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NFI National Formulary of India 5th Edition 2016
Government of India Ministry of Health & Family Welfare Sign up to vote on this title
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© 2016, Indian Pharmacopoeia Commission Commission All rights reserved No part of this publication may be reproduced, stored in a retrieval system/transmitted in any any form by any means such such as electronic, mechanical including photocopying, recording or otherwise without the prior written permission of the Indian Pharmacopoeia Commission.
ISBN-978-93-81238-02-8
NFI, 5th Edition On behalf of
:
Government of India Ministry of Health & Family Welfare Welfare
Produc Produced ed & publish published ed by
:
Indi Indian an Phar Pharm macop acopoe oeiaCom iaCommi miss ssio ion, n, Government of India, Ministry of Health & Family Welfare Sector 23, Raj Nagar, Ghaziabad- 201 002
Tel: Tel: (91-120)-278340 1 Fax: (91-120-2783311
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© 2016, Indian Pharmacopoeia Commission Commission All rights reserved No part of this publication may be reproduced, stored in a retrieval system/transmitted in any any form by any means such such as electronic, mechanical including photocopying, recording or otherwise without the prior written permission of the Indian Pharmacopoeia Commission.
ISBN-978-93-81238-02-8
NFI, 5th Edition On behalf of
:
Government of India Ministry of Health & Family Welfare Welfare
Produc Produced ed & publish published ed by
:
Indi Indian an Phar Pharm macop acopoe oeiaCom iaCommi miss ssio ion, n, Government of India, Ministry of Health & Family Welfare Sector 23, Raj Nagar, Ghaziabad- 201 002
Tel: Tel: (91-120)-278340 1 Fax: (91-120-2783311
Sign up to vote on this title Website: www.ipc.gov.in E-mail:
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Disclaimer NFI is not a regulatory document. It is a reference document for health professionals. Physicians are supposed to u se their professional experience, judgment etc while prescribing medicines or adopting treatment regimes. Treatment Treatment regimes in respect of the diseases and ailments included in this document may also change from time to time and users are advised to adopt the changed regimes. The references to statutory provisions/ requirements etc are based on the status of such provisions at the time of compilation of this document. Users are advised to refer to the statutory document concerned for updates. The contents such as ‘Indications’, ‘Strength’ etc included are based on the inputs available to the IPC. These shall not form the basis for any user or stakeholder to seek immunity under the “New Drug” status as specified in the Drugs and Cosmetics Act and Rules. In the event of any dispute in any of the content of these document and the statutes, the statutory provisions shall prevail. Where the use of any drug is banned in the country by the authority authority concerned, the monograph or other content of this document shall stand deleted or modified as the situation may demand. Where there is any anomaly between the content of NFI and any other non-statutory Official document exists, the decision of the Government or the implementing autho rity will prevail.
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Indian Pharmacopoeia Commission Mission To promote public and animal health in India b y bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers.
Vision To promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis.
Objectives •
•
•
•
To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active pharmaceutical You're Reading a Preview ingredients, pharmaceutical aids and dosage forms as well as medical devices and to keep them updated by revision on a regular basis. Unlock full access with a free trial. To develop monographs for herbal drugs, both raw drugs and extracts/formulations therefrom.
Download With Free To accord priority to monographs of drugsTrial included in the National Essential Medicines List and their dosage forms. To take note of the different levels of sophistication in analytical testing/instrumentation available while framing the monographs.
•
To accelerate the process of preparation, certification and distribution of IP Reference Substances, including the related substances, impurities and degradation products.
•
To collaborate with pharmacopoeias like the Ph Eur, BP, USP, JP, Sign up to vote on this title ChP and International Pharmacopoeia with a view to harmonizing with global standards. Useful Not useful
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To review existing monographs periodically with a view to deleting obsolete ones and amending those requiring upgrading/revision.
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Contents Page No. Preface
VIII
Introduction
XV
Acknowledgements
XVIII
List of Medicines Monographs in NFI
XXI
List of Medicines deleted from NFI
XXXIX
Common Abbreviations
XL
General Advice to Prescribers 1.
