Buprenorphine with naloxone

VERBATIM UK SPC §4.2 (SUBOXONE 8MG/2MG SUBLINGUAL TABLET, PLGB366990012, Indivior UK Limited): 'The recommended starting dose in adults and adolescents over 15 years of age is 4 mg/1 mg and can be repeated up to a maximum dose of 12 mg/ 3 mg on day 1 to minimise undue withdrawal symptoms and retain the patient in treatment.' 'The maximum single daily dose should not exceed 24 mg buprenorphine.' 'However, the dose given on any one day should not exceed 24 mg.' 'Patients requiring a titrated daily dose> 8 mg /day may not find this regimen adequate' (applies to the three-times-weekly schedule). STRENGTH (§2): each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate); §4.2 also refers to a 2 mg/0.5 mg tablet, and 'The dose can be made up from multiple Suboxone tablets of different strengths, which may be taken all at the same time or in two divided portions.' §4.1: 'Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse. Suboxone is indicated in adults and adolescents over 15 years of age who have agreed to be treated for addiction.' ESPRANOR IS NOT COVERED: the page also lists Espranor as a brand, but Espranor is buprenorphine alone (no naloxone) and is given on the tongue; no figure from it is used here, and other buprenorphine/naloxone products (e.g. Suboxone film) are not covered by this tablet SPC's mg figures beyond what §4.2 states. BEFORE INDUCTION (§4.2): start only when objective, clear signs of withdrawal are evident (e.g. mild to moderate on the Clinical Opioid Withdrawal Scale, COWS). Heroin or short-acting opioids: first dose when withdrawal signs appear, not less than 6 hours after last use. Methadone: reduce methadone to a maximum of 30 mg/day first; first dose only when withdrawal signs appear, not less than 24 hours after last methadone. SUPERVISION: treatment must be under a physician experienced in managing opiate dependence/addiction; daily supervision of dosing is recommended during initiation. SWITCHING: buprenorphine/naloxone and buprenorphine alone are interchangeable when used sublingually, but prescriber and patient must agree and the patient be monitored for a need to readjust. Suboxone tablets and Suboxone film start on the same dose, but film may have greater relative bioavailability (monitor for overdose when going tablet to film, and for withdrawal/underdosing when going film to tablet); combining or alternating the two formulations is not advised. MEDICAL WITHDRAWAL: once stabilised and with the patient's agreement, reduce gradually to a lower maintenance dose; 2 mg/0.5 mg and 8 mg/2 mg tablets allow downward titration, and the 0.4 mg buprenorphine sublingual tablet may be used for lower buprenorphine doses. CHILDREN/ELDERLY: the starting-dose sentence covers adults and adolescents over 15 years but the SPC gives no separate adolescent figure; safety and efficacy below 15 years are not established (no data); in patients over 65 years 'No recommendation on posology can be made.' The SPC states the sublingual route is the only effective and safe route. Some sections of the product information we used were incomplete — check the full SPC.