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BUTRANS 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. BuTrans is not suitable for the treatment of acute pain. BuTrans is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology BuTrans should be administered every 7th day. Patients aged 18 years and over The lowest BuTrans dose (BuTrans 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). 5) as needed until analgesic efficacy with BuTrans 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 BuTrans.
2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. 4). A BuTrans dose reduction or discontinuation of BuTrans treatment or treatment review may be indicated. Conversion from opioids BuTrans can be used as an alternative to treatment with other opioids.
5) during titration, as required. Paediatric population The safety and efficacy of BuTrans in children below 18 years of age has not been established. No data are available. Elderly No dosage adjustment of BuTrans is required in elderly patients.
Renal impairment No special dose adjustment of BuTrans is necessary in patients with renal impairment. Hepatic impairment There is no need for dosage adjustment of BuTrans 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 BuTrans. Patients with severe hepatic impairment may accumulate buprenorphine during BuTrans treatment.
Consideration of alternate therapy should be considered, and BuTrans 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.
4).
The following undesirable effects have occurred:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). 4) Depersonalisation System organ class MedDRA Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1000, <1/100) Rare (≥1/10,000, <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Nervous system disorders Headache Dizziness Somnolence Tremor Sedation Dysgeusia Dysarthria Hypoaesthesia Memory impairment Migraine Syncope Abnormal coordination Disturbance in attention Paraesthesia Balance disorder Speech disorder Involuntary muscle contractions Seizures, Sleep apnoea syndrome, Hyperalgesia Eye disorders Dry eye Blurred vision Visual disturbance Eyelid oedema Miosis Ear and labyrinth disorders Tinnitus Vertigo Ear pain Cardiac disorders Palpitations Tachycardia Angina pectoris Vascular disorders Hypotension Circulatory collapse Hypertension Flushing Vasodilatation Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Cough Wheezing Hiccups Respiratory depression Respiratory failure Asthma aggravated Hyperventilation Rhinitis Gastrointestinal disorders Constipation Nausea Vomiting Abdominal pain Diarrhoea Dyspepsia Dry mouth Flatulence Dysphagia Ileus Diverticulitis Hepatobiliary disorders Biliary colic Skin and subcutaneous tissue disorders Pruritus Erythema Rash Sweating Exanthema Dry skin Urticaria Face oedema Pustules Vesicles Dermatitis contact, Application skin discolouration Musculoskeletal and connective tissue disorders Muscular weakness Myalgia Muscle spasms System organ class MedDRA Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1000, <1/100) Rare (≥1/10,000, <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Renal and urinary disorders Urinary incontinence Urinary retention Urinary hesitation Reproductive system and breast disorders Erectile dysfunction Sexual dysfunction General disorders and administration site conditions Application site reactions1* Tiredness Asthenic conditions Peripheral oedema Fatigue Pyrexia Rigors Oedema Drug withdrawal syndrome Chest pain Influenza like illness Drug withdrawal syndrome neonatal Drug tolerance Investigations Alanine aminotransferase 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.
2) • Constipation Respiratory depression 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. 9). Caution should be exercised when prescribing BuTrans to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.
Concomitant use of opioids such as buprenorphine 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 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). 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 BuTrans .
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.
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4), the following directions of use should be followed: BuTrans 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.
BuTrans 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. BuTrans 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 BuTrans should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with BuTrans 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 BuTrans, 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 BuTrans, 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 BuTrans is to be followed by other opioids.
As a general rule, a […]
*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 BuTrans can lead to drug dependence, even at therapeutic doses. 4). After discontinuation of BuTrans, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Repeated use of BuTrans 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 BuTrans 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. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with buprenorphine.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. 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 […]