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BURPRENORPHINE is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sublingual substitution treatment for opioid drug dependence in adults and adolescents aged 15 years or older, within the framework of a comprehensive, adequately monitored medical, social and psychological supervision. The decision on the therapeutic indication should be limited to physicians at a special addiction…
Verbatim from this product's MHRA label. Tap a section to expand.
g. methadone. Buprenorphine should therefore be used in particular for the first substitution therapy of opioid addicts with a shorter duration of the addiction and less solidified addictions. Special precautions before initiating therapy Before the start of treatment, the treating physician should be aware of the partial agonistic effect of the molecule on the μ receptor, which can trigger a withdrawal syndrome in opioid-dependent patients.
e. long or short acting opioid), the period since the last opioid use, and the degree of opioid dependence. g. v. use or non- retarded oral morphine), the first dose of Buprenorphine should be given at the first signs of withdrawal, but not earlier than 6 hours after the last opioid use.
- In patients on methadone, the dose of methadone must be reduced to a maximum of 30 mg/day prior to the start of Buprenorphine therapy. When initiating Buprenorphine therapy, the long half-life of methadone should be considered. The first dose of Buprenorphine should not be administered until withdrawal symptoms appear, but at the earliest 24 hours after the patient took the last dose of methadone (higher doses of methadone may require a longer wait).
Buprenorphine may accelerate the onset of withdrawal symptoms in methadone-dependent patients. The recommended conversion ratio of methadone to buprenorphine is 5-6 : 1 and is especially valid for lower dose ranges up to about 60-80 mg methadone.
Above, often no satisfactory conversion is possible, or very high doses are required. - When switching from prolonged-release morphine to Buprenorphine, the rough conversion ratio is 25-30 : 1 after a waiting period of at least 24 hours.
Posology The buprenorphine dose is adjusted according to the needs of the patient taking into account his withdrawal symptoms and must be adapted to the individual situation of each patient and his subjective feeling.
Induction therapy:
The initial dose is 2 mg to 4 mg buprenorphine daily as a single dose. Depending on the individual needs of the patient, this dose can be repeated (if necessary several times) so that a total dose of 4 to 8 mg (if necessary up to a maximum of 24 mg) is achieved on day 1.
The daily dose administered on the second day is usually well below the dose of the first day (usually not more than 12 mg). From the 3rd day onwards, the dose is increased or decreased to the expected maintenance dose. Aim of the treatment is to stabilize the patient on day 2 or 3 with a dose that minimizes withdrawal symptoms and ensures that the patient maintains the therapy.
e. insomnia, headache, nausea, hyperhidrosis, and pain). Certain reported cases regarding seizures, vomiting, diarrhoea, and elevated liver function values have been classified as serious. 5%) reported adverse reactions) as well as post-marketing.
6) System organ class Very common Common Uncommon Not known peripheral oedema Investigations liver function test abnormal weight loss blood creatinine increased transaminases increased Injury, Poisoning and procedural complications injury heatstroke Description of selected adverse reactions that have been observed post marketing.
4). However, these adverse reactions are caused more likely by the abuse than by the medicinal substance itself. 4) if used before the agonistic effects caused by recent opioid use or abuse have subsided. • The most common signs and symptoms of hypersensitivity include rashes, urticaria, and pruritus.
3). 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. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Improper use and misuse Buprenorphine, can be misused or used improperly. The risks of misuse or improper use include overdose, spread of haematogenous viral or local and systemic infections, respiratory depression, and liver damage.
Unauthorized use of buprenorphine by persons who have not been prescribed the medicinal product also involves the risk of new drug addicts, who abuse buprenorphine as the major drug, if the medicinal product is or has been circulated directly by the patient for illicit use or if it is not adequately protected against theft.
Suboptimal treatment with buprenorphine may result in drug abuse by the patient, which may lead to overdose or treatment discontinuation. A patient receiving a too low dose of buprenorphine may continue to respond to uncontrolled withdrawal symptoms with self-treatment with opioids, alcohol or other sedatives/hypnotics, especially benzodiazepines.
To minimize the risk regarding improper use and misuse, physicians should take precautionary measures when prescribing and dispensing buprenorphine. Therefore, during early phase of therapy, prescribing several doses concurrently should be avoided and follow-up appointments for clinical monitoring should be scheduled adjusted to the patients need.