XLVI
Analgesics, Antipyretics, Non-Steroidal AntiInflammatory Drugs (NSAIDS)
3
2.
Antacids and Antiulcer Drugs
19
3.
Antiallergics and Drugs Used in Anaphylaxis
31
4.
Anti-Alzheimer and Anti-Parkinsonism Drugs
43
5.
You're Reading a Preview Anticonvulsants/Antiepileptics
53
6.
Antidiarrhoeals Unlockand full Laxatives access with a free trial.
75
7.
Antidotes and Substances Used in Poisoning
87
8.
Antiemetics
105
9.
Anti-Infectives
113
10. Antimigraine Drugs
251
11. Antineoplastics and Immunosuppressants
257
12. Antiseptics and Disinfectants
289
13. Basics of Medical Emergencies
297
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14. Cardiovascular Drugs 15. Dermatological Drugs 16. Diagnostic Agents 17. Dialysis Fluids
305
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23. Drugs for Myasthenia Gravis
469
24. Drugs for Oral Health
475
25. Drugs for Respiratory Diseases
485
2 6. Hormones, Contraceptives and Related Drugs
5 09
27. Immunologicals
579
28. Medicines banned in Sports
605
29. Muscle Relaxants
613
30. Ophthalmological Preparations
621
31. Psychotherapeutic Drugs
645
32 . Solutions Correcting Water, Electrolyte and Acid Base Disturbances
699
33 . Vitamins, Minerals and Antianaemic Drugs
71 1
Appendices Appendix 1: Appendix 2: Appendix 3: Appendix 4: Appendix 5:
Antimicrobial Resistance
737
You're Reading a Preview Advisories related to Medicines
741
Calculation of Electrolytes
742
Causality assessment of adverse drug reactions
746
Unlock full access with a free trial. Common Drugs Causing Download With FreeSevere Trial Allergic Reactions
749
Appendix 6:
Common Laboratory Parameters
751
Appendix 7:
Disposal of Unused/Expired Pharmaceutical Products
756
Appendix 8:
Domiciliary Care of seizures
762
Ap pendi x 9:
Poi sons Inf orma tion Cen tr es in Indi a
765
Appendix 10:
Drug Interactions
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a. Drug–Alcohol Interactions
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b. Drug– Cont race pti ve Intera cti ons
76 9
c. Drug–Drug Interactions
77 3
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Drugs banned in India (From year 2008 onwards)
884
App end ix 13 :
Nat iona l He alth Progr am me s ( NHPs )
885
Appendix 14:
National Immunisation and IAP Immunisation Schedule
887
National List of Essential Medicines of India, 2011
890
Appendix 16:
Pharmacogenetics
898
Appendix 17:
Pharmacovigilance Programme of India
905
Appendix 18:
Pictograms
907
Appendix 19:
Principles of Dose Calculation in Special Conditions a. Pediatrics b. Geriatrics
910 913
Appendix 20:
Storage of Medicines
916
Appendix 21:
You're Reading a Preview
Therapeutic Drug Monitoring
919
Appendix 22:
Tips for Healthy Life Style
922
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924
Appendix 15:
Index
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Preface The first, second and third editions of National Formulary of India (NFI) were published in 1960, 1966 and 1979 re sp ec tiv ely b y th e Min is tr y o f Hea lt h, G ovt. o f In dia . In the past 3 decades there has been vast expansion in the range of new drugs and their formulations. To address the n ee d o f p ub li ca tio n o f a n u pd ate d v er si on o f N FI, Ministry of Health and Family Welfare, Govt. of India vide their Notification No. F.No.X.11035/2/06- DFQC dated 8th May, 2008 assigned this mandatory responsibility to the Indian Pharmacopoeia Commission (IPC), Ghaziabad and hence the NFI is being published by the IPC on behalf of the Govt. of India, Ministry of Health and Family Welfare. The fourth edition of NFI was brought out by the IPC in 2011. ToYou're publishReading the 5 th Edition of NFI 2016, a High a Preview Power Committee was constituted by the Ministry of Health & Unlock Familyfull Welfare, Govt of trial. India vide letter access with a free rd No 11020/4/2012- DFQC dated 23 Jul 2012, to identify the experts. The Committee consisted of:
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HIGH POWER COMMITTEE 1.
