CF) patients admitted from January 1, 2005 to December 31, 2009 who received the dosing regimen for at least 7 days. Baseline and follow-up laboratory parameters were recorded. Statistical analysis was performed.
Results:
127 patients met inclusion criteria. The mean (+ or - SD) ticarcillin dose was 3.5 g (+ or - 2.16) every 6 h; while the mean (+ or - SD) total ticarcillin dose was 13.5 g (+ or - 6.5) per day. No significant differences occurred in liver function tests, white blood count, and platelet count from baseline. Serum creatinine showed a statistically significant decrease from baseline.
Conclusions:
Higher than FDA approved doses of ticarcillin-clavulanate may be safely used in the treatment of exacerbations in pediatric cystic fibrosis patients.
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