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TRANSTEC is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Moderate to severe cancer pain and severe pain which does not respond to non-opioid analgesics. TRANSTEC® is not suitable for the treatment of acute pain.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients over 18 years of age Treatment goals and discontinuation Before initiating treatment with TRANSTEC®, 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 TRANSTEC®, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). The lowest possible dosage providing adequate pain relief should be given. 5 micrograms/h and TRANSTEC® 70 micrograms/h. Initial dose selection: patients who have previously not received any analgesics should start with the lowest transdermal patch strength (TRANSTEC® 35 micrograms/h).
Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with TRANSTEC® 35 micrograms/h. According to the WHO recommendations, the administration of a non-opioid analgesic can be continued, depending on the patient's overall medical condition.
When switching from a step-III analgesic (strong opioid) to TRANSTEC® and choosing the initial transdermal patch strength, the nature of the previous medication, administration and the mean daily dose should be taken into account in order to avoid the recurrence of pain.
In general it is advisable to titrate the dose individually, starting with the lowest transdermal patch strength (TRANSTEC® 35 micrograms/h). 1). To allow for individual dose adaptation in an adequate time period sufficient supplementary immediate release analgesics should be made available during dose titration.
The necessary strength of TRANSTEC® must be adapted to the requirements of the individual patient and checked at regular intervals. After application of the first TRANSTEC® transdermal patch the buprenorphine serum concentrations rise slowly both in patients who have been treated previously with analgesics and in those who have not.
Therefore initially, there is unlikely to be a rapid onset of effect. Consequently, a first evaluation of the analgesic effect should only be made after 24 hours. The previous analgesic medication (with the exception of transdermal opioids) should be given in the same dose during the first 12 hours after switching to TRANSTEC® and appropriate rescue medication on demand in the following 12 hours.
The following adverse reactions were reported after administration of TRANSTEC® in clinical studies and from postmarketing surveillance.
The frequencies are given as follows:
Very common (≥1/10) Common (≥1/100, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (≤1/10,000) Not known (cannot be estimated from the available data) a) The most commonly reported systemic adverse reactions were nausea and vomiting.
The most commonly reported local adverse reactions were erythema and pruritus. g. g. pricking or burning skin sensation) Very rare: muscle fasciculation, parageusia Eye disorders Rare: visual disturbance, blurring of vision, eyelid oedema Very rare: miosis Ear and labyrinth disorders Very rare: ear pain Cardiac/Vascular disorders Uncommon: circulatory disorders (such as hypotension or, rarely, even circulatory collapse) Rare: hot flushes Respiratory, thoracic and mediastinal disorders Common: dyspnoea Rare: respiratory depression Very rare: hyperventilation, hiccups Gastrointestinal disorders Very common: nausea Common: vomiting, constipation Uncommon: dry mouth Rare: pyrosis Very rare: retching Skin and subcutaneous tissue disorders Very common: erythema, pruritus Common: exanthema, diaphoresis Uncommon: rash Rare: urticaria Very rare: pustules, vesicles Not known: dermatitis contact, application skin discolouration Renal and urinary disorders Uncommon: urinary retention, micturition disorders Reproductive system and breast disorders Rare: decreased erection General disorders and administration site conditions Common: oedema, tiredness Uncommon: weariness Rare: withdrawal symptoms*, administration site reactions Very rare: thoracic pain * see section c) c) In some cases delayed allergic reactions occurred with marked signs of inflammation.
In such cases treatment with TRANSTEC® should be terminated. Drug dependence Repeated use of TRANSTEC® can lead to drug dependence, even at therapeutic doses. 4). After discontinuation of TRANSTEC®, withdrawal symptoms are unlikely. This is due to the very slow dissociation of buprenorphine from the opiate receptors and to the gradual decrease of buprenorphine serum concentrations (usually over a period of 30 hours after removal of the last transdermal patch).
TRANSTEC® must only be used with particular caution in acute alcohol intoxication, convulsive disorders, in patients with head injury, shock, a reduced level of consciousness of uncertain origin, increased intracranial pressure without the possibility of ventilation.
Buprenorphine occasionally causes respiratory depression. Therefore care should be taken when treating patients with impaired respiratory function or patients receiving medicinal products which can cause respiratory depression. In healthy volunteer and patient studies with TRANSTEC®, withdrawal reactions have not been observed.
8). These symptoms are: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders. In patients abusing opioids, substitution with buprenorphine may prevent withdrawal symptoms. This has resulted in some abuse of buprenorphine and caution should be exercised when prescribing it to patients suspected of having drug abuse problems.
Post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI) Do not use 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 TRANSTEC®. Repeated use of TRANSTEC® can lead to Opioid Use Disorder (OUD).
A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of TRANSTEC® may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (eg.
1. 5) - patients suffering from myasthenia gravis - patients suffering from delirium tremens. 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dose titration and maintenance therapy TRANSTEC® should be replaced after 96 hours (4 days) at the latest. g. always on Monday morning and Thursday evening. The dose should be titrated individually until analgesic efficacy is attained.
If analgesia is insufficient at the end of the initial application period, the dose may be increased, either by applying more than one transdermal patch of the same strength or by switching to the next transdermal patch strength. At the same time no more than two transdermal patches regardless of the strength should be applied.
e. the total amount of opioids required, and the dosage adjusted accordingly. Supplementary administration of fast acting strong analgesics for treatment of breakthrough pain may be necessary, not only during dose titration but also during maintenance therapy.
If additional analgesic doses are regularly required, a switch to the next higher buprenorphine patch strength can be considered. Special population Paediatric population As TRANSTEC® has not been studied in patients under 18 years of age, the use of the medicinal product in patients below this age is not recommended.
Elderly patients No dosage adjustment of TRANSTEC® is required for elderly patients. Patients with renal insufficiency Since the pharmacokinetics of buprenorphine is not altered during the course of renal failure, its use in patients with renal insufficiency, including dialysis patients, is possible.
Patients with hepatic insufficiency 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 liver insufficiency should be carefully monitored during treatment with TRANSTEC®.
Method of application TRANSTEC® should be applied to non-irritated, clean skin on a non-hairy flat surface, but not to any parts of the skin with large scars. Preferable sites on the upper body are: upper back or below the collar-bone on the chest.
Any remaining hairs should be cut off with a pair of scissors (not shaved). If the site of application requires cleansing, this should be done with water. Soap or any other cleansing agents should not be used. Skin preparations that might affect adhesion of the transdermal patch to the area selected for application of TRANSTEC® should be avoided.
The skin must be completely dry before application. TRANSTEC® is to be applied immediately after removal from the sachet. Following removal of the release liner, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds.
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However, after long-term use of TRANSTEC® withdrawal symptoms, similar to those occurring during opiate 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.
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.
Buprenorphine is metabolised in the liver. The intensity and duration of effect may be altered in patients with liver function disorders. Therefore such patients should be carefully monitored during TRANSTEC® treatment. Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Risk from concomitant use of sedating medicinal products such as benzodiazepines or related substances Concomitant use of TRANSTEC® and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe TRANSTEC® concomitantly with sedating medicinal products, the lowest effective dose of TRANSTEC® should be used, and the duration of the concomitant 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. 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.
Paediatric population As TRANSTEC® has not been studied in patients under 18 years of age, the use of the medicinal product in patients below this age is not recommended. Patients with fever / external heat Fever and the presence of heat may increase the permeability of the skin.
Theoretically in such situations buprenorphine serum concentrations may be raised during TRANSTEC® treatment. Therefore on treatment with TRANSTEC®, attention should be paid to the increased possibility of opioid reactions in febrile patients or those with increased skin temperature due to other causes.