Paroxetine mesylate: Comparable to paroxetine hydrochloride?

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 2, 2010, Pages 185-193

  Pae, Chi Un ^a,b   Misra, Aayushman ^b   Ham, Byung Joo ^c   Han, Changsu ^c   Patkar, Ashwin A ^b   Masand, Prakash S ^b  

^a The Catholic University of Korea   (South Korea)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c Korea University College of Medicine   (South Korea)

Author keywords

Brand name product; Generic; Paroxetine hydrochloride; Paroxetine mesylate; Safety; Tolerability

Indexed keywords

ATOMOXETINE; DESIPRAMINE; GENERIC DRUG; PAROXETINE;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CARCINOGENICITY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG HALF LIFE; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; GENERALIZED ANXIETY DISORDER; HUMAN; MAJOR DEPRESSION; MAXIMUM PLASMA CONCENTRATION; MULTIPLE DRUG DOSE; NONHUMAN; OBSESSIVE COMPULSIVE DISORDER; PANIC; PHARMACODYNAMICS; PRURITUS; REPRODUCTIVE TOXICITY; REVIEW; SINGLE DRUG DOSE; TERATOGENICITY; TIME TO MAXIMUM PLASMA CONCENTRATION;

CONSUMER PRODUCT SAFETY; COST OF ILLNESS; DRUG APPROVAL; HUMANS; PAROXETINE; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 76749113797     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656560903451708     Document Type: Review

References (54)

