Pharmacokinetic Characteristics of Amiodarone in Long-Term Oral Therapy in Japanese Population
To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias...
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| Published in | Biological & Pharmaceutical Bulletin Vol. 28; no. 10; pp. 1934 - 1938 |
|---|---|
| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
The Pharmaceutical Society of Japan
01.10.2005
Pharmaceutical Society of Japan Japan Science and Technology Agency |
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| Online Access | Get full text |
| ISSN | 0918-6158 1347-5215 |
| DOI | 10.1248/bpb.28.1934 |
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| Abstract | To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias. Serum amiodarone and desethylamiodarone concentrations were determined by high performance liquid chromatography system. It was observed that the amiodarone and desethylamiodarone concentrations gradually increased with time. The frequency distribution in the amiodarone clearance of 245 subjects, who received fixed maintenance amiodarone therapy for at least 6 months, was nearly a unimodal one. The variation in the ratio of desetylamiodarone to amiodarone concentration in serum was very small. Although no differences in age, dose, dose duration, amiodarone or desethyamiodarone concentration or ratio were observed between men and women: however, the mean amiodarone clearance of women was significantly higer than that of men. The laboratory data were mostly within normal values and no significant relations were observed between serum amiodarone concentration and clinical laboratory data. These results suggest that the individual variation in pharmacokinetics of amiodarone is comparatively small, which might be sufficient to decide that the maintenance dose was the same one (200 mg/d) in long-term oral amiodarone therapy. |
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| AbstractList | To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias. Serum amiodarone and desethylamiodarone concentrations were determined by high performance liquid chromatography system. It was observed that the amiodarone and desethylamiodarone concentrations gradually increased with time. The frequency distribution in the amiodarone clearance of 245 subjects, who received fixed maintenance amiodarone therapy for at least 6 months, was nearly a unimodal one. The variation in the ratio of desetylamiodarone to amiodarone concentration in serum was very small. Although no differences in age, dose, dose duration, amiodarone or desethyamiodarone concentration or ratio were observed between men and women: however, the mean amiodarone clearance of women was significantly higer than that of men. The laboratory data were mostly within normal values and no significant relations were observed between serum amiodarone concentration and clinical laboratory data. These results suggest that the individual variation in pharmacokinetics of amiodarone is comparatively small, which might be sufficient to decide that the maintenance dose was the same one (200 mg/d) in long-term oral amiodarone therapy. To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias. Serum amiodarone and desethylamiodarone concentrations were determined by high performance liquid chromatography system. It was observed that the amiodarone and desethylamiodarone concentrations gradually increased with time. The frequency distribution in the amiodarone clearance of 245 subjects, who received fixed maintenance amiodarone therapy for at least 6 months, was nearly a unimodal one. The variation in the ratio of desetylamiodarone to amiodarone concentration in serum was very small. Although no differences in age, dose, dose duration, amiodarone