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BUNOV 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. Bunov is not suitable for the treatment of acute pain. Bunov is indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Patients aged 18 years and over:
The lowest Bunov dose (Bunov 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 Bunov is attained.
The dose of Bunov 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 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 buprenorphine.
2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. Bunov should be administered every 7th day. Duration of administration Bunov should under no circumstances be administered for longer than absolutely necessary.
If long-term pain treatment with Bunov 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 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 Bunov 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 patch. 5). Conversion from opioids Bunov can be used as an alternative to treatment with other opioids. 5) during titration, as required.
Special populations Elderly No dosage adjustment of Bunov is required in elderly patients. Renal impairment No special dose adjustment of Bunov is necessary in patients with renal impairment. 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 Bunov. Patients with severe hepatic impairment may accumulate buprenorphine during Bunov treatment.
4). 4) Depersona- lisation Nervous system disorders Headache, Dizziness, Somnolenc e Tremor Sedation, Dysgeusia, Dysarthria, Hypoaes- thesia, Memory impairmen t, Migraine, Syncope, Abnormal coordina- tion, Disturbanc e in attention, Paraestheia Balance disorder, Speech disorder Involuntar y muscle contraction s Convulsion s Eye disorders Dry eye, Blurred vision Visual disturbanc e, Eyelid oedema, Miosis Ear and labyrinth disorders Tinnitus, Vertigo Ear pain Cardiac disorders Palpitation s, Tachycardi a Angina pectoris Vascular disorders Hypoten- sion, Circulatory collapse, Hyperten- sion, Flushing Vasodilata -tion, Orthostatic hypotensio n Respiratory, thoracic and mediastinal disorders Dyspnoea Cough, Wheezing, Hiccups Respirator y depression, Respirator y failure, Asthma aggravated , Hyperventi -lation, Rhinitis Gastrointes- tinal disorders Constipa- tion, Nausea, Vomiting Abdominal pain, Diarrhoea, Dyspepsia, Dry mouth Flatulence Dysphagia, Ileus Diverticu- litis Hepatobili- ary disorders Biliary colic Skin and subcuta- neous tissue disorders Pruritus, Erythema Rash, Sweating, Exanthema Dry skin, Urticaria, Dermatitis contact Face oedema Pustules, Vesicles Applicatio n skin discoloura -tion Musculo- skeletal and connective tissue disorders Muscular weakness Myalgia, Muscle spasms Renal and urinary Urinary inconti- disorders nence, Urinary retention, Urinary hesitation Reproduc- tive system and breast disorders Erectile dysfunctio n, Sexual dysfunctio n General disorders and administra- tion site conditions Applicatio n site reaction1 Tiredness, Asthenic conditions, Peripheral oedema Fatigue, Pyrexia, Rigors, Oedema, Drug withdrawal syndrome, Applicatio n site dermatitis* , Chest pain Influenza like illness Drug withdrawa l syndrome neonatal Investiga- tions Alanine aminotrans -ferase increased, Weight decreased Injury, poisoning and procedural complica- tions 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.
Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported. Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on- line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. 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.
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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Consideration of alternate therapy should be considered, and Bunov should be used with caution, if at all, in such patients. Paediatric population The safety and efficacy of Bunov in children and adolescents below 18 years of age has not been established.
No data are available. Method of administration Bunov is for transdermal use. The patch must not be divided or cut into pieces. The patch should not be used if the seal is broken. Patch application Bunov 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.
Bunov 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. Bunov 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.
In such cases treatment with buprenorphine should be terminated. 1 Includes application site erythema, application site oedema, application site pruritus, application site rash. Buprenorphine has a low risk of physical dependence. After discontinuation of buprenorphine, 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, 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.
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 CSA in a dose-dependent fashion.
In patients who present with CSA, consider decreasing the total opioid dosage. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Bunov 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 Bunov 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), patients already treated with CYP3A4 inhibitors should have their dose of Bunov carefully titrated since a reduced dosage might be sufficient in these patients.
Buprenorphine is not recommended for analgesia in the immediate post- operative period. 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) 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 […]