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RELETRANS 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. Reletrans is not suitable for the treatment of acute pain. Reletrans is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Reletrans should be administered every 7th day. Patients aged 18 years and over The lowest Reletrans dose (Reletrans 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.
Reletrans should not be used at higher doses than recommended. 5) as needed until analgesic efficacy with Reletrans is attained. The dose of Reletrans may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established.
Subsequent dose increases may then be titrated based on the need for supplemental pain relief and the patient’s analgesic response to the transdermal patch. To increase the dose, a patch with a higher strength should replace the transdermal 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 transdermal patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine. Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment.
Conversion from opioids Buprenorphine transdermal patches can be used as an alternative to treatment with other opioids. 5) during titration, as required. Duration of administration Reletrans should under no circumstances be administered for longer than absolutely necessary.
If long-term pain treatment with Reletrans 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.
Discontinuation After removal of the transdermal 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 Reletrans 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 transdermal patch. 5). Special populations Elderly patients No dose adjustment of Reletrans is required in elderly patients. Renal impairment No special dose adjustment of Reletrans is necessary in patients with renal impairment.
4).
The following undesirable effects have occurred:
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) System organ class Very common Common Uncommon Rare Very rare Freque not kn Immune system disorders hypersensitivity anaphylactic reaction anaphy d react Metabolism and nutrition disorders anorexia dehydration Psychiatric disorders confusion, depression, insomnia, nervousness, anxiety Affect lability, sleep disorder, restlessness, agitation, euphoric mood, hallucinations, libido decreased, nightmares, aggression psychotic disorder drug depende nce, mood swings deperso tion System organ class Very common Common Uncommon Rare Very rare Freque not kn Nervous system disorders headache, dizziness, somnolenc e Tremor sedation, dysgeusia, dysarthria, hypoaesthesia, memory impairment, migraine, syncope, abnormal coordination, disturbance in attention, paraesthesia balance disorder, speech disorder involunt ary muscle contract ions seizure 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 vasodilatatio n, orthostatic hypotension Respiratory, thoracic and mediastinal disorders dyspnoea cough, wheezing, hiccups respiratory depression, respiratory failure, asthma aggravated, hyperventilati on, rhinitis Gastrointesti nal disorders Constipati on, nausea, vomiting abdominal pain, diarrhoea, dyspepsia, dry mouth flatulence dysphagia, ileus divertic Hepatobiliary disorders biliary System organ class Very common Common Uncommon Rare Very rare Freque not kn Skin and subcutaneous tissue disorders pruritus, erythema rash, sweating, exanthema dry skin, urticaria face oedema pustules , vesicles dermat contact applica site ski discolo n 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 dysfunction, sexual dysfunction General disorders and administratio n site conditions applicatio n site reaction, including erythema, oedema, pruritus, rash tiredness, asthenia, peripheral oedema fatigue, pyrexia, rigors, oedema, drug withdrawal syndrome, application site dermatitis*, chest pain influenza like illness drug withdra syndro neonat Investigations alanine aminotransferase increased, weight decreased Injury, poisoning and procedural complications accidental injury, fall * In some cases delayed local allergic reactions occurred with marked signs of inflammation.
2). Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder. 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.
5). 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). 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.
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 Reletrans. Repeated use of Reletrans can lead to OUD.
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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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 Reletrans.
Patients with severe hepatic impairment may accumulate buprenorphine during Reletrans treatment. Alternate therapy should be considered, and Reletrans should be used with caution, if at all, in such patients. 5), patients already treated with CYP3A4 inhibitors should have their dose of buprenorphine transdermal patches carefully titrated since a reduced dose might be sufficient in these patients.
Paediatric population The safety and efficacy of buprenorphine transdermal patches in children and adolescents below 18 years of age has not been established. No data are available. Method of administration Transdermal use. Treatment goals and discontinuation Before initiating treatment with Reletrans, 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 Reletrans, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of treatment Reletrans should not be used longer than necessary. Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces. Transdermal patch application Reletrans 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.
Reletrans 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 transdermal patch is applied. The transdermal patches 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 transdermal patch begin to peel off, the edges may be taped down with suitable skin tape, to ensure a 7-day period of wear. Bathing, showering, or swimming should not affect the transdermal patch. If a transdermal patch falls off, a new one should be applied and worn […]
In such cases treatment with Reletrans should be terminated. Drug dependence Repeated use of [Nationally completed name] can lead to drug dependence, even at therapeutic doses. 4). Buprenorphine has a low risk of physical dependence. After discontinuation of buprenorphine transdermal patches, 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 transdermal patches, 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. .
A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Reletrans 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.
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 dose.
Buprenorphine transdermal patches are 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. Controlled human and animal studies indicate that buprenorphine has a lower dependence liability than pure agonist analgesics.
In humans limited euphorigenic effects have been observed with buprenorphine. This may result in some abuse of the medicinal product and caution should be exercised when prescribing to patients known to have, or suspected of having, a history of drug abuse or alcohol abuse or serious mental illness.
Chronic use of buprenorphine can result in the development of physical dependence. 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.
Buprenorphine transdermal patches should not be used at higher doses than recommended. , 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.
Athletes must be aware that this medicinal product may cause a positive reaction to sports doping control tests. Use of Reletrans as a doping agent may become a health hazard.