Subutex 8mg

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1. Name of the medicinal product
Subutex 0.4 mg sublingual tablets

Subutex 2 mg sublingual tablets

Subutex 8 mg sublingual tablets

2. Qualitative and quantitative composition
Subutex 0.4 mg sublingual tablets

Each tablet contains 0.4 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

Subutex 2 mg sublingual tablets

Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

Subutex 8 mg sublingual tablets

Each tablet contains 8 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

3. Pharmaceutical form
Sublingual tablet

Subutex 0.4 mg sublingual tablets

Uncoated oval white flat bevelled edged tablet, nominal dimensions 8 mm x 4 mm, debossed with “04” on one side.

Subutex 2 mg sublingual tablets

Uncoated oval white flat bevelled edged tablet, nominal dimensions 10 mm x 5 mm, debossed with “B2” on one side.

Subutex 8 mg sublingual tablets

Uncoated oval white flat bevelled edged tablet, nominal dimensions 14 mm x 7 mm, debossed with “B8” on one side.

4. Clinical particulars
4.1 Therapeutic indications
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.

4.2 Posology and method of administration
Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). The decision to maintain a patient on a long-term opioid prescription should be an active decision agreed between the clinician and patient with review at regular intervals (usually at least three-monthly, depending on clinical progress).

Posology

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 opioid dependence.

Precautions to be taken before dosing

Prior to treatment induction, physicians should be aware of the partial agonist profile of buprenorphine to the opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients and 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 degree of opioid dependence. To avoid precipitating withdrawal, induction with Subutex 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).

• For patients dependent on heroin or short-acting opioids: the first dose of buprenorphine should be started when objective signs of withdrawal appear, but not less than 6 hours after the patient last used opioids.

• For patients receiving methadone: before beginning Subutex therapy, the dose of methadone should be reduced to a maximum of 30mg/day. Subutex may precipitate symptoms of withdrawal in patients dependent on methadone. The first dose of buprenorphine 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 the long half-life of methadone.

Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.

Induction:

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

Dosage adjustment and maintenance:

The dose of Subutex should be increased progressively according to the clinical effect of the individual patient and should not exceed a maximum single daily dose of 32mg. 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 0.4mg, 2mg and 8mg, respectively, allows for a downward titration of dosage. Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.

Special populations

Elderly

The safety and efficacy of buprenorphine in elderly patients over 65 years of age has not been established.

Hepatic impairment

Patients who are positive for viral hepatitis, on concomitant medicinal products and / or have existing liver dysfunction are at risk of greater liver injury. Patients should be monitored for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine (see section 4.4). Buprenorphine should be used with caution in patients with hepatic insufficiency (see section 5.2). Buprenorphine is contraindicated in patients with severe hepatic insufficiency (see section 4.3).

Renal impairment

Modification of the buprenorphine dose is not generally required for patients with renal impairment. Caution is recommended when dosing patients with severe renal impairment, which may require dose adjustment (creatinine clearance < 30 ml/min) (see section 5.2).

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