DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)78. KETOROLAC TROMETHAMOL (KETOROLAC TROMETHAMINE)The following statements shall be included in the package inserts of productscontaining Ketorolac tromethamol:THE PRODUCT SHALL BE INDICATED FOR THE FOLLOWINGFor short-term management of moderate to severe acute post-operative painfollowing surgical procedures associated with low risk of haemorrhage.DOSAGE AND DURATION OF TREATMENTParenteral administration: The starting dose should be 10mg with subsequentdoses of 10-30mg four to six hourly as required. The lowest effective doseshould be used. The total daily dose of 90mg for the non-elderly and 60mg forthe elderly should not be exceeded. Maximum duration of parenteral treatmentis 2 days for all age groups. In patients who have received parenteral ketorolacand are converted to oral tablets, the total combined daily dose of all forms ofketorolac should not exceed 90mg for non-elderly and 60mg for the elderly.Maximum duration of treatment for the oral formulation is 7 days.CONTRAINDICATIONSA history of peptic ulceration or gastrointestinal bleedingA history of haemorrhagic diathesisA history of confirmed or suspected cerebrovascular bleedingOperations associated with a high risk of haemorrhageA history of asthmaModerate or severe renal impairment (serum creatinine > 160mol/L)Hypovolaemia or dehydration from any causeHypersensitivity to NSAIDs or aspirinDuring pregnancy, labour, delivery or lactationConcomitant administration with other NSAIDs, anticoagulant includinglow dose heparin79. LEVODOPAPlease refer to DOPAMINERGIC INGREDIENTNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 394
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)80. LINCOMYCINFor all products containing Lincomycin:The package insert must emphasize the possibility of pseudomembranouscolitis with the use of the drug and must include the following boxed oremphasized statement/ warning:a. Lincomycin therapy has been associated with severe colitis which mayend fatally.b. It should be reserved for serious infections where less toxicantimicrobial agents are inappropriate.c. It should not be used in patients with nonbacterial infections, such asmost upper respiratory tract infections.d. Its use in newborns is contraindicated.81. LISURIDEPlease refer to DOPAMINERGIC INGREDIENT82. LIQUID PARAFFINThe following statement shall be included on the labels of products containingLiquid paraffin as laxative:Not recommended for use in children below 3 years of age;Not recommended for use in pregnant women;Repeated use is not advisable;Consult your doctor if laxatives are needed every day, if you havepersistent abdominal pain or have a condition which makes swallowingdifficult.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 395
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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