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FDA approves combination pill for severe acute pain in adults
The US Food and Drug Administration (FDA) has approved Seglentis a combination of celecoxib and tramadol hydrochloride for severe acute pain in adults, especially when alternative treatments fail to provide adequate pain relief
It is an innovative first-in-class product comprised of a co-crystal form of celecoxib an anti-inflammatory drug and tramadol ,an analgesic for the treatment of acute pain in adults.
The Food and drug administration will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis , as the combination carries the risks of addiction, abuse, and misuse with opioids, even at recommended doses.
The drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals. Further the patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
It is suggested that the prescribing doctors should make the patients aware of naloxone (Narcan) and consider prescribing the opioid antagonist naloxone based on the patient's risk factors for overdose.
Dr Kartikeya Kohli is an Internal Medicine Consultant at Sitaram Bhartia Hospital in Delhi with super speciality training in Nephrology. He has worked with various eminent hospitals like Indraprastha Apollo Hospital, Sir Gangaram Hospital. He holds an MBBS from Kasturba Medical College Manipal, DNB Internal Medicine, Post Graduate Diploma in Clinical Research and Business Development, Fellow DNB Nephrology, MRCP and ECFMG Certification. He has been closely associated with India Medical Association South Delhi Branch and Delhi Medical Association and has been organising continuing medical education programs on their behalf from time to time. Further he has been contributing medical articles for their newsletters as well. He is also associated with electronic media and TV for conduction and presentation of health programs. He has been associated with Medical Dialogues for last 3 years and contributing articles on regular basis.
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751