Lack of effect of erythromycin and ketoconazole on the pharmacokinetics and pharmacodynamics of steady-state intranasal levocabastine

Journal of Clinical Pharmacology

Volumn 39, Issue 1, 1999, Pages 76-85

  Pesco Koplowitz, Luana ^a,d   Hassell, Alan ^a   Lee, Peter ^a   Zhou, Honghui ^e   Hall, Nancy ^a   Wiesinger, Barbara ^a   Mechlinski, Witold ^a   Grover, Matthew ^a   Hunt, Thomas ^b   Smith, Randall ^c   Travers, Suzanne ^a  

^a Janseen Research Foundation   (United States)

^b PPD Pharmaco   (United States)

^c Novum Inc   (United States)

^d JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 INHIBITOR; ERYTHROMYCIN; HISTAMINE H1 RECEPTOR ANTAGONIST; KETOCONAZOLE; LEVOCABASTINE; PLACEBO;

ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG HALF LIFE; DRUG METABOLISM; EPISTAXIS; HEADACHE; HEART ARRHYTHMIA; HEART REPOLARIZATION; HUMAN; HUMAN EXPERIMENT; INTRANASAL DRUG ADMINISTRATION; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PHARMACODYNAMICS; PHARMACOKINETICS; QT INTERVAL; RANDOMIZED CONTROLLED TRIAL; RHINITIS; STEADY STATE; VIRUS INFECTION;

ADMINISTRATION, INTRANASAL; ADOLESCENT; ADULT; ANTI-BACTERIAL AGENTS; ANTI-INFECTIVE AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; BRADYCARDIA; CROSS-OVER STUDIES; DRUG INTERACTIONS; ELECTROCARDIOGRAPHY; ERYTHROMYCIN; HEADACHE; HEART BLOCK; HISTAMINE H1 ANTAGONISTS; HUMANS; KETOCONAZOLE; MALE; MIDDLE AGED; PIPERIDINES; RHINITIS; TIME FACTORS; VIRUS DISEASES;

EID: 0032947505     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/00912709922007589     Document Type: Article

References (35)

