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BUPRENORPHINE is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment goals and discontinuation Before initiating treatment with Buprenorphine Sublingual Tablets, 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). Posology Treatment with Buprenorphine 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 patient 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 buprenorphine therapy, the dose of methadone should be reduced to a maximum of 30mg/day.
Buprenorphine 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 Buprenorphine Sublingual Tablets 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. 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 deemed may be discontinued in some patients. 4 mg, 2 mg and 8 mg, respectively, allows for a downward titration of dosage.
This medicine is recommended only for the treatment of opioid drug dependence. It is also recommended that that treatment is prescribed by a physician who ensures comprehensive management of the drug addicted patient(s) Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Buprenorphine Sublingual Tablets.
Abuse or intentional misuse of Buprenorphine Sublingual Tablets may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). g. too early requests for refills). This includes the review of concomitant opioids and psychoactive drugs (like benzodiazepines).
For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. 5) or when buprenorphine was not used according to prescribing information. Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids.
If buprenorphine is administered to some nonopioid dependent individuals who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur. g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respirator depression or kyphoscoliosis).
Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-dependent persons who accidentally or deliberately ingest it. Protect children and non-dependent persons against exposure. 7). Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of buprenorphine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
1 - Children and adolescents less than 16 years of age - Severe respiratory insufficiency - Severe hepatic insufficiency - Acute alcoholism or delirium tremens - Breast feeding
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in United Kingdom.
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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 have 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. 4). 2). 3). Renal impairment Modification of the buprenorphine dose is not generally required for patients with renal impairment.
2). 3). Method of administration 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.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicines, the lowest effective dose of the sedative medicines should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.
Dependence:
Buprenorphine is a partial agonist at the mu-opiate receptor and chronic administration produces dependence of the opioid type. Studies in animals, as well as clinical experience, have demonstrated that buprenorphine may produce dependence, but at a lower level than a full agonist.
Abrupt discontinuation of treatment is not recommended as it may result in a withdrawal that may be delayed in onset.
Hepatitis, hepatic events:
Cases of acute hepatic injury have been reported in opioid-dependent patients both in clinical trials and in post-marketing adverse event reports. The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of cytolytic hepatitis, hepatic failure, hepatic necrosis, hepatorenal syndrome, hepatic encephalopathy and death.
In many cases, the presence of pre-existing liver enzyme abnormalities, genetic disease infection with hepatitis B or hepatitis C virus, alcohol abuse, anorexia, concomitant use of other potentially hepatotoxic drugs and ongoing injecting drug use may have a causative or contributory role.
These underlying factors must be taken into consideration before prescribing buprenorphine and during treatment. When a hepatic event is suspected further biological and etiological evaluation is required. Depending on the findings, buprenorphine may be discontinued cautiously so as to prevent withdrawal symptoms and to prevent a return to illicit drug use.
If treatment is continued, hepatic […]