Pharmacokinetic interaction studies of atosiban with labetalol or betamethasone in healthy female volunteers

BJOG: An International Journal of Obstetrics and Gynaecology

Volumn 112, Issue 11, 2005, Pages 1492-1499

  Rasmussen, Birgitte Buur ^a   Larsen, Lotte Seiding ^a   Senderovitz, Thomas ^a  

^a Ferring Pharmaceuticals AS   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ATOSIBAN; BETAMETHASONE; LABETALOL; ANTIHYPERTENSIVE AGENT; ARGIPRESTOCIN; DRUG DERIVATIVE; UTERUS SPASMOLYTIC AGENT;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG INFUSION; DRUG INTERACTION; DRUG TOLERABILITY; FEMALE; GERMANY; HUMAN; MAXIMUM PLASMA CONCENTRATION; MULTIPLE DRUG DOSE; NORMAL HUMAN; OPEN STUDY; PHARMACOKINETICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; DRUG COMBINATION; INTRAMUSCULAR DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED;

ADULT; ANTIHYPERTENSIVE AGENTS; AREA UNDER CURVE; BETAMETHASONE; CROSS-OVER STUDIES; DRUG COMBINATIONS; DRUG INTERACTIONS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; INJECTIONS, INTRAMUSCULAR; LABETALOL; MIDDLE AGED; TOCOLYTIC AGENTS; VASOTOCIN;

EID: 33644612956     PISSN: 14700328     EISSN: 14710528     Source Type: Journal    
DOI: 10.1111/j.1471-0528.2005.00735.x     Document Type: Article

References (26)

1. Report of the Consensus Development Conference on the effect of corticosteroids for fetal maturation on perinatal outcomes. Bethesda Maryland: National Institutes of Health, 1994. NIH Publication No. 95-3784.
2. Escobedo MB. Follow-up of prematurely born infants. Clin Obstet Gynecol 1988 31: 662 667.
3. Goodwin TM, Paul R, Silver H, Spellacy W, Parsons M, Chez R. The effect of the oxytocin antagonist atosiban on preterm uterine activity in the human. Am J Obstet Gynecol 1994 170: 474 478.
4. Goodwin TM, Millar L, North L, Abrams L, Weglin R, Holland M. The pharmacokinetics of the oxytocin antagonist atosiban in pregnant women with preterm uterine contractions. Am J Obstet Gynecol 1995 173: 913 917.
5. Goodwin TM, Valenzuela G, Silver H, Creasy G, the Atosiban Study Group. Dose ranging study of the oxytocin antagonist atosiban in the treatment of preterm labour. Obstet Gynecol 1996 88: 331 336.
6. Phaneuf S, Asboth G, MacKenzie IZ, Melin P, Lopez Bernal A. Effect of oxytocin antagonist on the activation of human myometrium in vitro: atosiban prevents oxytocin-induced desensitization. Am J Obstet Gynecol 1994 171: 1627 1634.
7. Romero R, Sibai BM, Sanchez-Ramos L, et al. An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue. Am J Obstet Gynecol 2000 182: 1173 1183.
8. Magee LA, Ornstein MP, von Dadelszen P. Management of hypertension in pregnancy. BMJ 1999 318: 1332 1336.
9. Briggs GG, Freeman RK, Yaffe SJ, editors. Drugs in Pregnancy and Lactation, 5th edition. Baltimore, USA: Williams and Wilkins, 1998: 474 475.
10. McNiel JJ, Louis WJ. Clinical pharmacokinetics of labetalol. Clin Pharmacokinet 1984 9: 157 167.
11. Martin LE, Hopkins R, Bland R. Metabolism of labetalol by animals and man. Br J Clin Pharmacol Suppl 1976: 695 710.
12. Crowley P. Prophylactic Corticosteroids for Preterm Birth [Cochrane review]. The Cochrane Library, Issue 4. Oxford: Update Software, 2001.
13. Robertson B. Corticosteroids and surfactant for prevention of neonatal RDS. Ann Med 1993 25: 285 288.
14. Petersen MC, Nation RL, McBride WG, Ashley JJ, Moore RG. Pharmacokinetics of betamethasone in healthy adults after intravenous administration. Eur J Clin Pharmacol 1983 25: 643 650.
15. Miyachi Y, Yotsumoto H, Kano T, Mizuchi A, Muto T, Yanagibashi K. Blood levels of synthetic glucocorticoids after administration by various routes. J Endocrinol 1979 82: 149 157.
16. Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). The European Agency for the Evaluation of Medicinal Products, 1 May 1996.
17. Steinijans W, Hartmann M, Huber R, Radtke HW. Lack of pharmacokinetic interaction as an equivalence problem. Int J Clin Pharmacol Ther Toxicol 1991 29: 323 328.
18. Note for Guidance (III/54/89-EN). Investigation of Bioavailability and Bioequivalence. CPMP Working Party on Efficacy of Medicinal Products, 1991.
19. Pratt JW. Remarks on zeros and ties in the Wilcoxon signed rank procedures. J Am Stat Assoc 1959 54: 665 667.
20. Tukey JW. The Simplest signed-rank tests. Mimeographed Report No. 17. Statistical Research Group, Princeton, 1949.
21. Lalonde RL, O'Rear TL, Wainer IW, Drda KD, Herring VL, Bottorf MB. Labetalol pharmacokinetics and pharmacodynamics: evidence of stereoselective disposition. Clin Pharmacol Ther 1990 48: 509 519.
22. Awni WM, Skaar DJ, Schwenk MH, Sirgo MA, Plachetka JR, Matzke GR. Interindividual and intraindividual variability in labetalol pharmacokinetics. J Clin Pharmacol 1988 28: 344 349.
23. Petersen MC, Ashley JJ, McBride WG, Nation RL. Disposition of betamethasone in parturient women after intramuscular administration. Br J Clin Pharmacol 1998 18: 383 392.
24. Moutquin JM, Sherman D, Cohen H, et al. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol 2000 182: 1191 1199.
25. The Worldwide Atosiban versus Beta-agonists Study Group. Effectiveness and safety of the oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of preterm labour. BJOG 2001 108: 133 142.
26. Valenzuela G, Sanchez-Ramos L, Romero R, et al. Maintenance treatment of preterm labor with the oxytocin antagonist atosiban. Am J Obstet Gynecol 2000 182: 1184 1190.