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Buprenorphine Neuraxpharm is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution treatment of opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. 3 Treatment is intended for use in adults and adolescents 15 years of age and older, who have agreed to be treated for addiction.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be under the supervision of a physician experienced in the management of opiate dependence/addiction. It is recommended that buprenorphine treatment be prescribed as part of comprehensive management for opioid drug dependence.
The result of the treatment depends on the dose prescribed as well as on the combined medical, psychological, social and educational measures taken in monitoring the patient. e. long or short-acting opioid), the time since last opioid use and the degree of opioid dependence.
To avoid precipitating withdrawal, induction with or buprenorphine only should be undertaken when objective and clear signs of withdrawal are evident (demonstrated by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).
For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine should be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids. For patients receiving methadone, the dose of methadone should be reduced to a maximum of 30 mg/day before beginning buprenorphine therapy.
The long half-life of methadone should be considered when starting buprenorphine. The first dose of buprenorphine should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.
Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone. Posology Initiation therapy (induction) The recommended starting dose in adults and adolescents over 15 years of age is 2 to 4 mg as a single daily dose.
An additional 2 to 4 mg may be administered on day one depending on the individual patient’s requirement. Buprenorphine Neuraxpharm can only be used for initiation therapy when a starting single daily dose of 4 mg is indicated. During the initiation of treatment, daily supervision of dosing is recommended to ensure proper sublingual placement of the film and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.
Dose adjustment and maintenance therapy Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect of the individual patient.
e. insomnia, headache, nausea, hyperhidrosis and pain). Tabulated list of adverse reactions Table 1 summarizes adverse reactions reported with a higher incidence in patients treated with buprenorphine (n=103) during a pivotal clinical study versus placebo (n=107).
The frequency of possible side effects listed below is defined using the following convention: 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).
And frequency not known (cannot be estimated from available data). 11 .
Table 1:
Adverse reactions observed in pivotal clinical studies and / or post marketing surveillance listed by body system System organ class Very common Common Rare Not known Infections and infestations Infection Pharyngitis Dental Caries Immune system disorders Hypersensitivity reactions Psychiatric disorders Insomnia Agitation Anxiety Nervousness Hallucination Drug dependence Nervous system disorders Headache Migraine Paraesthesia Somnolence Syncope Vertigo Hyperkinesia Vascular disorders Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory depression Gastrointestinal disorders Nausea Abdominal pain Constipation, Vomiting Hepatobiliary disorders Transaminases increase, Hepatitis Jaundice 12 Skin and subcutaneous tissue disorders Hyperhidrosis Musculoskeletal and connective tissue disorders Muscle spasms Reproductive system and breast disorders Dysmenorrhoea Leukorrhea General disorders and administration site conditions Drug withdrawal syndrome, Asthenia Drug withdrawal syndrome neonatal Description of selected adverse reactions Drug dependence Repeated use of buprenorphine neuraxpharm sublingual films can lead to drug dependence, even at therapeutic doses.
4). Respiratory depression Respiratory depression has occurred. 5), or when buprenorphine was not used according to prescribing information. 5). Drug withdrawal syndrome neonatal Neonatal withdrawal syndrome has been reported among newborns of women who have received buprenorphine during pregnancy.
Use in adolescents:
Due to lack of data in adolescents aged 15 – 17 years, patients in this age group should be more closely monitored during treatment. Misuse, abuse and diversion Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit.
Some risks of misuse and abuse include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury. Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicine is not safeguarded against theft.
In cases of intravenous drug misuse, local reactions, sometimes septic (abscess, cellulitis) and potentially serious acute hepatitis and other acute infections, such as pneumonia and endocarditis have been reported. Sub-optimal treatment with buprenorphine may prompt medicinal product misuse by the patient, leading to overdose or treatment dropout.
A patient who is under-dosed with buprenorphine may 6 continue responding to uncontrolled withdrawal symptoms and craving by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines. To minimise the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid prescribing multiple refills early in treatment and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient’s level of stability.
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.
1 • Severe respiratory insufficiency • Severe hepatic insufficiency • Acute alcoholism or delirium tremens
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in European Union.
