title: Post marketing surveillance of sublingual buprenorphine naloxone combination tablets.
abstract: OBJECTIVE
  A combination of buprenorphine-naloxone (Addnok-N) tablets has been recently introduced in India as treatment for Opioid dependence. This study was undertaken to evaluate the possible adverse consequences following use of the buprenorphine-naloxone tablets through post marketing surveillance.
  
  
  METHODS
  National Drug Dependence Treatment Centre (NDDTC), AIIMS, India, monitored all patients receiving buprenorphine-naloxone combination tablets from the centre over a period of two and half years. Evaluation included subjective and objective side effect checklist, physical examination, and laboratory investigation.
  
  
  RESULTS
  Data was obtained from 1132 observations among 158 patients. Commonly reported medication effects, like muscle aches (44.0%), sleepiness (44.0%), relief from pain (41.3%), etc; are expected in opioid substitution treatment. Laboratory investigations were mostly normal except for liver enzyme abnormalities (52.2% of cases). Eight adverse events were reported in the study. No dangerous event or mortality was reported during the study.
authors.affiliation: National Drug Dependence Treatment Centre (NDDTC), Department of Psychiatry, AIIMS, New Delhi--110 029. rayrajat@hotmail.com
authors.forename: Rajat
authors.initials: R
authors.lastname: Ray
authors.forename: Meera
authors.initials: M
authors.lastname: Vaswani
authors.forename: Koushik Sinha
authors.initials: KS
authors.lastname: Deb
authors.forename: Hem
authors.initials: H
authors.lastname: Sethi
authors.forename: Anita
authors.initials: A
authors.lastname: Chopra
authors.forename: Nand
authors.initials: N
authors.lastname: Kishore
authors.forename: Rakesh
authors.initials: R
authors.lastname: Goyal
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects*; D000069479:Buprenorphine, Naloxone Drug Combination; D004338:Drug Combinations; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D012044:Regression Analysis; D013607:Tablets
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D004338:Drug Combinations; D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine