Subutex 2mg sublingual tablets Ref.[2580] Active ingredients: Buprenorphine

Treatment with SUBUTEX sublingual tablets is intended for use in adults and children aged 16 years or over who have agreed to be treated for addiction.

Administration is sublingual. Physicians must advise patients that the sublingual route is the only effective and safe route of administration for this drug. The tablet should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes.

Adults

Initiation therapy: Baseline liver function tests documentation of viral hepatitis status is recommended prior to commencing therapy. Patients who are positive for viral hepatitis, on concomitant medication (see section 4.5) and/or have existing liver dysfunction are at risk of accelerated liver injury. Regular monitoring of liver function is recommended (see section 4.4)

Induction: Prior to treatment induction, consideration should be given to the types of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degrees of opioid dependence. To avoid precipitating withdrawal, induction with Subutex should be undertaken when objective and clear signs of withdrawal are evident.

The initial dose is from 0.8 mg to 4 mg, administered as a single daily dose.

• for opioid-dependent drug addicts who have not undergone withdrawal: one dose of SUBTEX tablet(s) administered sublingually at least 6 hours after the last use of opioid, or when the first signs of craving appear.
• for patients receiving methadone: before beginning SUBUTEX therapy, the dose of methadone should be reduced to a maximum of 30 mg/day. SUBUTEX may precipitate symptoms of withdrawal in patients dependent upon methadone.

Dosage adjustment and maintenance: the dose of SUBUTEX should be increased progressively according to the clinical effort of the individual patient and should not exceed a maximum single daily dose of 32 mg. The dosage is titrated according to reassessment of the clinical and psychological status of the patient.

Dosage reduction and termination of treatment: after a satisfactory period of stabilisation has been achieved, the dosage may be reduced gradually to a lower maintenance dose; when deemed appropriate, treatment may be discontinued in some patients. The availability of the sublingual tablet in doses of 0.4 mg, 2 mg and 8 mg, respectively, allows for a downward titration of dosage. Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.

In the event of accidental overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of patient. The major symptom requiring intervention is respiratory depression, which could lead to respiratory arrest and death. If the patient vomits, care must be taken to prevent aspiration of the vomitus.

Treatment: Symptomatic treatment of respiratory depression, following standard intensive care measures, should be instituted. A patent airway and assisted or controlled ventilation must be assured. The patient should be transferred to an environment within which full resuscitation facilities are available. Use of an opioid antagonist (i.e., naloxone) is recommended, despite the modest effect it may have in reversing the respiratory symptoms of buprenorphine compared with its effects on full agonist opioid agents.

The long duration of action of SUBUTEX should be taken into consideration when determining length of treatment needed to reverse the effects of an overdose.

2 Years.

Do not store above 30°C. Store in the original package.

7 or 28 tablets in nylon/aluminium/uPVC blister packs.

Not applicable.