DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 382
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)54. FIBRATESThe following statement shall be included in the package inserts of productscontaining Fibrates:a. Clofibrate,b. Bezafibratec. Ciprofibrate, Etofibrated. Fenofibratee. Simfibratef. etc.DRUG INTERACTIONConcurrent use of fibates with HMG-CoA reductase inhibitors may causesevere myositis and myoglobinuria.55. FLUCLOXACILLINThe following warning shall be included in the package insert of productscontaining Flucloxacillin:WARNINGLiver ToxicityFlucloxacillin can cause severe hepatitis and cholestatic jaundice,which may be protracted. This reaction is more frequent in olderpatients and those who take the drug for prolonged periods (seePrecaution, Adverse Reactions)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 383
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PART III: NON-CLINICAL DATADrug Reg
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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