Dr V. M. Katoch, Ex-Secretary, Department of Health Research (DHR) and Director General, Indian Council of Medical Research, New Delhi.
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2.
Prof. Y. K. Gupta, Head, Department of Pharmacology, Useful Not useful AIIMS, New Delhi.
3.
Prof. K.K. Talwar, Ex-Chairman, Board of Governors, Medical Council of India, New Delhi.
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Other Important Committees for NFI, 5th Edition, 2016 APEX BODY Chairman: Secretary ( Ex-off icio ), Ministry of Health & Family Welfare, Govt. of India.
Members 1.
Dr V. M. Katoch, Ex-Secretary, DHR and Director General, Indian Council of Medical Research, New Delhi.
2.
Dr Jagdish Prasad, Director General, Directorate General of Health Services, Ministry of Health and Family Welfare, Govt. of India, Nirman Bhawan, New Delhi.
3.
Additional Secretary and DG ( Ex-of ficio), Ministry of Health and Family Welfare, Govt. of India, You're Reading a Preview Nirman Bhawan, New Delhi.
4.
Unlock full Regulation access with a( Ex-officio), free trial. Ministry of Joint Secretary, Health and Family Welfare, Govt. of India, Nirman Bhawan, New Delhi.
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5.
Prof. B. Suresh, Chairman, Scientific Body, Indian Pharmacopoeia Commission, Ghaziabad.
6.
Prof. Y. K. Gupta, Head, Department of Pharmacology AIIMS, New Delhi.
7.
Mr. P. D. Sheth, Ex-Vice President, The Sign upInternational to vote on this title Pharmaceutical Federation, The Hague, The Netherlands.
8.
Prof. T. M. Mohapatra, Ex-Director & Dean, Institute of Medical Sciences, BHU, Varanasi.
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CORE GROUP Chairpersons: Prof. B. Suresh and Prof. Y.K. Gupta Member Secretary: Dr. G. N. Singh 1.
Director (Drugs) ( Ex-officio), Ministry of Health and Family Welfare, Govt. of India, New Delhi.
2.
Prof. Praveen Aggarwal, Department of Emergency Medicine, AIIMS, New Delhi.
3.
Dr Veena Gupta, Consultant, Department of Radiotherapy, Safdarjung Hospital, New Delhi.
4.
Dr Jai Prakash, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad.
5.
Dr G.C. Khilnani, Ex-Professor, Department of Medicine, AIIMS, New Delhi.
6.
You're Reading a Preview Prof. Lalit Kumar, Dr. B R Ambedkar Institute – Rotary Cancer Hospital, AIIMS, New Delhi. Unlock full access with a free trial. Mr P.D. Sheth, Ex-Vice President, The International Pharmaceutical Federation, The Hague, The Netherlands.
7. 8.
9.
Download With Free Dr Pramil Tiwari, Professor and Trial Head, Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research, Mohali, Punjab. Mr A.K. Pradhan, Deputy Drugs Controller (India), CDSCO North Zone, Ghaziabad.
10. Dr Bishwa Mohan Padhy, Assistant Professor, SignBhubaneswar. up to vote on this title Department of Pharmacology, AIIMS,
Useful Not 11. Dr Bikash Medhi, Additional Professor, Department of useful Pharmacology, PGIMER, Chandigarh. 12. Dr D. Roy, Deputy Drugs Controller (India) (Retd),
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SUBJECT REVIEW COMMITTEE Chairman : Prof. Y. K. Gupta Member Secretary : Dr Jai Prakash The manuscript was reviewed and the contents updated to align with Indian context by the Subject Review Committee. 1.
Dr Sridhar Dwivedi, Professor of Medicine/Preventive Cardiology, Hamdard Institute of Medical Sciences and Research, Associated Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard (Hamdard University), New Delhi-110062.
2.
Mr S. S. Venkatakrishnan, Drugs Controller (Retd), Kerala State, Thiruvananthapuram.
3.
Dr Pooja Gupta, Assistant Professor, Department of Pharmacology, AIIMS, New Delhi.
4. 5.
