Juon AM, Nikolaus Kühn-Velten W, Burkhardt T, Krähenmann F, Zimmermann R, von Mandach U
Nifedipine gastrointestinal therapeutic system (GITS) as an alternative to slow-release for tocolysis-Tolerance and pharmacokinetic profile. [JOURNAL ARTICLE]
Eur J Obstet Gynecol Reprod Biol 2008 Apr 2.
OBJECTIVE: To determine nifedipine plasma concentrations after a loading dose of nifedipine 10mg capsules, 40mg over 1h followed by slow-release tablets (60mg/d) versus gastrointestinal therapeutic system (GITS) tablets (90mg/d) for tocolysis.
STUDY DESIGN: Prospective study in 14 pregnant women treated for threatened preterm labor.
RESULTS: Following capsule administration there was a rapid rise in plasma concentration of drug achieving a peak of 97.5mug/l (median) at 1h, then declined to 59.5mug/l (median) at 5h. The concentration measured at 7200min (120h) was non-significantly higher in the slow-release group (median 25.5, range 6.9-67.2mug/l) than in the GITS group (median 14.6, range 6.0-20.0mug/l). Area under the curve (AUC) increased with the applied dose in both groups in a linear regression. Headache was more frequent in the slow-release group than in the GITS group (P=0.001).
CONCLUSIONS: GITS tablets 90mg/d are an alternative dosage regimen to previous used slow-release tablets 60mg/d for tocolysis with similar pharmacokinetic profile and a good tolerance. However, tocolysis with GITS tablets is simpler than that with slow-release tablets and may be associated with a higher compliance. GITS tablets are therefore also qualified for home monitoring.
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