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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 must be under the supervision of a physician experienced in the management of opiate dependence/addiction. 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 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 buprenorphine therapy, the dose of methadone should be reduced to a maximum of 30 mg/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. 8 mg to 4 mg, administered as a single daily dose. Dosage adjustment and maintenance The dose of buprenorphine 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. 4). 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.
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).
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. 4 mg, 2 mg and 8 mg, respectively, allows for a downward titration of dosage.
g. insomnia, headache, nausea and hyperhidrosis) and pain. Tabulated list of adverse reactions Table 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); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), 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.
System organ class Frequency Side effects Infections and infestations Common:
Bronchitis, infection, influenza, pharyngitis, rhinitis.
Blood and lymphatic system disorders Common:
Lymphadenopathy.
Immune system disorders Very rare:
Anaphylactic shock, angioedema, bronchospasm.
Metabolism and nutrition disorders Common:
Decreased appetite.
Very common:
Insomnia.
Common:
Agitation, anxiety, depression, hostility, nervousness, paranoia, thinking abnormal hallucination. 4).
Nervous system disorders Very Common:
Headache.
Buprenorphine 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).
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. Abuse or intentional misuse of buprenorphine 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.
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. The clinical need for continuing opioid substitution therapy should be reviewed regularly.
Buprenorphine is a partial agonist at the μ-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 syndrome that may be delayed in onset. 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.
1 - Children 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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4). 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. 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. Buprenorphine sublingual tablets should be kept under the tongue until dissolved, which usually occurs within 5 to 10 minutes.
The tablet should not be swallowed, crushed or chewed.
Common:
Dizziness, hypertonia, migraine, paraesthesia, somnolence, syncope, tremor.
Unknown:
Seizures.
Common:
Lacrimation disorder, visual impairment (including mydriasis, miosis).
Eye disorders Uncommon:
Diplopia, conjunctivitis.
Ear and labyrinth disorders Common:
Vertigo.
Cardiac disorders Common:
Palpitations, arrhythmias.
Vascular disorders Common:
Vasodilation, orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders Common:
Cough, dyspnoea, yawning, respiratory depression.
Gastrointestinal disorders Common:
Abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, gastrointestinal disorder, flatulence, tooth disorder, vomiting.
Not known:
Dental caries.
Hepatobiliary disorders Not known:
Hepatic disorders*.
Skin and subcutaneous tissue disorders Common:
Rash.
Musculoskeletal and connective tissue disorders Common:
Arthralgia, back pain, bone pain, muscle spasms, myalgia, neck pain.
Reproductive system and breast disorders Common:
Dysmenorrhoea.
Very common:
Pain.
Common:
Asthenia, chest pain, chills, malaise, oedema peripheral, pyrexia.
General disorders and administration site conditions Uncommon:
Drug withdrawal syndrome, neonatal drug withdrawal syndrome**. 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). 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 pruritis.
Drug dependence Repeated use of buprenorphine can lead to drug dependence, even at therapeutic doses. 4). 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.
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.
Seizures Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder. 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 non-opioid 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 respiratory 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 sublingual tablets and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
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 sublingual tablets 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 […]