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BUPLAST 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. Buplast 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 The dose should be adapted to the condition of the individual patient (pain intensity, suffering, individual reaction) and checked at regular intervals. The lowest possible dose providing adequate pain relief should be given.
5 micrograms/h and Buplast 70 micrograms/h. Initial dose selection: patients who have previously not received any analgesics should start with the lowest transdermal patch strength (Buplast 35 micrograms/h). Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with Buplast 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 Buplast and choosing the initial transdermal patch strength, the nature of the previous medicinal product, 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 (Buplast 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.
After application of the first Buplast 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 medicinal product (with the exception of transdermal opioids) should be given in the same dose during the first 12 hours after switching to Buplast and appropriate rescue medicinal products on demand in the following 12 hours.
Dose titration and maintenance therapy Buplast 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.
The following adverse reactions were reported after administration of buprenorphine transdermal patch in clinical studies and from post marketing surveillance.
The frequencies are given as follows:
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) 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 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 Drug dependence Repeated use of buprenorphine can lead to drug dependence, even at therapeutic doses.
4). In some cases delayed allergic reactions occurred with marked signs of inflammation. In such cases treatment with buprenorphine should be terminated. Buprenorphine has a low risk of dependence. After discontinuation of buprenorphine, withdrawal symptoms are unlikely.
4. 4. Paediatric population As buprenorphine transdermal patch 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. Method of administration For transdermal use.
Buplast 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 Buplast should be avoided.
The skin must be completely dry before application. Buplast 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.
The transdermal patch will not be affected when bathing, showering or swimming. Buplast should be worn continuously for up to 4 days. After removal of the previous transdermal patch a new Buplast transdermal patch should be applied to a different skin site.
At least one week should elapse before a new transdermal patch is applied to the same area of skin. 5) - patients suffering from myasthenia gravis - patients suffering from delirium tremens. 4 Special warnings and precautions for use 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 [product name].
Repeated use of [product 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).
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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At the same time no more than two transdermal patches regardless of the strength should be applied. If a patch falls off before it needs changing, the transdermal patch should not be used again. A new patch should be applied straight away.
e. the total amount of opioids required, and the dosage adjusted accordingly. g. 4 mg buprenorphine sublingual every 24 hours in addition to the transdermal patch. 6 mg sublingual buprenorphine is necessary, the next strength should be used.
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 Buplast should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Buplast 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 of Buplast After removal of Buplast 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 Buplast is to be followed by other opioids.
As a general rule, a subsequent opioid should not be administered within 24 hours after removal of Buplast. For the time being only limited information is available on the starting dose of other opioids administered after discontinuation of Buplast.
Elderly patients No dosage adjustment of Buplast is required for elderly patients. Patients with renal insufficiency See section
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).
However, after long-term use of buprenorphine withdrawal symptoms, similar to those occurring during opiate withdrawal, cannot be entirely excluded. These symptoms include: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastro-intestinal 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.
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 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.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Buplast 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 Buplast 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). Buprenorphine has a substantially lower dependence liability than pure opioid agonists. In healthy volunteer and patient studies with buprenorphine, 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.
Hepatic impairment 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 buprenorphine treatment.
Renal impairment 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. Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Patients with fever / external heat Fever and the presence of heat may increase the permeability of the skin. Theoretically in such situations […]