You're Reading a Preview Dr Sheffali Gulati, Professor, Department of Pediatric Neurology, AIIMS, New Delhi. Unlock full access with a free trial. Dr Pramil Tiwari, Professor and Head, Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research, Mohali, Download With FreePunjab. Trial
6.
Dr Prafull Kumar, Senior Resident, Department of Pharmacology, AIIMS, New Delhi.
7.
Dr N. Harivenkatesh, Senior Resident, Department of Pharmacology, AIIMS, New Delhi.
8.
Dr Ekta Arora, Senior Resident, Department of Pharmacology, AIIMS, New Delhi.Sign up to vote on this title
9.
Dr Guruprasad, Senior Resident, Department of useful Useful Not Pharmacology, AIIMS, New Delhi.
10. Dr Harmanjit Singh, Senior Resident, Department of
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13. Dr Biswa Mohan Padhy, Assistant Professor, Department of Pharmacology, AIIMS, Bhubaneswar. 14. Dr R K Sanghavi, Chairman, Medical Sub-Committee, IDMA, Mumbai. 15. Dr Madhur Gupta, Technical Officer, WHO-India (Country Office), New Delhi. 16. Dr R.N. Gupta, Professor, Birla Institute of Technology (BITS), Mesra, Ranchi. 17. Dr Vijaylaxmi Nag, Professor and Head, Department of Microbiology, AIIMS, Jodhpur. 18. Dr Rajat Ray, Ex-Professor and Head, Department of Psychiatry, & Chief, National Drug Dependence Treatment Centre , All India Institute Medical Sciences, New Delhi.
You're Reading a Preview 19. Dr Alka Beotra, Scientific Director, National Dope Testing Laboratory, Min. of Youth Affairs and Sports, Unlock full access with a free trial. New Delhi. 20. Dr Vijay Mathur, Additional Professor, Department of Download With Free Trial Dental Research AIIMS, New Delhi. 21. Dr Neena Valecha, Director, National Institute of Malaria Research, Dwarka, New Delhi. 22. Dr Deepali Anvikar, Scientist C, National Institute of Malaria Research, Dwarka, New Delhi.
Sign up to vote on this title 23. Prof. Anoop Mishra, Chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases Not useful Useful and Endocrinology, Fortis Hospital, Vasant Kunj and SDA, New Delhi.
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26. Dr B. Gupta, Professor and Head, Department of Medicine, Safdarjung Hospital, New Delhi. 27. Dr Jatinder Dhillon, Assistant Professor, Maulana Azad Institute of Dental Sciences, New Delhi.
IPC Scientific team Dr Jai Prakash (Chief Coordinator), Dr V. Kalaiselvan, Dr Manoj Kumar Pand ey, Dr M. Kalaivani, Mr K. K. Singh Ms Amandeep Bhatia, Mr Ashish Kushwaha, Ms Shruti Rastogi, Ms Neha Singh, Dr Divya Kaushik, Mr Hariom Singh.
The Criteria for Inclusion of Drugs in NFI: You're Reading a Preview • •
Drugs in National List of Essential Medicines 2011, India Unlock full access with a free trial. Drugs used in National Health Programmes
•
Drugs listed in Indian Pharmacopoeia
•
Drugs not covered but recommended by panel of experts
•
Any drug (s) considered appropriate by the IPC
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The Criteria for Exclusion of Drugs from NFI: Sign up to vote on this title
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Drugs banned in India
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Obsolete Drugs
•
Drugs considered inappropritate by IPC
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NFI Review Process To fulfil the mandate of publishing the NFI, the following process has been adopted: To Fulfil the mandate of publishing the NFI, the following has been adopted: High Powered Committee (for identification of experts and major policy decision) Policy Framework by Apex Body th NFI 4 Edition & WHO Model Formulary as base document Review by Core Group Modification suggested by Subject Review Committee You're Reading a Preview Unlock full access a free trial. Review bywith Core group Approval by Apex Body Download With Free Trial Draft content of NFI uploaded on the website of IPC for public comments and comments requested individually also from the targeted experts Review and incorporation of p ublic comments Sign up to vote on this title Adoption for NFI
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