Coadministration of lansoprazole and naproxen does not affect the pharmacokinetic profile of methotrexate in adult patients with rheumatoid arthritis

Journal of Clinical Pharmacology

Volumn 45, Issue 10, 2005, Pages 1179-1186

  Vakily, Majid ^a,b   Amer, Fouad ^a   Kukulka, Michael J ^a   Andhivarothai, Nupun ^a  

^a TAP Pharmaceuticals   (United States)

^b TAP PHARMACEUTICAL PRODUCTS INC   (United States)

Author keywords

7 hydroxymethotrexate; Interaction; Lansoprazole; Methotrexate; Naproxen; Pharmacokinetics; Renal clearance; Rheumatoid arthritis

Indexed keywords

7 HYDROXYMETHOTREXATE; LANSOPRAZOLE; METHOTREXATE; NAPROXEN; PROTON PUMP INHIBITOR;

ABDOMINAL PAIN; ADULT; AGED; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG METABOLISM; DRUG URINE LEVEL; DRUG WITHDRAWAL; DYSPEPSIA; DYSURIA; FEMALE; GASTROINTESTINAL TOXICITY; HEADACHE; HEART PALPITATION; HERPES ZOSTER; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LOW DRUG DOSE; MALE; MEAN RESIDENCE TIME; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE DRUG DOSE; MUSCLE STIFFNESS; NAUSEA; OPEN STUDY; PERIPHERAL EDEMA; RHEUMATOID ARTHRITIS; RHINITIS; STATISTICAL ANALYSIS; STOMACH PROTECTION; VOMITING;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ADMINISTRATION, ORAL; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIRHEUMATIC AGENTS; AREA UNDER CURVE; ARTHRITIS, RHEUMATOID; DIZZINESS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEADACHE; HUMANS; MALE; METABOLIC CLEARANCE RATE; METHOTREXATE; MIDDLE AGED; NAPROXEN; NAUSEA; OMEPRAZOLE; VOMITING;

EID: 25444526630     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270005280100     Document Type: Article

References (23)

1. Hochberg MC. Adult and juvenile rheumatoid arthritis: current epidemiologic concepts. Epidemiol Rev. 1981;3:27-44.
2. Guidelines for the management of rheumatoid arthritis. 2002 update. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Arthritis Rheum. 2002;46:328-346.
3. Wolfe MM, Lichtenstein DR, Singh G. Gastrointestinal toxicity of nonsteroidal antiinflammatory drugs. N Engl J Med. 1999;340:1888-1899.
4. Methotrexate [package insert]. Columbus, Ohio: Roxane Laboratories, Inc, 2000.
5. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized, controlled trial. JAMA. 2000;284:1247-1255.
6. Bombardier C, Laine L, Reicin A, et al, for the VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520-1528.
7. Singh G, Triadafilopoulus G. Epidemiology of NSAID-induced gastrointestinal complications. J Rheumatol Suppl. 1999;26:18-24.
8. Prevacid [package insert]. Lake Forest, Ill: TAP Pharmaceutical Products, Inc, 2004.
9. Reid Y, Yuon A, Catolico M, Carlson RW. Impact of omeprazole on the plasma clearance of methotrexate. Cancer Chemother Pharmacol. 1993;33:82-84.
10. Whelan J, Hoare D, Leonard P. Omeprazole does not alter plasma methotrexate clearance. Cancer Chemother Pharmacol. 1999;44:88-89.
11. Beorlegui B, Aldaz A, Ortega A, Aquerreta I, Sierrasesumega L, Giraldez J. Potential interaction between methotrexate and omeprazole. Ann Pharmacother. 2000;34:1024-1027.
12. Schwartz JI, Agrawal NGB, Wong PH, et al. Lack of pharmacokinetic interaction between rofecoxib and methotrexate in rheumatoid arthritis patients. J Clin Pharmacol. 2001;41:1120-1130.
13. Bremnes RM, Smeland E, Huseby NE, Eide TJ, Aarbakke J. Acute hepatotoxicity after high-dose methotrexate administration to rats. Pharmacol Toxicol 1991;69:132-139.
14. Smeland E, Bremnes RM, Andersen A, et al. Renal and hepatic toxicity after high-dose 7-hydroxymethotrexate in the rat. Cancer Chemother Pharmacol. 1994;34:119-124.
15. Bannwarth B, Péhoutcq F, Schaeverbeke T, Dehais J. Clinical pharmacokinetics of low-dose pulse methotrexate in rheumatoid arthritis. Clin Pharmacokinet. 1996;30:194-210.
16. Tracy TS, Krohn K, Jones DR, Bradley JD, Hall SD, Brater DC. The effects of salicylate, ibuprofen, and naproxen on the disposition of methotrexate in patients with rheumatoid arthritis. Eur J Clin Pharmacol. 1992;42:121-125.
17. Stewart CF, Fleming RA, Germain BF, Seleznick MJ, Evans WE. Aspirin alters methotrexate disposition in rheumatoid arthritis patients. Arthritis Rheum. 1991;34:1514-1520.
18. Furst DE, Herman RA, Koehnke R, et al. Effect of aspirin and sulindac on methotrexate clearance. J Pharm Sci. 1990;79:782-786.
19. Lilly MB, Omura GA. Clinical pharmacology of oral intermediate-dose methotrexate with or without probenecid. Cancer Chemother Pharmacol. 1985;15:220-222.
20. Iqbal MP, Baig JA, Ali AA, Niazi SK, Mehboobali N, Hussain MA. The effects of non-steroidal anti-inflammatory drugs on the disposition of methotrexate in patients with rheumatoid arthritis. Biopharm Drug Dispos. 1998;19:163-167.
21. Stewart CF, Fleming RA, Arkin CR, Evans WE. Coadministration of naproxen and low-dose methotrexate in patients with rheumatoid arthritis. Clin Pharmacol Ther. 1990;47:540-546.
22. Wallace CA, Smith AL, Sherry DD. Pilot investigation of naproxen/methotrexate interaction in patients with juvenile rheumatoid arthritis. J Rheumatol. 1993;20:1764-1768.
23. Singh G, Ramey DR, Morfeld D, Shi H, Hatoum HT, Fries JF. Gastrointestinal tract complications of nonsteroidal anti-inflammatory drug treatment in rheumatoid arthritis: a prospective observational cohort study. Arch Intern Med. 1996;156:1530-1536.