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ADDNOK is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment
Verbatim from this product's MHRA label. Tap a section to expand.
Adults:
Treatment with Addnok sublingual tablets is intended for use in adults who have agreed to be treated for addiction to opioids. Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction.
When treatment with Addnok is initiated, the physician should be aware of the partial agonist profile of the buprenorphine molecule. Buprenorphine binds to μ and κ opioid receptors and may trigger withdrawal symptoms in opioid-dependent patients.
Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. 5) and/or have existing liver dysfunction are at risk of accelerated liver injury. 4). Administration of Addnok is sublingual.
The physician must advise the patient that the sublingual route is the only effective and safe route of administration for this medicinal product. The sublingual tablet is to be placed under the tongue until dissolved, which usually occurs within 5 to 10 minutes.
The tablet should not be swallowed, crushed or chewed. 8 to 4mg administered as a single daily dose. Opioid-dependent drug addicts who have not undergone phaseout: one dose of Addnok sublingual tablet(s) administered sublingually at least 6 hours after the last dose of opioid, or when the first signs of withdrawal appear.
Patients receiving methadone: before starting treatment with Addnok, the dose of methadone should be reduced to a maximum of 30mg/day. Addnok may trigger symptoms of withdrawal in patients treated with methadone.
Dosage adjustment and maintenance:
The dose of Addnok should be increased progressively according to the clinical effect of the individual patient, 16mg daily is often sufficient. The maximum daily dose should not exceed 24mg. Especially during initiation of treatment, daily dispensing of buprenorphine is recommended.
After stabilisation has been achieved, patients considered trustworthy may be given a supply of the drug sufficient for several days of treatment. Furthermore local requirements should be followed with regard to dispensing.
Dosage reduction and termination of treatment:
The occurrence of undesirable effects depends on the patient’s tolerance threshold, which is higher in drug adapted patients than in the general population. 000) Immune system disorders Angioneurotic oedema, anaphylactic shock. 4 In patients with marked drug dependence, buprenorphine may initially produce an antagonist effect similar to that associated with naloxone.
4). Spontaneous abortion has been reported with buprenorphine. 6). A neonatal abstinence syndrome has been reported among newborns of women who have received buprenorphine during pregnancy. The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.
6).
Warnings Addnok sublingual tablets are recommended only for treatment of opioid drug dependence. National requirements should be followed with regard to dispensing. Discontinuation of treatment may cause withdrawal symptoms that may be delayed.
Due to the lack of data in adolescents (age 15 - <18), buprenorphine should be used only with caution in this age group. Patients should be closely monitored during the switching period from methadone to buprenorphine since withdrawal symptoms have been reported.
g. iv. administration), particularly at the initiation of treatment.
Diversion:
Diversion refers to the introduction of Addnok into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies. This diversion may lead to new addicts using Addnok as the primary drug of abuse with the risk of overdose, spread of blood borne viral infections, respiratory depression and hepatic injury.
The physician should consider the risk of diversion of buprenorphine into the illicit market before prescribing buprenorphine. The risk of overdose or treatment dropout is greater if the patient is under treated with buprenorphine and continues to self-medicate withdrawal symptoms with opioids , alcohol or other sedatives and hypnotics (in particular benzodiazepines).
Buprenorphine is a partial agonist at the μ opiate receptor and chronic administration produces dependence of the opioid type. 2). Conversely, withdrawal symptoms may also be associated with suboptimal dosing. 5). Animal studies, as well as clinical experience, have demonstrated that buprenorphine may cause dependence but at a lower level than morphine.
Discontinuation of treatment may result in a withdrawal syndrome that may be delayed. Buprenorphine can cause orthostatic hypotension. Buprenorphine is an opioid and may mask pain as a disease symptom. Medicinal products that inhibit the enzyme CYP3A4 may cause increased concentrations of buprenorphine.
Hypersensitivity to the active substance or to any of the excipients 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.
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After a satisfactory period of stabilisation has been achieved, the dosage may be reduced gradually to a lower maintenance dose. When deemed appropriate, treatment may be discontinued. 4mg, 2mg and 8mg, allows for a downward titration of the dosage.
Patients should be monitored following termination of buprenorphine treatment because of the potential for relapse.
Elderly:
The same dosage as adults Children (under the age of 18 years): Addnok should not be used for treatment of children under the age of 18 years, as experience with treatment of children is insufficient. For further information, see the national guidelines for buprenorphine treatment.
A reduction of the buprenorphine dose may be necessary. 5). Concomitant use of monoamine oxidase inhibitors (MAOI) can increase the efficacy of opioids based on experience with morphine. Due to the lack of data in adolescent age 15 - <18, Addnok should not be used in this age group.
5), or when buprenorphine was not used as prescribed. Cases of death have been reported in connection with concomitant administration of buprenorphine and other medical products that causes central nervous system depression such as alcohol or other opioids.
Hepatitis, hepatic disorders:
Cases of acute hepatic injury have been reported in opioid-dependent addicts both in clinical trials and in post-marketing adverse reports. The spectrum of abnormalities ranges from transient asymptomatic elevations in hepatic transaminases to case reports of cytolytic hepatitis, hepatic failure, hepatic necrosis, hepatorenal syndrome and hepatic encephalopathy and death.
In many cases the presence of pre-existing liver enzyme abnormalities, genetic disease, infection with hepatitis B or hepatitis C virus concomitant use of other potentially hepatoxic medicines, alcohol abuse, anorexia, and on-going injecting drug use may have a causative or contributory role.
These supplemental factors should be considered before prescribing Addnok and during treatment. If a hepatic event is suspected, further biological and aetiological investigation is required. Depending upon the findings, the medicinal product may be discontinued cautiously in order to prevent withdrawal symptoms and to prevent a return to illicit drug use.
If the treatment is continued, hepatic function should be monitored closely. Paediatric use No data is available in children less than 15 years of age; therefore, buprenorphine should not be used in children under the age of 15. 5) may increase the concentration of buprenorphine, it is recommended that patients, already treated with inhibitors of CYP3A4, should have their dosage of Addnok adjusted carefully since a reduced dose may be sufficient in these patients.
Addnok sublingual tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Serotonin syndrome Concomitant administration of Addnok sublingual tablets and other serotonergic agents, […]