SUBUTEX

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. e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence.

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. 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.

Treatment goals, reducing dosage and discontinuation (Medical taper) Before initiating treatment with buprenorphine, a treatment strategy including treatment duration and treatment goals, should be agreed together with the patient.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4). 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.

g. insomnia, headache, nausea and hyperhidrosis) and pain. Tabulated list of adverse reactions Table 1 summarises: • adverse reactions reported from pivotal clinical studies. The frequency of possible side effects listed below is defined using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), not known (cannot be estimated from the available data).

• the most commonly reported adverse drug reactions during post-marketing surveillance. Events occurring in at least 1% of reports by healthcare professionals and considered expected are included. Frequency of events not reported in pivotal studies cannot be estimated and is given as not known.

4). • In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a withdrawal effect similar to that associated with naloxone. • The most common signs and symptoms of hypersensitivity include rashes, urticaria, and pruritus.

3). 4). • Drug dependence Repeated use of buprenorphine can lead to drug dependence, even at therapeutic doses. 4). • Neonatal drug withdrawal syndrome has been reported among newborns of women who have received buprenorphine during pregnancy.

The syndrome may be milder than that seen with a full μ-opioid agonist and may be delayed in onset. 6). • Hallucination, orthostatic hypotension, urinary retention and vertigo have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Subutex sublingual tablets are recommended only for the treatment of opioid drug dependence. It is also recommended that treatment is prescribed by a physician who ensures comprehensive management of the opioid-dependent patient(s).

Drug dependence, tolerance, potential for abuse and diversion Prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Overuse or misuse may result in overdose and/or death.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for continuing opioid substitution therapy should be reviewed regularly. Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit. Some risks of misuse and abuse include overdose, spread of blood borne viral or localised infections, respiratory depression and hepatic injury.

Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicine is not safeguarded against theft.

Sub-optimal treatment with buprenorphine may prompt medication misuse by the patient, leading to overdose or treatment dropout. A patient who is under-dosed with buprenorphine may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.

To minimise the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient’s level of stability.

1 Children less than 16 years of age Severe respiratory insufficiency Severe hepatic insufficiency Acute alcoholism or delirium tremens Breast feeding