DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)40. COLCHICINEThe following statement shall be included in the package inserts of productscontaining Colchicines:INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHERFORMS OF INTERACTION:Potential risk of severe drug interactions, including death, in certainpatients treated with colchicine and concomitant P-glycoprotein or strongCYP3A4 inhibitors such as clarithromycin, cyclosporin, erythromycin, calciumchannel antagonists (e.g Verapamil and Diltiazem), telithromycin,ketoconazole, itraconazole, HIV protease inhibitors and nefazodone.P-Glycoprotein or strong CYP3A4 inhibitors are not to be used in patientswith renal or hepatic impairment who are taking colchicine.A dose reduction or interruption of colchicine treatment should beconsidered in patients with normal renal and hepatic function if treatment witha P-glycoprotein or a strong CYP3A4 inhibitor is required. Avoid consuminggrapefruit and grapefruit juice while using colchicine.Reference: Circular Bil (45) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Severe Drug Interaction Between Colchicine and P-Glycoprotein or Strong CYP3A4Inhibitors” Yang Perlu Dimuatkan Pada Sisip Bungkusan Produk ColchicineNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 375