or desethyamiodarone concentration or ratio were observed between men and women: however, the mean amiodarone clearance of women was significantly higer than that of men. The laboratory data were mostly within normal values and no significant relations were observed between serum amiodarone concentration and clinical laboratory data. These results suggest that the individual variation in pharmacokinetics of amiodarone is comparatively small, which might be sufficient to decide that the maintenance dose was the same one (200 mg/d) in long-term oral amiodarone therapy.To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias. Serum amiodarone and desethylamiodarone concentrations were determined by high performance liquid chromatography system. It was observed that the amiodarone and desethylamiodarone concentrations gradually increased with time. The frequency distribution in the amiodarone clearance of 245 subjects, who received fixed maintenance amiodarone therapy for at least 6 months, was nearly a unimodal one. The variation in the ratio of desetylamiodarone to amiodarone concentration in serum was very small. Although no differences in age, dose, dose duration, amiodarone or desethyamiodarone concentration or ratio were observed between men and women: however, the mean amiodarone clearance of women was significantly higer than that of men. The laboratory data were mostly within normal values and no significant relations were observed between serum amiodarone concentration and clinical laboratory data. These results suggest that the individual variation in pharmacokinetics of amiodarone is comparatively small, which might be sufficient to decide that the maintenance dose was the same one (200 mg/d) in long-term oral amiodarone therapy. To evaluate the pharmacokinetic properties and an optimum dose schedule of amiodarone in long-term oral therapy, serum concentrations of amiodarone and its metabolite, desethylamiodarone, were monitored from 345 Japanese inpatients who received amiodarone therapy for a variety of cardiac arrhythmias. Serum amiodarone and desethylamiodarone concentrations were determined by high performance liquid chromatography system. It was observed that the amiodarone and desethylamiodarone concentrations gradually increased with time. The frequency distribution in the amiodarone clearance of 245 subjects, who received fixed maintenance amiodarone therapy for at least 6 months, was nearly a unimodal one. The variation in the ratio of desetylamiodarone to amiodarone concentration in serum was very small. Although no differences in age, dose, dose duration, amiodarone or desethyamiodarone concentration or ratio were observed between men and women：however, the mean amiodarone clearance of women was significantly higher than that of men. The laboratory data were mostly within normal values and no significant relations were observed between serum amiodarone concentration and clinical laboratory data. These results suggest that the individual variation in pharmacokinetics of amiodarone is comparatively small, which might be sufficient to decide that the maintenance dose was the same one (200 mg/d) in long-term oral amiodarone therapy. |
| Author | Kashima, Asami Kitakaze, Masafumi Kamakura, Shiro Funahashi, Miho Ueno, Kazuyuki Fukumoto, Kyoko Komamura, Kazuo |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/16204949$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1007_s00508_008_1017_2 crossref_primary_10_1016_j_taap_2009_07_005 crossref_primary_10_1097_FTD_0b013e318239a728 crossref_primary_10_5507_bp_2017_016 crossref_primary_10_1016_j_ejps_2006_11_006 crossref_primary_10_1111_ctr_13779 crossref_primary_10_3851_IMP2715 crossref_primary_10_1016_j_amjmed_2015_08_039 crossref_primary_10_1007_s40261_017_0582_4 crossref_primary_10_1111_j_1365_2710_2008_00987_x crossref_primary_10_1089_thy_2007_0215 crossref_primary_10_3389_fneur_2018_00119 crossref_primary_10_1016_j_tiv_2013_06_024 crossref_primary_10_1002_pds_4851 crossref_primary_10_2165_00044011_200828090_00002 crossref_primary_10_1007_s00228_017_2195_5 crossref_primary_10_2196_43734 |
