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BUPRAMYL is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Bupramyl is not suitable for the treatment of acute pain. Bupramyl is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients aged 18 years and over The lowest buprenorphine dose (Bupramyl 5 microgram/hour transdermal patch) should be used as the initial dose. 5) as well as to the current general condition and medical status of the patient.
5) as needed until analgesic efficacy with Bupramyl is attained. During the titration process, the dose may be adjusted every 3-days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch.
To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine.
2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. Bupramyl should be administered every 7th day. 4). A Bupramil dose reduction or discontinuation of Bupramil treatment or treatment review may be indicated.
Conversion from opioids Bupramyl can be used as an alternative to treatment with other opioids. 5) during titration, as required. Treatment goals and discontinuation Before initiating treatment with [<invented name>], a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
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. When a patient no longer requires therapy with [<invented name>], it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of administration Bupramyl should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Bupramyl is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
4).
The following undesirable effects have occurred:
System organ class MedDRA Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,0 00) Not known (cannot be estimated from the available data) Immune system disorders Hypersensiti vity Anaphylact ic reaction Anaphylac toid reaction Metabolism and nutrition disorders Anorexia Dehydratio n Psychiatric disorders Confusion, Depression, Insomnia, Nervousness , Anxiety Sleep disorder, Restlessness , Agitation, Euphoric mood, Affect lability, Hallucinatio ns, Nightmares, Decreased libido, Aggression Psychotic disorder Drug dependen ce, Mood swings Depersona lisation Nervous system disorders Headache, Dizziness, Somnolenc e Tremor Sedation, Dysgeusia, Dysarthria, Hypoaesthes ia, Memory impairment, Migraine, Syncope, Abnormal coordination , Co- ordination, abnormal, Disturbance in attention, Paraesthesia Balance disorder, Speech disorder Involunta ry muscle contracti ons Seizures Sleep apnoea syndrome Hyperalge sia Eye disorders Dry eye, Blurred vision Visual disturbance , Eyelid oedema, Miosis Ear and Tinnitus, Ear pain labyrinth disorders Vertigo Cardiac disorders Palpitations, Tachycardia Angina pectoris Vascular disorders Hypotension , Circulatory collapse, Hypertensio n, Flushing Vasodilatat ion, Orthostatic hypotensio n Respiratory, thoracic and mediastinal disorders Dyspnoea Cough, Wheezing, Hiccups Respirator y depression, Respirator y failure, Asthma aggravated , Hyperventi lation, Rhinitis Gastrointestin al disorders Constipati on, Nausea, Vomiting Abdominal pain, Diarrhoea, Dyspepsia, Dry mouth Flatulence Dysphagia, Ileus Diverticuli tis Hepatobiliary disorders Biliary colic Skin and subcutaneous tissue disorders Pruritus, Erythema Rash, Sweating, Exanthema Dry skin, Urticaria, Dermatitis contact Face oedema Pustules, Vesicles Applicatio n skin discoloura tion Musculoskele tal and connective tissue disorders Muscular weakness Myalgia, Muscle spasms Renal and urinary disorders Urinary incontinence , Urinary retention, Urinary hesitation Reproductive system and breast disorders Erectile dysfunctio n, Sexual dysfunctio n General disorders and administratio Applicatio n site reaction1* Tiredness, Asthenic conditions, Fatigue, Pyrexia, Rigors, Influenza like illness Drug withdrawa l n site conditions Peripheral oedema Oedema, Drug withdrawal syndrome, Chest pain syndrome neonatal, Drug tolerance Investigations Alanine aminotransf erase increased, Weight decreased Injury, poisoning and procedural complications Accidental injury, Fall 1 Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritus, rash, vesicles, painful/burning sensation at the application site.
5). 2), - constipation 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.
Respiratory depression:
Concomitant use of opioids such as Bupramyl 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 Bupramyl concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route.
A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly. Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported.
Caution should be exercised when prescribing Bupramyl to patients known to have, or suspected of having, problems with drug or alcohol abuse of serious mental illness. The patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests. , as an increase in absorption of buprenorphine may occur. When treating febrile patients, one should be aware that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and thereby increased risk of opioid reactions.
5) - patients suffering from myasthenia gravis - patients suffering from delirium tremens.
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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Discontinuation After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Bupramyl is to be followed by other opioids.
As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. 5). Special populations Elderly No dosage adjustment of Bupramyl is required in elderly patients. Renal impairment No special dose adjustment of Bupramyl is necessary in patients with renal impairment.
Hepatic impairment There is no need for dosage adjustment of Bupramyl in patients with mild to moderate hepatic impairment. Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function.
Therefore, such patients should be carefully monitored during treatment with Bupramyl. Patients with severe hepatic impairment may accumulate buprenorphine during Bupramyl treatment. Consideration of alternate therapy should be considered, and Bupramyl should be used with caution, if at all, in such patients.
5), patients already treated with CYP3A4 inhibitors should have their dose of Bupramyl carefully titrated since a reduced dosage might be sufficient in these patients. Paediatric population The safety and efficacy of Bupramyl in children and adolescents below 18 years of age has not been established.
No data are available. Method of administration Bupramyl is for transdermal use. The patch is to be worn for 7 days. The patch must not be divided or cut into pieces. The patch should not be used if the seal is broken. 4), the following directions of use should be followed: Bupramyl should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars.
Bupramyl should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven. If the application site must be cleaned, it should be done with clean water only.
Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. Bupramyl should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be […]
* In some cases delayed local allergic reactions (allergic contact dermatitis) occurred with marked signs of inflammation. g. laceration) are also possible in patients with fragile skin. Chronic inflammation may lead to long-lasting sequelae, such as post inflammatory hyper- and hypopigmentation, as well as dry and thick scaly skin lesions, which may closely resemble scars.
4). Drug dependence Repeated use of [<invented name>] can lead to drug dependence, even at therapeutic doses. 4). Buprenorphine has a low risk of physical dependence. After discontinuation of buprenorphine, withdrawal symptoms are unlikely.
This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch). However, after long-term use of buprenorphine, withdrawal symptoms similar to those occurring during opioid withdrawal, cannot be entirely excluded.
These symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders. 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.
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. 1). 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 [<invented name>].
Repeated use of [<invented name>] can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of [<invented name>] may result in overdose and/or death. g.
major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g.
too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Withdrawal syndrome A withdrawal syndrome may occur upon abrupt cessation of therapy. Withdrawal (abstinence syndrome), when it occurs, is generally mild, begins after 2 days and may last up to 2 weeks. Withdrawal symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.
When a patient no longer requires therapy with buprenorphine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. Administration of buprenorphine to person who are physically dependent on full μ-opioid agonists may precipitate an abstinence syndrome depending on the level of physical dependence, and the timing and dose of buprenorphine.
Skin […]