DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)70. GLUCOSAMINE70.1 The following statement shall be included on the labels and packageinserts of products containing Glucosamine (derived from seafood);“DERIVED FROM SEAFOOD”70.2 The following statement shall be included in the package inserts ofproducts containing Glucosamine:SIDE EFFECTCardiovascularPeripheral oedema, tachycardia were reported in a few patientsfollowing larger clinical trials investigating oral administration inosteoarthritis. Causal relationship has not been established.Central nervous systemDrowsiness, headache, insomnia have been observed rarely duringtherapy (less than 1%).GastrointestinalNausea, vomiting, diarrhoea, dyspepsia or epigastric pain,constipation, heartburn and anorexia have been described rarelyduring oral therapy with glucosamine.SkinSkin reactions such as erythema and pruritus have been reportedwith therapeutic administration of glucosamine.Reference:a) Circular Bil (52) dlm BPFK/02/5/1.3: Muatkan Kenyataan 'Derived From Seafood'Pada Label Produk Jika Bahan AKtif Adalah Dari Sumber Laut'b) Circular Bil (72) dlm BPFK/02/5/1.3: Mengemaskini dan menyelaraskan maklumatmengenai kesan sampingan pada label & sisip bungkusan produk yang mengandungiglucosamine71. HIV PROTEASE INHIBITORSThe following statement shall be included in the package inserts of productscontaining HIV Protease inhibitors:ADVERSE REACTIONAlthough a causal relationship has not been definitively established, proteaseinhibitors may contribute to increase in blood sugar levels and even diabetesin HIV patients. Close monitoring of blood glucose level is recommended.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 389