1. World Health Organization. Depression: what is depression? Available from: http://www.who.int/mental-health/ management/depression/definition/en/ [Last accessed 14 August 2009]
2. Antidepressant Market. Available from: http://www.wikinvest.com/concept/ Antidepressant-Drug-Market [Last accessed 17 August 2009]
3. Bourin M, Chue P, Guillon Y. Paroxetine: a review. CNS Drug Rev 2001;7:25-47
4. Pae CU, Patkar AA. Paroxetine: current status in psychiatry. Expert Rev Neurother 2007;7:107-120
5. GlaxoSmithKline. GSK annual report 2008. Available from: http://www.gsk. com/investors/reps08/ GSK-Report-2008-full.pdf [Last accessed 14 August 2009]
6. Center for Drug Evaluation and Research. Medical Review. Application Number 21-299. Available from: http://www. accessdata.fda.gov/scripts/cder/ drugsatfda/ index.cfm?fuseaction=Search. Label-ApprovalHistory#apphist [Last accessed 30 July 2009]
7. Center for Drug Evaluation and Research. Clinical Pharmacology and Biopharmaceutics Review. Available from: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2001/21-299. pdf-Paroxetine%20Mesylate-BioPharmr. pdfAccess [Last accessed 21 July 2009]
8. Noven Therapeutics I. Prescribing information. Paroxetine Mesylate (Pexeva). Available from: http://www. pexeva.com/ [Last accessed 21 July 2009]
9. Kaye CM, Haddock RE, Langley PF, et al. A review of the metabolism and pharmacokinetics of paroxetine in man. Acta Psychiatr Scand Suppl 1989;350:60-75
10. Gunasekara NS, Noble S, Benfield P. Paroxetine. An update of its pharmacology and therapeutic use in depression and a review of its use in other disorders. Drugs 1998;55:85-120 (Pubitemid 28035127)
11. Wagstaff AJ, Cheer SM, Matheson AJ, et al. Paroxetine: an update of its use in psychiatric disorders in adults. Drugs 2002;62:655-703
12. Einarson A, Koren G. Counseling pregnant women treated with paroxetine. Concern about cardiac malformations. Can Fam Physician 2006;52:593-594
13. Center for Drug Evaluation and Research. Pharmacology Review. Available from: http://www.accessdata.fda.gov/ drugsatfda-docs/nda/2001/21-299. pdf-Paroxetine%20Mesylate-Pharmr.pdf [Last accessed 21 July 2009]
14. Owens MJ, Krulewicz S, Simon JS, et al. Estimates of serotonin and norepinephrine transporter inhibition in depressed patients treated with paroxetine or venlafaxine. Neuropsychopharmacology 2008;33:3201-3212
15. Owens MJ, Nemeroff CB. Role of serotonin in the pathophysiology of depression: focus on the serotonin transporter. Clin Chem 1994;40:288-295
16. Bang LM, Keating GM. Paroxetine controlled release. CNS Drugs 2004;18:355-64; discussion 65-66
17. Thomas DR, Nelson DR, Johnson AM. Biochemical effects of the antidepressant paroxetine, a specific 5-hydroxytryptamine uptake inhibitor. Psychopharmacology (Berl) 1987;93:193-200
18. Marks DM, Park MH, Ham BJ, et al. Paroxetine: safety and tolerability issues. Expert Opin Drug Saf 2008;7:783-794
19. GlaxoSmithKline. Paxil. 2006. Available from: http://www.gsk.com [Last accessed 15 July 2009]
20. GlaxoSmithKline. Paxil CR. 2006. Available from: http://www.gsk.com [Last accessed 15 July 2009]
21. Rosenthal J, Kong B, Jacobs L, Katzman M. Did a switch to a generic antidepressant cause relapse? J Fam Pract 2008;57:109-114
22. Vergouwen AC, Bakker A. Adverse effects after switching to a different generic form of paroxetine: paroxetine mesylate instead of paroxetine HCl hemihydrate. Ned Tijdschr Geneeskd 2002;146:811-812
23. Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 2003;25:1578-1592
24. Meyer MC. United States Food and Drug Administration requirements for approval of generic drug products. J Clin Psychiatry 2001;62(Suppl 5):4-9, discussion 23-24
25. Korean Food and Drug Administration. Available from: http://kfda.go.kr/ open-content/data/law-search.php [Last accessed 29 August 2009]
26. Sheehan DV, Keene MS, Eaddy M, et al. Differences in medication adherence and healthcare resource utilization patterns: older versus newer antidepressant agents in patients with depression and/or anxiety disorders. CNS Drugs 2008;22:963-973
27. Jonsdottir H, Friis S, Horne R, et al. Beliefs about medications: measurement and relationship to adherence in patients with severe mental disorders. Acta Psychiatr Scand 2009;119:78-84
28. Kessler RC, Chiu WT, Demler O, et al. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry 2005;62:617-627 (Pubitemid 40973437)
29. Kessler RC, Berglund P, Demler O, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA 2003;289:3095-3105
30. Mofsen R, Balter J. Case reports of the reemergence of psychotic symptoms after conversion from brand-name clozapine to a generic formulation. Clin Ther 2001;23:1720-1731
31. Lam YW, Ereshefsky L, Toney GB, Gonzales C. Branded versus generic clozapine: bioavailability comparison and interchangeability issues. J Clin Psychiatry 2001;62(Suppl 5):18-22, discussion 3-4 (Pubitemid 32295160)
32. Ereshefsky L, Glazer WM. Comparison of the bioequivalence of generic versus branded clozapine. J Clin Psychiatry 2001;62:(Suppl 5):25-27 (Pubitemid 32295162)
33. Locniskar A, Greenblatt DJ, Harmatz JS, Shader RI. Bioinequivalence of a generic brand of diazepam. Biopharm Drug Dispos 1989;10:597-605
34. Mikati M, Bassett N, Schachter S. Double-blind randomized study comparing brand-name and generic phenytoin monotherapy. Epilepsia 1992;33:359-365
35. Welty TE, Pickering PR, Hale BC, Arazi R. Loss of seizure control associated with generic substitution of carbamazepine. Ann Pharmacother 1992;26:775-777
36. Berg MJ, Gross RA, Tomaszewski KJ, et al. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology 2008;71:525-530
37. Dhanaraj M, Jayavelu A. Non-equivalence of bioavailability between generic and branded form of sodium valproate. Neurol India 2004;52:398
38. Sherwood Brown E, Shellhorn E, Suppes T. Gastrointestinal side-effects after switch to generic valproic acid. Pharmacopsychiatry 1998;31:114
39. MacDonald JT. Breakthrough seizure following substitution of Depakene capsules (Abbott) with a generic product. Neurology 1987;37:1885
40. Gidal BE. Bioequivalence of antiepileptic drugs: how close is close enough? Curr Neurol Neurosci Rep 2009;9:333-337
41. Wilner AN. Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav 2004;5:995-998
42. Bakish D, Miller C, Hooper CL, et al. A double-blind, crossover study comparing generic and brand fluoxetine in the treatment of major depressive disorder. NCDEU, 2001
43. Yu BP, Chong YS, Maguire GA. Is generic fluoxetine effective? J Affect Disord 2004;81:185-186
44. Van Ameringen M, Mancini C, Patterson B, Bennett M. Symptom relapse following switch from Celexa to generic citalopram: an anxiety disorders case series. J Psychopharmacol 2007;21:472-476
45. Center for Drug Evaluation and Research. Review of therapeutic equivalence: generic bupropion XL 300 mg and Wellbutrin XL 300 mg. US Food and Drug Administration. Available from: http:// www.fda.gov/AboutFDA/ CentersOffices/ CDER/ucm153270.htm [Last accessed 20 August]
46. Chenu F, Batten LA, Zernig G, et al. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry 2009;70:958-966
47. Byrne SE, Rothschild AJ. Loss of antidepressant efficacy during maintenance therapy: possible mechanisms and treatments. J Clin Psychiatry 1998;59:279-288
48. Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry 2006;163:1905-1917
49. Dotoli D, Spagnolo C, Bongiorno F, et al. Relapse during a 6-month continuation treatment with fluvoxamine in an Italian population: the role of clinical, psychosocial and genetic variables. Prog Neuropsychopharmacol Biol Psychiatry 2006;30:442-448
50. Keller MB, Trivedi MH, Thase ME, et al. The Prevention of Recurrent Episodes of Depression with Venlafaxine for Two Years (PREVENT) study: outcomes from the 2-year and combined maintenance phases. J Clin Psychiatry 2007;68:1246-1256
51. Paton C. Generic clozapine: outcomes after switching formulations. Br J Psychiatry 2006;189:184-185
52. Healy DJ, Taylor S, Goldman M, et al. Clinical equivalence of generic clozapine. Community Ment Health J 2005;41:393-398
53. Alessi-Severini S, Honcharik PL, Simpson KD, et al. Evaluation of an interchangeability switch in patients treated with clozapine: a retrospective review. J Clin Psychiatry 2006;67:1047-1054
54. Jefferson JW. Antidepressants: brand name or generic? Psychiatric Times 2009;26