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Impact of rokitamycin, a new 16-membered macrolide, on serum theophylline
M Cazzola1, M G Matera, E Paternò
1Institute of Pharmacology and Toxicology, 1st Medical School, Federico II University, Naples, Italy.
Abstract:
Side effects have been observed when 14-membered macrolides, erythromycin and troleandromycin, have been prescribed concurrently in patients receiving therapeutic doses of theophylline. Rokitamycin is a new 16-membered macrolide antibiotic. We have evaluated its effect on theophylline serum concentrations in 12 adult patients suffering from chronic obstructive pulmonary disease. Initially, six patients were treated for four consecutive days with theophylline as sustained-release formulation in the amount of 600 mg daily; six other patients received for four consecutive days a short term intravenous infusion of 240 mg aminophylline, given over a period of 30 min twice daily. On the last day, blood samples were taken for theophylline determination. Theophylline concentrations were measured serially for 12 hours after oral formulation and 4 hours after aminophylline by enzyme immunoassay technique. Subsequently, while theophylline and aminophylline treatments were continued at the same dosage, each patient received in addition rokitamycin tablets, 400 mg every 12 hours. After seven days of this combined medication, the serial assays of serum theophylline were repeated at the same time intervals as before. Concomitant administration of therapeutic doses of rokitamycin did not affect significantly the steady-state pharmacokinetics of oral theophylline and did not alter the (pseudo-) steady-state pharmacokinetics of intravenous aminophylline, showing that the two drugs may be coadministered without any theophylline dose adjustment.
Insights
This study found that rokitamycin, a 16-membered macrolide antibiotic, does not significantly alter theophylline serum concentrations in patients with chronic obstructive pulmonary disease. Therefore, rokitamycin and theophylline can be safely coadministered without dose adjustments.
Area of Science:
- Pharmacology
- Clinical Medicine
- Antibiotic Research
Background:
- 14-membered macrolides can interact with theophylline, causing adverse effects.
- Rokitamycin is a novel 16-membered macrolide antibiotic.
- Investigating rokitamycin's interaction with theophylline is crucial for patient safety.
Purpose of the Study:
- To evaluate the effect of rokitamycin on theophylline serum concentrations.
- To determine if rokitamycin and theophylline can be safely coadministered.
- To assess the impact of rokitamycin on the pharmacokinetics of oral theophylline and intravenous aminophylline.
Main Methods:
- 12 adult patients with chronic obstructive pulmonary disease were enrolled.
- Patients received either oral theophylline or intravenous aminophylline.
- Theophylline serum concentrations were measured before and after coadministration with rokitamycin (400 mg every 12 hours) for seven days.
- Enzyme immunoassay technique was used for theophylline determination.
Main Results:
- Concomitant administration of rokitamycin did not significantly affect the steady-state pharmacokinetics of oral theophylline.
- Rokitamycin did not alter the (pseudo-) steady-state pharmacokinetics of intravenous aminophylline.
- No significant changes in theophylline serum concentrations were observed.
Conclusions:
- Rokitamycin can be safely coadministered with therapeutic doses of theophylline.
- Theophylline dose adjustment is not necessary when combined with rokitamycin.
- This finding supports the safe use of rokitamycin in patients requiring theophylline therapy.