1. Awouters F, Niemegeers CJE, Jansen T, Megens AAHP, Janssen PAJ: Levocabastine: pharmacological profile of a highly effective inhibitor of allergic reactions. Agents Actions 1992;35:12-18.
2. Noble S, McTavish D: Levocabastine: an update of its pharmacology, clinical efficacy and tolerability in the topical treatment of allergic rhinitis and conjunctivitis. Drugs 1995;50:1032-1049.
3. Vanden Bussche G: Levocabastine hydrochloride. Drugs Future 1986;11:841-843.
4. Bachert C, Wagenmann M, Vossen-Hozenkamp S: Intranasal levocabastine provides fast and effective protection from nasal allergen challenge. Rhinology 1996;34:140-143.
5. Palma-Carlos AG, Palma-Carlos ML, Rombaut N: The effect of levocabastine nasal spray in nasal provocation tests. Int J Clin Pharmacol Res 1988;8:25-30.
6. Spector S, Corren J, Rachelefsky G, Schanker H, Siegel S: Evaluation of efficacy and duration of action of levocabastine (LEVO) nasal spray under nasal challenge conditions (abstract 1015). J Allergy Clin Immunol 1996;97(1 Pt. 3):436.
7. 1 antagonist, on nasal provocation reaction to allergen. Am J Rhinol 1993;7:85-88.
8. Bahmer FA, Ruprecht KW: Safety and efficacy of topical levocabastine compared with oral terfenadine. Ann Allergy 1994;72:429-434.
9. Søhoel P, Freng BA, Kramer J, Poppe S, Rebo R, Korsrud FR, Garud O, Woxen OJ, Olsen A-K: Topical levocabastine compared with orally administered terfenadine for the prophylaxis and treatment of seasonal rhinoconjunctivitis. J Allergy Clin Immunol 1993;92:73-81.
10. Swedish GP Allergy Team: Topical levocabastine compared with oral loratadine for the treatment of seasonal allergic rhinoconjunctivitis. Allergy 1994;49:611-615.
11. Livostin Study Group: A comparison of topical levocabastine and oral terfenadine in the treatment of allergic rhinoconjunctivitis. Allergy 1993;48:530-534.
12. Dahl R, Pedersen B, Larsen B: Intranasal levocabastine for the treatment of seasonal allergic rhinitis: a multicentre, double-blind, placebo-controlled trial. Rhinology 1995;33:121-125.
13. Hampel FC, Martin BG, Dolen J, Travers S, Karcher K, Holton D: Efficacy and safety of levocabastine nasal spray for seasonal allergic rhinitis. Am J Rhinol (in press).
14. Heykants J, Van Peer A, Van de Velde V, Snoeck E, Meuldermans W, Woestenborghs R: The pharmacokinetic properties of topical levocabastine: a review. Clin Pharmacokinet 1995;29:221-230.
15. 1-receptor antagonist therapy. Clin Pharmacokinet 1991;21:372-393.
16. Honig PK, Woosley RL, Zamani K, Conner DP, Cantilena LR Jr: Changes in the pharmacokinetics and electrocardiographic pharmacodynamics of terfenadine with concomitant administration of erythromycin. Clin Pharmacol Ther 1992;52:231-238.
17. Kivistö KT, Neuvonen PJ, Klotz U: Inhibition of terfenadine metabolism: pharmacokinetic and pharmacodynamic consequences. Clin Pharmacokinet 1994;27:1-5.
18. Yumibe N, Huie K, Chen KJ, Snow M, Clement RP, Cayen MN: Identification of human liver cytochrome P450 enzymes that metabolize the nonsedating antihistamine loratadine: formation of descarboethoxyloratadine by CYP3A4 and CYP2D6. Biochem Pharmacol 1996;51:165-172.
19. Bishop RO, Gaudry PL: Prolonged Q-T interval following astemizole overdose. Arch Emerg Med 1989;6:63-65.
20. Honig PK, Wortham DC, Zamani K, Conner DP, Mullin JC, Cantilena LR: Terfenadine-ketoconazole interaction: pharmacokinetic and electrocardiographic consequences. JAMA 1993;269:1513-1518.
21. Biglin KE, Faraon MS, Constance TD, Lieh-Lai M: Drug-induced torsades de pointes: a possible interaction of terfenadine and erythromycin (letter). Ann Pharmacother 1994;28:282.
22. Crane JK, Shih H-T: Syncope and cardiac arrhythmia due to an interaction between itraconazole and terfenadine. Am J Med 1993;95:445-446.
23. Goss JE, Ramo BW, Blake K: Torsades de pointes associated with astemizole (Hismanal) therapy (letter). Arch Intern Med 1993;153:2705.
24. Mathews DR, McNutt B, Okerholm R, Flicker M, McBride G: Torsades de pointes occurring in association with terfenadine use (letter). JAMA 1991;266;2375-2376.
25. Monahan BP, Ferguson CL, Killeavy ES, Lloyd BK, Troy J, Cantilena LR Jr: Torsades de pointes occurring in association with terfenadine use. JAMA 1990;264:2788-2790.
26. Paris DG, Parente TF, Bruschetta HR, Guzman E, Niarchos AP: Torsades de pointes induced by erythromycin and terfenadine. Am J Emerg Med 1994;12:636-638.
27. Pohjola-Sintonen S, Viitasalo M, Toivonen L, Neuvonen P: Itraconazole prevents terfenadine metabolism and increases risk of torsades de pointes ventricular tachycardia. Eur J Clin Phamacol 1993;45:191-193.
28. Snook J, Boothman-Burrell D, Watkins J, Colin-Jones D: Torsade de pointes ventricular tachycardia associated with astemizole overdose. Br J Clin Pract 1988;42:257-259.
29. Zimmermann M, Duruz H, Guinand O, Broccard O, Levy P, Lacatis D, Bloch A: Torsades de pointes after treatment with terfenadine and ketoconazole. Eur Heart J 1992;13:1002-1003.
30. Edberg SC: The measurement of antibiotics in human body fluids: techniques and significance. In, Lorain V (ed.): Antibiotics in Laboratory Medicine. 2nd ed. Baltimore, MD: Williams & Wilkins, 1986.
31. Anhalt JP: Assays for antimicrobial agents in body fluids. In, Balows A (ed.): Manual of Clinical Microbiology. 5th ed. Washington, DC: American Society for Microbiology, 1991.
32. Andrews FA, Peterson LR, Beggs WH, Crankshaw D, Sarosi GA: Liquid chromatographic assay of ketoconazole. Antimicrob Agents Chemother 1981;19:110-113.
33. Morganroth J, Brozovich FV, McDonald JT, Jacobs RA: Variability of the QT measurement in healthy men, with implications for selection of an abnormal QT value to predict drug toxicity and proarrhythmia. Am J Cardiol 1991;67:774-776.
34. Woosley RL, Chen Y, Freiman JP, Gillis RA: Mechanism of the cardiotoxic actions of terfenadine. JAMA 1993;269:1532-1536.
35. von Moltke LL, Greenblatt DJ, Duan SX, Harmatz JS, Shader RI: In vitro prediction of the terfenadine-ketoconazole pharmacokinetic interaction. J Clin Pharmacol 1994;34:1222-1227.