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Theophylline Content on Serum in Patient with Chronic Bronchiale Asthma after Euphilline Retard Administration (Kadar Mantap teofilin dalam Serum Penderita Asma Bronkial Kronik setelah Pemberian Tablet Euphyllin (R) Retard)

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Euphillin (R) retard (EN) is a slow-release preparation of theophylline marketed in Indonesia. The usual dose for patients with chronic bronchial asthma is 1 tablet twice daily. Information on the steady-state serum concentration of theophylline after ER administration is still lacking. This information is important because theophylline has a narrow margin of safety and a large inter-and intra-individual variation in reaching the serum levels. The present study is aimed to find out the steady-state serum concentration of theophylline after ER administration at the usual dose, percentage of patients reaching the therapeutic level and the correlation between the serum concentration and the dose of theophyline. The study was carried out in 53 patients with chronic bronchial asthma who visited the Asthma Clinic of the Pulmonology Department, Persahabatan Hospital, Jakarta, consisting of 38 males and 15 females, aged 17-52 years, height 140.5-178.0 cm, and weight 31-73 kg. Thirteen patients received Euphyllin (R) retard mite (ERM), containing 128 mg of theophylline/tablet, and 40 patients received Euphyllin(R) retard (ER), containing 256 mg of theophyline/tablet. The drug was given daily, after breakfast and dinner, for 3 days. On day 4, vein blood samples were taken just before the morning dose and hours there after, in order to obtain the peak and through steady-state theophylline concentrations. The serum concentrations of theophyline were measured by fluorescence polarization immunoassay using TDx (Abbott). In all 53 patients, the mean theophylline dose was 8.91 (SD 2.44) mg/kg BW/day, resulting in mean peak and through steady-state serum theophylline concentrations of 13.17 (SD 6.10) ug/ml and 8.95 (SD 3.99) ug/ml, respectively. In 40 patients receiving ER 2 x 1 tablet, equivalent to mean theophylline dose of 9.94 (SD 1.78) mg/kg BW/day, the mean peak and through steady-state concentrations were 14.97 (SD 5.20) ug/ml and 9.87 (SD 3.54) ug/ml, respectively. A therapeutic level of 10-20 ug/ml was attained by 14 patients (26.4 percent), 1 patient received ERM (7.7 percent) and 13 patients got ER (32.5 percent). Therapeutic level of 8-20 ug/ml were found in 23 patients (42.4 percent), 1 patient received ERM (7.7 percent) and the 22 patients received ER (55.0 percent). Among 40 patients receiving ER, the theophylline dose ranged between 6.74 and 12.80 mg/kg BW/day (a variation of 1.9 times), but the peak levels ranged from 6.19 to 26.43 ug/ml (varied 4.3 times) and the through levels from 4.27 to 17.83 ug/ml (varied 4.2 times). The theophylline dose per kg BW/day correlated with the peak steady-state serum concentration (r=0.496; p less than 0.001) as well as the through level (r = 0.347; p less than 0.01). From the results of the present study, conducted in 53 adult patients with chronic bronchial asthma, it is concluded that : (a) Theophylline dose from EMR 2 x 1 tablet daily is not adequate, while ER 2 x 1 tablet reached a therapeutic level of 8-20 ug/ml in 55.0 percent of patients. (b) Administration of a slow-release theophylline preparation results in a large interindividual variation in the serum concentrations of theophylline, so that monitoring of the serum theophylline concentration would still be required. (c) The theophylline dose calculated per kg BW/day correlates with its serum concentration.

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Majalah Farmakologi dan Terapi Indonesia,12(2)1996

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: ., 1996

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asthma
theophylline

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