Precautions for use In case of the following diseases while using Buprenorphine sublingual tablets, caution should be exercised and the dose of the medicinal product reduced if necessary: Take-home prescription In the case of a take-home prescription, the doctor must ensure that the risks of self- or third-party harm resulting from carrying along the substitution medicinal product are excluded as far as possible and that the patient uses the substitution medicinal product prescribed for him as intended.
In the event of improper, abusive use by the patient, the take-home prescription must be stopped immediately. g. v.. 5) or when it was not used according to the product information. Furthermore, deaths related to concomitant use of buprenorphine and other centrally depressing substances, such as alcohol and other opioids, have been reported.
1 • Severe respiratory insufficiency • Severe hepatic insufficiency • Acute alcoholism or delirium tremens • Concomitant use of opioid antagonists (naltrexone, nalmefene) for treatment of alcohol or opioid dependence
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This is generally the case for a single daily dose ranging from 12 to 16 mg.
Dose adjustment and maintenance:
The buprenorphine dose must be determined individually for each patient. The maintenance dose varies by patient and should be increased gradually until the minimum effective dose is found. This is usually 12 to 16 mg/day. It is recommended not to exceed a maximum daily dose of 24 mg, but the individual dose will be determined by the physician and will depend on the clinical status and condition of the patient.
Alternate dosing Due to the pharmacokinetic properties of buprenorphine, the clinical effectiveness of Buprenorphine can last for 48 to 72 hours, depending on the dose. After a stable maintenance dose has been reached, the patient can alternately be administered double (for a 2-day interval) or triple (for a 3-day interval) daily dose of buprenorphine under supervision.
The dose setting must be carried out under medical supervision. While setting the double or triple dose, the patient should be monitored for 3-4 hours for possible overdose symptoms. g. benzodiazepines) must be excluded. Optimized doses are to be used individually.
In individual cases, lower dosages may be sufficient. In clinical studies, the efficacy and safety of buprenorphine for alternating doses of 8 to 34 mg/70 kg body weight were sublingually every other day for buprenorphine solution or, for alternating doses, for a 3-day interval in doses of 12 to 44 mg / 70 kg body weight of buprenorphine solution shown sublingually.
Signs of excessive effect of buprenorphine A reduction in the dose of buprenorphine is recommended in cases where patients show signs and symptoms of excessive buprenorphine effect characterized by discomfort such as "feeling weird", poor concentration, drowsiness, and perhaps standing dizziness.
Buprenorphine withdrawal If the prescribed buprenorphine dose is too low, withdrawal symptoms may occur during the 24-hour dosing interval (congestion of the nose, abdominal symptoms, diarrhoea, myalgia, anxiety). Doctors should be aware of the potential need to change the dose of Buprenorphine sublingual tablets when patients report withdrawal symptoms.
Duration of use The duration of treatment depends on the agreed treatment goal.
Dose reduction and termination of treatment:
After a satisfactory period of stabilisation has been achieved, doses should be reduced gradually with the agreement of the patient and in some favourable cases until complete termination of treatment can be achieved. However, withdrawal should always be in agreement with the patient and should not be forced on the patient in order to avoid relapse.
The availability of other medicinal products with buprenorphine for substitution treatment in other […]
g. chronic obstructive pulmonary disease, cor pulmonale, restricted respiratory reserves, hypoxia, hypercapnia, pre-existing respiratory depression, or kyphoscoliosis (curvature of the spine with potentially resultant respiratory distress)).
Buprenorphine may cause severe or potentially fatal respiratory depression in children and non-dependent persons if accidentally or deliberately ingested. Patients should be reminded to keep the blister in a safe place, never open the blister in advance, keep the blister out of reach of children and other household members, and never take this medicine in front of children.
In case of accidental ingestion or suspicion of ingestion, an emergency service should be notified immediately. 5). Alcoholic beverages or medicinal products containing alcohol must not be taken during treatment with Buprenorphine. The simultaneous use of central depressants, other opioid derivatives (analgesics and antitussives), certain antidepressants, sedative H1 receptor antagonists, barbiturates, anxiolytics, neuroleptics, clonidine and related substances requires medical supervision.
Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of Buprenorphine and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma, and death.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Buprenorphine concomitantly with sedative medicinal products, the lowest effective dose 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). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Tolerance and opioid use disorder (abuse and dependence) Buprenorphine is a partial μ (mu) opioid receptor agonist.
As shown in animal studies and during clinical experience, buprenorphine can lead to dependence, but at a lower level than in a full agonist-like substance, such as morphine. 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). Before initiating treatment with Buprenorphine and during the treatment, treatment goals and a […]