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| References | 1) Singh B. N., Clin. Cardiol., 20, 608—618 (1997). 16) Funck-Brentano C., Becquemont L., Kroemer H. K., Buhl K., Knebel N. G., Eichelbaum M., Jaillon P., Clin. Pharmacol. Ther., 55, 256—269 (1994). 26) Shimada T., Yamazaki H., Mimura M., Inui Y., J. Pharmacol. Exp. Ther., 270, 414—423 (1994). 18) Chitwood K. K., Abdul-Haqq A. J., Heim-Duthoy K. L., Ann. Pharmacother., 27, 569—571 (1993). 12) Nolan P. E., Jr., Erstad B. L., Hoyer G. L., Bliss M., Gear K., Marcus F. I., Am. J. Cardiol., 65, 1252—1257 (1990). 13) Nolan P. E., Jr., Marcus F. I., Hoyer G. L., Bliss M., Gear K., Clin. Pharmacol. Ther., 46, 43—50 (1989). 15) Haefeli W. E., Bargetzi M. J., Follath F., Meyer U. A, J. Cardiovasc. Pharmacol., 15, 776—779 (1990). 21) Eichelbaum M., Gross A. S., Pharmacol. Ther., 46, 377—394 (1990). 8) Heimark L. D., Wienkers L., Kunze K., Gibaldi M., Eddy A. C., Trager W. F., Robert A. O'R., Darklis A. G., Clin. Pharmacol. Ther., 51, 398—407 (1992). 23) Kakumoto M., Takara K., Sakaeda T., Tanigawara Y., Kita T., Okumura K., Biol. Pharm. Bull., 25, 1604—1607 (2002). 17) Nicolau D. P., Uber W. E., Crumbley A. J., Strange C., J. Heart Lung Transplant., 11, 564—568 (1992). 20) Masaki K., Ueno K., Tsuji M., Hiraki K., Kamakura S., Takada M., Shibakawa M., Jpn. J. Hosp. Pharm., 25, 28—33 (1999). 28) Palovaara S., Kivisto K. T., Tapanainen P., Manninen P., Neuvonen P. J., Laine K., Br. J. Clin. Pharmacol., 50, 333—337 (2000). 10) Almog S., Shafran N., Halkin H., Weiss P., Farfel Z., Martinowitz U., Bank H., Eur. J. Clin. Pharmacol., 28, 257—261 (1985). 30) Fukagawa N. K., Bandini L. G., Young J. B., Am. J. Physiol., 259, 233—238 (1990). 32) Heger J. J., Prystowsky E. N., Zipes D. P., Am. Heart J., 16, 931—935 (1983). 3) Latini R., Tognoni G., Kates R. E., Clin. Pharmacokinet., 9, 136—156 (1984). 7) Ohyama K., Nakajima M., Suzuki M., Shimada N., Yamazaki H., Yokoi T., Br. J. Clin. Pharmacol., 49, 244—253 (2000). 11) Nolan P. E., Jr., Marcus F. I., Karol M. D., Hoyer G. L., Gear K., J. Clin. Pharmacol., 30, 1112—1119 (1990). 19) Pollak P. T., Bouillon T., Shafer S. L., Clin. Pharmacol. Ther., 67, 642—652 (2000). 9) Watt A. H., Stephens M. R., Buss D. C., Routledge P. A., Br. J. Clin. Pharmacol., 20, 707—709 (1985). 25) Schmucker D. L., Woodhouse K. W., Wang R. K., Wynne H., James O. F., McManus M., Clin. Pharmacol. Ther., 48, 365—374 (1990). 2) Estes N. A., Weinstock J., Wang P. J., Homoud M. K., Link M. S., Am. J. Cardiol., 91, 45D—52D (2003). 31) Staubli M., Bircher J., Galeazzi R. L., Remund H., Studer H., Eur. J. Clin. Pharmacol., 24, 485—494 (1983). 24) Hunt C. M., Westerkam W. R., Stave G. M., Biochem. Pharmacol., 44, 275—283 (1992). 29) Williams P. A., Cosme J., Vinkovic D. M., Ward A., Angove H. C., Day P. J., Vonrhein C., Tickle I. J., Jhoti H., Science, 300, 683—686 (2004). 4) Ohyama K., Nakajima M., Nakamura S., Shimada N., Yamazaki H., Yokoi T., Drug Metab. Dispos., 28, 1303—1310 (2000). 27) George J., Byth K., Farrell G. C., Biochem. Pharmacol., 50, 727—730 (1995). 5) Lesko L. J., Clin. Pharmacokinet., 17, 130—140 (1989). 6) Marcus F. I., Am. Heart J., 106, 924—930 (1983). 14) Shea P., Lal R., Kim S. S., Schechtman K., Ruffy R., J. Am. Coll. Cardiol., 7, 1127—1130 (1986). 22) Kubota T., Yamamura Y., Ohkawa N., Hara H., Chiba K., Br. J. Clin. Phramacol., 50, 31—34 (2000). 