Buprenorphine (Opioid Dependence)

Source: UK SPC (eMC) for Buprenorphine 0.4 mg Sublingual tablets, §4.2 (https://www.medicines.org.uk/emc/product/100954/smpc) — this is the opioid-dependence licence, matching this page's indication. INDICATION SCOPE: treatment is intended for use in adults and children aged 16 years or over who have agreed to be treated for opioid dependence. PRECAUTIONS BEFORE DOSING: the prescriber should be aware of the partial agonist profile of buprenorphine at opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients, and should consider the type of opioid dependence (long- or short-acting), the time since last opioid use, and the degree of dependence. To avoid precipitating withdrawal, induction should be undertaken when objective and clear signs of withdrawal are evident, e.g. a score higher than 12 on the Clinical Opioid Withdrawal Scale (COWS). PATIENTS DEPENDENT ON HEROIN OR SHORT-ACTING OPIOIDS: the first dose should be started when objective signs of withdrawal appear, but NOT LESS THAN 6 HOURS after the patient last used opioids. PATIENTS RECEIVING METHADONE: before beginning buprenorphine therapy the methadone dose should be reduced to a maximum of 30 mg/day; buprenorphine may precipitate withdrawal in methadone-dependent patients, so the first dose should be started only when objective signs of withdrawal appear and generally NOT LESS THAN 24 HOURS after the patient last used methadone, because of methadone's long half-life. Baseline liver function tests and documentation of viral hepatitis status are recommended prior to commencing therapy. DOSAGE ADJUSTMENT AND MAINTENANCE: the dose should be increased progressively according to the clinical effect of the individual patient and should not exceed a maximum single daily dose of 32 mg; dosage is titrated according to reassessment of the clinical and psychological status of the patient. DOSAGE REDUCTION AND TERMINATION: after a satisfactory period of stabilisation the dosage may be reduced gradually to a lower maintenance dose and, when deemed appropriate, treatment may be discontinued in some patients; availability of 0.4 mg, 2 mg and 8 mg sublingual tablets allows downward titration. Patients should be monitored following termination because of the potential for relapse. PRIOR TO STARTING: a discussion should be held with patients to put in place a strategy for ending treatment, to minimise the risk of addiction and drug withdrawal syndrome; the decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between clinician and patient, with review at regular intervals (usually at least three-monthly, depending on clinical progress). ELDERLY: safety and efficacy in patients over 65 years of age have not been established. HEPATIC IMPAIRMENT: patients who are positive for viral hepatitis, on concomitant medicinal products and/or with existing liver dysfunction are at risk of greater liver injury and should be monitored for signs of toxicity or overdose; use with caution in hepatic insufficiency; contraindicated in severe hepatic insufficiency. PAEDIATRIC: contraindicated in children under the age of 16 — hence paedDose is null. Verify any under-18 use against a children's formulary. Note: §4.5 was not retrieved in this bundle — the interactions listed below are taken from the US label; verify the full UK §4.5.