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Dose titration is guided by reassessment of the clinical and psychological status of the patient, and should not exceed a maximum single daily dose of 24 mg buprenorphine. 4 mg, 4 mg, 6 mg and 8 mg strengths. Daily dispensing of buprenorphine is recommended, particularly during the initiation of treatment.
Then, after stabilisation, the patient may be given a supply of the product sufficient for several days of treatment. However, it is recommended that the amount of the product dispensed be limited to a maximum of 7 days. Less than daily dosing After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to dosing every other day at twice the individually titrated daily dose.
For example, a patient stabilised to receive a daily dose of 8 mg buprenorphine may be given 16 mg buprenorphine on alternate days, with no dose on the intervening days. In some patients, after a satisfactory stabilisation has been achieved, the frequency of dosing may be decreased to 3 times a week (for example on Monday, Wednesday and Friday).
The dose on Monday and Wednesday should be twice the individually titrated daily dose, and the dose on Friday should be three times the individually titrated daily dose, with no dose on the 4 intervening days. However, the dose given on any one day should not exceed 24 mg buprenorphine.
Patients requiring a titrated daily dose superior to 8 mg buprenorphine /day may not find this regimen adequate. Reducing dosage and stopping treatment (medical taper) When clinical evaluation and the will of the patient lead to consider treatment discontinuation, it must be achieved with caution.
The decision to discontinue therapy with buprenorphine after a period of maintenance or brief stabilisation should be made as part of a comprehensive treatment plan. To avoid withdrawal symptoms and potential relapse to illicit drug use, the buprenorphine dose may be progressively decreased over time in favourable cases until treatment can be discontinued.
After a satisfactory period of stabilisation has been achieved, if the patient agrees, the dosage of buprenorphine may be reduced gradually; in some favourable cases, treatment may be discontinued. 4 mg, 4 mg, 6 mg and 8 mg, respectively, allows for a downward titration of dosage but alternative buprenorphine formulations may be needed.
Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse. 4 mg, 4 mg, 6 mg and 8 mg were shown to be similar to the respective dosage strengths of Subutex® buprenorphine sublingual tablets.
If switching between film and sublingual tablets, the patient should nevertheless be monitored in case a need to readjust the dose occurs. Interchangeability with other buprenorphine medicinal products (apart from sublingual tablets) has not been studied.
Dose adjustments may be necessary when switching between medicinal products. Patients should be monitored for overdose, withdrawal or other indications of underdosing. Special populations Elderly The safety and efficacy of buprenorphine in elderly patients over 65 years of age have not been established.
No recommendation on posology can be made. […]
The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists. 6). Hypersensitivity reactions The most common signs and symptoms of hypersensitivity include rashes, urticaria and pruritus. Cases of bronchospasm, respiratory depression, angioedema and anaphylactic shock have been reported.
4). 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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5) or when buprenorphine was not used according to the prescribing information. Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol or other opioids. If buprenorphine is administered to some non-opioid dependent individuals, who are not tolerant to the effects of opioids, potentially fatal respiratory depression may occur.
g. chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis (curvature of spine leading to potential shortness of breath)). Patients with the physical and/or pharmacological risk factors above should be monitored, and dose reduction may be considered.
Buprenorphine may cause severe, possibly fatal, respiratory depression in children and nondependent persons in case of accidental or deliberate ingestion. Patients must be warned to store the sachet safely, to never open the sachet in advance, to keep them out of the reach of children and other household members, and not to use this medicinal product in front of children.
An emergency unit should be contacted immediately in case of accidental ingestion or suspicion of ingestion. 7). Risk from concomitant use of sedative medicinal products such as benzodiazepines, gabapentinoids or related medicinal products.
Concomitant use of buprenorphine and sedative medicinal products such as benzodiazepines, gabapentinoids 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 of the sedative medicines 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). Tolerance and opioid use disorder (abuse and dependence) 7 Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as buprenorphine neuraxpharm Abuse or intentional misuse of buprenorphine neuraxpharm may result in overdose and/or death.
g. major depression, anxiety and personality disorders). 2). g. too early requests for refills). This includes the review of concomitant opioids and psychoactive drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Serotonin syndrome Concomitant administration of buprenorphine and other serotonergic agents, such as MAO inhibitors, selective serotonin re-uptake […]