23 24 27 Fukagawa N. K., Bandini L. G., Youn (30) 1990; 259 28 Williams P. A., Cosme J., Vinkovic (29) 2004; 300 (31) 1983; 24 (15) 1990; 15 (10) 1985; 28 OHYAMA K (4) 2000; 28 (13) 1989; 46 Latini R., Tognoni G., Kates R. E. (3) 1984; 9 Heger J. J., Prystowsky E. N., Zipe (32) 1983; 16 Marcus F. I. (6) 1983; 106 (8) 1992; 51 (9) 1985; 20 Shea P., Lal R., Kim S. S., Schecht (14) 1986; 7 19 Singh B. N. (1) 1997; 20 (16) 1994; 55 (5) 1989; 17 (26) 1994; 270 (11) 1990; 30 Nolan P. E., Jr., Erstad B. L., Hoy (12) 1990; 65 Masaki K., Ueno K., Tsuji M., Hirak (20) 1999; 25 7 Chitwood K. K., Abdul-Haqq A. J., H (18) 1993; 27 (25) 1990; 48 Estes N. A., Weinstock J., Wang P. (2) 2003; 91 Nicolau D. P., Uber W. E., Crumbley (17) 1992; 11 Kubota T., Yamamura Y., Ohkawa N. (22) 2000; 50 21 |
| References_xml | – reference: 25) Schmucker D. L., Woodhouse K. W., Wang R. K., Wynne H., James O. F., McManus M., Clin. Pharmacol. Ther., 48, 365—374 (1990). – reference: 27) George J., Byth K., Farrell G. C., Biochem. Pharmacol., 50, 727—730 (1995). – reference: 6) Marcus F. I., Am. Heart J., 106, 924—930 (1983). – reference: 7) Ohyama K., Nakajima M., Suzuki M., Shimada N., Yamazaki H., Yokoi T., Br. J. Clin. Pharmacol., 49, 244—253 (2000). – reference: 12) Nolan P. E., Jr., Erstad B. L., Hoyer G. L., Bliss M., Gear K., Marcus F. I., Am. J. Cardiol., 65, 1252—1257 (1990). – reference: 14) Shea P., Lal R., Kim S. S., Schechtman K., Ruffy R., J. Am. Coll. Cardiol., 7, 1127—1130 (1986). – reference: 19) Pollak P. T., Bouillon T., Shafer S. L., Clin. Pharmacol. Ther., 67, 642—652 (2000). – reference: 24) Hunt C. M., Westerkam W. R., Stave G. M., Biochem. Pharmacol., 44, 275—283 (1992). – reference: 1) Singh B. N., Clin. Cardiol., 20, 608—618 (1997). – reference: 3) Latini R., Tognoni G., Kates R. E., Clin. Pharmacokinet., 9, 136—156 (1984). – reference: 8) Heimark L. D., Wienkers L., Kunze K., Gibaldi M., Eddy A. C., Trager W. F., Robert A. O'R., Darklis A. G., Clin. Pharmacol. Ther., 51, 398—407 (1992). – reference: 11) Nolan P. E., Jr., Marcus F. I., Karol M. D., Hoyer G. L., Gear K., J. Clin. Pharmacol., 30, 1112—1119 (1990). – reference: 29) Williams P. A., Cosme J., Vinkovic D. M., Ward A., Angove H. C., Day P. J., Vonrhein C., Tickle I. J., Jhoti H., Science, 300, 683—686 (2004). – reference: 31) Staubli M., Bircher J., Galeazzi R. L., Remund H., Studer H., Eur. J. Clin. Pharmacol., 24, 485—494 (1983). – reference: 4) Ohyama K., Nakajima M., Nakamura S., Shimada N., Yamazaki H., Yokoi T., Drug Metab. Dispos., 28, 1303—1310 (2000). – reference: 21) Eichelbaum M., Gross A. S., Pharmacol. Ther., 46, 377—394 (1990). – reference: 28) Palovaara S., Kivisto K. T., Tapanainen P., Manninen P., Neuvonen P. J., Laine K., Br. J. Clin. Pharmacol., 50, 333—337 (2000). – reference: 15) Haefeli W. E., Bargetzi M. J., Follath F., Meyer U. A, J. Cardiovasc. Pharmacol., 15, 776—779 (1990). – reference: 20) Masaki K., Ueno K., Tsuji M., Hiraki K., Kamakura S., Takada M., Shibakawa M., Jpn. J. Hosp. Pharm., 25, 28—33 (1999). – reference: 23) Kakumoto M., Takara K., Sakaeda T., Tanigawara Y., Kita T., Okumura K., Biol. Pharm. Bull., 25, 1604—1607 (2002). – reference: 16) Funck-Brentano C., Becquemont L., Kroemer H. K., Buhl K., Knebel N. G., Eichelbaum M., Jaillon P., Clin. Pharmacol. Ther., 55, 256—269 (1994). – reference: 18) Chitwood K. K., Abdul-Haqq A. J., Heim-Duthoy K. L., Ann. Pharmacother., 27, 569—571 (1993). – reference: 5) Lesko L. J., Clin. Pharmacokinet., 17, 130—140 (1989). – reference: 22) Kubota T., Yamamura Y., Ohkawa N., Hara H., Chiba K., Br. J. Clin. 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| Title | Pharmacokinetic Characteristics of Amiodarone in Long-Term Oral Therapy in Japanese Population |
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