Clozapine/Cyamemazine 985 Verse Effects, Clozapine Therapy Should Be Introduced Account
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Clozapine/Cyamemazine 985 verse effects, clozapine therapy should be introduced account. There have been a few reports of exacerbation of psy- Clozapine has shown consistent clinical benefit in schizophrenic chotic symptoms in patients who were switched to a generic for- patients with persistent aggressive or violent behaviour.2,9 gradually, beginning with low doses and increasing ac- 6,7 cording to response. mulation. Whether this is due to a sedative effect, a specific antiaggressive 1. Sajbel TA, et al. Converting patients from brand-name clozapine action, or just reflects an overall improvement in psychosis is un- In the treatment of schizophrenia, including reducing to generic clozapine. Ann Pharmacother 2001; 35: 281–4. known. 2. Makela EH, et al. Branded versus generic clozapine for treat- the risk of suicidal behaviour, the usual oral dose is ment of schizophrenia. Ann Pharmacother 2003; 37: 350–3. Clozapine has been advocated for use in schizophrenic patients 12.5 mg once or twice on the first day followed by 3. Stoner SC, et al. A program to convert patients from trade-name with moderate to severe tardive dyskinesia. It is still unclear 25 mg once or twice on the second day. Thereafter the to generic clozapine. Pharmacotherapy 2003; 23: 806–10. whether clozapine can itself cause tardive dyskinesia but some 4. Bazire S, Burton V. Generic clozapine in schizophrenia: what is patients with established tardive dyskinesia have experienced daily dosage may be increased gradually in steps of 25 all the fuss about? Pharm J 2004; 273: 720–1. improvement in their symptoms when using clozapine.10,11 to 50 mg to achieve a daily dose of up to 300 mg within 5. Lam YW, et al. Branded versus generic clozapine: bioavailabil- 1. Kane J, et al. Clozapine for the treatment-resistant schizophren- 14 to 21 days (in the USA, up to 450 mg daily is per- ity comparison and interchangeability issues. J Clin Psychiatry ic: a double-blind comparison with chlorpromazine. Arch Gen 2001; 62 (suppl 5): 18–22. Psychiatry 1988; 45: 789–96. mitted by the end of 2 weeks). Subsequent increases in 6. Kluznik JC, et al. Clinical effects of a randomized switch of pa- 2. Buckley PF. New dimensions in the pharmacologic treatment of steps of 50 to 100 mg may be made once or twice tients from clozaril to generic clozapine. J Clin Psychiatry 2001; schizophrenia and related psychoses. J Clin Pharmacol 1997; 62 (suppl 5): 14–17. 37: 363–78. Correction. ibid. 1998; 38: 27. weekly; a daily dosage of 900 mg should not be ex- 7. Mofsen R, Balter J. Case reports of the reemergence of psychotic 3. Wahlbeck K, et al. Clozapine versus typical neuroleptic medi- ceeded. Once a therapeutic response has been ob- symptoms after conversion from brand-name clozapine to a ge- cation for schizophrenia. Available in The Cochrane Database neric formulation. Clin Ther 2001; 23: 1720–31. tained, a gradual reduction of dosage to a suitable of Systematic Reviews; Issue 4. Chichester: John Wiley; 1999 Bipolar disorder. Clozapine is of benefit for the treatment of (accessed 24/05/05). maintenance dose is recommended; most patients re- 4. Meltzer HY, et al. A prospective study of clozapine in treat- mania in patients with bipolar disorder (p.372), and the use of ment-resistant schizophrenic patients I: preliminary report. Psy- spond to 200 to 450 mg daily. The total daily dose is atypical antipsychotics in the management of such patients is in- chopharmacology (Berl) 1989; 99: S68–S72. given in divided doses; a larger portion may be given at creasing. However, the adverse effects of clozapine may restrict 5. Conley RR, et al. Time to clozapine response in a standardized its use. trial. Am J Psychiatry 1997; 154: 1243–7. night. Daily maintenance doses of 200 mg or less may 6. Meltzer HY, Okayli G. Reduction of suicidality during clozapine be given as a single dose in the evening. If clozapine is Dementia. Although atypical antipsychotics such as clozapine treatment of neuroleptic-resistant schizophrenia: impact on to be withdrawn, this should be done gradually over a have been tried in elderly patients with dementia, the licensing risk-benefit assessment. Am J Psychiatry 1995; 152: 183–90. 7. Kerwin RW. Clozapine: back to the future for schizophrenia re- 1- to 2-week period. However, immediate withdrawal authorities in the USA now recommend against such use, see un- der Precautions, above. For further discussion of the manage- search. Lancet 1995; 345: 1063–4. with careful observation is essential if neutropenia de- 8. Meltzer HY, et al. Clozapine treatment for suicidality in schizo- ment of disturbed behaviour, see p.954. phrenia: International Suicide Prevention Trial (InterSePT). velops or if myocarditis or cardiomyopathy is suspect- Parkinsonism. Clozapine is used as an alternative to classical Arch Gen Psychiatry 2003; 60: 82–91. Correction. ibid. 735. ed (see Precautions, above). 