DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)136. THROMBOLYTIC AGENTSThe following caution shall be disclosed prominently in the package inserts ofproducts containing “systemic thrombolytic agent” in particular “the tissueplasminogen activators”:WARNINGSevere bleeding such as intracranial haemorrhage may occur followingadministration of the drug, particularly in the elderly patients. The risk must bebalanced against the potential benefit of thrombolysis.The following precautions need to be observed:Patients should be carefully observed for clinical signs during and followingadministration of the drug for early detection of bleeding. Frequenthaematological tests such as blood coagulation tests are mandatory.To prevent bleeding at the site of centesis or other regions, caution must beexercised concerning procedures and management of arterial/ venuspuncture.The use of heparin in conjunction with the thrombolytic agent for the purposeof prevention of reocclusion may increase the risk of intracranial haemorrhage.Close monitoring of patients is strongly recommended.137. TIAPROFENIC ACIDThe following statement shall be included in the package inserts of productscontaining Tiaprofenic acid:PRECAUTIONUrinary symptoms (bladder pain, dysuria, and frequency), haematuria orcystitis may occur. In certain exceptional cases, the symptoms have becomesevere on continued treatment. Should urinary symptoms occur, treatmentwith tiaprofenic acid must be stopped.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 421