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BUTEC 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 Butec is not suitable for the treatment of acute pain. Butec is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Butec should be administered once per week on the same day each week.
Patients aged 18 years and over:
The lowest Butec dose (Butec 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. 4).
Titration:
During initiation of treatment with Butec, short-acting supplemental analgesics may be required as needed until analgesic efficacy with Butec is attained. The dose of Butec may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established.
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. 2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.
Conversion from opioids:
Butec can be used as an alternative to treatment with other opioids. Such patients should be started on the lowest available dose (Butec 5 microgram/hour transdermal patch) and continue taking short-acting supplemental analgesics during titration, as required.
Paediatric population:
The safety and efficacy of Butec in children below 18 years of age has not been established. No data are available.
Elderly:
No dosage adjustment of Butec is required in elderly patients.
Renal impairment:
No special dose adjustment of Butec is necessary in patients with renal impairment.
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 patients with hepatic insufficiency should be carefully monitored during treatment with Butec.
4). The following frequency categories form the basis for classification of the undesirable effects: Term Frequency 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 Frequency not known Cannot be estimated from the available data Immune system disorders: Uncommon: hypersensitivity.
Rare: anaphylactic reaction. Frequency not known: anaphylactoid reaction.
Metabolism and nutrition disorders:
Common: anorexia. Rare: dehydration.
Psychiatric disorders:
Common: confusion, depression, insomnia, nervousness, anxiety. Uncommon: affect lability, sleep disorder, restlessness, agitation, euphoric mood, hallucinations, decreased libido, nightmares, aggression. Rare: psychotic disorder. Very rare: mood swings.
4), depersonalisation.
Nervous system disorders:
Very common: headache, dizziness, somnolence. Common: tremor. Uncommon: sedation, dysgeusia, dysarthria, hypoaesthesia, memory impairment, migraine, syncope, abnormal co-ordination, disturbance in attention, paraesthesia. Rare: balance disorder, speech disorder.
Very rare: involuntary muscle contractions. Frequency not known: seizure, hyperalgesia, sleep apnoea syndrome.
Eye disorders:
Uncommon: dry eye, blurred vision. Rare: visual disturbance, eyelid oedema, miosis.
Ear and labyrinth disorders:
Uncommon: tinnitus, vertigo. Very rare: ear pain.
Cardiac disorders:
2) or constipation. The primary risk of opioid excess is respiratory depression. 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. Concomitant use of Butec 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 Butec concomitantly with sedative medicines, 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). 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. 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.
Skin reactions at application site Application site reactions usually present as a mild to moderate skin inflammation (contact dermatitis) with erythema, oedema, pruritis, rash, vesicles and pain or a burning sensation at the application site.
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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Patients with severe hepatic impairment may accumulate buprenorphine during Butec treatment. Consideration of alternate therapy should be considered, and Butec should be used with caution, if at all, in such patients.
Method of administration Route of administration:
Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces. ) the following directions of use should be followed. Butec 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.
Butec 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. Butec should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges.
If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear. The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch.
If a patch falls off, a new one should be applied and worn for 7 days.
Duration of administration:
Butec should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Butec 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.
Treatment goals and Discontinuation:
Before initiating treatment with Butec, 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 Butec, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). 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 Butec 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).
Patients with fever or exposed to external heat:
While wearing the patch, patients should be advised to avoid exposing the application site to external heat […]
Uncommon: palpitations, tachycardia Rare: angina pectoris.
Vascular disorders:
Uncommon: hypotension, circulatory collapse, hypertension, flushing. Rare: vasodilation, orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea. Uncommon: cough, wheezing, hiccups. Rare: respiratory depression, respiratory failure, asthma aggravated, hyperventilation, rhinitis.
Gastrointestinal disorders:
Very common: constipation, nausea, vomiting. Common: abdominal pain, diarrhoea, dyspepsia, dry mouth. Uncommon: flatulence. Rare: dysphagia, ileus. Frequency not known: diverticulitis.
Hepatobiliary disorders:
Frequency not known: biliary colic.
Skin and subcutaneous tissue disorders:
Very common: pruritis, erythema. Common: rash, sweating, exanthema. Uncommon: dry skin, urticaria. Rare: face oedema. Very rare: pustules, vesicles.
Frequency not known:
Dermatitis contact, skin discolouration.
Musculoskeletal and connective tissue disorders:
Common: muscular weakness. Uncommon: myalgia, muscle spasms.
Renal and urinary disorders:
Uncommon: urinary incontinence, urinary retention, urinary hesitation.
Reproductive system and breast disorders:
Rare: erectile dysfunction, sexual dysfunction.
General disorders and administration site conditions:
Very common: application site skin reactions*. Common: tiredness, asthenic conditions, peripheral oedema. Uncommon: fatigue, pyrexia, rigors, oedema, drug withdrawal syndrome, chest pain. Rare: influenza-like illness. Frequency not known: neonatal drug withdrawal syndrome, drug tolerance.
* Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritis, rash, vesicles and pain/burning sensation at the application site. In some cases late onset allergic contact dermatitis has occurred with marked signs of inflammation.
In such cases treatment with Butec patches should be terminated.
Investigations:
Uncommon: alanine aminotransferase increased, weight decreased.
Injury, poisoning and procedural complications:
Uncommon: accidental injury, fall Drug dependence Repeated use of Butec can lead to drug dependence, even at therapeutic doses. 4). After discontinuation of Butec, withdrawal symptoms are uncommon. 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).
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.
The reaction typically resolves spontaneously following removal of the Butec patch. 2 reduces the risk of skin reactions at the application site. Butec patches may also cause skin sensitisation and subsequent immune- mediated, type IV hypersensitivity reaction allergic contact dermatitis.
Allergic contact dermatitis may develop with a significant delay of up to several months following initiation of treatment with Butec patches. This may manifest either with symptoms similar to irritant contact dermatitis or with more severe symptoms, including burn-like lesions with bullae and discharge which spread beyond the application site and may not resolve rapidly following removal of the patch.
Patients and caregivers should be instructed to monitor the application site for such reactions. If allergic contact dermatitis is suspected, relevant diagnostic procedures should be performed to determine whether sensitisation has occurred and is caused by the patches.
3). Continued treatment with Butec patches in patients experiencing allergic contact dermatitis may lead to complications, including blistering of the skin, open wound, bleeding, ulceration and subsequent infections. Mechanical injuries during patch removal, such as 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 lesions which may closely resemble scars. Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder.
5), patients already treated with CYP3A4 inhibitors should have their dose of Butec carefully titrated since a reduced dosage might be sufficient in these patients. Butec is not recommended for analgesia in the immediate post-operative period or in other situations characterised by a narrow therapeutic index or a rapidly varying analgesic requirement.
Prolonged release opioids should not be used for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). 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 Butec.
Repeated use of Butec 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 Butec may result in overdose and/or death. g. major depression, anxiety and personality disorders).
Before initiating treatment with […]