Post marketing surveillance of sublingual buprenorphine naloxone combination tablets.

ABSTRACT

Background & Objectives: A combination of buprenorphinenaloxone (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 buprenorphinenaloxone 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.