DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)13. ANTIPSYCHOTIC AGENTS13.1 ALL ANTIPSYCHOTIC AGENTSThe following statement shall be included in the package inserts ofproducts containing antipsychotic:PREGNANCY AND LACTATIONNeonates exposed to antipsychotic drugs during the third trimester ofpregnancy are at risk for extrapyramidal and/or withdrawal symptomsfollowing delivery. There have been reports of agitation, hypertonia,hypotonia, tremor, somnolence, respiratory distress, and feeding disorderin these neonates. These complications have varied in severity; while insome cases symptoms have been self-limited, in other cases neonateshave required intensive care unit support and prolonged hospitalisation.[BRAND NAME] should be used during pregnancy only if the potentialbenefit justifies the potential risk to the foetus.Reference: Circular Bil (16) dlm BPFK/PPP/01/03 Jld 1: Direktif Kenyataan AmaranBerkaitan Dengan Risiko Extrapyrimidal And/or Withdrawal Symptoms Bagi NeonatYang Terdedah Kepada Produk Antipsikotik Semasa Trimester Ketiga Kehamilan PadaSisip Bungkusan Semua Produk Antipsikotik13.2 ATYPICAL ANTIPSYCHOTIC AGENTSThe following statement shall be included in the package inserts ofproducts containing atypical antipsychotic agents:a. Clozapineb. Olanzepinec. Risperidoned. Quetiapinee. Ziprasidonef. AripiprazoleWARNINGHyperglycemia and Diabetes MellitusHyperglycemia in some cases extreme and associated with ketoacidosisor hyperosmolar coma or death, has been reported in patients treatedwith atypical antipsychotics. Assessment of the relationship betweenatypical antipsychotics use and glucose abnormalities is complicated bythe possibility of an increased background risk of diabetes mellitus inpatients with schizophrenia and the increasing incidence of diabetesmellitus in the general population. Given this confounders, theNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 356
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)relationship between atypical antipsychotic use and hyperglycemiarelatedadverse events is not completely understood. However,epidemiological studies suggest an increased risk of treatment-emergenthyperglycemia-related adverse events in patients treated with the atypicalantipsychotics. Precise risk estimates for hyperglycemia-related adverseevents in patients treated with atypical antipsychotics are not available.Patients with an established diagnosis of diabetes mellitus who arestarted on atypical antipsychotics should be monitored regularly forworsening of glucose control. Patients with risk factors for diabetesmellitus (e.g. obesity, family history of diabetes) who are startingtreatment with atypical antipsychotics should undergo fasting bloodglucose testing at the beginning of treatment and periodically duringtreatment. Any patient treated with atypical antipsychotics should bemonitored for symptoms of hyperglycemia including polydipsia, polyuria,polyphagia, and weakness. Patients who develop symptoms ofhyperglycemia during treatment with atypical antipsychotics shouldundergo fasting blood glucose testing. In some cases, hyperglycemia hasresolved when the atypical antipsychotic was discontinued; however,some patients required continuation of anti-diabetic treatment despitediscontinuation of the suspect drug.Reference: Circular Bil (31)dlm BPFK/02/5/1.3: Tambahan Amaran Berkaitan DenganHyperglycemia Bagi Keluaran 'Atypical Antipsychotic Agents'14. APOMORPHINEPlease refer to DOPAMINERGIC INGREDIENT15. ARGININEThe following statement shall be included on the labels and in the packageinserts of oral preparations containing Arginine for health supplementproducts:WARNINGArginine is not recommended for patients following a heart attack.Reference: Circular Bil (64) dlm BPFK/02/5/1.3: Pernyataan Amaran Produk Mengandungi'Arginine'16. ARIPIPRAZOLEPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 357
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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