DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)84. LORATADINEThe following boxed warning shall be included in the package inserts ofproducts containing Loratadine:WARNINGDrugs known to inhibit hepatic metabolism should be co-administered withcaution until definitive interaction studies can be completed. The numberof subjects who concomitantly received macrolide antibiotics,ketoconazole, cimetidine, ranitidine, or theophylline along with loratadinein controlled clinical trials is too small to rule out possible drug interactions.85. LORAZEPAMPlease refer to SEDATIVE – HYPNOTIC PRODUCTS86. METHYL SALICYLATEThe following statements shall be included in the package inserts and productliterature of topical preparations containing methyl salicylate ≥5%:CAUTIONThis product contains methyl salicylate and when applied or rub on to the skin,can be absorbed through the skin into the blood. For patients taking warfarin,excessive application on to the skin for muscle or joint pains may increase thechances of bleeding.87. METHYLPHENIDATE HCLThe following boxed statement shall be included on the labels and in thepackage insert of products containing Methylphenidate HCl:FOR SPECIALIST‟S USE ONLYNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 388