DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)132. SULPHONAMIDES/ TRIMETHOPRIM132.1 The following statement shall be included on the labels of productscontaining Sulphonamides and Trimethoprim as single ingredient or incombination of both ingredients:Discontinue treatment with this drug immediately if skin rash or any signof adverse reaction occurs.132.2 The following statement shall be included in the package inserts ofproducts containing Sulphonamides and Trimethoprim as singleingredient or in combination of both ingredients:Fatalities associated with the administration of sulphonamides andtrimethoprim, either alone or in combination, have occurred due to severereactions, including Steven-Johnson syndrome, toxic epidermal necrolysisand other reactions. The drug should be discontinued at the firstappearance of skin rash or any sign of adverse reaction.133. TERBUTALINE133.1 The following statement shall be included in the package inserts ofproducts containing Terbutaline in injection dosage form:As maternal pulmonary oedema and myocardial ischaemia havebeen reported during or following premature labour in patientsreceiving beta2 – agonists, careful attention should be given to fluidbalance and cardio-respiratory function, including ECG monitoring.If signs of pulmonary oedema and myocardial ischaemia develop,discontinuation of treatment should be considered.Due to the risk of pulmonary oedema and myocardial ischaemiathat has been observed during the use of beta2-agonists in thetreatment of premature labour, before these products are given toany patient with known heart disease, an adequate assessment ofthe patients‟s cardiovascular status should be made by a physicianexperienced in cardiology.Cautious use of terbutaline injections is required in pregnantpatients when it is given for relief of bronchospasm so as to avoidNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 415