[Evaluation of biological availability and anti-arrhythmic effect of a new drug Phenytoinum "Polfa"].
Studies were performed in 15 patients with ventricular arrhythmia. During the first day, the patients received 1000 mg of a new micronised form of Phenytoinum "Polfa" or adequate dose of a foreign drug in 3 doses every 3 hours and subsequently during 10 days alternatively native or foreign drug in a daily dose 300 mg. Twenty-four EKG Holter monitoring and determination of serum drug level were carried out after a 10-day treatment; area under the curve (AUC) in one 8 h dose interval was determined. Studies have shown usefulness of a new form of Phenytoinum (Polfa). Blood serum drug levels near to the therapeutic ones were observed. Steady-state Phenytoinum concentration was 11.1 +/- 5.9 micrograms/ml and after foreign drug it was 11.7 +/- 6.1 micrograms/ml, AUC0-8 was 90.4 and 105.3 micrograms/ml/h respectively. In 9/15 patients (60%) Phenytoinum (Polfa) produced substantial improvement in the cardiac arrhythmia.
Wierzchowiecki
M
M
Z II Klinik Kardiologii Instytutu Kardiologii, Zakładu Farmacji Klinicznej Katedry Technologii Postaci Leku i Biofarmacji AM w Poznaniu.
Masiakowski
J
J
Michalski
M
M
Juszczak
A
A
Dyderski
S
S
D000328:Adult; D000368:Aged; D001682:Biological Availability; D005117:Cardiac Complexes, Premature / Q000188:drug therapy* / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010672:Phenytoin / Q000008:administration & dosage / Q000493:pharmacokinetics*; D011044:Poland
D010672:Phenytoin
Ocena dostepności biologicznej i działania przeciwarytmicznego nowego preparatu Phenytoinum "Polfa".