DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)51. DOPAMINERGIC INGREDIENTThe following warning/ statement related to “Sudden sleep onset” shall beincluded in the package insert and product literature of products containingdopaminergic ingredients:a. alpha-dihydroergocryptineb. apomorphinec. bromocriptined. cabergolinee. levodopaf. lisurideg. piribedilh. pramipexolei. quinagolidej. ropiniroleSPECIAL WARNING & SPECIAL PRECAUTIONS FOR USE……. has been associated with somnolence and episodes of sudden onset,particularly in patients with Parkinson‟s diseases. Sudden onset of sleepduring daily activities, in some cases without awareness or warning signs, hasbeen reported very rarely. Patients must be informed of this and advised toexercise caution while driving or operating machines during treatment with……. Patients who have experienced somnolence and/or an episode ofsudden sleep onset must refrain from driving or operating machines.Furthermore a reduction of dosage or termination of therapy may beconsidered.EFFECTS ON ABILITY TO DRIVE AND USE MACHINESPatients being treated with ……. and presenting with somnolence and/orsudden sleep episodes must be informed to refrain from driving or engaging inactivities where impaired alertness may put themselves or others at risk ofserious injury or death (e.g. operating machines) until such recurrent episodesand somnolence have resolved (see also section on special warnings andspecial precautions for use).UNDESIRABLE EFFECTS……. is associated with somnolence and has been associated very rarely withexcessive daytime somnolence and sudden sleep onset episodes.Reference: Circular (bil 14) dlm bpfk02/5/1.3: keluaran yang mengandungi bahan aktifdopaminergik- tanda amaran berkaitan dengan ' sudden sleep onset'National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 378
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)52. EPHEDRINEThe following statement shall be included on the labels and in the packageinserts of products containing Ephedrine:WARNINGWhen used for treatment of cough and cold:(a) Not to be used in children less than 2 years of age(b) To be used with caution and doctor‟s/ pharmacist‟s advice in children2 to 6 years of age.Reference: Circular Bil (34) dlm. BPFK/PPP/01/03: Kenyataan Amaran Pada Label danSisip Bungkusan Produk Persediaan Cecair Oral Untuk Rawatan Batuk dan Selsema (Coughand Cold) yang Mengandungi Antihistamin, Antitusif dan Dekongestan (Sebagai Bahan AktifTunggal atau Kombinasi)53. FAMOTIDINEThe following statement shall be included in the package inserts of productscontaining Famotidine:DOSAGEDosage adjustment is required for patients with moderate to severe renalinsufficiency. Since CNS adverse effects have been reported in patients withmoderate to severe renal insufficiency, to avoid excess accumulation of thedrug, the dose of famotidine may be reduced to half the recommended dose orthe dosing interval may be prolonged to 36 - 48 hours as indicated by thepatient‟s clinical response.PRECAUTIONAs elderly patients are more likely to have decreased clearance of famotidine,care should be taken in dose selection and it may be useful to monitor renalfunction.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 379
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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