9. Volavka J, et al. Overt aggression and psychotic symptoms in antipsychotics in the management of treatment-resistant psy- patients with schizophrenia treated with clozapine, olanzapine, Elderly patients may require lower doses of clozapine choses in patients with Parkinson’s disease (p.791). Some neu- risperidone, or haloperidol. J Clin Psychopharmacol 2004; 24: and it is recommended that treatment should start with rologists even consider clozapine to be the antipsychotic of 225–8. choice in these patients,1 although this remains to be determined. 10. Tamminga CA, et al. Clozapine in tardive dyskinesia: observa- a dose of 12.5 mg on the first day and that subsequent A review2 in 1994 considered that there was little evidence to tions from human and animal model studies. J Clin Psychiatry dose increments should be restricted to 25 mg. 1994; 55 (suppl B): 102–6. support clozapine as first choice given the quality of the available 11. Nair C, et al. Dose-related effects of clozapine on tardive dysk- For patients who are restarting treatment after an inter- studies and the need for extensive monitoring. However a subse- inesia among "treatment-refractory" patients with schizophre- val of more than 2 days, 12.5 mg may be given once or quent double-blind, placebo-controlled study3 showed that low- nia. Biol Psychiatry 1996; 39: 529–30. dose clozapine treatment (up to 50 mg daily) significantly im- Preparations twice on the first day. If this dose is well tolerated it proved drug-induced psychosis without worsening parkinson- may be possible to increase the dosage more quickly ism. Adverse effects noted in this study were generally mild, al- USP 31: Clozapine Tablets. than when first starting. However, patients who have though in the clozapine group of 30 patients, there was 1 report Proprietary Preparations (details are given in Part 3) of leucopenia. A similar study also reported benefit,4 although 7 Arg.: Lapenax; Sequax; Austral.: Clopine; Clozaril; Austria: Lanolept; Lep- had respiratory or cardiac arrest with initial dosing, but onex; Belg.: Leponex; Braz.: Leponex; Zolapin†; Canad.: Clozaril; Chile: were then successfully titrated to a therapeutic dose, of 32 patients noted some aggravation of parkinsonism, usually Leponex; Cz.: Leponex; Denm.: Leponex; Fin.: Froidir; Leponex; Fr.: Lep- mild and transient, while receiving clozapine. Adverse effects re- onex; Ger.: Elcrit; Leponex; Gr.: Leponex; Hong Kong: Clozaril; Hung.: should be re-titrated with extreme caution after a break ported from other individuals have also included a patient with Leponex; India: Lozapin; Sizopin; Indon.: Clozaril; Sizoril; Irl.: Clozaril; Is- of even 24 hours. Additional monitoring of blood cell parkinsonism who had worsening of psychotic symptoms when rael: Leponex; Lozapine; Ital.: Leponex; Malaysia: Clozaril; Zapine; 5 Mex.: Clopsine; Leponex; Neth.: Leponex; Norw.: Leponex; NZ: counts may also be required if treatment is interrupted, her dose of clozapine was increased, and the sudden return of Clopine; Clozaril; Philipp.: Leponex; Pol.: Klozapol; Leponex; Port.: Lep- see Treatment Break, under Monitoring, above. psychosis in another patient with parkinsonism whose psychosis onex; Ozapim; Rus.: Leponex (Лепонекс); S.Afr.: Cloment; Leponex; Sin- was successfully treated with clozapine for 5 years.6 gapore: Clozaril; Spain: Leponex; Swed.: Leponex; Switz.: Clopin; Lep- It is recommended that oral therapy with other antipsy- Low-dose clozapine (about 40 mg daily) also appears to be of onex; Thai.: Cloril; Clozaril; Turk.: Leponex; UK: Clozaril; Denzapine; Zaponex; USA: Clozaril; FazaClo; Fazalco†; Venez.: Leponex. chotics should be withdrawn gradually before treat- benefit in the management of levodopa-induced dyskinesias in ment with clozapine is started. patients with severe Parkinson’s disease.7 Clozapine has also been given by intramuscular injec- 1. Klein C, et al. Clozapine in Parkinson’s disease psychosis: 5- year follow-up review. Clin Neuropharmacol 2003; 26: 8–11. Cyamemazine (rINN) tion. 2. Pfeiffer C, Wagner ML. Clozapine therapy for Parkinson’s dis- ease and other movement disorders. Am J Hosp Pharm 1994; 51: Ciamemazina; Cyamémazine; Cyamemazinum; Cyamepro- In the management of treatment-resistant psychoses in 3047–53. mazine; RP-7204. 10-(3-Dimethylamino-2-methylpropyl)pheno- Parkinson’s disease, the initial oral dose of clozapine 3. The Parkinson Study Group. Low-dose clozapine for the treat- thiazine-2-carbonitrile. is no more than 12.5 mg once daily in the evening. ment of drug-induced psychosis in Parkinson’s disease. N Engl J Med 1999; 340: 757–63. Циамемазин Thereafter, the daily dosage may be increased in incre- 4. The French Clozapine Parkinson Study Group. Clozapine in C19H21N3S = 323.5. ments of 12.5 mg up to twice a week; a dose of 50 mg drug-induced psychosis in Parkinson’s disease. Lancet 1999; CAS — 3546-03-0 (cyamemazine); 93841-82-8 (cyam- daily should not be reached before the end of the sec- 353: 2041–2. emazine tartrate). 5. Auzou P, et al.