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CARLOSAFINE 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. Buprenorphine 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). The lowest possible dose providing adequate pain relief should be given. 5 micrograms/h and Buprenorphine 70 micrograms/h.
Initial dose selection: patients who have previously not received any analgesics should start with the lowest transdermal patch strength (Buprenorphine 35 micrograms/h). Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with Buprenorphine 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 Buprenorphine 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 (Buprenorphine 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 Buprenorphine must be adapted to the requirements of the individual patient and checked at regular intervals. After application of the first Buprenorphine 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 Buprenorphine and appropriate rescue medicinal products on demand in the following 12 hours.
Dose titration and maintenance therapy Buprenorphine 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.
The following adverse reactions were reported after administration of buprenorphine in clinical studies and from postmarketing 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) a) The most commonly reported systemic adverse reactions were nausea and vomiting.
b) 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 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 buprenorphine should be terminated. Buprenorphine has a low risk of dependence. After discontinuation of Buprenorphine, 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).
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.
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. 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. 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. Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Carlosafine 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 Carlosafine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
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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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. g. 2 mg buprenorphine sublingual tablets every 24 hours in addition to the transdermal patch. 6 mg sublingual buprenorphine is necessary, the next strength should be used.
Elderly patients No dosage adjustment of Buprenorphine 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 Buprenorphine.
Paediatric population As Buprenorphine 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 Buprenorphine 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 Buprenorphine should be avoided. The skin must be completely dry before application.
Buprenorphine 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.
, sauna, infra-red radiation) Buprenorphine should be worn continuously for up to 4 days. After removal of the previous transdermal patch a new Buprenorphine 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.
Duration of administration Buprenorphine should under no circumstances be administered for longer than […]
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
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.
Paediatric population As Buprenorphine 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 buprenorphine treatment. Therefore on treatment with buprenorphine, attention should be paid to the increased possibility of opioid reactions in febrile patients or those with increased skin temperature due to other causes.
g. sauna, infrared-radiation).